Document No: SADCAS PM 01 Issue No: 14
Prepared by: SADCAS CEO
Approved by: SADCAS Board of Directors
Approval Date: 2017-08-11
Effective Date: 2017-08-11
SADCAS POLICY
MANUAL
Document No: SADCAS PM 01 Issue No: 14
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Table of Contents
1 PURPOSE AND SCOPE............................................................................................................................. 4
2. SADCAS POLICY STATEMENT .................................................................................................................. 5
3. SADCAS BASIC ACTIVITY AND ORGANIZATION ...................................................................................... 6
3.1 Background ............................................................................................................................... 6
3.2 SADCAS Mission ........................................................................................................................ 6
3.3 SADCAS Objectives .................................................................................................................... 6
3.4 SADCAS Vision ........................................................................................................................... 7
3.5 SADCAS Services ........................................................................................................................ 7
3.6 Authority and Legal Responsibility ........................................................................................... 8
3.7 Organization and Governance .................................................................................................. 8
3.8 Responsibilities and Duties ..................................................................................................... 11
3.9 Company Values...................................................................................................................... 14
3.10 Liability and Funding ............................................................................................................... 16
3.11 Interested Parties .................................................................................................................... 16
3.12 Related Bodies ........................................................................................................................ 17
3.13 SADCAS Publications and Communication ............................................................................. 18
3.14 Regional and International Connections ................................................................................. 19
4. SADCAS QUALITY MANAGEMENT SYSTEM .......................................................................................... 20
4.1 Responsibility for Quality ........................................................................................................ 20
4.2 Documentation of SADCAS Quality Management System ..................................................... 20
4.3 Records.................................................................................................................................... 22
4.4 Nonconformities and Corrective Actions ................................................................................ 22
4.5 Preventive Actions .................................................................................................................. 22
4.6 Internal Audits ......................................................................................................................... 23
4.7 Management Review .............................................................................................................. 23
4.8 Customer Feedback ................................................................................................................ 24
5. HUMAN RESOURCES ............................................................................................................................ 25
5.1 Personnel Associated with SADCAS ........................................................................................ 25
5.2 Personnel Involved in the Accreditation Process ................................................................... 25
5.3 Monitoring ............................................................................................................................. 26
5.4 Personnel Records .................................................................................................................. 26
6. ACCREDITATION PROCESS ................................................................................................................... 27
6.1 General Requirements for Accreditation ................................................................................ 27
6.2 Accreditation Criteria .............................................................................................................. 27
6.3 The Accreditation Process ....................................................................................................... 28
6.4 Assessment Report ................................................................................................................. 30
6.5 Accreditation Decision ............................................................................................................ 31
6.6 Conditions under which SADCAS Certificates are Issued ........................................................ 31
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6.7 Confidentiality ......................................................................................................................... 32
6.8 Transfer of Accreditation ........................................................................................................ 33
6.9 Suspension and Termination of Accreditation........................................................................ 33
6.10 Subcontracting of Accreditation Work ................................................................................... 33
6.11 Appeals .................................................................................................................................... 34
6.12 Records on Conformity Assessment Bodies ........................................................................... 34
6.13 Proficiency Testing/Inter laboratory Comparisons for Laboratories ...................................... 34
6.14 Traceability .............................................................................................................................. 35
6.15 Responsibilities of SADCAS and the Conformity Assessment Body ........................................ 37
6.16 Cross Frontier Accreditation ................................................................................................... 39
APPENDIX A - CROSS REFERENCING ISO/IEC 17011 CLAUSES, SADCAS POLICY MANUAL AND OTHER SADCAS
DOCUMENTS ............................................................................................................................. 40
APPENDIX B – AMENDMENT RECORD .............................................................................................................. 59
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1. PURPOSE AND SCOPE
This document gives an overview of the organization of SADCAS and describes the key elements of
SADCAS quality management system. All SADCAS personnel are required to be fully aware of the
requirements of SADCAS quality management system and follow it at all times.
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2. SADCAS POLICY STATEMENT
The Southern African Development Community Accreditation Service (SADCAS), a subsidiarity
institution of the Southern African Development Community (SADC) is a multi-economy
accreditation body established in terms of Article 15 B of the Technical Barriers to Trade
(TBT) Annex to the SADC Protocol on Trade. It is a non-profit limited company incorporated
under the Botswana Companies Act Ch. 42.01.
SADCAS objective is to provide accreditation services to calibration and testing laboratories,
certification bodies (management systems /product/ personnel) and inspection bodies operating in
those SADC Member States who do not have their own national accreditation bodies. The
accreditation services are aimed at supporting regional and international trade, enhancing the
protection of consumers and the environment and improving the competitiveness of SADC products
and services.
SADCAS is committed to providing credible, cost-effective value-adding accreditation services.
In order to meet its objectives and commitments, SADCAS:
� Implements a quality management system in compliance with the requirements of ISO/IEC
17011 and of AFRAC, SADCA, ILAC and IAF for the purpose of Mutual Recognition Arrangements
(MRA)/ Multilateral Agreements (MLA).
� Shall ensure availability of competent staff, assessors and experts for confidence in accredited
services.
� Uphold the following core values in service delivery:
� Impartiality
� Transparency
� Non-discrimination
� Integrity
� Innovation
� Diversity
� Periodically reviews its management system for continual improvement.
Since quality is everyone’s responsibility, SADCAS Top Management shall ensure that this policy is
communicated, understood, implemented and maintained at all levels of the organization and by
all concerned.
Signed:
Date: 2017-05-06
Maureen P Mutasa
SADCAS Chief Executive Officer
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3. SADCAS BASIC ACTIVITY AND ORGANIZATION
3.1 Background
The Southern African Development Community Accreditation Service (SADCAS) is a multi-economy
accreditation body incorporated in Botswana under the Botswana Companies Act Ch. 42:01 as a
non-profit limited company. SADCAS is established in terms of Article 15 B of the Technical
Barriers to Trade (TBT) Annex to the SADC Protocol on Trade). SADCAS is recognized by the
SADC Council of Ministers as a subsidiarity organization of SADC. The relationship between SADCAS
and SADC is formalized through a memorandum of understanding on general cooperation.
SADCAS is responsible for the accreditation of laboratories (calibration/testing/medical),
certification bodies (management systems/product/personnel) and inspection bodies to relevant
international standards and the respective International Laboratory Accreditation Cooperation
(ILAC) and International Accreditation Forum (IAF) interpretations thereof. The SADCAS
Memorandum of Association allows SADCAS to expand its scope of work as required.
3.2 SADCAS Mission
SADCAS mission is to provide credible, cost effective accreditation services for SADC Member States
aimed at supporting trade enhance the protection of consumers and the environment and improve
the competitiveness of SADC products and services in both the voluntary and regulatory areas.
3.3 SADCAS Objectives
SADCAS Objectives are to:
� Provide accreditation services to SADC Member States that do not have a national accreditation
body for their laboratories, certification and inspection bodies.
� Provide accreditation services to SADC Member States whose national accreditation body only
service a limited scope of accreditation.
� Provide international recognition of conformity assessment results produced by conformity
assessment service providers accredited by SADCAS.
� Provide accreditation services that promote, develop and maintain good regulatory practices.
� Provide an opportunity for SADC Member States to participate in multilateral arrangements for
recognition of conformity assessment results.
� Provide a database of all conformity assessment bodies accredited by SADCAS.
� Provide accreditation expertise, qualify register and use of experts from amongst SADC Member
States.
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� Facilitate a National Accreditation Focal Point for those SADC Member States using SADCAS’
services.
SADCAS shall comply with the requirements of ISO/IEC 17011 and the relevant interpretation
documents and/or other standards as appropriate.
3.4 SADCAS Vision
SADCAS’ vision is to be a sustainable accreditation body at the cutting edge of credible accreditation
service delivery.
3.5 SADCAS Services
SADCAS provides accreditation services and training in accreditation associated activities.
3.5.1 Accreditation services
SADCAS offers accreditation programmes for:
� Calibration/testing laboratories in accordance with ISO/IEC 17025;
� Medical laboratories in accordance with ISO 15189;
� Management systems certification bodies in accordance with ISO/IEC 17021-1;
� Product certification bodies in accordance with ISO/IEC 17065;
� Personnel certification bodies in accordance with ISO/IEC 17024; and
� Inspection bodies in accordance with ISO/IEC 17020.
SADCAS will broaden its scope of accreditation as needs arise. SADCAS has in a place procedure for
the development of new accreditation programmes.
References:
1. SADCAS AP 16: Procedure for the Development of New Accreditation Programmes
3.5.2 Training services
SADCAS provides external training services in accreditation associated activities. The objective of
the training programmes is to create awareness on the benefits and importance of accreditation
and to promote an understanding of the key accreditation standards’ requirements.
In order not to compromise its impartiality and status in training service delivery, SADCAS does not
give specific advice for the development of an organization’s operations. Furthermore the training
courses delivered or facilitated by SADCAS are not a precondition of accreditation neither do they
guarantee accreditation by SADCAS.
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3.6 Authority and Legal Responsibility
The objects, powers and rules for the operation of SADCAS are set out in the Memorandum and
Articles of Association lodged with The Registrar of Companies (Botswana). These documents also
include the terms of appointment and terms of reference of the members and Board of Directors.
The Company Secretary retains the current version of the Articles and Memorandum of Association.
SADCAS is recognized by the SADC Council of Ministers as a subsidiarity organization of SADC hence
an agency of SADC. SADCAS has signed a Memorandum of Understanding (MoU) with SADC. This
MoU serves as the basis for recognition of SADCAS by SADC Member States as a multi-economy
accreditation body. The Memorandum of Understanding is reviewed from time to time to take into
account any changes that may develop.
As a non-profit company incorporated in Botswana, SADCAS shall ensure compliance with the
Botswana Companies Act (Companies Act 2003) and any other Act or Regulation that may be
applicable to SADCAS and accreditation.
References:
1. Certificate of Incorporation
2. Record of SADC Council of Ministers meeting held in August 2007
3. TBT Annex to the SADC Protocol on Trade
4. Memorandum and Articles of Association of the SADCAS
5. SADCAS/SADC Memorandum of Understanding
6. Botswana Companies Act, 2003 Act No. 32 of 2004
Note: These documents are available from SADCAS upon request.
3.7 Organization and Governance
3.7.1 SADCAS general assembly
SADCAS is a non-profit company limited by guarantee, having members instead of shareholders.
The members of the company consist of:
� Subscribers to the Memorandum and Articles of Association;
� Members of the Board of Directors;
� Appointed representatives of National Accreditation Focal Points in each SADC Member State
using the services of SADCAS;
� Individuals or organizations who apply for admission as members of SADCAS.
References:
1. Register of SADCAS Members
2. Register of SADCAS Board Members
3. Register of NAFP Members
Note: These documents are available from SADCAS upon request.
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3.7.2 SADCAS governance
SADCAS is governed by the General Assembly. Drawn out of the General Assembly is the Board of
Directors which oversees the running of SADCAS and fulfils any function that the SADCAS General
Assembly may delegate to it. The Board is responsible for the appointment of a Chief Executive
Officer who is responsible for the day to day functioning of SADCAS and is an ex-officio member of
the Board of Directors.
References:
1. SADCAS Articles and Memorandum of Association
2. BP 01 Terms of Reference of the Finance, Risk and Audit Committee of the SADCAS
Board of Directors
3. BP 02 Terms of Reference of the Human Resources and Remuneration Committee
of the SADCAS Board of Directors
4. BP 07: Part 1: SADCAS Board of Directors Skills and Expertise Requirements
5. BP 07: Part 2: SADCAS Board of Directors Matrix
3.7.3 SADCAS staff structure
SADCAS is composed of three functional units. The technical unit is responsible for the overall
management of the accreditation process. The corporate services unit provides support services to
internal and external business interests and is responsible for ICT, marketing and public relations,
business development and administration of training services. The finance and administration unit
is responsible for financial management, human resources management and general administration
of the company. Refer to Figure 1.
3.7.4 National Accreditation Focal Points
National Accreditation Focal Points are based in those countries using the services of SADCAS. The
National Accreditation Focal Points serve as the administrative links between SADCAS and
clients/potential clients in Member States. The National Accreditation Focal Points are responsible
for the administration, coordination, promotion and marketing of accreditation in their respective
countries. Although National Accreditation Focal Points are appointed by and report to their
respective governments, they are also accountable to the Chief Executive Officer of SADCAS for all
accreditation activities. Refer to Figure 1.
Reference: Register of NAFP Members
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Figure 1 – SADCAS Organizational Structure
General Assembly
Board of Directors Finance Risk and Audit Committee
Appeal Committee
Human Resources and Remuneration
Committee
CEO PA to CEO
Quality
Manager
Corporate Services
Manager
SADC Member
States National
Governments.
Comms.
& PR
Officer
ICT
Officer Training
Admin.
Pool of Trainers
NAFPs
Business
Dev
Officer
Finance & Admin
Manager
Manager
Finance
Officer
HR
Officer
Admin Assistant
Cleaner/Messenger
Programme
Coordinator
IBAP &
CBAP- Prod
CBAP - MS
Programme
Coordinator
MLAP, GLP, GCP
and
Pharmaceuticals
Programme
Coordinator
TLAP, PT &
VLAP
Programme
Coordinator
CLAP &
Verification
Technical Manager
Manager
Pool of Assessors
Accreditation Administrators
AAC
AC
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3.7.5 Committees
3.7.5.1 Accreditation Approvals Committee
The SADCAS Accreditation Approvals Committee is responsible for making decisions on granting,
denying or extending, suspending and withdrawal of accreditation. The Accreditation Approvals
Committee shall consist of not less than 2 members, one of whom shall be the SADCAS Chief
Executive Officer. For decisions arising from surveillance assessments, extension to new scopes
and additional signatories, the AAC shall consist of at least one member. Any other specialized
technical expert shall be invited to serve on the AAC as deemed necessary.
References:
1. SADCAS AP 14: Accreditation Decision Making Process
2. List of SADCAS Accreditation Approvals Committee Members
3.7.5.2 Advisory committees
SADCAS has other Committees to support the technical credibility of accreditation activities. These
Committees cover the main disciplines and sectors within which SADCAS operates.
References:
1. SADCAS AP 11: Terms of Reference, Registration and Responsibilities of Advisory
Committees
2. List of SADCAS Advisory Committee Members
3.7.5.3 Appeals committee
Appeals Committee shall be established by the Board to handle valid appeals on accreditation
decisions.
References:
1. SADCAS AP 08: Customer Feedback
2. SADCAS BP 05: Terms of Reference of the Appeals Committee
3.8 Responsibilities and Duties
3.8.1 The Chief Executive Officer
The Chief Executive Officer is responsible to the Board of Directors for the development, direction
and management of SADCAS in accordance with the Strategic/Business Plan and Annual
Implementation Plans objectives. In his/her absence the Chief Executive Officer shall appoint an
acting Chief Executive Officer. The appointment shall be formalized in a memo and distributed to
relevant persons within SADCAS. Heads of units are responsible for SADCAS activities within their
own units. The responsibilities and duties of the Chief Executive Officer are outlined in a job
description duly signed by the Chief Executive Officer and the Board of Directors.
Reference: Job description - Chief Executive Officer
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3.8.2 Technical Manager
The Technical Manager is responsible for the overall management of the accreditation and
assessment services. The responsibilities and duties of the Technical Manager are outlined in a job
description duly signed by the Technical Manager and the Chief Executive Officer as the immediate
supervisor.
Reference: Job description - Technical Manager
3.8.3 Programme Coordinator
The Programme Coordinator is responsible for ensuring that assessments for the assigned
accreditation programme are conducted in accordance with the relevant standards and SADCAS
requirements and for implementing action plans from SADCAS Strategic and Annual
Implementation plans in conjunction with the Technical Manager.
Reference: Job description – Programme Coordinator
3.8.4 Accreditation Administrator
The Accreditation Administrator is responsible for overseeing all administrative activities and
assessment processes. The responsibilities and duties of the Accreditation Administrator are
outlined in a job description duly signed by the Accreditation Administrator and the Programme
Coordinator as immediate supervisor.
Reference: Job description - Accreditation Administrator
3.8.5 Finance and Administration Manager
The Finance and Administration Manager is responsible for maintaining books of accounts and
other records relating to accounting transactions of the company, budgeting and budgetary
control and preparation of monthly and financial statements. The Finance and Administration
Manager shall ascertain that financial statements are true and fair and in accordance with
International Financial Reporting Standards and in a manner required by the donor. The Finance
and Administration Manager shall report to the Chief Executive Officer. The responsibilities and
duties of the Finance and Administration Manager are outlined in a job description duly signed by
the Finance and Administration Manager and the Chief Executive Officer as the immediate
supervisor.
Reference: Job description - Finance and Administration Manager
3.8.6 Administrative Assistant
The Administrative Assistant is responsible for providing administrative support to staff and
assumes general office administration duties.
Reference: Job description – Administrative Assistant
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3.8.7 National Accreditation Focal Points
The National Accreditation Focal Points who are appointed by their respective SADC Member
States’ governments are responsible for the administration, coordination, promotion and
marketing of accreditation in their respective countries. National Accreditation Focal Points serve
as the administrative link between SADCAS and clients/prospective clients in Member States. The
responsibilities and duties of National Accreditation Focal Points are outlined in a job description
duly signed by the National Accreditation Focal Points respective immediate supervisors and the
SADCAS Chief Executive Officer and elaborated in the National Accreditation Focal Points (NAFP)
handbook.
References:
1. Job descriptions National Accreditation Focal Points
2. National Accreditation Focal Points (NAFP) Handbook
3.8.8 Assessors/technical experts
Assessors are experts from the public and private sectors as well as from technical
institutions/associations in the SADC region who have been trained, qualified and registered as
assessors by SADCAS. The SADCAS’ assessors are responsible for undertaking accreditation
assessments on behalf of SADCAS on a contracted basis. Assessors trained and qualified by other
accreditation bodies and evaluated for competence can also undertake assessments on behalf of
SADCAS. Assessment teams consist of a Lead Assessor and an appropriate number of Technical
Assessors to cover the scope of accreditation. The Lead Assessor is responsible for organizing,
directing and conducting assessments, report findings and to evaluate corrective action. During
the assessment the Lead Assessor is also responsible for assessing the quality management system
of the applicant as well as undertaking technical assessment within his/her field of expertise. The
Technical Assessors are responsible for advising the Lead Assessor on specialist technical matters
relating to the applicant’s scope of accreditation. SADCAS may use technical experts on a
subcontracted basis to assist in the assessment of an applicant or accredited facility. A SADCAS
assessor always accompanies experts on assessment visits. Experts may also be contracted to
provide expert opinion on any aspect of activities being assessed.
SADCAS keeps a register of assessors and database of technical experts.
Reference:
1. SADCAS AP 10: Contracting of Assessment Personnel
2. SADCAS F 49: Independent Contractor Agreement between SADCAS and Assessor/
Expert
3. SADCAS F 53: SADCAS Register of Assessors/Experts
3.8.9 Quality Manager
The SADCAS Quality Manager is responsible for ensuring amongst other duties that SADCAS
complies with the requirements of ISO/IEC 17011 and other relevant criteria in order to achieve
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and maintain international recognition. The responsibilities and duties of the Quality Manager are
outlined in a job description duly signed by the Quality Manager and the Chief Executive Officer as
the immediate supervisor.
Reference: Job description - Quality Manager
Quality is everybody’s business in SADCAS. Therefore it is the responsibility of each SADCAS staff
member to ensure that SADCAS policies and procedures as contained in the SADCAS quality
management system are adhered to at all times. Each staff member shall read and understand
the Quality Management System Manual which is made available to all staff at all times.
3.8.10 Outsourcing of functions
SADCAS outsources various functions including IT and website maintenance, legal and litigation,
human resources and marketing and communication. Subcontractors who may have access to
confidential information and where deemed necessary shall sign confidentiality statements from
SADCAS and the confidentiality statements shall be maintained in a file by the Accreditation
Administrator.
Reference: SADCAS F 45 b: Nondisclosure/Confidentiality Statement – Subcontractors
(Other than Assessors/Experts)
3.9 Company Values
In its service delivery, SADCAS upholds the following 6 core values:
Impartiality We are organized and operate so as to safeguard objectivity and impartiality
of our services.
Transparency We are dedicated to provide complete transparency in our work by
communicating effectively with our clients.
Non-discrimination We treat our clients fairly and in an equitable manner.
Integrity We act with honesty and integrity.
Innovation We generate new ideas and utilize creative approaches to problems for
continuous improvement.
Diversity We respect the diversity of our clients and ensure balance of interest in
representation.
SADCAS value proposition is to deliver confidence, assure competency and to guarantee quality.
In general SADCAS Committees shall have a balance of interest, be impartial and have no conflict
of interest and shall be competent. SADCAS Committees shall declare all possible conflicts of
interest. The SADCAS Board shall ensure that SADCAS company values are addressed in policies
and procedures and upheld in operations and service delivery. Applicants and existing clients shall
all be treated fairly and in an equitable manner.
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SADCAS operates an impartial complaints and appeals procedure open to all stakeholders. Persons
engaged in work for SADCAS are required to provide assurance that they are not under undesirable
pressures of any kind (financial, commercial, personal etc.) that affect their judgment, quality or
results of their work. Any staff member who is found not to comply with policies and procedures
shall be disciplined accordingly. Contract workers found not uphold company values and
contravene with policies and procedures in place to address these issues shall cease to work for
SADCAS immediately. Staff and contract workers are encouraged to advise the Chief Executive
Officer of any individual or client who approaches them financially or otherwise to operate in a
manner that contravenes SADCAS policies and procedures.
SADCAS permanent staff contracted assessors/technical experts are required to sign a contract
with SADCAS that specifies their agreement to confidentiality, impartiality and non - conflict of
interest. Copies of signed contracts shall be kept at the SADCAS office. In addition, each
assessor/expert shall sign a non - disclosure/confidentiality statement indicating any relationship
they may have or have had with the organization/facility being assessed. SADCAS
Board/Committee members and National Accreditation Focal Points shall sign a non -
disclosure/confidentiality statement upon appointment. Copies of confidentiality and conflict of
interest are kept at SADCAS office.
SADCAS neither provides consultancy services to any organization that it offers accreditation nor
to other developing accreditation bodies. SADCAS shall not offer or provide any conformity
assessment services that conformity assessment bodies perform.
The objects, powers, and rules for the operation of SADCAS are set out in the Memorandum and
Articles of Association lodged with the Registrar of Companies (Botswana). SADCAS is recognized
by the SADC Council of Ministers as a subsidiarity organization of SADC hence an agency of SADC.
A Memorandum of Understanding (MoU) between SADC and SADCAS serves as the basis for the
recognition of SADCAS by SADC Member States, as a multi-economy accreditation body. SADCAS
is governed by a General Assembly out of which is elected a Board of Directors. The Board of
Directors keeps activities of SADCAS under review and fulfils any function that the SADCAS General
Assembly may delegate to it. The Board is independent.
SADCAS has interactions with other organizations within and outside the region. None of these
relationships have any implications on SADCAS’ ability to meet the requirement for impartiality.
Refer to Table 1
References:
1. SADCAS F 27: SADCAS Gift Register
2. SADCAS F 45 a: Nondisclosure/Confidentiality Statement – Assessors/Experts
3. SADCAS F 45 b: Nondisclosure/Confidentiality Statement – Subcontractors (Other than
Assessors/Experts)
4. SADCAS F 45 c: Nondisclosure/Confidentiality Statement – SADCAS Staff members
5. SADCAS F 45 d: Nondisclosure/Confidentiality Statement – SADCAS Board/Committee
members
6. SADCAS F 45 e: Nondisclosure/Confidentiality Statement – National Accreditation
Focal Points (NAFPs)
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7. SADCAS F 49: Independent Contractor Agreement between SADCAS and Assessors/
Experts
8. SADCAS F 50: Employment Agreement
9. SADCAS F 74: Independent Contractor Agreement Between SADCAS and Trainer
3.10 Liability and Funding
3.10.1 Liability
SADCAS does not accept liability for possible errors made by accredited facilities. All accredited
facilities are required to absolve SADCAS of any such liabilities by signing the appropriate section
of SADCAS application form for accreditation and on the accreditation agreement. Liability is
limited to SADCAS assets and staff (both permanent and contract), assessors/experts, trainers and
Board of Directors for which SADCAS has an insurance for general liability and professional liability.
3.10.2 Funding
SADCAS is a non-profit limited company. The establishment and operationalization of SADCAS was
funded by the Norwegian Government through the Norwegian Agency for Development
Cooperation (NORAD).SADCAS generates its own income from accreditation services and training
on accreditation associated activities. SADCAS operational budget deficit is funded by the
Governments of SADC Member States that are serviced by SADCAS.
SADCAS accreditation services are priced fairly and equitably to recover all direct and indirect costs
associated with the service. All costs are based on the financial rates of the Botswana Pula.
SADCAS shall make publicly available and update regularly fees relating to its services. The SADCAS
Strategic/Business Plan and Annual Implementation Plans/Budgets are approved by the Board and
are set to cover costs and to enable SADCAS to secure a viable long-term future, meeting its future
obligations. Financial reports are provided to the SADCAS Board at each Board meeting for
monitoring purposes. SADCAS Strategic/Business Plan and Annual Implementation Plans also set
out SADCAS goals and objectives in service delivery.
References:
1. SADCAS Strategic/Business Plan
2. SADCAS Annual Budgets
3. SADCAS Annual Implementation Plans
4. SADCAS AP 02: SADCAS Service Fees
3.11 Interested Parties
Interested parties are defined in ISO/IEC 17011 as parties with a direct or indirect interest in
accreditation. SADCAS ensures that interested parties participate in its processes through
membership to General Assembly, Board of Directors and Committees. SADCAS ensures that
policies and procedures are communicated to interested parties and are also available on the
SADCAS website.
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3.12 Related Bodies
Relationships with related bodies either through common reporting or twinning partnership
arrangements are listed in Table 1.
Table 1 - SADCAS Related Bodies
Related Body
Type Relationship Risk Risk Mitigation
South African
National
Accreditation
System (SANAS)
National
Accreditation Body
Member of SADC
Cooperation in
Accreditation. SADCA is a
regional cooperation of
government recognized
accreditation bodies of
Member States where such
a body does not exist an
institution nominated by the
Minister responsible for
industry and trade
Twinning Partner
Perceived
competition
between
SADCAS and
SANAS
SADCAS to accredit
conformity assessment
bodies operating in SADC
Member States without
national accreditation
bodies i.e. 13 countries
excluding South Africa and
Mauritius
Mauritius
Accreditation
Service
(MAURITAS)
National
Accreditation Body
Member of SADC
Cooperation in
Accreditation.
Perceived
competition
between
SADCAS and
MAURITAS
SADCAS to accredit
conformity assessment
bodies operating in SADC
Member states without
national accreditation
bodies i.e. 13 countries
excluding South Africa and
Mauritius
National
Accreditation
Focal Points
National
Accreditation Focal
Point is housed in a
National Standards
Bodies that offer
conformity
assessment services
NAFPs established by
respective Member States
Governments serve as the
administrative link between
SADCAS and clients and
potential clients in Member
States
Perceived
preferential
treatment in
granting
accreditation
NAFPs are not involved in
the accreditation process.
All SADCAS decisions on
accreditations are made
by an independent
decision making process
SADC
Cooperation in
Measurement
Traceability
(SADCMET)
SADCMET is a
regional
cooperation of
National Metrology
Institutes in the
region.
SADCMET is one of the 7
structures of the SADC
infrastructure for
Standardization, Quality
Assurance, Accreditation
and Metrology
Perceived
preferential
treatment in
granting
accreditation
All SADCAS decisions on
accreditations are made
by an independent
decision making process
SADC
Cooperation in
Legal Metrology
(SADCMEL)
SADCMEL is a
regional
cooperation of legal
national metrology
Institutes in the
region.
SADCMEL is and is one of
the 7 regional cooperation
structures of the SADC
infrastructure for
Standardization, Quality
Assurance, Accreditation
and Metrology
Perceived
preferential
treatment in
granting
accreditation
All SADCAS decisions on
accreditations are made
by an independent
decision making process
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Related Body
Type Relationship Risk Risk Mitigation
SADCTBT
Stakeholder
Committee
(SADCTBT SC)
SADCTBT SC is a
regional
cooperation of
national delegates
representative of
private sector
organizations and
regulators having
an interest in SQAM
issues
SADCTBT SC is one of the 7
regional cooperation
structures of the SADC
infrastructure for
Standardization, Quality
Assurance, Accreditation
and Metrology
Perceived
preferential
treatment in
granting
accreditation
All SADCAS decisions on
accreditations are made
by an independent
decision making process
SADC Technical
Regulations
Liaison
Committee
(SADCTRLC)
SADCTRLC is a
regional
cooperation of
representatives of
governments
departments of
SADC Member
States who have
the overall
responsibility for
compliance with
WTO TBT
Agreement and TBT
Annex to the SADC
Protocol on Trade
SADCTLRC is and is one of
the 7 regional cooperation
structures of the SADC
infrastructure for
Standardization, Quality
Assurance, Accreditation
and Metrology
Perceived
preferential
treatment in
granting
accreditation
All SADCAS decisions on
accreditations are made
by an independent
decision making process
SADC
Cooperation in
Standardization
(SADCSTAN)
SADCSTAN is a
regional
cooperation of
national standards
bodies in the
region. Typically
Standards bodies in
the region offer
conformity
assessment services
SADCSTAN is and is one of
the 7 regional cooperation
structures of the SADC
infrastructure for
standardization, quality
assurance, accreditation
and metrology
Perceived
preferential
treatment in
granting
accreditation
All SADCAS decisions on
accreditations are made
by an independent
decision making process
3.13 SADCAS Publications and Communication
SADCAS Policy Manual and relevant procedures are freely available to all assessors, SADCAS
accredited organizations and all other interested parties to download from the SADCAS website:
www.sadcas.org. It is the responsibility of users to ensure that they are using up to date
documents by comparing with the contents list on the SADCAS website.
SADCAS makes available the necessary requirements for obtaining and maintaining accreditation.
Information on the assessment process is available on the website as well as from SADCAS office/
National Accreditation Focal Points offices in Member States.
SADCAS disseminates information through various publications including:
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� SADCAS Directories of accredited organizations.
� SADCAS Annual Report.
� SADCAS newsletter “The Pioneer”.
� SADCAS corporate brochures/pamphlets.
� SADCAS reports and position papers.
Copies of SADCAS publications are available from SADCAS office/ NAFP offices/website.
3.14 Regional and International Connections
SADCAS is
� A full member of the International Laboratory Accreditation Cooperation (ILAC).
� An accreditation body member of the International Accreditation Forum (IAF).
� An arrangement member of the African Accreditation Cooperation (AFRAC).
� An ordinary member of SADC Cooperation in Accreditation (SADCA).
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4. SADCAS QUALITY MANAGEMENT SYSTEM
4.1 Responsibility for Quality
4.1.1 Overall responsibility
Quality is everyone’s responsibility within SADCAS. Therefore each person within SADCAS,
assessors and contractors has to read and understand the policies and procedures and ensure that
SADCAS complies with the requirements of the documented management system. The Chief
Executive Officer has the overall responsibility for SADCAS’ management system.
4.1.2 The Quality Manager
The work of establishing and maintaining SADCAS Quality Management System documentation
shall be delegated to the Quality Manager by the Chief Executive Officer.
The Quality Manager shall report to the SADCAS Quality Management Committee on the
performance of the SADCAS management system and shall make suggestions for improvement. The
SADCAS Quality Management Committee shall comprise of all SADCAS staff. The Quality Manager
shall arrange for internal audits. The results of internal audit shall be reviewed as part of the
management review process. The Quality Manager arranges for the SADCAS Quality Management
System review meetings.
4.2 Documentation of the SADCAS Quality Management System
The SADCAS Quality Management System is supported by a number of documents.
4.2.1 Structure of the quality management system manual
All SADCAS quality management system documents are assigned specific identification number and
shall be legible and presented in prescribed format.
The hierarchy of SADCAS documents is given in Table 2.
Table 2 – Hierarchy of SADCAS Documents
Document Type Prefix
SADCAS Policy Manual PM
Strategic and Budget Documents SD
Accreditation Procedural Documents AP
Financial Policies and Procedures FPP
Administrative and Human Resources Policies and Procedures APP
SADCAS Board Policies and Procedures BP
SADCAS Forms F
Advisory Documents AD
Technical Requirements Documents TR
Technical Guidance Documents TG
SADCAS Sample Letters SL
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The SADCAS Quality Management System Manual consists of a Policy Manual, Procedures Manual
and SADCAS forms and other documents.
4.2.1.1 Policy manual
The SADCAS Policy Manual describes the SADCAS Management System which is designed to ensure
SADCAS’ compliance with the requirements of ISO/IEC 17011 and ILAC/IAF guidance/
interpretations thereof and support SADCAS staff and contractors in their work as well as serve as
information to other stakeholders on SADCAS quality management system. SADCAS staff and
contractors shall read, understand, implement and abide with the SADCAS Quality Policy Manual.
4.2.1.2 Procedures manual
SADCAS has a number of procedures that detail the routines to be followed in undertaking SADCAS
work. A list of procedures is found in the procedures manual.
4.2.1.3 SADCAS documents and forms
SADCAS documents and forms are published to provide information to applicants and other
interested parties and to facilitate SADCAS daily work. List of forms and documents are available.
4.2.2 Authorization
Apart from SADCAS Board of Directors’ documents and policy manuals which shall be authorized by
the SADCAS Board, all other documents depending on their type shall be authorized by the Chief
Executive Officer.
4.2.3 Implementation and maintenance
The Chief Executive Officer shall be responsible for ensuring the implementation of the SADCAS
quality management system. The Quality Manager shall, amongst other duties, be responsible for
managing the SADCAS Quality Management System and ensuring that it complies with the
requirements of ISO/IEC 17011 and other relevant criteria in order to achieve and maintain
international recognition.
4.2.4 Distribution
All staff in SADCAS and assessors/ experts shall, whenever amendments or new documents are
issued, be informed by email and in turn they shall acknowledge receipt and confirm that they have
familiarized and understand the document and further commit to implement the document.
SADCAS quality management system documents shall be available to SADCAS staff.
Accredited and applicant conformity assessment bodies shall access updated versions of relevant
documents and of new documents from the SADCAS website www.sadcas.org.
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4.2.5 Amendments
All amendments to the SADCAS Policy Manual, procedures manuals, documents and forms shall be
authorized. Information about amendments is issued by the Accreditation Administrator and
distributed electronically. When a document or section of the Quality Policy Manual is amended
the “issue number” effective date and approval date shall change accordingly.
Reference: SADCAS AP 03: Document Control
4.3 Records
SADCAS maintains all appropriate records as required by ISO/IEC 17011. Records maintained
include amongst others, personnel and facilities of accredited/applicant organizations, checklist and
assessment reports, applications for accreditations and extensions, committee deliberations,
accreditation decisions, accreditation fees invoices/receipts, SADCAS staff/assessor/experts
records etc. These records shall be kept at the SADCAS office. SADCAS ensures that all accredited/
applicant organization’s records are held in a confidential manner and access is controlled. All
records have to be signed out and back to the filing system. Access to files is controlled by the
respective record keeper. Files may not be removed from SADCAS office under any circumstances.
In the unlikely event that a file needs to be removed then a copy of the contents of the file has to
be made in full. Assessors may be given photocopies of sections of the file as required. After use
the assessor shall destroy copies of the records. System back-up for the server are kept by the IT
hosted backup contractor.
Reference: SADCAS AP 04: Records Management
4.4 Nonconformities and Corrective Actions
SADCAS has a documented procedure of nonconformities that arise in its entire operation.
Nonconformities are regarded as opportunities for improvement and can be raised by anyone
within and from outside SADCAS. Corrective actions are taken in order to address and eliminate
the causes of nonconformities so as to prevent their recurrence. Corrective actions taken shall be
appropriate to the impact of the problems environment.
Reference: SADCAS AP 05: Identification and Management of Nonconformities
4.5 Preventive Actions
SADCAS has established mechanisms for the identification of opportunities for improvement and
to take preventive actions to eliminate the causes of potential nonconformities. Preventive actions
taken shall be appropriate to the impact of the potential problems. Progress on implementation of
improvement measures shall be an input to the management review meetings and shall be reported
upon by the Quality Manager.
SADCAS has developed a risk profile which is reviewed annually with measures being put in place
to militate against the identified risks.
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Reference: SADCAS AP 05: Identification and Management of Nonconformities
SADCAS BP 06: SADCAS Risk Profile
4.6 Internal Audits
SADCAS undertakes internal audits to:
� Determine compliance with its quality management system elements as specified in the Policy
Manual, procedures manual, job descriptions and other documents.
� Determine the effectiveness and suitability of the quality management system; and
� Identify opportunities for improvement.
Internal audits are planned and initiated by the Quality Manager who may carry out the audit
personally or may be assisted by other SADCAS personnel or may appoint an external auditor. It is
important that no member of staff audits his/her own work. The audit shall address elements of
the quality system at least once a year. The results of the internal audit shall be reviewed as part
of the management review process.
Reference: SADCAS AP 06: Internal Audits
4.7 Management Review
Reviews of the SADCAS quality management system are performed by the Quality Management
Committee. The reviews are arranged by the Quality Manager. Inputs or agenda items for the
management review meetings shall include:
a) Results of audits;
b) Results of peer evaluation;
c) Participation in international activities;
d) Feedback from interested parties;
e) New areas of accreditation;
f) Trends in nonconformities;
g) Status of preventive and corrective actions;
h) Follow up actions from earlier management reviews;
i) Fulfillment of objectives;
j) Changes that could affect the management system;
k) Appeals; and
l) Analyses of complaints.
The minutes of the management review meetings shall be filed for records.
Reference: SADCAS AP 07: Management Review
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4.8 Customer Feedback
SADCAS shall actively encourage customer feedback, negative and positive. This information shall
be used as a basis for the improvement and development of SADCAS services. SADCAS shall decide
on the validity of complaints. Customer complaints shall be registered, investigated and resolved.
The person investigating the complaint shall be independent to the complaint. All complaints
relating to an organization accredited by SADCAS shall be first referred to the accredited
organization. Only when the accredited organization has not been able to resolve the complaint
shall the matter be referred to SADCAS. Complaints which have not been resolved through the
SADCAS complaints handling system are classified as disputes and shall be brought to the attention
of the Chief Executive Officer for resolution.
The records pertaining to complaints, disputes shall be kept and maintained by the Accreditation
Administrator.
References:
1. SADCAS AP 08: Customer Feedback Handling Procedure
2. SADCAS BP 05: Terms of Reference of the Appeals Committee
3. SADCAS AP 04: Records Management
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5. HUMAN RESOURCES
5.1 Personnel Associated with SADCAS
SADCAS only employs personnel who have the prerequisite qualifications and experience to enable
them to undertake the work for which they are employed for. In all job advertisements, the
prerequisite qualifications, experience and skills shall be included. All SADCAS staff shall sign an
employment contract and a copy of a job description which outlines his/her responsibilities/ duties.
National Accreditation Focal Points who are employed by their respective governments but serve
as administrative links between SADCAS and clients/potential clients in Member States have job
descriptions which outline their responsibilities/duties. National Accreditation Focal Points shall
sign copies of their job descriptions. All copies of signed National Accreditation Focal Points job
descriptions are kept by SADCAS at its office.
As part of its staff development, training is given to all staff in both technical and administrative
areas as appropriate. All personnel are given the opportunity to undertake further training to
advance their career. Training plans are discussed with all personnel.
References:
1. Job descriptions
2. SADCAS F 50: Employment Agreement
3. SADCAS AP 09: Training of SADCAS Personnel
4. SADCAS APP 05: Recruitment and Selection Policy and Procedures
5.2 Personnel Involved in the Accreditation Process
SADCAS contracts on a needs basis, a number of qualified and registered assessors and experts
Refer to section 3.8.6. SADCAS has a procedure for the nomination, selection and training of
assessors and selection of SADCAS assessment team members. SADCAS keeps information records
of assessors/experts and a register of all qualified assessors. Upon engagement, each
assessor/expert shall sign a contract with SADCAS that specifies their agreement to confidentiality,
impartiality and non-conflict of interest. In addition each contracted assessor/ expert shall sign a
nondisclosure/confidentiality statement.
References:
1. SADCAS AP 01: Nomination, Selection and Training of SADCAS Assessors; Selection of
SADCAS Assessment Team Members; and Monitoring of SADCAS Assessors’
Performance
2. SADCAS AP 10: Contracting of Assessment Personnel
3. SADCAS TG 02: Guidance for SADCAS Accreditation Assessors
4. SADCAS F 26 SADCAS Assessors/Experts Information Records
5. SADCAS F 45 a: Nondisclosure/Confidentiality Statement – Assessor/ Expert
6. SADCAS F 49: Independent Contractor Agreement between SADCAS and Assessor/
Expert
7. SADCAS F 53: SADCAS Register of Assessors/Experts
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5.3 Monitoring
In order to facilitate the monitoring of performance and competence of the personnel involved in
the accreditation process, SADCAS has documented a procedure for monitoring of SADCAS
assessors’ performance which enables the regular review of performance and competence of
assessors/experts. Monitoring shall be through onsite observation, review of assessment records
feedback from conformity assessment bodies and peer monitoring. The performance of the
Accreditation Approvals Committee members is also monitored. Whenever monitoring indicates a
need for improvement, appropriate measures as agreed shall be effected.
References:
1. SADCAS AP 01: Nomination, Selection and Training of SADCAS Assessors; Selection of
SADCAS Assessment Team Members; and Monitoring of SADCAS Assessors’ Performance
2. SADCAS AP 14: Accreditation Decision Making Process
5.4 Personnel Records
SADCAS maintains up to date records of each person (including assessors/experts) involved in the
accreditation process. Records include:
a) Name and address;
b) Position held and in the case of assessors/experts, position held in their own organizations;
c) Educational qualifications and professional status;
d) Work experience;
e) Training in management systems, assessment and conformity assessment activities;
f) Competence for specific assessment tasks; and
g) Experience in assessment and result of their regular monitoring.
References:
1. SADCAS AP 04: Records Management
2. SADCAS F 26: SADCAS Assessors/Experts Information Records
3. SADCAS F 25: National Accreditation Focal Points Record
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6. ACCREDITATION PROCESS
6.1 General Requirements for Accreditation
SADCAS aims to achieve and maintain international recognition of all the accreditation programmes
it operates. SADCAS policy is therefore to accredit conformity assessment bodies that fully meet
the requirements of the relevant international standard/guide and the appropriate ILAC/IAF
guidance or interpretations thereof.
6.2 Accreditation Criteria
6.2.1 Laboratories
The criteria which laboratories must comply with to obtain accreditation are contained in ISO/IEC
17025 and the appropriate SADCAS requirement documents which include the appropriate ILAC
criteria. Laboratories have to fully comply with all the requirements of the relevant standard for
which accreditation is sought.
6.2.2 Medical laboratories
The criteria which laboratories must comply with to obtain accreditation are contained in ISO
15189. Medical laboratories that perform only medical testing shall be accredited to this standard.
Medical laboratories can also be accredited to ISO/IEC 17025. Medical laboratories may decide on
which standard to be accredited to, based on guidance from SADCAS.
6.2.3 Certification bodies
SADCAS accredits management systems/product/personnel certification bodies.
6.2.3.1 Management systems certification bodies
SADCAS accredits quality/environmental/occupational health and safety/food safety management
systems. The criteria which quality/environmental/occupational health and safety management
systems certification body must comply with to obtain accreditation are contained in ISO/IEC
17021-1 and the IAF guidance or interpretations thereof.
The criteria which food safety management systems certification bodies must comply with to obtain
accreditation are contained in ISO 22003 and the relevant IAF guidance or interpretations thereof.
6.2.3.2 Product certification bodies
The criteria which product certification bodies must comply with to obtain accreditation are
contained in ISO/IEC 17065 and the IAF guidance or interpretations thereof.
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6.2.3.3 Personnel Certification Bodies
The criteria which personnel certification bodies must comply with to obtain accreditation are
contained in ISO/IEC 17024 and the relevant IAF guidance or interpretations thereof.
6.2.4 Inspection bodies
The criteria which inspection bodies must comply with to obtain accreditation are contained in
ISO/IEC 17020 and the national standards specific to the field in which the inspection body operates
in. Inspection bodies that are accredited for a national standard which does not include all the
requirements of the ISO/IEC 17020 shall not be part of any International Recognition Agreement.
Fields and scopes of accreditation are available.
References:
1. ISO/IEC 17025 – General requirements for the competence of testing and calibration
laboratories
2. ISO 15189 - Medical laboratories – Particular requirements for quality and competence
3. ISO/IEC 17021-1 – Conformity assessment – Requirements for bodies providing audit
and certification of management systems
4. ISO/IEC 17024 – Conformity assessment – General requirements for bodies operating
certification of persons
5. ISO/IEC 17020 – General criteria for the operation of various types of bodies performing
inspection
6. ISO/IEC 17065- General requirements for bodies operating product certification systems
7. ISO 22003 – Food safety management systems- Requirements for bodies providing audit
and certification of food safety management systems
8. SADCAS TR 02 - Accreditation Requirements
9. SADCAS TR 05 - Criteria for the accreditation of Inspection Bodies Performing Inspection
in terms of the Pressure vessels/boilers regulations in Zimbabwe.
10. SADCAS TR 11- Criteria for the accreditation of calibration satellite laboratories and
branch offices
11. SADCAS TG 03- Area of Accreditation
12. SADCAS AP 12- Part 1: Accreditation Process for Testing/ Calibration/ Medical
Laboratories
13. SADCAS AP 12: Part -: Accreditation of Inspection Bodies Operating in the Regulatory/
Voluntary Area
14. SADCAS AP 12- Part 3: Accreditation Process for Certification Bodies.
15. Applicable IAF MD Series Documents
6.3 The Accreditation Process
The SADCAS accreditation process may include the following activities:
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6.3.1 Application and document review
Applications for accreditation shall be accompanied by a quality manual detailing the organization’s
ability to meet the requirements of the relevant international standard. A SADCAS appointed Lead
Assessor will conduct a desk review of the documents. Once the applicant’s documented quality
management system has been confirmed to address all the requirements of the relevant standards,
an onsite assessment will be scheduled.
6.3.2 Pre-assessments
Prior to or after embarking on the formal accreditation process, organizations that seek
accreditation may voluntarily request SADCAS to conduct a pre-assessment to assess their readiness
for accreditation. Pre-assessments may however be compulsory for new organizations seeking
accreditation depending on the regulator’s condition of acceptance. Pre-assessments are carried
on site by the Lead/Technical Assessor.
6.3.3 Initial assessment
Initial assessment is undertaken onsite at the applicant organization’s premises and involves an
opening meeting, the assessment of the organization’s competence to perform specific tasks for
which accreditation is sought, witnessing of select technical activities and a closing meeting. The
initial assessment covers all aspects of the organization’s scope of application. The findings from
the assessment are recorded as nonconformities where the conformity assessment body needs to
institute corrective action. Conformity assessment bodies shall be invited to identify and propose
corrective action on the findings raised, within one month after the assessment. The SADCAS
Accreditation Approvals Committee will base its decision on whether or not to grant accreditation,
to a large extent on the information gathered during the initial assessment.
6.3.4 Surveillance assessment
In order to maintain accreditation periodical surveillance assessments are conducted on site. The
first surveillance assessment shall be undertaken not more than twelve (12) months after
accreditation. Thereafter surveillance visits are scheduled annually throughout the accreditation
cycle as defined in 6.3.5. Surveillance assessments are scheduled to cover a representative sample
of the organization’s full scope of accreditation. Surveillance on-site assessments shall be planned
taking into account other surveillance activities. Conformity assessment bodies be invited to
identify and propose corrective action within one month after the surveillance assessment.
6.3.5 Reassessments
Reassessments will be conducted at least six (6) months before the end of an assessment cycle. This
will be a complete assessment covering the organization’s scope of accreditation and including all
elements of the relevant standard. An assessment cycle shall be five (5) years.
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6.3.6 Extraordinary Assessments
SADCAS may decide that at any time assessments be undertaken as a result of complaints or
changes in the conformity assessment body where such assessments are deemed necessary.
SADCAS shall advice the conformity assessment body accordingly and of the scope and reasons for
the extraordinary assessment.
6.3.7 Extension of SADCAS accreditation
An accredited organization may extend its scope of accreditation by applying to SADCAS. After the
scope extension has been assessed and approved, the organization’s certificate will be revised and
issued to the organization.
References:
1. SADCAS TG 01 – Information to Organizations Applying for Accreditation
2. SADCAS AD 01 – SADCAS Contact Details for Communicating with Clients
3. SADCAS AP 10 – Contracting of assessment personnel
4. SADCAS AP 12: Part 1: Accreditation Process for Testing/ Calibration/ Medical
Laboratories
5. SADCAS AP 12: Part 2: Accreditation of Inspection bodies Operating in the Regulatory/
Voluntary Area
6. SADCAS AP 12: Part 3 – Accreditation process for certification bodies
7. SADCAS AP 15: SADCAS Accreditation Administration Process
8. SADCAS AP 17: Onsite Clearance of Findings
9. SADCAS AP 18: Criteria for Extraordinary Assessments
10. SADCAS AP 20: Sampling for assessment purposes
11. TPA J01: Guidelines for SADCAS/SANAS Joint assessments under the TPA
12. SADCAS F 43 a – Application for Accreditation of Calibration Laboratory
13. SADCAS F 43 b – Application for Accreditation of Testing Laboratory
14. SADCAS F 43 c – Application for Accreditation of Medical Laboratory
15. SADCAS F 43 d – Application for Accreditation of Certification Body – Management
Systems
16. SADCAS F 43 e – Application for Accreditation of Certification Body - Products
17. SADCAS F 43 f – Application for Approval of Personnel
18. SADCAS F 43 g – Application for Accreditation of Certification Body for Personnel
19. SADCAS F 43 h – Application for Accreditation of Inspection Body
6.4 Assessment Report
The Lead Assessor shall prepare an assessment report with the input from assessment team
members. All applicants shall be advised of nonconformities raised during the assessment to enable
them to institute the necessary corrective action. The assessment report shall include
recommendations on suitability for accreditation. SADCAS shall remain responsible for the content
of the assessment report including nonconformities, even if the Lead assessor is not a permanent
member of SADCAS staff.
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6.5 Accreditation Decision
SADCAS maintains two (2) approaches to accreditation decision making process as follows:
a) Decisions arising from initial assessments, reassessments and extensions to new scopes shall
be made by the Accreditation Approvals Committee (AAC); and
b) Decisions arising from surveillance assessments, extension of existing scopes and additional
signatories to existing accredited facilities shall be made by the SADCAS technical Manager.
SADCAS shall, without undue delay, make the decision on whether to grant or extend accreditation.
All accreditation decisions shall be made based on the information gathered and the
recommendations made by the respective assessment team. , The recommendation together with
supporting documentation shall be forwarded to the Accreditation Approvals Committee for
decision. The supporting documentation shall include the following, as minimum:
a) Unique identification of the conformity assessment body;
b) Date(s) of the on-site assessment;
c) Name(s) of the assessor(s) and/or experts involved in the assessment;
d) Unique identification of all premises assessed;
e) Proposed scope of accreditation that was assessed;
f) The assessment report;
g) A statement on the adequacy of the internal organization and procedures adopted by
Conformity Assessment Bodies to give confidence in its competence, as determined through its
fulfillment on the requirements for accreditation;
h) Information on the resolution of all nonconformities;
i) Any further information that may assist in determining fulfillment of requirements and the
competence of the Conformity Assessment Bodies; and
j) Where applicable, summary of the results of proficiency testing or other comparisons
conducted by the Conformity Assessment Bodies and any actions taken as a consequence of
the results.
Personnel who have carried out the assessment shall not participate in the decision-making process.
Should the decision of the Accreditation Approvals Committee be to grant accreditation, the
applicant is issued with a SADCAS Certificate of Accreditation which shall include a schedule of
accreditation detailing the scope of accreditation. The accreditation certificate shall be valid for
five (5) years being the accreditation cycle as defined in 6.3.5.
Reference: SADCAS AP 14: Accreditation Decision Making Process
6.6 Conditions under which SADCAS Certificates are Issued
An accredited facility may only issue a SADCAS certificate for the type and range of activities for
which accreditation has been granted and which is listed on the accompanying schedule of
accreditation.
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The certificate shall include the following information:
a) The SADCAS accreditation mark;
b) SADCAS name;
c) Name of accredited facility;
d) Unique accreditation number;
e) Premises from which key activities are performed and which are covered by the accreditation;
f) Details of the scope of accreditation:
� Tests or types of tests performed and materials or products tested.
� Where appropriate, the methods used (for testing/medical laboratories).
� For calibration laboratories to include the types of measurements performed, the
calibration and measurement capability (CMC) expressed as uncertainty of measurement,
measurement range and additional parameters where applicable, e.g. frequency of applied
voltage.
� For inspection bodies to include the field, type and range of inspection.
g) Statement of conformity and reference to the standards/ other normative documents;
h) Contact details of the accredited facility;
i) Personnel approved;
j) Validity of accreditation of 5 years;
k) Effective date of granting accreditation i.e. the date of issue of certificate;
l) Date of expiry of certificate; and
m) Signature of the SADCAS Chief Executive Officer.
Status of Accreditation - SADCAS shall make publicly available on the website the current status of
the accreditations it has granted to conformity assessment bodies.
6.7 Confidentiality
SADCAS maintains confidentiality in its operations by requiring Board members, Committee
members, National Accreditation Focal Points, subcontractors, assessors/experts and all staff to
commit to confidentiality.
All the above including SADCAS assessors are required to sign a declaration of confidentiality where
they commit that no information gained while working for SADCAS shall be revealed to others than
the relevant staff in SADCAS. Applicant names are confidential to SADCAS and applicant files and
accredited organizations files are kept at SADCAS office.
References:
1. SADCAS F 45 a: Nondisclosure/Confidentiality Statements – Assessor/Expert
2. SADCAS F 45 b: Nondisclosure/Confidentiality Statement – Subcontractors (Other than
Assessors/Experts)
3. SADCAS F 45 c: Nondisclosure/Confidentiality Statement – SADCAS Staff members
4. SADCAS F 45 d: Nondisclosure/Confidentiality Statement – SADCAS Board/Committee
members
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5. SADCAS F 45 e: Nondisclosure/Confidentiality Statement – National Accreditation Focal
Points (NAFPs)
6. SADCAS F 49: Independent Contractor Agreement between SADCAS and Assessor/
Expert
7. SADCAS F 35-1, 35-2, 35-3: SADCAS Board and Committee Attendance Registers
6.8 Transfer of Accreditation
Transfer of accreditation is applicable when the legal status (e.g. ownership) of an accredited facility
changes without affecting its personnel and organization and the organization’s fulfillment of the
requirements for accreditation. Such transfer of accreditation shall be authorized by SADCAS.
6.9 Suspending, Withdrawal or Reducing Accreditation
An organization may have its accreditation suspended, withdrawn or the accreditation scope can
be reduced when it fails to comply with the accreditation requirements. Suspension is normally the
first step taken when serious non-compliance are noted. When an accreditation is suspended in
part or as a whole, the accreditation is reinstated only when the necessary corrective actions have
been instituted and after SADCAS has verified that the organization has fulfilled the requirements.
A suspended accreditation will be withdrawn if the organization is not able or willing to institute
the necessary corrective actions within the timelines acceptable to SADCAS. In severe cases,
withdrawal may be effected without prior suspension. When an accreditation has been withdrawn,
possible renewal shall be dealt with according to the procedure for dealing with new applications.
Reducing accreditation is the process of cancelling accreditation for part of the scope of
accreditation.
Decisions to suspend/withdraw/ reduce scope of accreditation shall be made by the Accreditation
Approvals Committee.
References:
1. SADCAS TG 01: Information for Organizations Applying for Accreditation
2. SADCAS TR 01: Accreditation Requirements
3. TR 06: Suspension and Reinstatement of Accredited Organizations
6.10 Subcontracting of Accreditation Work
SADCAS will normally carry out assessments itself. However, it may be necessary to subcontract
parts of or whole of, an assessment of a specific organization. SADCAS will in such cases remain with
the total responsibility for the assessment granting of accreditation and surveillance and
maintenance of the accreditation and all other decisions about accreditation. Accreditation
assessments will only be subcontracted to Accreditation Bodies that are signatories to the relevant
multilateral agreements with IAF/ILAC. Where SADCAS plans to use a subcontractor, a written
consent of the conformity assessment bodies shall be obtained prior to the assessment. SADCAS
shall maintain a list of subcontractors.
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6.11 Appeals
SADCAS accepts appeals from organizations on accreditation decisions. Appeals shall be in writing.
Appeals shall be handled by the Appeals Committee. Throughout the investigation of an appeal, all
decisions made prior to the appeal, stand.
Records pertaining to appeals shall be kept by the Chief Executive Officer.
References:
1. SADCAS AP 08: Customer Feedback Handling Procedure
2. SADCAS BP 05: Terms of Reference of the Appeals Committee
3. SADCAS AP 04: Records Management
6.12 Records on Conformity Assessment Bodies
SADCAS shall maintain records of all applicants and accredited organizations. The files shall contain
at least the following information:
a) Applicant forms;
b) A copy of the accreditation certificate and schedule of accreditation;
c) Correspondence including correspondence with assessors;
d) Information on proficiency testing/inter-laboratory comparisons (where relevant);
e) Assessment records and report; and
f) Records of committee deliberations, if applicable, and accreditation decisions.
The accreditation scopes for all accredited organizations are kept in SADCAS database and are
published in the Directory of accredited facilities on the SADCAS website.
References:
1. SADCAS AP 04: Records Management
2. SADCAS TG 03: Area of Accreditation
6.13 Proficiency Testing/Inter Laboratory Comparisons for Laboratories
6.13.1 Test laboratories
Applicant and accredited laboratories are required to participate in appropriate proficiency testing
schemes/ inter laboratory comparisons and where such schemes are available in their technical
field of work in order to demonstrate their capabilities and to assist in maintaining quality of
laboratory performance. Laboratories are required to maintain complete records of participation
in such schemes and to have procedures for evaluation of performance and implementation of
corrective action. SADCAS assesses performance during assessments, surveillance and
reassessments. If the results are outside the acceptable limits, corrective action shall be instituted.
If causes for unacceptable results are not found within a reasonable time or if a laboratory is not
undertaking suitable investigation to solve the problem, then the accreditation for the specific
parameter/method/ analysis may be suspended or terminated.
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SADCAS maintains links to PT service providers on the website www.sadcas.org
References:
1. SADCAS TR 08: Proficiency Testing and Other Comparison Programmes Requirements
for Testing and Medical Laboratories
2. ILAC P 9: ILAC Policy for Participation in Proficiency Testing Activities
6.13.2 Calibration laboratories
Applicant and accredited laboratories are required to participate in proficiency testing schemes/
inter laboratory comparisons before being accredited and thereafter in order to demonstrate their
capabilities and to assist in maintaining quality of laboratory performance. The results of artifact
measurement are communicated to the assessment team prior to the assessment. The assessment
team shall ensure that corrective actions needed on the results of proficiency testing/inter
laboratory comparison participation are actioned.
SADCAS maintains links to PT service providers on the website www.sadcas.org.
References:
1. SADCAS TR 04 – Proficiency Testing and other Comparison Programmes Requirements
for Calibration Laboratories
6.14 Traceability
Accredited conformity assessment bodies are required to demonstrate that calibration of critical
equipment and hence the measurement results generated by that equipment, relevant to their
scope of accreditation, are traceable to the International System of Units (SI Units). Where this is
not possible, traceability shall be to specified reference materials provided by a competent supplier
and/or other specified methods or consensus standards.
6.14.1 Metrological Traceability - Equipment and reference standards used by calibration laboratories and
having an impact on the accuracy and validity of measurements results shall be calibrated by:
a) A National Metrology Institute (NMI) whose service is suitable for the intended need and
belongs to the CIPM and are signatories to its Mutual Recognition Agreement (MRA) amongst
NMIs and who have approved CMC’s within the BIPM Key Comparison Database (KCDB) which
includes the range and uncertainty for each listed service.
b) A calibration laboratory accredited by an accreditation body covered by the ILAC Arrangement
or by Regional Arrangements recognized by ILAC whose service is suitable for the appropriate
calibration.
c) An NMI whose service is suitable for the intended need but not covered by the CIPM MRA. The
National Metrology Institute shall have participated in the SADC Cooperation in Metrology
(SADCMET) through which SADC countries that are not yet signatory to the CIPM can get their
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traceability. Calibration certificates issued by the NMI shall provide sufficient information
regarding the process of calibration.
The acceptance of other NMIs other than those of CIPM MRA partners shall be at the discretion
of the SADCAS Chief Executive Officer after due consultations of the appropriate Advisory
Committee subject to satisfactory evidence of the technical competence of the laboratory using
appropriate methods as outlined in the technical procedures.
d) A calibration laboratory whose service is suitable for the intended need but not covered by the
ILAC Arrangement or by regional arrangements recognized by ILAC.
For options c) and d) appropriate evidence for the technical competence of the laboratory
and claimed metrological traceability shall include the following:
- Record of calibration method validation;
- Procedures for estimation of uncertainty ;
- Documentation for traceability of measurements;
- Documentation for assuring the quality of calibration results;
- Documentation for the competence of staff;
- Documentation for accommodation and environmental conditions; and
- Audits of the calibration laboratory.
Options a) and b) above are the preferred SADCAS options for metrological traceability. Options c)
and d) are only applicable when options a) and b) are not possible.
6.14.2 Traceability for Testing/ Medical Laboratories
Equipment and instruments used by testing/ medical laboratories and having a significant impact
on the measurements results shall be calibrated. SADCAS accepts evidence of traceability as
outlined in 6.14.1.
Where traceability as stated above is not technically possible or reasonable or available, the
testing/ medical laboratories and client and other interested parties may agree to using reference
materials /certified reference materials as outlined in 6.14.4.
6.14.3 Traceability for Inspection Bodies
Equipment used by inspection bodies and having significant impact on measurement results shall
be calibrated. SADCAS accepts evidence of traceability as outlined in 6.14.1.
Where traceability as stated above is not technically possible or reasonable or available, the
inspection body and client and other interested parties may agree to using reference materials
/certified reference materials as outlined in 6.14.4.
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6.14.4 Traceability Provided From Reference Materials
When the conformity assessment bodies use reference materials (RM)/certified reference materials
(CRM) to establish traceability then
(a) The RM/ CRM must be produced by a NMI, and covered by BIPM/KCDB ; or
(b) The RM/CRM must be produced by Reference Materials Producer (RMP) which is accredited by
any accreditation body which is signatory to the ILAC Mutual Recognition Arrangement or by a
recognized regional cooperation (APLAC/EA/IAAC) Mutual Recognition Arrangement for RMP
in the accredited scope.
Note: For use of RM/CRM, ISO Guide 33: Reference materials – Good practice in using reference
materials” may be referred.
References:
1. SADCAS TR 02: Accreditation Requirements
2. SADCAS TR 09: Criteria for Performing Calibration and intermediate Checks on
Equipment Used in Accredited Facilities.
3. SADCAS TR 12: Estimation of the Uncertainty of Measurement by Calibration
Laboratories and Specification of Calibration and Measurement Capability on Schedules
of Accreditation
4. ILAC P 10: ILAC Policy on the Traceability of Measurement Results
5. ILAC P 14: ILAC Policy for Uncertainty in Calibration
6. ISO Guide 33: Reference materials – Good practice in using reference materials
6.15 Responsibilities of SADCAS and the Conformity Assessment Body
6.15.1 Obligations of the Conformity Assessment Body
The conformity assessment bodies accredited by SADCAS shall sign an agreement which details the
obligations of the accredited conformity assessment body and of SADCAS with regard to
accreditation. The contract covers all aspects that the accredited conformity assessment body must
comply with in order to maintain accreditation including:
� Agreement to adapt to changes in the requirements for accreditation.
� Provision of the necessary cooperation to SADCAS to enable it to verify the fulfillment of the
requirements for accreditation in all the premises where the conformity assessment body’s
activities take place.
� Provision of information, documents and records as necessary for the assessment and
maintenance of accreditation.
� Provision of documents that provide insight into the level of independence and impartiality of
the conformity assessment body from its related bodies where applicable.
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� Arranging for witnessing of conformity assessment body services when requested by SADCAS.
� Claiming accreditation only with respect to the scope for which accreditation has been granted.
� Not to use its accreditation in a manner that will bring SADCAS into disrepute.
� Pay accreditation fees as determined by SADCAS.
� Advise SADCAS, without delay of any significant changes relevant to its accreditation relating
to:
� its legal, commercial ownership or organization status
� Organization, top management and key personnel
� Main policies
� Resources and premises
� Scope of accreditation etc.
Reference: SADCAS F 44 – SADCAS Accreditation Agreement
6.15.2 Obligations of SADCAS
SADCAS undertakes to provide credible accreditation services. SADCAS shall:
� Enter into twinning partnership with internationally recognized accreditation cooperations for
skills transfer.
� Participate in regional and continental accreditation cooperation such as the SADC Cooperation
in Accreditation (SADCA) and the African Accreditation Cooperation (AFRAC).
� Participate in international accreditation bodies i.e. the International Laboratory Accreditation
Cooperation (ILAC) and the International Accreditation Forum (IAF).
� Participate in relevant committees of ILAC and IAF.
SADCAS undertakes to provide conformity assessment bodies with information on suitable ways to
obtain traceability of measurement results in relation to the scope for which accreditation is
provided.
Should there be changes to any of the accreditation requirements SADCAS shall, within a reasonable
period of time, notify all accredited conformity assessment bodies affected by any such changes.
SADCAS shall give sufficient time for the accredited conformity assessment body to accommodate
the changes. Such timelines shall be in line with IAF/ILAC stipulations. SADCAS shall verify actions
implemented to address the change(s). Verification can be done as an additional assessment or as
part of the annual assessment. Where verification has been carried out as an additional
assessment, then the accredited conformity assessment body shall be responsible for the additional
charges incurred. Where verification has been carried out as a part of the annual assessment no
additional charges shall be raised.
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6.15.3 Reference to accreditation and use of accreditation mark
SADCAS shall remain the sole proprietary owner of its trademark/accreditation mark which has
been registered and is therefore protected. The conditions for the use of the SADCAS accreditation
mark are documented. SADCAS also has documented requirements for use of combined marks.
The procedures also outline actions that SADCAS shall take in cases where the mark is misused.
SADCAS will not hesitate to take appropriate legal action in those instances where its
trademark/accreditation mark has been misused.
References:
1. SADCAS TR 01: Part 1 - Conditions for the use of SADCAS Accreditation Marks
2. SADCAS TR 01: Part 2 – Use of Combined Marks
3. ILAC/IAF A2: IAF/ILAC Multi- Lateral Mutual Recognition Arrangements (Arrangements):
Requirements and Procedures for Evaluation of a single Accreditation Body
4. ILAC/IAF A3: IAF/ILAC Multi - Lateral Mutual Recognition Arrangements (Arrangements):
Narrative Framework for Reporting on the Performance of an Accreditation Body
5. ILAC P 8: ILAC Mutual Recognition Arrangement ( Arrangement): Supplementary
Requirements and Guidelines for the Use of Accreditation Symbols and for Claims of
Accreditation Status by Accredited Laboratories and Inspection Bodies
6. ILAC R 7: Rules for the use of the ILAC MRA Mark
6.16 Cross Frontier Accreditation
SADCAS is a multi- economy accreditation body established to meet the accreditation needs of SADC
Member States which do not have national accreditation bodies or where national accreditation body has a
limited scope. Applications for accreditation received by SADCAS from conformity assessment bodies based
in countries that are not part of the Southern African Development Community (SADC) shall be handled in
accordance with the cross frontier procedure. SADCAS is committed to abide by the ILAC/IAF cross frontier
accreditation principles of cooperation.
References:
1. SADCAS AP 19: Cross frontier Accreditation
2. ILAC G 21: Cross Frontier Accreditation Principles for Cooperation
3. IAF GD 3: Guidance on Cross Frontier
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APPENDIX A – CROSS REFERENCING BETWEEN ISO/IEC 17011 AND SADCAS DOCUMENTS
ISO/IEC 17011 Clause SADCAS Policy Manual PM 01
Clause
Other Documents
4. Accrediting Body
4. 1 Legal responsibility 3.6 � Certificate of incorporation
� Record of SADC Council of Ministers Meeting held in August 2007
� TBT Annex to the SADC Protocol on Trade
� Memorandum and Articles of Association of the SADCAS;
� SADCAS/SADC Memorandum of Understanding
4.2 Structure
4.2.1
3.7.4
� SADCAS Organizational Structure
� SADCAS Strategic/Business plan, Annual Implementation plans
� Registers of SADCAS Members, Board, National Accreditation Focal Points,
Accreditation Approvals Committee, Advisory Committee Members
4.2.2 3.6, 6.5 � SADCAS AP 14: Accreditation Decision making Process
� Memorandum and Articles of Association of SADCAS
� SADCAS/SADC Memorandum of Understanding
� SADCAS TR 06: Suspension and Reinstatement of Accredited Organizations
4.2.3
3.6, 3.7
� Certificate of incorporation
� Memorandum and Articles of Association of the SADCAS;
4.2.4 3.8 � Job Descriptions
4.2.5
3.8, 4.1, 4.2, 6.5, 3.7.5
� Memorandum and Articles of Association of the SADCAS
� SADCAS BP 01: Terms of Reference of the Finance, Risk and Audit
Committee of the SADCAS Board of Directors
� SADCAS BP 02: Terms of Reference of the Human Resources and
Remuneration Committee of the SADCAS Board of Directors
� Job Descriptions
� SADCAS F 44: SADCAS Accreditation Agreement
� SADCAS F 49: Independent Contractor Agreement between SADCAS and
Assessor/Expert
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ISO/IEC 17011 Clause SADCAS Policy Manual PM 01
Clause
Other Documents
� SADCAS AP 11: Terms of Reference, Registration and Responsibilities of
Advisory Committees
4.2.6
3.7, 5.2, 6.5
� SADCAS AP 01: Nomination, Selection, and Training of SADCAS Assessors,
Selection of SADCAS Assessment Team Members: and Monitoring of
SADCAS Assessors Performance
� SADCAS AP 11: Terms of Reference, Registration and Responsibilities of
Advisory Committees
� SADCAS AP 14: Accreditation Decision Making Process
4.2.7
3.7, 5.2, 6.5
� SADCAS AP 11: Terms of Reference, Registration and Responsibilities of
Advisory Committees
� SADCAS AP 14: Accreditation Decision Making Process
� SADCAS BP 01: Terms of Reference of the Finance, Risk and Audit
Committee of the SADCAS Board of Directors
� SADCAS BP 02: Terms of Reference of the Human Resources and
Remuneration Committee of the SADCAS Board of Directors
� Articles of Association of SADCAS
� SADCAS BP 07: Part 1: SADCAS Board of Directors Skills and Expertise
Requirements
� SADCAS BP 07: Part 2: SADCAS Board of Directors Expert Matrix
4.2.8 3.7.4 � Organizational Structure
� SADCAS BP 01: Terms of Reference of the Finance, Risk and Audit
Committee of the SADCAS Board of Directors
� SADCAS BP 02: Terms of Reference of the Human Resources and
Remuneration Committee of the SADCAS Board of Directors
� Job Descriptions
� Articles of Association of SADCAS
4.3 Impartiality
4.3.1 3.9 � SADCAS F 45 a: Nondisclosure/Confidentiality Statement – Assessors/
Experts
� SADCAS F 45 b: Nondisclosure/Confidentiality Statement –
Subcontractors (Other than Assessors/Experts)
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ISO/IEC 17011 Clause SADCAS Policy Manual PM 01
Clause
Other Documents
� SADCAS F 45 c: Non - disclosure/Confidentiality Statement – SADCAS
Staff Members
� SADCAS F 45 d: Non - disclosure/Confidentiality Statement – SADCAS
Board/ Committee Members
� SADCAS F 45 e: Non - disclosure/Confidentiality Statement – National
Accreditation Focal Points (NAFPs)
� SADCAS F 49: Independent Contractor Agreement between SADCAS and
Assessor/Expert
� SADCAS F 50: Employment Agreement
� SADCAS F 74 ; Independent Contractor Agreement between SADCAS and
Trainer
4.3.2 3.9, 4.8, 6.11 � SADCAS AP 08: Customer Feedback Handling Procedure
� SADCAS AP 11: Terms of Reference, Registration and Responsibilities of
Advisory Committees
� SADCAS AP 14: Accreditation Decision Making Process
� SADCAS BP 05: terms and Reference of the Appeals Committee
4.3.3 3.9
� SADCAS AP 12: Part 1: Accreditation Process for
Testing/Calibration/Medical Laboratories
� SADCAS AP 12: Part 2: Accreditation Process for Inspection Bodies
Operating in the Regulatory/Voluntary Process for Certification Bodies
� SADCAS TR 02: Accreditation Requirements
� SADCAS TG 01: Information to Organizations Applying for Accreditation
4.3.4
3.9
� SADCAS APP 03: SADCAS Staff Conditions of Service
� SADCAS F27: SADCAS Gift Register
� SADCAS F 45 a: Non - disclosure/Confidentiality Statement –
Assessors/Experts
� SADCAS F 45 c: Non - disclosure/Confidentiality Statement – SADCAS
Staff members
� SADCAS F 45 d: Non - disclosure/Confidentiality Statement – SADCAS
Board/Committee members
� SADCAS F 45 e: Non - disclosure/Confidentiality Statement – National
Accreditation Focal Points (NAFPs)
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ISO/IEC 17011 Clause SADCAS Policy Manual PM 01
Clause
Other Documents
� SADCAS F 49: independent Contractor Agreement between SADCAS and
Assessor/Expert
� SADCAS F 50: Employment Agreement
� SADCAS F 74 ; Independent Contractor Agreement between SADCAS and
Trainer
4.3.5 6.5 � SADCAS AP 14: Accreditation Decision making Process
4.3.6 3.9, 3.5.1
4.3.7 3.12, Table 1
4.4 Confidentiality 3.9 � SADCAS APP 03: SADCAS Staff Conditions of Service
� SADCAS F 44: SADCAS Accreditation Agreement
� SADCAS F 45 a: Non - disclosure/Confidentiality Statement –
Assessors/Experts
� SADCAS F 45 b: Non - disclosure/Confidentiality Statement –
Subcontractors (Other than Assessors/Experts)
� SADCAS F 45 c: Non - disclosure/Confidentiality Statement – SADCAS Staff
Members
� SADCAS F 45 d: Non - disclosure/Confidentiality Statement – SADCAS
Board/Committee Members
� SADCAS F 45 e: Non - disclosure/Confidentiality Statement – National
Accreditation Focal Points (NAFPs)
� SADCAS F 49: independent Contractor Agreement between SADCAS and
Assessor/Expert
� SADCAS F 50: Employment Agreement
� SADCAS F 74: Independent Contractor Agreement between SADCAS and
Trainer
4.5 Liability and Financing
4.5.1 3.10.1
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Clause
Other Documents
4.5.2
3.10.2
� SADCAS Strategic/Business Plan
� SADCAS Annual Implementation plan
� Financial Agreements
� Budgets
� SADCAS AP 02: SADCAS Service Fees
4.6 Accreditation Activity
4.6.1 2, 6 � SADCAS TG 01: Information to Organizations Applying for Accreditation
� SADCAS TG 03: Area of Accreditation
� SADCAS TR 02: Accreditation Requirements
4.6.2
3.7.5
� SADCAS AP 11: Terms of Reference, Registration and Responsibilities of
Advisory Committees
4.6.3 3.5.2 � SADCAS AP 16: Procedure for the Development of New Accreditation
Programmes
5. Management
5.1.1
4.5, 4.6, 4.7, 4.8 � SADCAS AP 05: Identification and management of Non conformities
� SADCAS AP 06: Internal Audits
� SADCAS AP 07: Management Review
� SADCAS AP 08: Customer Feedback Handling Procedure
� SADCAS BP 05: Terms and Reference of the Appeals Committee
5.1.2 4.2, 4.3 � SADCAS AP 03: Document Control
� SADCAS AP 04: Records Management
5.2 Management System
5.2.1 2, 3.3, 3.13, 4.1.1
� SADCAS Strategic/Business Plan
� SADCAS Annual Implementation plan
� SADCAS Policy Statement
� SADCAS AP 09: Training of SADCAS Personnel
� SADCAS SL 17: Documents Acknowledgement
5.2.2 1, 2, 4 � SADCAS PM 01: Policy Manual
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Clause
Other Documents
5.2.3 4.1.1, 4.1.2 � Job Descriptions
5.3 Document Control 4.2 � SADCAS AP 03: Document Control
5.4 Records 4.3
5.4.1 � SADCAS AP 04: Records Control
5.4.2
4.3
� SADCAS AP 04: Records Control
5.5 Nonconformities and
Corrective Action
4.4 � SADCAS AP 05: Identification and Management of Nonconformities
5.6 Preventive Actions 4.5 � SADCAS AP 05: Identification and Management of Nonconformities
� SADCAS BP 06: SADCAS Risk Profile
5.7 Internal Audits
5.7.1, 5.7.2, 5.7.3
4.6
� SADCAS AP 06: Internal Audits
5.8 Management Review
5.8.1, 5.8.2, 5.8.3 4.7 � SADCAS AP 07: Management Review
5.9 Complaints 4.8 � SADCAS AP 08: Customer Feedback Handling Procedure
� SADCAS BP 05: Terms and Reference of the Appeals Committee
� SADCAS F 57: Feedback from Assessments
� SADCAS F 86: Customer Satisfaction Survey – Accreditation Services
6. Human Resources
6.1 Personnel Associated with
the Accreditation body
6.1.1 5.1, 5.2 � SADCAS APP 05: Recruitment and Selection Policy and Procedures
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Clause
Other Documents
� SADCAS AP 01: Nomination, Selection, and training of SADCAS Assessors,
Selection of SADCAS Assessment Team Members; and Monitoring of
SADCAS Assessors’ Performance
� SADCAS AP 09: Training of SADCAS Personnel
� SADCAS AP 10: Contracting of Assessment personnel
6.1.2 5.1, 5.2 � SADCAS F 53: Register of Assessors/ Experts
6.1.3 3.8, 5.1 � Job Description
� SADCAS APP 03: SADCAS Staff Conditions of Service
� SADCS F 49: Independent contractor Agreement between SADCAS and
Assessor/ Expert
� SADCAS F 50: Employment Agreement
6.1.4 5.1 � SADCAS F 45 (a): Nondisclosure/Confidentiality Statement – Assessors/
Experts
� SADCAS F 45 (b): Nondisclosure/ Confidentiality Statement –
Subcontractors (Other than Assessors/Experts)
� SADCAS F 45 (c): Nondisclosure/Confidentiality Statement – SADCAS Staff
Members
� SADCAS F 45 (d): Nondisclosure/Confidentiality Statement – SADCAS
Board/ Committee Members
� SADCAS F 45 (e): Nondisclosure/Confidentiality Statement – National
Accreditation Focal Points (NAFPs)
� SADCAS F 50: Employment Agreement
6.2 Personnel Involved in the
Accreditation process
6.2.1
3.8, 5.1
� Job specification contained in job description
� SADCAS AP 09: Training of SADCAS Personnel
� SADCAS AP 01: Nomination, Selection, and training of SADCAS Assessors,
Selection of SADCAS Assessment Team Members; and Monitoring of
SADCAS Assessors’ Performance
� SADCAS AP 14; Accreditation Decision Making Process
� SADCAS BP 05: Terms of Reference - Appeals Committee
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Other Documents
6.2.2 5.2 � SADCAS AP 01: Nomination, Selection, and training of SADCAS Assessors,
Selection of SADCAS Assessment Team Members; and Monitoring of
SADCAS Assessors’ Performance
6..2.3 5.2 � SADCAS AP 01: Nomination, Selection, and training of SADCAS Assessors,
Selection of SADCAS Assessment Team Members; and Monitoring of
SADCAS Assessors’ Performance
� SADCAS F 53: SADCAS Register of Assessors/Experts
6.2.4 5.2 � SADCAS AP 01: Selection of SADCAS Assessment Team Members; and
Monitoring of SADCAS Assessors’ Performance
� SADCAS TG 02: Guidance for SADCAS Accreditation Assessors
� SADCAS SL 17 : New /Revised QMS Documents
6.3 Monitoring
6.3.1, 6.3.2 5.3 � SADCAS AP 01: Nomination, Selection, and training of SADCAS Assessors,
Selection of SADCAS Assessment Team Members; and Monitoring of
SADCAS Assessors’ Performance
� SADCAS AP 09: Training of SADCAS Personnel
� SADCAS AP 14: Accreditation Decision Making Process
� SADCAS F 33: Monitoring of Assessors
� SADCAS F 57: Feedback from Assessments
6.4 Personnel Records
6.4.1
5.4
� SADCAS AP 04: Records Management
� Personnel files
6.4.2
5.4 � SADCAS AP 04: Records Management
� SADCAS F 26: SADCAS Assessors/ Experts Information Record
� SADCAS F 53: SADCAS Register of Assessors/Experts
7. Accreditation Process
6.2
7.1 Accreditation Criteria and
Information
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Other Documents
7.1.1 6.2 � SADCAS TG 01: Information to organizations Applying for Accreditation
� SADCAS TG 03: Area of Accreditation
� SADCAS TR 02: Accreditation Requirements
� Accreditation promotional pamphlets available on SADCAS website
www.sadcas.org
7.1.2 6.2 � SADCAS website www.sadcas.org
� SADCAS PM 01: Policy Manual
� SADCAS TG 01: Information to organizations Applying for Accreditation
� SADCAS TG 03: Area of Accreditation
� SADCAS AP 01: Nomination, Selection, and training of SADCAS Assessors,
Selection of SADCAS Assessment Team Members; and Monitoring of
SADCAS Assessors’ Performance
� SADCAS AP 02: SADCAS Service Fees
� SADCAS AP 08: Customer Feedback Handling Procedure
� SADCAS AP 12: Part 1: Accreditation Process for Testing/ Calibration/
Medical Laboratories
� SADCAS AP 12: Part 2: Accreditation of Inspection Bodies Operating in the
Regulatory/ Voluntary Area
� SADCAS AP 12: Part 2: Accreditation Process for inspection Bodies
Operating in the Regulatory/Voluntary area
� SADCAS AP 12: Part 3: Accreditation Process for Certification Bodies
� TPA J01: Guidelines for SADCAS/SANAS Joint Assessment under the TPA
� SADCAS TR 01:Part 1: Conditions for the use of SADCAS Accreditation Mark
� SADCAS TR 01: Part 1: Use of Combined Marks
� SADCAS TR 02: Accreditation Requirements
� SADCAS TR 03: Nominated Representative and Signatories:
Responsibilities, Qualification and Approval
� SADCAS TR 04: Proficiency Testing and other Comparison Programme
Requirements for Calibration Laboratories
� SADCAS TR 05: Criteria for the Accreditation of Inspection Bodies
Performing Inspection in Terms of the Pressure Vessels/ Boilers
Regulations in Zimbabwe
� SADCAS TR 06: Suspension and Re-instatement of Accredited
Organizations
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Clause
Other Documents
� SADCAS TR 07: SADCAS Policy for ISO/IEC 17020:2012 Transition
� SADCAS TR 08: Proficiency Testing and other Comparison Programmes
Requirements for Testing and Medical Laboratories
� SADCAS TR 09: Criteria for Performing Calibration and Intermediate
Checks on Equipment used in Accredited Facilities
� SADCAS BP 05: terms and Reference of the Appeals Committee
� SADCAS F 44: SADCAS Accreditation Agreement
� Applicable IAF MD Series Documents
7.2 Application for Accreditation
7.2.1, 7.2.2, 7.2.3
6.3 � SADCAS F 43 (a) – Application for Accreditation of Calibration Laboratory
� SADCAS F 43 (b) – Application for Accreditation of Testing Laboratory
� SADCAS F 43 (c) – Application for Accreditation of Medical Laboratory
� SADCAS F 43 (d) – Application for Accreditation of Certification Body –
Management Systems
� SADCAS F 43 (e) – Application for Accreditation of Certification Body -
Products
� SADCAS F 43 (f) – Application for Approval of Personnel
� SADCAS F 43 (g) – Application for Accreditation of Certification Body -
Personnel
� SADCAS F 44: SADCAS Accreditation Agreement
� SADCAS TG 01
� SADCAS TG 03: Area of Accreditation
� SADCAS TR 02: Accreditation Requirements
� SADCAS TR 03: Nominated Representative and Signatories:
Responsibilities, Qualification and Approval
7.3 Resource Review
7.3.1, 7.3.2
� SADCAS AP 10: Contracting of Assessment Personnel
� SADCAS AP 12: Part 1: Accreditation Process for Testing/ Calibration/
Medical Laboratories
� SADCAS AP 12: Part 2: Accreditation of Inspection Bodies Operating in the
Regulatory/ Voluntary Area
Document No: SADCAS PM 01 Issue No: 14
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ISO/IEC 17011 Clause SADCAS Policy Manual PM 01
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Other Documents
� SADCAS AP 12: Part 3: Accreditation Process for Certification Bodies
� SADCAS F 80 Internal Cost Estimate Sheet for Quotation
7.4 Subcontracting the
Assessment
7.4.1, 7.4.2, 7.4.3 6.10 � SADCAS AP 10: Contracting of Assessment Personnel
� SADCAS AP 14: Accreditation Decision Making Process
7.5 Preparation for Assessment
7.5.1
3.9
� SADCAS AP 12: Part 1: Accreditation Process for Testing/ Calibration/
Medical Laboratories
� SADCAS AP 12: Part 2: Accreditation of Inspection Bodies Operating in the
Regulatory/ Voluntary Area
� SADCAS AP 12: Part 3: Accreditation Process for Certification Bodies
� TPA J01: Guidelines for SADCAS/SANAS Joint Assessment under TPA
� SADCAS F 61 (d): Pre assessment Report for Laboratories
7.5.2 5.2, 6.3 � SADCAS AP 10: Contracting of Assessment Personnel
� SADCAS AP 12: Part 1: Accreditation Process for Testing/ Calibration/
Medical Laboratories
� SADCAS AP 12: Part 2: Accreditation of Inspection Bodies Operating in the
Regulatory/ Voluntary Area
� SADCAS AP 12: Part 3: Accreditation Process for Certification Bodies
� SADCAS AP 15: SADCAS Accreditation Administration Process
� SADCAS TG 01: Information to organizations Applying for Accreditation
� SADCAS F 53: SADCAS Register of Assessors/Experts
7.5.3
3.9
� SADCAS AP 10: contracting of Assessment Personnel
� SADCAS AP 12: Part 1: Accreditation Process for Testing/ Calibration/
Medical Laboratories
� SADCAS AP 12: Part 2: Accreditation of Inspection Bodies Operating in the
Regulatory/ Voluntary Area
� SADCAS AP 12: Part 3: Accreditation Process for Certification Bodies
� SADCAS F 45 a: Nondisclosure/ Confidentiality Statement – Assessors/
Experts
Document No: SADCAS PM 01 Issue No: 14
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ISO/IEC 17011 Clause SADCAS Policy Manual PM 01
Clause
Other Documents
� SADCAS F 45 a: Nondisclosure/Confidentiality Statement – Assessors/
Experts
� SADCAS F 45 c: Nondisclosure/Confidentiality Statement – SADCAS Staff
Members
� SADCAS F 49: Independent Contractor Agreement Between SADCAS and
Assessor/Expert
7.5.4
6
� SADCAS AP 10: Contracting of Assessment Personnel
� SADCAS AP 12: Part 1: Accreditation of Laboratories
� SADCAS AP 12: Part 2: Accreditation of Inspection Bodies Operating in the
Regulatory/ Voluntary Area
� SADCAS AP 12: Part 3: Accreditation Process for Certification Bodies
� SADCAS TG 01: Information to Organizations Applying for Accreditation
� SADCAS TG 02: Guidance for SADCAS Accreditation Assessors
� SADCAS TR 02: Accreditation Requirements
� SADCAS F 88: Assessment Team Objections/Appeals Received and Reasons
- Register
7.5.5 5.2
� SADCAS TG 02: Guidance for SADCAS Accreditation Assessors
7.5.6 to 7.5.10 6.3 � SADCAS TG 02:Guidance for SADCAS Accreditation Assessors
� SADCAS AP 12: Part 1: Accreditation Process for Testing/ Calibration/
Medical Laboratories
� SADCAS AP 12: Part 2: Accreditation of Inspection Bodies Operating in the
Regulatory/ Voluntary Area
� SADCAS AP 12: Part 3: Accreditation Process for Certification Bodies
� SADCAS AP 15: SADCAS Accreditation Administration Processes
7.6 Document and Record
Review
7.6.1, 7.6.2
6.3.1
� SADCAS TG 01: Information to Organizations Applying for Accreditation
� SADCAS TG 02:Guidance for SADCAS Accreditation Assessors
Document No: SADCAS PM 01 Issue No: 14
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Clause
Other Documents
� SADCAS AP 12: Part 1: Accreditation Process for Testing/ Calibration/
Medical Laboratories
� SADCAS AP 12: Part 2: Accreditation of Inspection Bodies Operating in the
Regulatory/ Voluntary Area
� SADCAS AP 12: Part 3: Accreditation Process for Certification Bodies
� SADCAS F 61 (a-1): Document Review Report for Laboratories – ISO/IEC
17025
� SADCAS F 61 (a-2): Document Review Report for Laboratories – ISO/IEC
17020
� SADCAS F 61 (a-3): Document review report for laboratories – ISO 15189
7.7 On site Assessment
7.7.1
6.3.3 � SADCAS TG 01: Information to Organizations Applying for Accreditation
� SADCAS TG 02: Guidance for SADCAS Accreditation Assessors
� SADCAS AP 12: Part 1: Accreditation Process for Testing/ Calibration/
Medical Laboratories
� SADCAS AP 12: Part 2: Accreditation of Inspection Bodies Operating in the
Regulatory/ Voluntary Area
� SADCAS AP 12: Part 3: Accreditation Process for Certification Bodies
� TPA J01: Guidelines for SADCAS/SANAS Joint Assessment under TPA
� SADCAS F 46 a: Onsite Assessment – Opening Meeting Agenda
� SADCAS F 46 b: Onsite Assessment – Closing Meeting Agenda
� SADCAS F 46 c: Attendance register – onsite Assessment- opening/Closing
Meetings
7.7.2 6.3.3 � SADCAS TG 01: Information to Organizations Applying for Accreditation
� SADCAS TG 02: Guidance for SADCAS Accreditation Assessors
� SADCAS AP 12: Part 1: Accreditation Process for Testing/ Calibration/
Medical Laboratories
� SADCAS AP 12: Part 2: Accreditation of Inspection Bodies Operating in the
Regulatory/ Voluntary Area
� SADCAS AP 12: Part 3: Accreditation Process for Certification Bodies
Document No: SADCAS PM 01 Issue No: 14
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ISO/IEC 17011 Clause SADCAS Policy Manual PM 01
Clause
Other Documents
� TPA J01: Guidelines for SADCAS/SANAS Joint Assessment under TPA
� SADCAS F 60 a: Management Requirements of ISO/IEC 17025:2005
� SADCAS F 60 b: Technical Requirements of ISO/IEC 17025:2005
� SADCAS F 60 c: Vertical Assessment Laboratories ISO/IEC 17025
� SADCAS F 60 e: Onsite Evaluation of Calibration Laboratories
� SADCAS F 61 e: Proficiency Testing Requirements ISO/IEC 17025:2005
Clause 5.9 and SADCAS Requirements
� SADCAS F 61 f: Vertical assessment –Inspection ISO/IEC 17020:1998
7.7.3 6.3.3 � SADCAS TG 01: Information to Organizations Applying for Accreditation
� SADCAS TG 02:Guidance for SADCAS Accreditation Assessors
� SADCAS AP 12: Part 1: Accreditation Process for Testing/ Calibration/
Medical Laboratories
� SADCAS AP 12: Part 2: Accreditation of Inspection Bodies Operating in the
Regulatory/ Voluntary Area
� SADCAS AP 12: Part 3: Accreditation Process for Certification bodies
� TPA J01: Guidelines for SADCAS/SANAS Joint Assessment under TPA
� SADCAS F 60 d: Witnessing of Activity
� SADCAS F 61 F: Vertical assessment – Inspection ISO/IEC 17020:1998
7.8 Analysis of Findings and
Assessment Report
6.4
7.8.1, 7.8.2, 7.8.3
6.3, 6.4
� SADCAS TG 02:Guidance for SADCAS Accreditation Assessors
� SADCAS AP 12: Part 1: Accreditation Process for Testing/ Calibration/
Medical Laboratories
� SADCAS AP 12: Part 2: Accreditation of Inspection Bodies Operating in the
Regulatory/ Voluntary Area
� SADCAS AP 12: Part 3: Accreditation Process for Certification Bodies
� SADCAS F 46 b: Onsite Assessment – Closing Meeting Agenda
7.8.4 6.4 � SADCAS TG 02: Guidance for SADCAS Accreditation Assessors
� SADCAS AP 12: Part 1: Accreditation Process for Testing/ Calibration/
Medical Laboratories
Document No: SADCAS PM 01 Issue No: 14
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ISO/IEC 17011 Clause SADCAS Policy Manual PM 01
Clause
Other Documents
� SADCAS AP 12: Part 2: Accreditation of Inspection Bodies Operating in the
Regulatory/ Voluntary Area
� SADCAS AP 12: Part 3: Accreditation Process for Certification Bodies
� SADCAS F 60 a: Management Requirements of ISO/IEC 17025:2005.
� SADCAS F 60 b: Technical Requirements of ISO/IEC 17025:2005
� SADCAS F 60 c: Vertical Assessment Laboratories ISO/IEC 17025b
� SADCAS F 60 d: Witnessing of Activity
� SADCAS F 61 b: Conformity Assessment Body – Nonconformity, Corrective
Action and Clearance Report
� SADCAS F 61 c: Assessment recommendation Report
7.8.5
6.5
� SADCAS AP 15: SADCAS Accreditation Administration Processes
7.8.6 6.5 � SADCAS AP 14: Accreditation Decision making Process
7.9 Decision Making and
Granting Accreditation
7.9.1, 7.9.2
6.5, 6.6 � SADCAS AP 14: Accreditation Decision Making Process
� SADCAS F 75: Accreditation Approvals Committee’s evaluation of
Assessment Packs
� SADCAS F 77: Technical Manager’s Evaluation of Assessment Packs
7.9.3 6.10 � SADCAS AP 14: Accreditation Decision Making Process
� SADCAS AP 15: SADCAS Accreditation Administration Processes
� SADCAS TR 02; Accreditation Requirements
� Accreditation Certificate and Schedule
� TPA J01: Guidelines for SADCAS/SANAS Joint Assessment under TPA
7.9.4, 7.9.5 6.5, 6.6
� SADCAS AP 14: Accreditation Decision Making Process
� SADCAS AP 15: SADCAS Accreditation Administration Processes
� SADCAS TR 02; Accreditation Requirements
Document No: SADCAS PM 01 Issue No: 14
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ISO/IEC 17011 Clause SADCAS Policy Manual PM 01
Clause
Other Documents
7.10 Appeals
7.10.1, 7.10.2 6.11 � SADCAS AP 08: Customer Feedback Handling Procedure
� SADCAS BP 05: Terms and Reference of the Appeals Committee
� SADCAS AP 04: Records Management
7.11 Reassessment and
Surveillance
7.11.1, 7.11.2, 7.11.3, 7.11.4,
7.11.5
6.3.4, 6.3.5
� SADCAS AP 12: Part 1: Accreditation Process for Testing/ Calibration/
Medical Laboratories
� SADCAS AP 12: Part 2: Accreditation of Inspection Bodies Operating in the
Regulatory/ Voluntary Area
� SADCAS AP 12: Part 3: Accreditation Process for Certification Bodies
� SADCAS TG 01: Information to Organizations Applying for Accreditation
� SADCAS TG 02:Guidance for SADCAS Accreditation Assessors
� SADCAS TR 02: Accreditation Requirements
7.11.6 6.5 � SADCAS AP 14: Accreditation Decision Making Process
SADCAS F 75: Accreditation Approvals Committee’s Evaluation of
Assessment Packs
7.11.7
6.3.6
� SADCAS AP 12: Part 1: Accreditation Process for Testing/ Calibration/
Medical Laboratories
� SADCAS AP 12: Part 2: Accreditation of Inspection Bodies Operating in the
Regulatory/ Voluntary Area
� SADCAS AP 12: Part 3: Accreditation Process for Certification Bodies
SADCAS AP 18: Criteria for Extraordinary Assessments
� SADCAS TG 01: Information to Organizations Applying for Accreditation
� SADCAS TG 02:Guidance for SADCAS Accreditation Assessors
7.12 Extending Accreditation 6.3.7 � SADCAS AP 12: Part 1: Accreditation Process for Testing/ Calibration/
Medical Laboratories
� SADCAS AP 12: Part 2: Accreditation of Inspection Bodies Operating in the
Regulatory/ Voluntary Area
Document No: SADCAS PM 01 Issue No: 14
Page 56 of 74
ISO/IEC 17011 Clause SADCAS Policy Manual PM 01
Clause
Other Documents
� SADCAS AP 12: Part 3: Accreditation Process for Certification bodies
� SADCAS TG 01: Information to Organizations Applying for Accreditation
� SADCAS TG 02:Guidance for SADCAS Accreditation Assessors
7.13 Suspending, Withdrawing or
Reducing Accreditation
7.13.1, 7.13.2, 7.13.3 6.9 � SADCAS AP 14: Accreditation Decision Making Process
� SADCAS TG 01: Information to Organizations Applying for Accreditation
� SADCAS TR 02: Accreditation Requirements
� SADCAS TR 06: Suspension and Reinstatement of Accredited Organizations
� SADCAS F 75: Accreditation Approvals Committee’s Evaluation of
Assessment Packs
� SADCAS F 77: Technical Manager’s Evaluation of Assessment Packs
7.14 Records of Conformity
Assessment Bodies
7.14.1 6.12 � SADCAS AP 04: Records Management
7.15 Proficiency Testing and
Other Comparisons for
Laboratories
� SADCAS TR 04: Proficiency Testing and other Comparison Programmes
Requirements for Calibration Laboratories
� SADCAS TR 08: Proficiency Testing and other Comparison Programmes
Requirements for Testing and Medical Laboratories
� Website Links to PT Service Providers
7.15.1, 7.15.2, 7.15.3 6.13 � SADCAS TR 04: Proficiency Testing and Other Comparison Programmes
Requirements for Calibration Laboratories
� SADCAS TR 08: Proficiency Testing and Other Comparison Programmes
Requirements for Testing and Medical Laboratories
� SADCAS website for links to PT service providers
� SADCAS 61 (e): Proficiency Testing Requirements ISO/IEC 17025:2005
Clause 5.9 and SADCAS Requirements
� ILAC P 9: ILAC Policy for Participation in Proficiency Testing Activities
Document No: SADCAS PM 01 Issue No: 14
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ISO/IEC 17011 Clause SADCAS Policy Manual PM 01
Clause
Other Documents
8. Responsibilities of the
Accreditation Body and the
Conformity Assessment
Body
8.1 Obligations of the
Conformity Assessment
Body
8.1.1, 8.1.2 6.15.1 � SADCAS TG 01: Information to Organizations Applying for Accreditation
� SADCAS TR 02: Accreditation Requirements
� SADCAS F 44: SADCAS Accreditation Agreement
8.2 Obligations of the
Accreditation Body
8.2.1 6.6 � Directory of Accredited facilities on SADCAS website www.sadcas.org
� Accreditation Certificate and Schedule
� SADCAS AP 19: Cross frontier accreditation
8.2.2 6.14 � SADCAS TR 02: Accreditation Requirements
� SADCAS TR 12: Estimation of the uncertainty of Measurement by
Calibration Laboratories and Specification of Calibration and
Measurement Capability on Schedules of Accreditation
� ILAC P 10: ILAC Policy on the Traceability of Measurement Results
� ILAC P 14: ILAC Policy for Uncertainty in Calibration
� ISO Guide 33: Reference materials – Good practice in using reference
materials
8.2.3 6.15.2
8.2.4 6.9 � SADCAS TR 06: Suspension and reinstatement of accredited organizations
8.3 Reference to Accreditation
and Use of Symbol
Document No: SADCAS PM 01 Issue No: 14
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Other Documents
8.3.1, 8.3.2, 8.3.3 6.15.3 � SADCAS TR 01: Conditions for Use of SADCAS Accreditation Mark
� SADCAS TR 01: Part 2: Use of Combined Marks
� SADCAS TG 01: SADCAS TG 01: Information to Organizations Applying for
Accreditation
� SADCAS TR 06: Suspension and Reinstatement of Accredited Organizations
� ILAC/IAF A2: IAF/ILAC Multi- Lateral Mutual Recognition Arrangements
(Arrangements): Requirements and Procedures for Evaluation of a single
Accreditation Body
� ILAC/IAF A3: IAF/ILAC Multi - Lateral Mutual Recognition Arrangements
(Arrangements): Narrative Framework for Reporting on the Performance
of an Accreditation Body � ILAC P 8: ILAC Mutual Recognition Arrangement ( Arrangement):
Supplementary Requirements and Guidelines for the Use of Accreditation
Symbols and for Claims of Accreditation Status by Accredited Laboratories
and Inspection Bodies
� ILAC R 7: Rules for the use of the ILAC MRA Mark
6.16 � ILAC G 21: Cross frontier Accreditation Principles for Cooperation
� IAF GD 3: Guidance on Cross Frontier
Document No: SADCAS PM 01 Issue No: 14
Page 59 of 74
APPENDIX B - AMENDMENT RECORD
Revision
Status
Change
Approved by Effective Date Page Clause/ Sub
clause
Description of Change
Issue 3 - - - SADCAS
Board
2011-11-25
Issue 3 3 Table of
Contents
� Inserted 2 new items “6.14 Traceability”
and “6.15 Reference Materials” and
renumber the old “6.14” to 6.16”
� Deleted “Annex 1” and substituted with
“APPENDIX A”.
� Added “APPENDIX B – AMENDMENT
RECORD”.
SADCAS
Board
2013-05-31
7 3.5.2 2nd paragraph - Added at end of sentence
“SADCAS has in place procedures for the
development of new accreditation
programmes”.
Reference – Added “SADCAS AP 16: Procedure
for the Development of New Accreditation
Programmes”.
SADCAS
Board 2013-05-31
8 3.7.1 Bullet 4 – Deleted bullet in its entirety
SADCAS
Board 2013-05-31
9 3.7.2 Added to list of references :
� “SADCAS BP 07: Part 1: SADCAS Board of
Directors Skills and Expertise Requirements
� SADCAS BP 07: Part 2: SADCAS Board of
Directors Expertise Matrix”.
SADCAS
Board 2013-05-31
10 3.7.4 Replaced Figure 1 with revised SADCAS
Organizational Structure as approved by the
Board.
SADCAS
Board 2013-05-31
19 4.1.2 2nd paragraph – After first sentence inserted new
sentence as follows:
“The SADCAS Quality Management Committee
shall comprise of all SADCAS staff”
SADCAS
Board 2013-05-31
20 4.2.2 Line 2 – Deleted “Board Chairman” and
substituted with “SADCAS Board”.
Line 3 – Deleted “/Technical Manager/ Quality
Manager”.
Lines 3 to 6 – Deleted last sentence.
SADCAS
Board 2013-05-31
4.2.4 Line 1 – Inserted “and assessors/experts”
between “SADCAS” and “shall”.
SADCAS
Board 2013-05-31
Document No: SADCAS PM 01 Issue No: 14
Page 60 of 74
Revision
Status
Change
Approved by Effective Date Page Clause/ Sub
clause
Description of Change
21 4.2.5 Line 2 – Deleted “Quality Manager” and
substitute with “Accreditation Administrator”
SADCAS
Board 2013-05-31
4.3 Line 8 – Deleted “Accreditation Administrator”
and substituted with “respective record
Keeper”.
SADCAS
Board 2013-05-31
22 4.6 2nd paragraph – Deleted “selected from the pool
of registered ...... peer evaluators”.
SADCAS
Board 2013-05-31
23 4.8 � Line 2 – After 2nd sentence added new
sentence as follows: “SADCAS shall decide
on the validity of complaints. Valid”
� Added 2nd paragraph as follows: “The
records pertaining to complaints and
disputes shall be kept by the Accreditation
Administrator”.
� Added to list of Reference documents
“SADCAS AP 04: Records Management”.
SADCAS
Board 2013-05-31
26 6.2.3.2 Line 2 – Deleted “ISO/IEC Guide 65” and
substituted with “ISO/IEC 17065”.
SADCAS
Board 2013-05-31
27 6.2.4 References – Added the following to list of
references:
� SADCAS AP 12: Part 1: Accreditation Process
for Testing/ Calibration/ Medical
Laboratories
� SADCAS AP 12: Part 1: Accreditation of
Inspection Bodies Operating in the
Regulatory/ Voluntary Area
SADCAS
Board 2013-05-31
28 6.3.3 Line 6 – Inserted “Conformity assessment bodies
shall identify and propose corrective action on
the findings raised within one month after the
assessment” between “action” and “action.” and
“The”.
SADCAS
Board 2013-05-31
6.3.4 At end of paragraph assed new sentence as
follows “Surveillance onsite assessments shall be
planned taking into account other surveillance
activities. Conformity assessment bodies shall
identify and propose corrective action within
one month after the surveillance assessment”.
SADCAS
Board 2013-05-31
Document No: SADCAS PM 01 Issue No: 14
Page 61 of 74
Revision
Status
Change
Approved by Effective Date Page Clause/ Sub
clause
Description of Change
6.3.5 Line – Inserted “least six months before”.
SADCAS
Board 2013-05-31
29 6.3.7 References: Added the following documents to
list of references:
� SADCAS AP 12: Part 1: Accreditation Process
for Testing/ Calibration/ Medical
Laboratories
� SADCAS AP 12: Part 2: Accreditation of
Inspection bodies Operating in the
Regulatory/ Voluntary Area
� SADCAS AP 15: SADCAS Accreditation
Administration Processes
� SADCAS AP 17: Onsite Clearance of Findings
� SADCAS AP 18: Criteria for Extraordinary
Assessments
SADCAS
Board 2013-05-31
6.4 Added at the end of paragraph “SADCAS shall
remain responsible for the content of the
assessment report including nonconformities,
even if the Lead assessor is not a permanent
member of SADCAS staff.”
SADCAS
Board 2013-05-31
6.5 Added new paragraph after (b) as follows:
“SADCAS shall, without undue delay make the
decision on whether to grant or extend
accreditation”.
SADCAS
Board 2013-05-31
30 6.6 Added new paragraph to read “Status of
Accreditation - SADCAS shall make publicly
available on the website” www.sadcas.org the
current status of the accreditation it has granted
to conformity assessment bodies”.
SADCAS
Board 2013-05-31
31
6.9 � Title – Deleted title and substituted with
“Suspending, Withdrawal or Reducing
Accreditation”.
� 1st paragraph – Deleted “terminated in part
or as a whole” and substitute with
“withdrawn or the accreditation scope can
be reduced”.
� 2nd paragraph – line 4 - Deleted
“terminated” and substituted with
“withdrawn”.
� 2nd paragraph – line 3 – Deleted
“termination” and substituted with
“withdrawal”.
SADCAS
Board 2013-05-31
Document No: SADCAS PM 01 Issue No: 14
Page 62 of 74
Revision
Status
Change
Approved by Effective Date Page Clause/ Sub
clause
Description of Change
� 3rd paragraph – line 1 – Deleted “terminate”
and substituted with “withdraw/ reduce
scope of”.
32 6.10 Line 4 – Added “assessments” between
“Accreditation” and “will”.
Issue 4 32 6.11 Added new paragraph as follows: “Records
pertaining to appeals shall be kept by the Chief
Executive Officer”.
SADCAS
Board 2013-05-31
6.12 6.12 (e) – Inserted “records and” between
“Assessment” and “report”.
SADCAS
Board 2013-05-31
33 6.13.1 Line 1
� Added at the end of line 1”/ Inter laboratory
Comparison”.
� Added Reference list as follows: “SADCAS TR
08: Proficiency Testing and Other
Comparison Programmes Requirements for
Testing and Medical Laboratories”.
SADCAS
Board 2013-05-31
6.13.2 Added Reference list as follows: SADCAS TR 04:
Proficiency Testing and other Comparison
Programmes Requirements for Calibration
Laboratories
SADCAS
Board 2013-05-31
34 6.14 Added new sub clause as follows: “6.14
Traceability Accredited conformity assessment
bodies are required to demonstrate that
calibration of critical equipment and hence the
measurement results generated by that
equipment, relevant to their scope of
accreditation, and traceable to the International
System of Units (SI Units).
Metrological traceability can be demonstrated by
having calibrations performed by National
Metrology Institutes or by accredited calibration
laboratories. The following SADC countries’
National Metrology Institutes are signatory to the
CIPM Mutual Recognition Arrangement:
Botswana, Mauritius, Namibia, Seychelles,
Zambia and Zimbabwe. The SADC Cooperation in
Metrology (SADCMET) has a system in place in
the region through which the rest of the
countries that are not yet signatory to the CIPM
MRA get their traceability.
SADCAS
Board 2013-05-31
Document No: SADCAS PM 01 Issue No: 14
Page 63 of 74
Revision
Status
Change
Approved by Effective Date Page Clause/ Sub
clause
Description of Change
Calibration certificates issued by non accredited
facilities shall provide sufficient information
regarding the process of calibration”.
34 6.15 Added new sub clause as follows: “6.15
Reference Materials - SADCAS accredited
testing/ medical laboratories shall have a
programme and procedure in place for the
calibration of its reference standards shall
be calibrated by a body that can provide
traceability.”
SADCAS
Board 2013-05-31
6.14 Renumbered “6.14’ to 6.16” and subsequent
subclasses.
SADCAS
Board 2013-05-31
6.14.3
renumbered
6.16.3
Title – lines 1, 3 and 6 – Deleted “symbol” and
substituted with “mark”.
SADCAS
Board 2013-05-31
37 Appendix A Updated cross referencing between ISO/IEC
17011 and SADCAS Documents taking into
account newly developed documents.
SADCAS
Board 2013-05-31
Issue 5 3 Contents Added “6.17 Cross frontier accreditation”.
SADCAS
Board 2013-11-21
7 3.5.1 Paragraph 1: Delete last sentence.
Added 2nd paragraph which reads “In order not to
compromise its impartiality and status in training
service delivery, SADCAS does not give specific
advice for the development of an organization’s
operations. Furthermore the training courses
delivered or facilitated by SADCAS are not a
precondition of accreditation neither do they
guarantee accreditation by SADCAS.”
SADCAS
Board 2013-11-21
9 3.6 References: Added to list of references “Record
of SADC Council of Ministers meeting held in
August 2007”
SADCAS
Board 2013-11-21
16 3.9 References: Added to list of references “SADCAS
F 27: Gift register”
SADCAS
Board 2013-11-21
3.10.1 Lines 1 and 2: Deleted “organizations” and
substituted with “facilities”.
Line 3: Inserted “and on the accreditation
agreement” between “accreditation” and
“Liability”.
SADCAS
Board 2013-11-21
17 3.10.2 References: Added to list of references “SADCAS
Annual Budgets”
SADCAS
Board 2013-11-21
Document No: SADCAS PM 01 Issue No: 14
Page 64 of 74
Revision
Status
Change
Approved by Effective Date Page Clause/ Sub
clause
Description of Change
22 4.5 New 2nd Paragraph: Added 2nd paragraph which
reads “SADCAS has developed a risk profile which
is reviewed annually with measures being put in
place to mitigate against the identified risks.”
References: Added to list of references “SADCAS
BP 06: SADCAS Risk Profile”
SADCAS
Board 2013-11-21
26 5.4 References: Added to list of references “SADCAS
F 25: national Accreditation Focal points Record”
SADCAS
Board 2013-11-21
28 6.2.4 References: Added the following to list of
references:
� ISO 22003 – Food safety management
systems- Requirements for bodies providing
audit and certification of food safety
management systems
� SADCAS TR 05 - Criteria for the accreditation
of Inspection Bodies Performing Inspection in
terms of the Pressure vessels/boilers
regulations in Zimbabwe.
� SADCAS TR 11- Criteria for the accreditation of
calibration satellite laboratories and branch
offices
� SADCAS AP 12- Part 3:Accreditation Process
for Certification Bodies
SADCAS
Board 2013-11-21
29 6.3.3 Line 6: Inserted “be invited to” between “shall”
and “identify”
SADCAS
Board 2013-11-21
6.3.4 Lines 6 and 7: Inserted “be invited to” between
“shall” and “identify”
SADCAS
Board 2013-11-21
31 6.3.7 References: Added the following to list of
references
� SADCAS AP 10 – Contracting of assessment
personnel
� SADCAS AP 12: Part 3 – Accreditation process
for certification bodies
� SADCAS AP 20: Sampling for assessment
purposes
� TPAJ01: Guidelines for SADCAS/SANAS joint
assessments under the TPA
SADCAS
Board 2013-11-21
33 6.6 2nd Paragraph : Elaborated on (f) as follows
� Tests or types of tests performed and
materials or products tested.
� Where appropriate, the methods used (for
testing/medical laboratories).
� For calibration laboratories to include the
types of measurements performed, the
calibration and measurement capability
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(CMC) expressed as uncertainty of
measurement, measurement range and
additional parameters where applicable, e.g.
frequency of applied voltage.
� For inspection bodies to include the field,
type and range of inspection.
New Bullet (h) and (i): Added 2 new bullets as
follows:
� “Contact details of the accredited facility:
� Personnel approved”
35 6.12 New Bullet: Added new bullet (f) as follows:
“(f) Records of committee deliberations, if
applicable, and accreditation decisions”
SADCAS
Board 2013-11-21
6.13.1 1st sentence: deleted 1st sentence and
substituted with “Applicant and accredited
laboratories are required to participate in
appropriate proficiency testing schemes/ inter
laboratory comparisons and where such
schemes are available in their technical field of
work in order to demonstrate their capabilities
and to assist in maintaining quality of laboratory
performance.”
SADCAS
Board 2013-11-21
36 6.13.2 1st sentence: Added “and to assist in maintaining
quality of laboratory performance.” At the end
of the sentence.
SADCAS
Board 2013-11-21
37 6.14 2nd and 3rd Paragraph: deleted 2nd and 3rd
paragraph an substituted with
7.3.1 Metrological Traceability - Equipment and
reference standards used by calibration
laboratories and having an impact on the
accuracy and validity of measurements results
shall be calibrated by:
e) A National Metrology Institute whose service
is suitable for the intended need and belongs
to the CIPM and are signatories to its Mutual
Recognition Agreement (MRA) amongst NMIs
and who have approved CMC’s within the
BIPM Key Comparison Database (KCDB) which
includes the range and uncertainty for each
listed service. Within the SADC region the
following SADC Countries’ National Metrology
Institutes are signatory to the CIPM MRA:
Botswana, Mauritius, Namibia, South Africa,
Seychelles, Zambia and Zimbabwe.
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f) A calibration laboratory accredited by an
accreditation body covered by the ILAC
Arrangement or by Regional Arrangements
recognized by ILAC whose service is suitable
for the appropriate calibration.
g) A National Metrology Institute whose service
is suitable for the intended need but not
covered by the CIPM MRA. The National
Metrology Institute shall have participated in
the SADC Cooperation in Metrology
(SADCMET) through which SADC countries
that are not yet signatory to the CIPM can get
their traceability. Calibration certificates
issued by the National Metrology Institute
shall provide sufficient information regarding
the process of calibration.
Options a) and b) above are the preferred
SADCAS options for metrological traceability.
Option c) is only applicable when options a) and
b) are not possible.
6.14.2 Traceability for Testing/ Medical
Laboratories. – Equipment and instruments used
by testing/medical laboratories and having a
significant impact on the measurements results
shall be calibrated. If however calibration is not a
dominant factor in the testing result, traceability
does not need to be demonstrated but the
laboratory shall have quantitative evidence to
demonstrate that the calibration contributes
insignificantly to the measurement results and
the measurement uncertainty of the test.
In the case where traceability is provided from
reference materials and certified materials the
following shall apply:
a) Testing/medical laboratories shall have a
programme and procedure for the
calibration of the reference materials.
b) Reference materials used by testing/medical
laboratories shall be inspected, verified as
complying with standards specifications/
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requirements defined in the methods for the
tests and/or calibrations concerned.
c) Reference materials shall be, where possible,
traceable to SI units of measurements. They
shall be calibrated by one of the process
defined in 3.2.5.1
d) Where calibrations cannot be made to SI
units, testing/medical laboratories shall
provide confidence in measurements results
by the use of certified reference materials
provided by a competent supplier and/or to
other specified methods or consensus
standards.
To maintain confidence in the calibration status,
intermediate checks need to be performed
by all accredited facilities. SADCAS
requirements are outlined in SADCAS TR 09
– Criteria for Performing Calibration and
Intermediate Checks on Equipment used in
Accredited Facilities
References:
� SADCAS TR 02: Accreditation Requirements
� SADCAS TR 09: Criteria for performing
calibration and intermediate checks on
equipment used in accredited facilities”.
40 6.17 New Sub clause 6.17: Added new sub clause 6.17
which reads “SADCAS is a multi economy
accreditation body established to meet the
accreditation needs of SADC Member States
which do not have national accreditation bodies
or where national accreditation body has a
limited scope. Applications for accreditation
received by SADCAS from conformity assessment
bodies based in countries that are not part of the
Southern African Development Community
(SADC) shall be handled in accordance with the
cross frontier procedure. The cross frontier
document also covers the procedure to be
followed when SADCAS accredited facilities
whose main office or head office is based in any
one of the SADC countries that are serviced by
SADCAS and has issued SADCAS accredited
certificates to clients based from outside the
respective country. SADCAS is committed to
SADCAS
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abide by the ILAC/IAF cross frontier accreditation
principles of cooperation.
References:
SADCAS AP 19: Cross frontier Accreditation”
41
to
63
Appendix A Updated Appendix A SADCAS
Board 2013-11-21
Issue 5 27 6.2.4 Added to list of reference documents “Applicable
IAF MD Series Documents”
SADCAS
Board
2014-09-28
34 6.13.1 Added to list of reference documents “ILAC P 9:
ILAC Policy for Participation in Proficiency Testing
Activities”
SADCAS
Board
2014-09-28
34 6.14.1 a) Deleted last sentence which reads “Within the
SADC region................Zimbabwe.”
Added new paragraph which reads “The
acceptance of other NMIs other than those of
CIPM MRA partners shall be at the discretion of
the SADCAS Chief Executive Officer after due
consultations of the appropriate Advisory
Committee.”
SADCAS
Board
2014-09-28
35 6.14.1 d) Added new sub clause 6.14.1 d) which reads “A
calibration laboratory whose service is suitable
for the intended need but not covered by the
ILAC Arrangement or by regional arrangements
recognized by ILAC.
For options c) and d) appropriate evidence for
the technical competence of the laboratory and
claimed metrological traceability shall include
the following:
- Record of calibration method validation;
- Procedures for estimation of uncertainty ;
- Documentation for traceability of
measurements;
- Documentation for assuring the quality of
calibration results;
- Documentation for the competence of staff;
- Documentation for accommodation and
environmental conditions; and
- Audits of the calibration laboratory.”
SADCAS
Board
2014-09-28
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35 6.14.1 Deleted last paragraph which reads “Options a)
and b) ............are not possible and substituted
with "Options a) and b) above are the preferred
SADCAS options for metrological traceability.
Options c) and d) are only applicable when
options a) and b) are not possible"
SADCAS
Board
2014-09-28
36 6.14.2 Added to list of reference documents “ILAC P 10:
ILAC Policy on the Traceability of Measurement
Results and ILAC P 14: ILAC Policy for Uncertainty
in Calibration
SADCAS
Board
2014-09-28
38
and
39
6.16.3 Added to list of reference documents “ILAC/IAF
A2: IAF/ILAC Multi- Lateral Mutual Recognition
Arrangements (Arrangements): Requirements
and Procedures for Evaluation of a single
Accreditation Body; ILAC/IAF A3: IAF/ILAC Multi
- Lateral Mutual Recognition Arrangements
(Arrangements): Narrative Framework for
Reporting on the Performance of an
Accreditation Body; ILAC P 8: ILAC Mutual
Recognition Arrangement (Arrangement):
Supplementary Requirements and Guidelines for
the Use of Accreditation Symbols and for Claims
of Accreditation Status by Accredited
Laboratories and Inspection Bodies; and ILAC R 7:
Rules for the use of the ILAC MRA Mark
SADCAS
Board
2014-09-28
39 6.17 Added to list of reference documents “ILAC G 21:
Cross frontier accreditation Principles; and IAF
GD 3: Guidance on Cross Frontier”
SADCAS
Board
2014-09-28
49,
57,
58
Appendix A Updated cross referencing to include ILAC/IAF
documents
SADCAS
Board
2014-09-28
Issue 6 34 6.14.1 (a) 2nd paragraph – Inserted “subject to satisfactory
evidence of the technical competence of the
laboratory using appropriate methods as
outlined in the technical procedures” after
“Advisory Committee”
SADCAS
Board
2015-02-03
Issue 7 7 3.5.1 Bullet 4 – Deleted “Guide 65” and substituted
with “17065”
SADCAS
Board
2015-05-07
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10 3.7.5.1 Deleted 2nd sentence and substituted with “The
Accreditation Approvals Committee shall consist
of not less than 2 members, one of whom shall be
the SADCAS Chief Executive Officer. For decisions
arising from surveillance assessments, extension
to new scopes and additional signatories, the AAC
shall consist of at least one member. Any other
specialized technical expert shall be invited to
serve on the AAC as deemed necessary.”
SAEDCAS
Board
2015-05-07
22 4.7 (g) Inserted “and corrective” between “preventive”
and “actions”
SADCAS
Board
2015-05-07
49 7.5.1 Cross Referencing to SADCAS Policy Manual PM
01 – delete “6.3.2” and substitute with “3.9”
SADCAS
Board
2015-05-07
Issue 8 34 6.14.1 a) – Deleted second paragraph.
c) – Added second paragraph which reads: “The
acceptance of other NMIs other than those of
CIPM MRA partners shall be at the discretion of
the SADCAS Chief Executive Officer after due
consultations of the appropriate Advisory
Committee subject to satisfactory evidence of
the technical competence of the laboratory using
appropriate methods as outlined in the technical
procedures”.
SADCAS
Board
2015-05-26
Issue 9 5 2 1st paragraph line 3 – Deleted “10(1) and 10 (2) of
the SADC Memorandum of Understanding-------
and Metrology” and substituted with “15 B of the
Technical Barriers to Trade (TBT) Annex to the
SADC Protocol on Trade.”
SADCAS
Board
2015-07-29
6 3.1 1st paragraph lines 3 to 6 – Deleted 10(1) and 10
(2) of the SADC Memorandum of Understanding-
------SADC Protocol on Trade” and substituted
with ““15 B of the Technical Barriers to Trade
(TBT) Annex to the SADC Protocol on Trade.”
SADCAS
Board
2015-07-29
8 3.6 List of References – Deleted “2 SADC SQAM
Memorandum of Understanding” and
renumbered subsequent reference.
SADCAS
Board
2015-07-29
26 New 6.14.3 Inserted new sub clause 6.14.3 before list of
references, entitled “Traceability Provided From
Reference Materials” which reads
SADCAS
Board
2015-07-29
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“When the conformity assessment bodies use
reference materials (RM)/certified reference
materials (CRM) to establish traceability then
a) The RM/ CRM must be produced by a NMI,
and covered by BIPM/KCDB ; or
(b) The RM/CRM must be produced by Reference
Materials Producer (RMP) which is
accredited by any accreditation body which
is signatory to the ILAC Mutual Recognition
Arrangement or by a recognized regional
cooperation (APLAC/EA/IAAC) Mutual
Recognition Arrangement for RMP in the
accredited scope.
Note: For use of RM/CRM, ISO Guide
33: Reference materials – Good practice in using
reference materials” may be referred.
26 6.14.3 Added to list of references
“SADCAS TR 12: Estimation of the Uncertainty
of Measurement by Calibration Laboratories and
Specification of Calibration and Measurement
Capability on Schedules of Accreditation.
ISO Guide 33: Reference materials – Good
practice in using reference materials.”
SADCAS
Board
2015-07-29
26 6.15 Deleted Clause 6.15 in its entirety and
renumbered subsequent clauses accordingly.
SADCAS
Board
2015-07-29
38 6.16 Deleted 3rd Sentence which reads “The cross
frontier document also covers the procedure to
be followed when SADCAS accredited facilities
whose main office or head office is based in any
one of the SADC countries that are serviced by
SADCAS and has issued SADCAS accredited
certificates to clients based from outside the
respective country.”
SADCAS
Board
2015-07-29
39
to
57
Appendix A Updated Appendix A in line with the above
changes.
SADCAS
Board
2015-07-29
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Issue 10 32 6.9 Inserted new paragraph between paragraphs 2
and 3 to define ‘reducing accreditation”
SADCAS
Board
2016-07-22
34 6.13.1
6.13.2
At the end of both sub clauses added a sentence
which reads “SADCAS maintains links to PT
service providers on the website
www.sadcas.org”
Issue 11 2 Contents Added “3.14 Regional and International
connections”
SADCAS
Board
2017-05-05
5 Policy
Statement
Page 5 Bullet 1 – Inserted “AFRAC , SADCA”
between “of” and “ILAC”
7 3.4 Updated the SADCAS vision
18 3.14 Added new sub clause 3.14 on membership in
regional and international accreditation fora
35
and
36
6.14.2 Deleted sub -clause and substituted with
a) Equipment and instruments used by testing/
medical laboratories and having a significant
impact on the measurements results shall be
calibrated.
b) If however calibration is not a dominant
factor in the testing result, traceability does
not need to be demonstrated but the
laboratory shall have quantitative evidence
to demonstrate that the calibration
contributes insignificantly to the
measurement results and the measurement
uncertainty of the test. “
Issue 12 9 3.7.3 • Deleted Clause in its entirety and substituted
with text for the new structure which reads:
“SADCAS is composed of three functional units.
The technical unit is responsible for the overall
management of the accreditation process. The
corporate services unit provides support
services to internal and external business
interests and is responsible for ICT, marketing
and public relations, business development and
administration of training services. The finance
and administration unit is responsible for
financial management, human resources
management and general administration of the
company. Refer to Figure 1.”
SADCAS
Board
2017-06-14
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• Deleted old organizational structure and
substituted with new structure”
11 3.8.3 Added new sub clause which covers the
summary of responsibilities of the Programme
Coordinator
3.8.4 Changed the title of the Financial Administrator
3.8.6 Added new sub clause which covers the
summary of responsibilities of the
Administrative assistant.
Renumbered all subsequent sub clauses
accordingly
16 3.10
Changed title of subclause 3.10 to “Liability and
Funding”
3.10.2 Updated the sub clause on Funding of SADCAS
to make mention to the funding of operational
budget deficit by Governments of SADC Member
States that are serviced by SADCAS
35 6.14.3 Added new sub clause 6.14.3 entitled
“Traceability for Inspection Bodies” and which
reads:
“Equipment used by inspection bodies and
having significant impact on measurement
results shall be calibrated. SADCAS accepts
evidence of traceability as outlined in 6.14.1.
Where traceability as stated above is not
technically possible or reasonable or available,
the inspection body and client and other
interested parties may agree to using reference
materials/ certified reference materials as
outlined in 6.14.4.”
Issue 13 12 3.8.4 Delete sub clause and substitute with “The
Accreditation Administrator is responsible for
overseeing all administrative activities and
assessment processes. The responsibilities and
duties of the Accreditation Administrator are
outlined in a job description duly signed by the
Accreditation Administrator and the Programme
Coordinator as the immediate supervisor.”
SADCAS
Board
2017-08-11
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Issue 13 36 6.14.2 Deleted text in 6.14.2 and substituted with
“Equipment and instruments used by testing/
medical laboratories and having a significant
impact on the measurements results shall be
calibrated. SADCAS accepts evidence of
traceability as outlined in 6.14.1.
Where traceability as stated above is not
technically possible or reasonable or available,
the testing/ medical laboratories and client and
other interested parties may agree to using
reference materials /certified reference
materials as outlined in 6.14.4.”
37 6.14.3 Renumbered the 2nd 6.14.3 to 6.14.4