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WELCOME. 2013 C ommunication Meeting September 2013. CEO Report. 2013 C ommunication Meeting September 2013. Focus 2010 to 2015. Accreditation for Conformity Assessment, Calibration and Good Laboratory Practice Act, 2006 (Act 19 of 2006 ) Functions: - PowerPoint PPT PresentationTRANSCRIPT
WELCOME
2013 Communication MeetingSeptember 2013
CEO Report
2013 Communication MeetingSeptember 2013
Accreditation for Conformity Assessment, Calibration and Good Laboratory Practice Act, 2006 (Act 19 of 2006)
Functions:
d) Promote the acceptance of its activities and those of all bodies accredited by SANAS or its international counterparts;
e) Promote the recognition of accredited bodies by users of conformity assessment;
f) Liaise with regional and international standard bodies and with technical regulatory and metrology organisations in respect of any matter related to accreditation;
Focus 2010 to 2015
Content• Growth in accreditation & analysis;• New areas and associate conformity assessment required;• Acceptance of Conformity Assessment results in Africa;• Support for Conformity Assessment Bodies;• Preparing SANAS• Feedback on Customer Experience measure;• Upcoming events
Accreditation Stats – June 2013
Testing
Medical
Veterinary
BBBEE
Verifica
tion
Calibration
Inspection
Pharmace
utical
BTS
Forensic
s
GCP/GLP
CRM PTS
Certifica
tion0
50
100
150
200
250
300
350
302292
17
65
149
211
148
6
181
2 7 2 4
34
Total Number of Accredited Facilities: 1420 as at June 2013
Growth Statistics: March 2012 to March 2013
Total Number of Accredited Facilit -ies: June 2013
Calibration
CRM PTSCert
Medical
Legal M
etr
Inspection
Testing
BTS
Veterinary GLP GCP
Forensic
Pharmace
utical
BBBEE-10
-5
0
5
10
15
20
12
0 0 0
3
-7
1820
0
31
0 10
-8
Growth increase by (58) 43 accredited facilities since 2012
Upcoming ExtensionsOwner Status Inspection/
VerificationTesting Calibration Certificatio
nOthe
r
Dept. of tourism Responsible tourism Launched
- - - X -
Dept. Of Labour Occupational Health and
SafetyPartially rolled out
X X X
Risk Based Inspection (RBI) Launched x x
Dept. of Energy & BUSA
Energy Management ISO/IEC 5003 - February 2014 Carbon tax incentives
Feb 2014 roll out
X
- OHSAS 1800 LaunchedX
BUSAGreenhouse Gas ISO/IEC 14065 Validation and Verification ,
Launchedx x
Dept. Environmental Affairs
Air Quality Monitoring newX x
Water & Environmental Affairs
Waste Water Management newX x
Industrial Policy Action Plan (IPAP) Priority Sector needs
Sector Testing Calibration Certification Inspection
Green Economy: Energy savings
Stack Emission Testing X X
Certification of Buildings X X
Nuclearx x X X
Information Security X
Road transport Management
Truck owner compliance
?? ??
Supporting the acceptance of Conformity Assessment Bodies (CAB’s) results in AfricaPan African Accreditation Cooperation (AFRAC)The aim is to ensure the acceptance of our goods and service in Africa based on the acceptance of our testing, inspection and certification results.
– South Africa through SANAS hold the Chair and Secretariat of AFRAC;
– MoU signed between AFRAC, African Standards Organisation (ARSO), African Electro technical Standards Commission (AFSEC) and the African Metrology Institute (AFRIMETS);
– The above cooperation known as the Pan African Quality Infrastructure (PAQI) approved by the African Union (AU) Council of Ministers of Trade (CAMI) and will be table at the upcoming Heads of AU States meeting early new year for endorsement
Support for Conformity Assessment Bodies (CAB’s)
• MCEP : a Department of Trade and Industry incentive, supporting CAB’s on a cost share basis:– Development& Implementation of Management
system;– Equipment;– Extension of facilities;– Further incentive for job creation;
– the dti website: www.thedti.gov.za
SANAS’ AlignmentArea Status June 2013 Target (2015)
Staff compliment62 75
• Improve service delivery & communication
ICT• Application process
partially automated;• Finance and
procurement updated
• Online registration and tracking of processes
Customer Experience measure • 47.2 • 60
Finance (Under recovery on provision of services excluding government contribution)
- 6.78 0
• Invoicing;• Budgeting: Under
recovering for services rendered;
• Efficiency improvement
Customer Experience Measure 2012/13
Methodology & Sample Realisation
• All interviews were done telephonically (CATI system) • Interviews were conducted 4 March to 4 April 2013• Average duration of interviews: 11min 30secs
Target Sample: 170Sample realised: 236
Total Sample = 236(5.29% margin of error at a confidence level of 93%)
Available Contacts: 752
2011 2012 2013Sample (n) = 171 Sample (n) = 144 Sample (n) = 236
NPS 20.6% 28.6% 35.1%
CSM
40.00 100
55.3%
Failure Delight
43.70 100
2.8% 60.4%
Failure Delight
47.20 100
1.7% 61.4%
Failure Delight
0.6%
Modelled Score – Annual Change20132011 2012
NPS = Net Promoters Score;CSM = Customer Satisfaction Measure
Slide 15
Modelled Index Score by Division by Year2011 2012 2013
Sample (n) = 171 Sample (n) = 144 Sample (n) = 236
Query
Assessment
Benefits
Certificates
66.5 70.0 73.00 100 0 100 0 100
77.1 80.3 82.50 100 0 100 0 100
69.4 71.9 73.70 100 0 100 0 100
67.7 71.3 74.70 100 0 100 0 100
20122011 2013
EventsEvent Date
Accreditation Day - Durban 9 June 2013
Annual Communication Meeting - Gauteng
16 September 2013
Annual Communication Meeting - Durban
18 September 2013
Annual Communication Meeting – Cape Town & PE
19 & 20 September 2013
AFRAC General Assembly (Kenya) 24 to 27 September 2013
ILAC and IAF General Assembly (Korea) 16 to 25 October 2013
Thank You
RE-ASSESSMENT AND ASSOCIATED DOCUMENTATION REVIEWS
Linda Grundlingh
Field Manager: Inspection2013 Communication Meetings
RE-ASSESSMENTS
ISO/IEC 17011 clause 7.11.1:• Re-assessment is similar to an Initial
assessment as described in clauses 7.5 to 7.9, except that experience gained during previous assessments shall be taken into account.
• During the August 2011 peer evaluation, it was brought to our attention that we did not comply with clauses 7.5.10, 7.6 & 7.11.1 in that we did not conduct document reviews prior to Re-assessment.
SANAS CORRECTIVE ACTION
• Re-assessments are conducted at least 3-months (6-months in regulatory fields) prior to the start of each new accreditation cycle.
• Re-assessment visits will involve a comprehensive re-examination of the facility’s accredited activities at the beginning of each new cycle, and will be similar to the Initial assessment.
• This includes a full documentation review.
RECENT CHANGES
• The Re-assessment process has been revised to include a re-application process which is mandatory, followed by the review of facility documents prior to the Re-assessment.
• This means that as of 01 April 2013, each facility is required to re-apply for accreditation at least 6-months prior to, and in the case of Inspection Bodies 9-months prior to the expiry of their Certificate and Schedule of Accreditation.
WHAT HAS CHANGED?
1. On re-application, each facility will need to complete the relevant revised F14 application form and submit it to SANAS with the relevant documentation as prescribed in each application form.
2. This will include the facilities Management System Documentation (Quality manual), along with specific information or documents as specified in each application (Checklists etc.)
WHAT HAS CHANGED?
3. On receipt of the application, SANAS will conduct a review of the information submitted.
4. SANAS will arrange for a Re-assessment approximately 3-months prior to, and in the case of Inspection Bodies 6-months prior to the expiry of the Certificate and Schedule of Accreditation.
WHAT IF A FACILITY DOES NOT RE-APPY?
1. Where SANAS has not received the application for Re-assessment, the Re-assessment will not be scheduled.
2. The facility’s accreditation will expire on the expiry of the Certificate and Schedule of accreditation.
HOW CAN THIS BE PREVENTED?• To prevent any periods of non-accreditation,
or to prevent losing your accreditation status, facilities must re-apply within the timelines stipulated by SANAS. These are:
• At least 6-months prior to, and in the case of Inspection Bodies 9-months prior to the expiry date of their Certificate and Schedule of Accreditation).
IMPLEMENTATION TIME LINE
Facilities should have submitted their applications already for Certificates expiring in October and November 2013, however, if this has not yet been done, SANAS will allow a grace period and still accept the applications for Re-assessment at this stage.
WHAT ELSE HAS CHANGED?
• Whilst reviewing the re-application process, SANAS also took the opportunity to review the current Accreditation Agreement.
• Decrease the administrative burden of obtaining a signed accreditation agreement from each and every applicant.
• Also decrease the risk of not having a contractual arrangement with our accredited facilities.
WHAT ARE THE IMPLICATIONS • Once an applicant signs an application form,
they will automatically accept the Terms and Conditions of Accreditation.
• Very soon SANAS will implement an on-line system to accept the Terms and Conditions and submit the application.
• F 147 - SANAS Terms and Conditions for Accreditation
• F 199 - SANAS Terms and Conditions for GLP/GCP Compliance.
DOCUMENTATION REVIEW FINDINGS
• In the case of an Initial assessment, a maximum period of 6-months is allowed for applicant facilities to address the document review findings, after which the application will cease.
• For Re-assessments, SANAS will not
require evidence of corrective actions prior to the re-assessment, as these will be verified during the re-assessment.
BRANCH FACILITIES
• If branch facilities operate under the same management system as the Head Office:
• The checklists submitted by the Head Office as well as the Lead Assessor’s document review report will be sent to any other Lead Assessor(s) appointed to conduct assessment(s) at branch facilities.
PAYMENT CONDITIONS
Thank you
Terms and Conditions of Accreditation & GLP/GCP Compliance
Stakeholder input • Terms and Conditions together with an example of the revised application form
(ISO/IEC 17025) were published on the SANAS website for a period of 60 days.
• 125 comments were received from 13 stakeholders
• Each comment was reviewed, considered and where viable the Terms were amended
• Published on 30 May ‘13:
• F 147-01 Terms and Conditions of Accreditation• F 199-01 Terms and Conditions of GLP/GCP Compliance
Terms and Conditions of Accreditation or GLP/GCP Compliance
Replaces the following documents:
• F57 Accreditation Agreement• R01 “Transfer of Accreditation / GLP Compliance and Franchising” • R05 “The Requirements, Obligations and Duties of an Accredited / GLP Compliant
Facility
Main Changes
• List of definitions• The TOR becomes binding on signing the application form and remains in force for
the period of validity of the Certificate of Accreditation• Conditions for objections to assessors• Full payment required before accreditation services conducted• Conditions for acceptance of an application• Specifies the validity period for applications
Terms and Conditions of Accreditation or GLP/GCP Compliance
Main Changes • Extraordinary assessments and the development of short-term methods of
assessment• The period for which the CAB is required to maintain records for accreditation
purposes• Conditions under which an assessment can be terminated• Conditions for the use of the combined mark• Conditions for renewal of accreditation• Information SANAS requires from a Certification Body on termination of accreditation• Publishing the accreditation status of CAB’s.
Revised: Generic Procedures and Requirements
F 14
9 x SANAS Application Forms
Main Changes• Invoicing Information• Information on key personnel and deputies – specific to standard• Application for Approval of Personnel – replaces F18• 17025: Detailed information on Proficiency Testing• Standard specific checklist – indicates an overview of
implementation of requirements. Specifies the minimum policies and procedures required.
• Signing of the application form binds the applicant to the Terms and Conditions
2013/05/30
F14M-2012Application for Medical Laboratory Accreditation to ISO 15189:2012
New Document, to the new IOS 15189 standard2013/05/30
F 14TC-01
Application for Testing and Calibration Laboratory Accreditation to ISO/IEC 17025
New, Combined all the ISO/IEC Application Forms, i.e. Testing, Calibration, Forensic, Pharmaceutical, Veterinary, Blood Transfusion
2013/05/30
Stakeholder input
Documents published for a comment period:
• Draft R51-07 “Suspensions, Withdrawals and Re-Instatement of Accredited Organisations” – 30 day by 6 Sept’12
• Draft R03-07 “Nominated Representative and Signatories: Responsibilities, Qualifications and Approval”– 30 day by 15 Nov ’12
• Draft SANAS application form (F14:17025) – 60 day by 14 Sept
Revised: Generic Procedures and Requirements
Doc Title Date
A 01-09References, Acronyms and Definitions
Refer to amendment form – aligns to TOR 2013/06/13
P14-23
SANAS Fees
Applied 5.5% increase to fees as per National Treasury Requirements, Corrected amount for Certification Bodies: Additional assessor units per day.
2013-07-31
P 32-03Transition to New Standards
Minor changes regarding SANAS internal processes2013/02/27
Revised: Generic Procedures and Requirements
Doc Title Date
R 03-07Nominated Representative and Signatories: Responsibilities, Qualifications and Approval.
Refer to amendment form – aligns to TOR2013/06/13
R 51-07Suspension and Re-instatement of Accredited / Compliant Organisations
Entire document re-written to clarify requirements and align with TOR 2013/06/06
Calibration, Testing, Medical: Revised Requirements
Doc Title Date
R 50-03
Estimation of the Uncertainty of Measurement by Calibration Laboratories and Specification of Calibration and Measurement Capability on Schedules of Accreditation
Revised to align with ILAC P14 “ILAC Policy for Uncertainty in Calibration”2013-08-14
R 79-03Requirements for the Issue of SANAS Calibration Certificates
Minor amendments 2013-07-31
TG 07-01
Technical Guidelines for validation of methods used by chemical laboratories in the food, water and related industries
New document2012/10/10
TR 87-01Calibration of Installation and Appliance Testers
New document 2013/02/13
Inspection: Revised Technical Requirements (TR) & Forms (F)
Doc Title Date
TR 78-03
Department of Health (DoH) and SANAS Technical Requirements for the application of SANS/ISO/IEC 17020: 2012 for testing of Diagnostic X-Ray Imaging Systems by Inspection Bodies
Minor amendment – 1 clause added2013/02/13
TR 89-01
SANAS Technical Requirements on the Application of SANS/ISO/IEC 17020:2012
New document2013/03/14
Transition to ISO/IEC 17020:2012 ends 1 March 2015
Certification: NEW Requirements
Doc Title Date
TR 88-01Technical Requirements for Bodies providing Greenhouse Gas Validation and Verification
New document
2013/03/14
Documents made Obsolete
Doc. Title Date Obsolete Reason
CL 14 x SANAS Manual contents for the individual programmes 2013/06/06
The SANAS Website “Publications and Manuals” search function replaces the
need for programme specific contents lists
F 14B Application for Accreditation of Blood Transfusion Service Laboratories 2013/05/30
Replaced by F14TC “Application for Testing and
Calibration Laboratory Accreditation to ISO/IEC
17025”
F 14C Application for Accreditation of Calibration Laboratories 2013/05/30F 14F Application for Accreditation of Forensic Laboratories 2013/05/30
F 14PH Application for Accreditation of Pharmaceutical Laboratories 2013/05/30
F 14T Application for Accreditation of Testing Laboratories 2013/05/30
F 14TP Application for Accreditation of Mechanical & Physical Testing Laboratories 2013/05/30
F 14V Application for Accreditation of Veterinary Laboratories 2013/05/30
F 14PH Application for Accreditation of Pharmaceutical Laboratories 2013/05/30
F 171 Organs of State Accreditation Agreement 2013/05/30 Replaced by F 147 “Terms and Conditions of
Accreditation” and F 199 “Terms and Conditions of
GLP/GCP Compliance”
F 57 Accreditation Agreement 2013/05/30
F 114 Accreditation Agreement - International Facilities 2013/05/30
F 18 Application for the Approval of Personnel 2013/05/30Included a section for
approval of personnel in each F14 application form
International Laboratory Accreditation Co-operation (ILAC) documents revised
Doc Title Date
ILAC P14-01/ 2013
ILAC Policy for Uncertainty in Calibration
Date of implementation: January 2014. 2013/02
ILAC P10-01/2013
ILAC Policy on the Traceability of Measurement Results
Date of implementation: January 2014. 2013/02
Thank You
COMMUNICATION MEETINGAAC PROCESS
Christinah LeballoSenior Manager: Testing, Certification and BBBEE
WHAT IS AAC PROCESS
• It is a decision making process on the granting, denying, extending, suspending or withdrawal of accreditation
• It is a requirement of ISO/IEC 17011. Clause 7.9. 2 states that the accreditation body shall, without undue delay, make the decision on whether to grant or extend accreditation on the basis of an evaluation of all information received (see 7.8.6) and any other relevant information.
AAC PROCESS
ISO/IEC 17011 also requires that the AB describes its accreditation decision-making process including effective separation of the assessment team and the decision makersSANAS DECISION-MAKING PROCESS METHODS (SANAS P20)◙ For high risk decision making emanating from initial,
re-assessments and extension of new scopes of accreditation, recommendations are made by an Approval Advisory Committee.
◙ For surveillance assessments, extension of existing scopes of accreditation and additional signatories of existing accredited facilities, decisions are made by SANAS Field Managers.
AAC PROCESS
◙ The AAC shall consist of not less than 2 members of which 1 shall be a permanent SANAS staff member.
SELECTION CRITERIA
Members are selected based on:
◙ their knowledge of the accreditation process;
◙ a general knowledge of the area of assessment to be evaluated;
◙ knowledge of SANAS requirements; and
◙ where applicable, regulatory requirements
AAC MEMBERS
TRAINING
◙ Induction
◙ Mentoring during at least one formal AAC proceeding;
◙ Monitoring:
The competence of a “new” AAC member will be confirmed by an approved AAC member re-evaluating a pack reviewed by that member
ON GOING MONITORING: IS AT LEAST ONCE IN EVERY 3 YEARS
AAC MEMBERS
AAC PROCESSInformation to be supplied to the AAC ◙ Assessment documentation, corrective actions and relevant
supporting evidence
Proceedings◙ a review of the completeness of the documentation; ◙ evaluating whether the information submitted is adequate ◙ evaluation of the corrective actions and supporting evidence◙ the coverage of the scope assessed;◙ evidence that validation, verification of results and
proficiency testing data had been assessed◙ A review of the evidence submitted in support of
granting signatory status ◙ Review of proposed schedule of accreditation
recommended;
◙ Unconditional accreditation
◙ Deferral of decision(Initial)
◙ Rejection of accreditation
◙ Conditional accreditation
◙ Suspension of accreditation
◙ Withdrawal of accreditation
TYPES OF DECISIONS
Questions
Thank You