accreditation – iso/iec 17025

In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching

Kaus, R.: Accreditation – ISO/IEC 17025 © Springer-Verlag Berlin Heidelberg 2003

Accreditation – ISO/IEC 17025

Rüdiger Kaus



What is Accreditation ?(According to ISO/IEC 17025) Confirmation of competence of a testing or

calibration laboratory by an independent third party, the accreditation body



Accreditation Body

Usually there are national regulations for one or several accreditation bodies in each country

There is cooperation between accreditation bodies in international organisations Europe: European Accreditation Cooperation (EA) Worldwide: International Laboratory Accrediation

Cooperation (ILAC)



International Multilateral Agreement Between Accreditation Bodies



Accreditation Procedure Application to the accreditation body Contract with the accreditation body Nomination and commissioning of assessors Technical audit of the application documents On-site laboratory assessment If necessary proficiency testing Assessment report Inspection of the report in the sectoral

committee Accreditation decision Publication



ISO/IEC 17025

“General requirements for the competence of testing and calibration laboratories”



ISO/IEC 17025:1999

addresses the technical competence of laboratories to carry out specific tests and is used by laboratory accreditation bodies world wide as the core requirements for the accreditation of laboratories.



Contents of ISO 17025 - I

Foreword

1 Scope

2 Normative references

3 Terms and definitions



Contents of ISO 17025 - II4 Management requirements

4.1 Organization4.2 Quality System4.3 Document control4.4 Review of requests, tenders and contracts4.5 Subcontracting of tests and calibrations4.6 Purchasing Services and supplies4.7 Service to the client4.8 Complaints4.9 Control of nonconforming testing and/or calibration work4.10 Corrective action4.11 Preventive action4.12 Control of records4.13 Internal audits4.14 Management reviews



Contents of ISO 17025 - III5 Technical requirements

5.1 General

5.2 Personnel

5.3 Accommodation and environmental conditions

5.4 Test and calibration methods and method validation

5.5 Equipment

5.6 Measurement traceability

5.7 Sampling

5.8 Handling of test and calibration items

5.9 Assuring the quality of test and calibration results

5.10 Reporting the results



Contents of ISO 17025 - IVAnnex A (informative)

Nominal Cross-references to ISO 9001 :1994 and ISO 9002 :1994

Annex B (informative)Guidelines for establishing applications for specific fieldsBibliography

Annex ZA (normative)Normative references to international publications with their relevant European publications



Chapter 1 of ISO 17025: Scope A laboratory may apply quality assurance

procedures according to ISO/IEC 17025 to all (or part) of its operations.

Where a laboratory claims compliance against or certification or accreditation to a particular standard, it is important to be clear to what this compliance, certification or accreditation applies.

The formal statement of the activities, which have been certified against ISO 9001, or accredited against ISO 17025 is known as the "scope".



Scope of ISO/IEC 17025 - I

Quality management is supported by a clear statement of activities, which ideally should define the range of

work covered, without restricting the laboratory's

operation.



Scope of ISO/IEC 17025 - II

is typically defined in terms of: range of products, materials or sample

types measurements (or types of measurements) specification or

method/equipment/technique concentration range and uncertainty



Chapter 4 of ISO 17025

“Management requirements”



Organization (Ch. 4.1)

legal responsibility (4.1.1)

meeting the requirements of this International Standard, satisfying the needs of the client, the regulatory authorities or organizations providing recognition (4.1.2)

The management system shall cover work carried out in all facilities: laboratory's permanent facilities, at sites away from its permanent facilities, or in associated temporary or mobile facilities

(4.1.3)




Responsibilities of key personnel shall be defined in order to identify potential conflicts of interest (4.1.4)




Requirements on the laboratory (4.1.5) (1 of 3) managerial and technical personnel with the

authority and resources needed to carry out their duties …

management and personnel free from any undue internal and external commercial, financial and other pressures and influences that may adversely affect the quality of their work

policies and procedures to ensure the protection of its clients' confidential Information and proprietary rights…



Organization (Ch. 4.1) Requirements on the laboratory (4.1.5) (2 of 3)

policies and procedures to avoid involvement in any activities that would diminish confidence in its competence, impartiality judgement or operational integrity

define the organization and management structure of the laboratory, its place in any parent organization, and the relationships between quality management, technical operations and support services

specify the responsibility, authority and interrelationships of all personnel who manage, perform or verify work affecting the quality of the tests and/or calibrations




Requirements on the laboratory (4.1.5) (3 of 3) adequate supervision of testing and calibration

staff, … technical management with overall responsibility

for the technical operations … appoint a member of staff as quality manager … appoint deputies for key managerial personnel

Individuals may have more than one function and it may be impractical to appoint deputies for every function.



Quality System (Ch. 4.2)

Establishing, implementing and maintaining a quality system appropriate to the scope of its activities.

Documenting its policies, systems, programmes, procedures and instructions to the extent necessary to assure the quality of the test and/or calibration results.

The system's documentation shall be communicated to, understood by, available to, and implemented by the appropriate personnel. (4.2.1)




Quality manual (4.2.2)

The laboratory's quality system policies and objectives shall be defined in a quality manual (however named).

Quality policy statement (4.2.2)

The overall objectives shall be documented in a quality policy statement. The quality policy statement shall be issued under the authority of the chief executive.




Contents of the quality policy statement (4.2.2) (1 of 3)It shall include at least the following: the laboratory management's commitment

to good Professional practice and to the quality of its testing and calibration in servicing its clients

the management‘s Statement of the laboratory's Standard of Service




Contents of the quality policy statement (4.2.2) (2 of 3) the objectives of the quality system; a requirement that all personnel concerned with

testing and calibration activities within the laboratory familiarize themselves with the quality documentation and implement the policies and procedures in their work; and

the laboratory management's commitment to compliance with this International Standard.




Contents of the quality policy statement (4.2.2) (3 of 3) The quality policy statement should be concise

and may include the requirement that tests and/or calibrations shall always be carried out in accordance with stated methods and clients' requirements.

When the test and/or calibration laboratory is part of a larger organization, some quality policy elements may be in other documents.



Quality Manual (Ch. 4.2.3 and 4.2.4)

The quality manual shall include or make reference to the supporting procedures including technical procedures.

It shall outline the structure of the documentation used in the quality system.

The roles and responsibilities of technical management and the quality manager, including their responsibility for ensuring compliance with this International Standard, shall be defined in the quality manual.



Document Control (Ch. 4.3)

General (4.3.1) (1 of 2) The laboratory shall establish and maintain

procedures to control all documents that form part of its quality system Master list(internally generated or from external sources)

such as regulations, standards, other normative documents, test and/or calibration methods, as well as drawings, software, specifications, instructions and manuals.




General (4.3.1) (2 of 2) In this context "document" could be policy

statements, procedures, specifications, calibration tables, charts, text books, posters, notices, memoranda, software, drawings, plans, etc.

These may be on various media, whether hardcopy or electronic, and they may be digital, analog, photographic or written.

The control of data related to testing and calibration is covered in 5.4.7. The control of records is covered in 4.12.



Basis Documents Proof DocumentsDifferences

Basis Documents(4.2.3 quality manual and 4.3 Document control)

Requirements or prerequisites

Target Changeable Valid for a longer

period

Proof Documents(4.12 Control of records)

Proof Actual stock Not changeable Valid for a single

incident



Document Approval and Issue (Ch. 4.3.2)

Review of the documents (4.3.2.1) The procedure(s) adopted shall ensure that:

authorized editions of appropriate documents are available at all locations where operations essential to the effective functioning of the laboratory are performed;

documents are periodically reviewed and, where necessary, revised to ensure continuing suitability and compliance with applicable requirements;

invalid or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use;

obsolete documents retained for either legal or knowledge preservation purposes are suitably marked. (4.3.2.2)




Quality system documents generated by the laboratory shall be uniquely identified (4.3.2.3)



Review of Requests, Tenders and Contracts (Ch. 4.4)

Policies and procedures (4.4.1)

Records of reviews (4.4.2)

Review for repetitive routine tasks



Subcontracting of Tests and Calibrations (4.5)

Purchasing Services and Supplies (4.6)



Service to the Client (Ch. 4.7)

The laboratory shall afford clients and their representatives cooperation to clarify the client's request and to monitor the laboratory's performance relation to the work performed,

provided that the laboratory ensures confidentiality to other clients.



Ensuring the Quality

Complaints (4.8)

Control of nonconforming testing and/or calibration work (4.9)

Corrective action (4.10)

Preventive action (4.11)



Control of Records (Ch. 4.12)

The laboratory shall establish and maintain procedures for identification, collection, indexing, access, fixing, storage, maintenance and disposal of quality and technical records. (4.12.1.1)

Quality records shall include reports from internal audits and management reviews as well as records of corrective and preventive actions.



Internal Audits (Ch. 4.13)

The laboratory shall periodically and in accordance with a predetermined schedule and procedure conduct internal audits of its activity to verify that its operations continue comply

with the requirements of the quality system and this International Standard. … (4.13.1)



Management Reviews (Ch. 4.14)

Laboratory's executive management shall periodically conduct a review about the laboratory's quality system testing and/or calibration activities: ensure their continuing suitability effectiveness, and to introduce necessary changes or improvements. (4.14.1)



Management Reviews (Ch. 4.14) Review shall take into account (4.14.1):

the suitability of policies and procedures reports from managerial and surveyor personnel the outcome of recent internal audits corrective and preventive actions assessments by external bodies the results of interlaboratory comparisons or

proficiency tests changes in the volume and type of the work client feedback complaints other relevant factors, such as quality control

activities, resources and staff training.



Management Reviews (Ch. 4.14)

A typical period for conducting a management review is once every 12 months.

Results should feed into the laboratory planning system and should include the goals, objectives and action plans for the coming year.

A management review includes consideration of related subjects at regular management meetings.

Findings from management reviews and the actions that arise from them shall be recorded. The management shall ensure that those actions are carried out within an appropriate and agreed timescale. (4.14.2)



Chapter 5 of ISO 17025

“Technical Requirements”



General (Ch. 5.1)

Factors which determine the correctness and reliability of the tests and/or calibrations performed by a laboratory (5.1.1) human factors (5.2)

accommodation and environmental conditions (5.3)

test and calibration methods and method validation (5.4)

equipment (5.5)

measurement traceability (5.6)

sampling (5.7)

the handling of test and calibration items (5.8)



General (Ch. 5.1)

Influence to the total uncertainty (5.1.2)

The extent to which the factors contribute to the total uncertainty of measurement differs considerably between (types of) tests and between (types of) calibrations.

The laboratory shall take account of these factors in developing test and calibration methods and procedures, in the training and qualification of personnel, and in the selection and calibration of the equipment it uses.



Personnel (Ch. 5.2)

Requirements for personnel (5.2.1)

Ensuring the competence of all who operate specific equipment, perform tests and/or calibrations, evaluate results, and sign test reports and calibration certificates.

Personnel certification: the laboratory is responsible for fulfilling specified personnel certification requirements.



Personnel (Ch. 5.2)

Training programme (5.2.2)

Supervising additional personnel (5.2.3)

Authorization (5.2.5)



Accommodation and Environmental Conditions (Ch. 5.3)

Laboratory facilities (5.3.1)

Monitoring the environmental conditions (5.3.2)

Tests and calibrations shall be stopped when the environmental conditions jeopardize the results of the tests and/or calibrations.

(Remember: “No data is better than poor data”) Preventing cross-contimination (5.3.3)

Access to the laboratory (5.3.4)

Good housekeeping (5.3.5)



Test and Calibration Methods and Method Validation (Ch. 5.4)

General (5.4.1)

Using appropriate methods and procedures for all tests and/or calibrations within its scope.

The laboratory shall have instructions on the use and operation of all relevant equipment, and on the handling and preparation of items for testing and/or calibration,

shall be kept up to date and shall be made readily available to personnel



Test and Calibration Methods and Method Validation (Ch. 5.4)

Selection of methods (5.4.2)

Laboratory developed methods (5.4.3)

Non-standard methods (5.4.4)

Validation of methods (5.4.5)

Estimation of uncertainty of measurement (5.4.6)

Control of data (5.4.7)



Equipment (Ch. 5.5)Records of Equipment (5.5.5)

The records shall include at least the following: the identity of the item of equipment and its software the manufacturer's name, type identification, and serial number

or other unique identification checks that equipment complies with the specification the current location, where appropriate the manufacturer's instructions, if available, or reference to their

location dates, results and copies of reports and certificates of all

calibrations, adjustments, acceptance criteria, and the due date of next calibration

the maintenance plan, where appropriate, and maintenance carried out to date

any damage, malfunction, modification or repair to the equipment



Measurement Traceability (Ch. 5.6)

The laboratory shall have an established programme and procedure for the calibration of its equipment.

Such a programme should include a system for selecting, using, calibrating, checking, controlling and maintaining measurement standards, reference materials used as measurement standards, and measuring and test equipment used to perform tests and calibrations. …



Measurement Traceability (Ch. 5.6)

Specific requirements (5.6.2)

for calibration laboratories traceable to the International System of Units

(SI) (Systeme international d'unites). (5.6.2.1.1)

Testing (5.6.2.2)

Reference standards and reference materials (5.6.3)



Further Chapters

Sampling (Ch. 5.7)

Handling of test and calibration items (Ch. 5.8)

Assuring the quality of test and calibration results (Ch. 5.9)



Reporting the Results (Ch. 5.10)

shall be reported accurately, clearly, unambiguously objectively in accordance with any specific

instructions in the test or calibration methods.




Test Reports and Calibration Certificates (5.10.2) (1 of 2)

Each test report or calibration certificate shall include at least the following information, unless the laboratory has valid reasons for not doing so:

a title (e.g. "Test Report" or "Calibration Certificate") the name and address of the laboratory, and the location where

the tests and/or calibrations were carried out, if different from the address of the laboratory

unique identification of the test report or calibration certificate (such as the serial number), and an each page an identification in order to ensure that the page is recognized as a part of the test report or calibration certificate, and a clear identification of the end of the test report or calibration certificate

the name and address of the client identification of the method used





a description of, the condition of, and unambiguous identification of the item(s) tested or calibrated

the date of receipt of the test or calibration item(s) where this is critical to the validity and application of the results, and the date(s) of performance of the test or calibration

reference to the sampling plan and procedures used by the laboratory or other bodies where these are relevant to the validity or application of the results

the test or calibration results with, where appropriate, the units of measurement

the name(s), function(s) and signature(s) or equivalent identification of person(s) authorizing the test report or calibration certificate

where relevant, a statement to the effect that the results relate only to the items tested or calibrated





Hard copies of test reports and calibration certificates should also include the page number and total number of pages.

It is recommended that laboratories include a statement specifying that the test report or calibration certificate shall not be reproduced except in full, without written approval of the laboratory




Test Reports (5.10.3)

In addition to the requirements listed in 5.10.2, test reports shall, where necessary for the interpretation of the test results, include the following: deviations from, additions to, or exclusions from the test

method, and information an specific test conditions, such as environmental conditions;

Where relevant, a statement of compliance/non-compliance with requirements and/or specifications; where applicable, a statement on the estimated uncertainty of measurement; information on uncertainty is needed in test reports when it is relevant to the validity or application of the test results, when a client's instruction so requires, or when the uncertainty affects compliance to a specification limit; where appropriate and needed, opinions and interpretations (see 5.10.5);

additional information which may be required by specific methods, clients or groups of clients. (5.10.3.1)




Test Reports (5.10.3) the results of sampling shall include the following,

where necessary for the interpretation of test results: the date of sampling unambiguous identification of the substance, material or

product sampled (including the name of the manufacturer, the model or type of designation and serial numbers as appropriate)

the location of sampling, including any diagrams, sketches or photographs

a reference to the sampling plan and procedures used details of any environmental conditions during sampling that

may affect the interpretation of the test results any standard or other specification for the sampling method

or procedure, and deviations, additions to or exclusions from the specification concerned. (5.10.3.2)




Calibration Certificates (5.10.4)

shall include: the conditions (e.g. environmental) under which

the calibrations were made that have an influence an the measurement results

the uncertainty of measurement and/or a statement of compliance with an identified metrological specification or clauses thereof

evidence that the measurements are traceable




Opinions and Interpretations (5.10.5)

Documenting the basis upon which the opinions and interpretations have been made

Opinions and interpretations shall be clearly marked as such in a test report.




Opinions and Interpretations (5.10.5)

No confusion with inspections and product certifications as intended in ISO/IEC 17020 and ISO/IEC Guide 65 (5.10.5 Note 1)

Possible contents: an opinion on the statement of compliance/non-

compliance of the results with requirements fulfilment of contractual requirements recommendations and how to use the results guidance to be used for improvements (5.10.5 Note 2)




Testing and calibration results obtained from subcontractors (5.10.6)

Clear Identification Electronic transmission of results (5.10.7)

Requirements of this International Standard shall be met (see also 5.4.7)




Format of Reports and Certificates (5.10.8)

Accommodating each type of test or calibration carried out

Minimizing the possibility of misunderstanding or misuse.

Headings should be standardized as far as possible.




Amendments to Test Reports and Calibration Certificates (5.10.9)

Material amendments should include the statement: "Supplement to Test Report [or Calibration

Certificate], serial number ... [or as otherwise identified]", …

When it is necessary to issue a complete new test report or calibration certificate, this shall be uniquely identified and shall contain a reference to the original that it replaces



Summary

Accreditation according to ISO/IEC 17025 is not an easy task, especially when done for the first time. But it assures most customers a feeling of quality and correct procedures.