iso/iec 17025 a review of the new standard for laboratory accreditation

ISO/IEC 17025

A review of the new standard for laboratory

accreditation

Background

ISO Guide 25

- 1978

ISO/IEC Guide 25

- 1982

ISO/IEC Guide 25

- 1990

ISO 9000 Series

- 1987

ISO/IEC 17025

- 2000

ISO TC/176

established

ISO 9000 Series

- 1994

International Laboratory Accreditation Cooperation

Structure

1. Scope2. Normative references3. Terms and definitions4. Management

requirements5. Technical

requirementsAnnexes


Technical Requirements of ISO/IEC17025

• General• Personnel• Accommodation and

environmental conditions

• Test and calibration methods and method validation

• Equipment


Technical Requirements of ISO/IEC17025 (cont)

• Measurement traceability• Sampling• Handling of test and

calibration items• Assuring the quality of

test and calibration results

• Reporting the results


Technical Requirements of ISO/IEC 17025 (cont)

• Technical requirements described in greater detail but ideas are not really new for accredited laboratories

• Reference to “needs” of client

• Requirement for sampling plan if doing sampling


Technical Requirements of ISO/IEC 17025 (cont)

Greater emphasis/detailed requirements on:

• Method validation• Estimation of measurement

uncertainty/ traceability for TESTING laboratories

• Provision for inclusion of interpretations and opinions on test reports


Management Requirements

4.1 Organization and management

4.2 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 client


Management Requirements (cont)

4.8 Complaints4.9 Control of non-conforming

testing and/or calibration work

4.10 Corrective action4.11 Preventive action4.12 Control of records4.13 Internal audits4.14 Management reviews


4.1 Organisation

New aspect• identification of potential

conflicts of interest


4.2 Quality System

New aspect• more detailed

requirements for quality policy statement


4.3 Document Control

• specific requirements for control, review and approval, issue and amendment of documents

• incorporates ISO 9000 requirements


4.4 Requests, Tenders, Contracts

• identification of customer needs

• ensure capability to meet needs

• dealing with changes and deviations



4.5 Sub-contracting

aspects cover permanent sub-contracting, agency or franchising arrangements


4.6 Purchasing

• incorporates ISO 9001 requirements in simplified form


4.7 Service to Clients

• cooperation with clients• notes cover various aspects

of laboratory-client relationship

• closest equivalent in ISO 9001 is clause 4.19 Servicing


4.8 Complaints

Same general coverage as Guide 25 Section 16 in simplified form


4.9 Non-conforming Work

• specific procedures for dealing with non-conforming testing or calibration work/results

• points to need for corrective action

• consistent with ISO 9001 requirements


4.10 Corrective Action

• specific procedures for cause analysis, selection and implementation of corrective action,subsequent monitoring and follow-up audits



4.11 Preventive Action

• dealing with potential problems• quality improvement process• incorporates ISO 9001 requirements


4.12 Records

• covers quality system and technical records

• consistent with ISO 9001 requirements


4.13 Internal Audits

Same general coverage as Guide 25 - paras 5.3 and 5.5


4.14 Management Reviews

• specific guidance on matters to be considered

• to be conducted periodically

iso/iec 17025 a review of the new standard for laboratory accreditation

Documents

laboratory accreditation

sampling slide

client slide

cont technical requirements

clients cooperation

simplified form slide

isoiec guide

quality of test