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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
International Laboratory Accreditation Cooperation
Technical Requirements of ISO/IEC17025
• General• Personnel• Accommodation and
environmental conditions
• Test and calibration methods and method validation
• Equipment
International Laboratory Accreditation Cooperation
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
International Laboratory Accreditation Cooperation
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
International Laboratory Accreditation Cooperation
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
International Laboratory Accreditation Cooperation
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
International Laboratory Accreditation Cooperation
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
International Laboratory Accreditation Cooperation
4.1 Organisation
New aspect• identification of potential
conflicts of interest
International Laboratory Accreditation Cooperation
4.2 Quality System
New aspect• more detailed
requirements for quality policy statement
International Laboratory Accreditation Cooperation
4.3 Document Control
• specific requirements for control, review and approval, issue and amendment of documents
• incorporates ISO 9000 requirements
International Laboratory Accreditation Cooperation
4.4 Requests, Tenders, Contracts
• identification of customer needs
• ensure capability to meet needs
• dealing with changes and deviations
• incorporates ISO 9001 requirements
International Laboratory Accreditation Cooperation
4.5 Sub-contracting
aspects cover permanent sub-contracting, agency or franchising arrangements
International Laboratory Accreditation Cooperation
4.6 Purchasing
• incorporates ISO 9001 requirements in simplified form
International Laboratory Accreditation Cooperation
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
International Laboratory Accreditation Cooperation
4.8 Complaints
Same general coverage as Guide 25 Section 16 in simplified form
International Laboratory Accreditation Cooperation
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
International Laboratory Accreditation Cooperation
4.10 Corrective Action
• specific procedures for cause analysis, selection and implementation of corrective action,subsequent monitoring and follow-up audits
• incorporates ISO 9001 requirements
International Laboratory Accreditation Cooperation
4.11 Preventive Action
• dealing with potential problems• quality improvement process• incorporates ISO 9001 requirements
International Laboratory Accreditation Cooperation
4.12 Records
• covers quality system and technical records
• consistent with ISO 9001 requirements
International Laboratory Accreditation Cooperation
4.13 Internal Audits
Same general coverage as Guide 25 - paras 5.3 and 5.5
International Laboratory Accreditation Cooperation
4.14 Management Reviews
• specific guidance on matters to be considered
• to be conducted periodically
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