ISO/IEC 17025 A review of the new standard for laboratory accreditation

Background 1 ISO Guide 25 - 1978 ISO TC/176 established ISO/IEC Guide 25 - 1982 - 1990 ISO 9000 Series - 1987 ISO/IEC 17025 - 2000 ISO TC/176 established - 1994 1

Structure 1. Scope 2. Normative references 3. Terms and definitions 4. Management requirements 5. Technical requirements Annexes

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 system 4.3 Document control 4.4 Review of requests,tenders and contracts 4.5 Subcontracting of tests and calibrations 4.6 Purchasing services and supplies 4.7 Service to the client

Management Requirements (cont) 4.8 Complaints 4.9 Control of non-conforming testing and/or calibration work 4.10 Corrective action 4.11 Preventive action 4.12 Control of records 4.13 Internal audits 4.14 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 incorporates ISO 9001 requirements

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 incorporates ISO 9001 requirements

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