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Accreditation – ISO/IEC 17025

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.

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Accreditation – ISO/IEC 17025

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  1. Accreditation – ISO/IEC 17025 Rüdiger Kaus In:Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching

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

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

  4. International Multilateral Agreement Between Accreditation Bodies In:Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching

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

  6. “General requirements for the competence of testing and calibration laboratories” ISO/IEC 17025 In:Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching

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

  8. Contents of ISO 17025 - I Foreword   1 Scope 2 Normative references 3 Terms and definitions In:Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching

  9. Contents of ISO 17025 - II 4 Management requirements 4.1 Organization 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 4.8 Complaints 4.9 Control of nonconforming 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 In:Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching

  10. Contents of ISO 17025 - III 5 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 In:Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching

  11. Contents of ISO 17025 - IV Annex 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 In:Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching

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

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

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

  15. Chapter 4 of ISO 17025“Management requirements” In:Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching

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

  17. Organization (Ch. 4.1) • Responsibilities of key personnel shall be defined in order to identify potential conflicts of interest (4.1.4) In:Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching

  18. Organization (Ch. 4.1) • 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… In:Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching

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

  20. Organization (Ch. 4.1) • 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. In:Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching

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

  22. Quality System (Ch. 4.2) • 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. In:Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching

  23. Quality System (Ch. 4.2) • 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 In:Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching

  24. Quality System (Ch. 4.2) • 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. In:Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching

  25. Quality System (Ch. 4.2) • 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. In:Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching

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

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

  28. Document Control (Ch. 4.3) • 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. In:Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching

  29. 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 Basis Documents  Proof DocumentsDifferences In:Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching

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

  31. Document Control (Ch. 4.3) • Quality system documents generated by the laboratory shall be uniquely identified (4.3.2.3) In:Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching

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

  33. Subcontracting of Tests and Calibrations (4.5)Purchasing Services and Supplies (4.6) In:Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching

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

  35. Ensuring the Quality • Complaints(4.8) • Control of nonconforming testing and/or calibration work (4.9) • Corrective action (4.10) • Preventive action (4.11) In:Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching

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

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

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

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

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

  41. Chapter 5 of ISO 17025“Technical Requirements” In:Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching

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

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

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

  45. Personnel (Ch. 5.2) • Training programme (5.2.2) • Supervising additional personnel (5.2.3) • Authorization (5.2.5) In:Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching

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

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

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

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

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

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