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Management requirements :

Management requirements :. Contracts Subcontracting Suppliers Complaints Corrective and preventive actions (CAPA) Internal audits Management reviews. Review of request tenders and contracts -1 (ISO 17025: 2005, 4.4). Policy and procedures required

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Management requirements :

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  1. Management requirements: • Contracts • Subcontracting • Suppliers • Complaints • Corrective and preventive actions (CAPA) • Internal audits • Management reviews

  2. Review of request tenders and contracts -1 (ISO 17025: 2005, 4.4) • Policy and procedures required • Differences between request and the contract shall be resolved before work starts • Relevant discussions with a customer are registrated

  3. Review of request tenders and contracts - 2 (ISO 17025: 2005, 4.4) • Contract has to be acceptable for customer and laboratory In contract procedure: • Requirements including the method are adequately defined, documented and understood • Capacity ad resources of laboratory are assured • How to act in case of deviations

  4. Review of request tenders and contracts - 3 (ISO 17025:2005, 4.4) • A contract can be a written or oral agreement • Review of compatibility by earlier work or proven skills to perform

  5. Subcontracting tests(ISO 17025; 2005, 4.5) • Documented policy and procedure available including review of subcontractors (ISO 17025 accreditation preferred) • Contracts with subcontractors are documented in a register • Laboratory is also responsible for subcontracted tests • Gain approval of customer for subcontracting

  6. Suppliers -1 (ISO 17025: 2005, 4.6) • Policy and procedure for selection and use of supplies and services • Procedures for inspection, acceptance and storage of supplies

  7. Suppliers -2 (ISO 17025: 2005, 4.6) Evaluation of suppliers critical for the quality of test results • Services • Subcontracting • Equipment • Reference substances • Reagents • Critical consumables

  8. Suppliers - 3 (ISO 17025: 2005, 4.6) • Criteria for evaluation of suppliers • Documentation of evalution • Preventive action in case of poor performance

  9. Complaints The laboratory shall have a policy and procedure for the resolution of complaints(ISO 17025:2005, 4.8)

  10. Control of nonconforming testing work (ISO 17025; 2005, 4.9) • Policy and procedure required for nonconforming work and registration • Evalution of the significance is made • Correction is taken immediately • When necessary customer is notified and work recalled • Authorization of resumption of work is defined

  11. Corrective Actions -1(ISO 17025; 2005, 4.11) • The laboratory shall establish a policy and procedure and shall designate appropriate authorities for implementing corrective action when nonconforming work or departures from the policies and procedures in the quality system or technical operations have been identified.

  12. Corrective actions -2 • Analyse cause, select and implement corrective actions (if necessary audit related activities) • Document changes resulting form corrective actions

  13. Preventive actions (ISO 17025; 2005, 4.12) • Needed improvements and potential sources of nonconformities shall be identified • Pro-active process: elements can be risk analysis, possibility for quality improvement

  14. Internal audits -1 (ISO 17025: 2005, 4.12) • Verify that laboratory operations continue to comply the requirements of the management system and ISO 17025:2005

  15. Internal audits - 2 (ISO 17025: 2005, 4.12) • All elements of the management system have to be audited periodically • Audit programme made by Quality manager • Carried out by trained and qualified independent personnel (if allowed by resources) • If audit findings results in doubts about effectiveness of results/processes timely corrective actions are taken • Follow up audit activities shall verify undertaken actions

  16. Audits in general • Horizontal audits 1 subject example personnel and competence • Vertical audits following a process through an organization

  17. Management reviews (ISO 17025: 2005, 4.15) The laboratory’s executive management shall periodically conduct a review of the laboratory's management system

  18. Pitfalls • Managerial system • Bureaucratic • Static system • Not flexible

  19. management license samples registration Analytical methods law Document control accommodation reference standards calibration validation permits equipment Profiency testing personnel environment storage (local) government Building a Quality System

  20. Final Remark • Laboratory Accreditation is a tool to demonstrate the true underlying quality of the analytical testing program !

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