5.2 Personnel

1. 5.2 Personnel • Use competent staff • Supervise as necessary • Document qualifications and training • Maintain documented training program • Define responsibilities and authorities • Applies also to contracted workers

2. 5.3 Accommodation, Environment • Accommodation & environment to suit • testing • equipment • Monitor environment as needed, records • Control access to laboratories • Good housekeeping

3. 5.4 Test Methods, Validation • Use appropriate methods • Methods to meet client needs • Prefer standard methods • Validate any non-standard procedure • Various ways to validate • Retain validation data

4. 5.5 Equipment • Use appropriate equipment • Authorised personnel operate • Instructions available • Unique identification, inventory • Equipment calibration (also 5.6) • Applies to outside equipment

5. ISO/IEC 17025 - Technical 5.6 Measurement traceability 5.7 Sampling 5.8 Handling test items 5.9 Quality assurance 5.10 Reporting

6. 5.6 Measurement Traceability • Calibrate equipment • Ensure measurement traceability • Use interlaboratory comparisons where possible • Calibrate reference materials • Protect reference materials

7. 5.7 Sampling • Ensure statistical validity

8. 5.8 Handling Test Items • Documented handling procedures • Secure identification of samples • Ensure sample condition acceptable • Protect samples

9. 5.9 Quality Assurance • Use quality control • Participate in proficiency testing • Use statistics if practicable

10. 5.10 Reporting • Minimum requirements for reports • Keep interpretation distinct • Identify testing by subcontractors • Apply also to electronic transmission • Amendments - supplementary documents

11. ISO/IEC 17025 - Management 4.1 Organisation 4.2 Quality system 4.3 Document control 4.4 Contract review 4.5 Subcontracting 4.6 Purchasing 4.7 Service to the client

12. 4.1 Organisation • Quality Manager (title irrelevant) • may have other duties • direct access to top management “defined responsibility and authority for ensuring that the quality system is implemented and followed at all times”

13. 4.4 Contract Review • Requirements for any testing • documented • understood • Appropriate methods used • Adequately resourced • Changes documented & agreed

14. 4.5 Subcontracting • Testing subcontracted to another lab • subcontractor competent • also accredited to standard? • client advised in writing • register of subcontractors used • evidence of suitability

15. 4.6 Purchasing • Procedures for selection and purchasing • where it affects test quality • Inspected to confirm compliance • Lists of suppliers • records of evaluation

16. 4.7 Service to the client • Communication and co-operation

17. ISO/IEC 17025 - Management 4.8 Complaints 4.9 Control of nonconforming testing 4.10 Corrective action 4.11 Preventive action 4.12 Control of records 4.13 Internal Audits 4.14 Management Reviews

18. 4.9 Control of Nonconforming Testing • When testing or results do not: • conform with procedures • meet client requirements • Remedial actions • what is done - by whom • Client notified if necessary

19. A Documented Quality System

20. Outline • What is a quality system? • Why documentation is necessary • Requirements for documentation • Documentation structures • Quality manuals, procedures, work instructions • Guidance on documentation

21. What is a Quality System ? • ISO/IEC Guide 25 (from ISO 8402) “The organisational structure, responsibilities, procedures, processes and resources for implementing quality management”

22. Why Document the System? • For system to function • Define responsibilities and authorities • who does what • Ensure compliance with standard(s)

23. What is Required? • Communicated • Available • Understood • Implemented • Easily updated

24. Verbal Instructions • Often: • Not heard • Misunderstood • Quickly forgotten • Ignored

25. What is Required? • A quality manual • A quality policy • Document key areas of activity

26. A Typical Documentation Structure Quality Manual  Procedures  Work Instructions  Forms  Records

27. Document Design Definition of System (Company Policy & Quality System Outline) Manual Increasing Description of the Processes Detail (Defines how the Policy is carried Procedure Manual(s) out in individual work Processes) Instructions for Individual Job Functions Work Instructions (Defines how specific tasks that are referenced in procedures are carried out) Work Functions

28. What is a Quality Manual? • ISO/IEC Guide 25 “A document stating the quality policy, quality system and quality practices of an organisation”

29. Required in Quality Manual • Quality policy • Structure of documentation • Cross reference supporting documents • Include or refer to: • systems, instructions • responsibilities and authorities

30. Quality Policy • Concise • Overall objectives • Authorised by chief executive • Commitment to good practice • Commitment to Standard(s) • Staff must familiarise and use

31. Must Document: • Scope of activities • Document control and review • Customer complaints • Corrective, preventive action • Internal audits

32. Must Document: • Management review • Approved signatories • Equipment inventory • Equipment calibration & maintenance • Training records

33. Quality Manager Typically: • Creates documentation structure • Creates numbering system • Decides formats and styles • Writes Quality Manual • Writes some other documents • e.g. document control • how to write a document

34. Quality Manager • Keeps overview of documentation • Makes system work • documentation • document review • document control