1. HOKLAS 003 8 th Edition HOKLAS 003 7 th Edition Vs. 8 th Edition Major Changes HOKLAS 003 8 th Edition

2. HOKLAS 003 8 th Edition Section 4 Management System HOKLAS 003 8 th Edition

3. HOKLAS 003 8 th Edition 4.1.5 The laboratory shall a) have managerial and technical personnel with who, irrespective of other responsibilities, have the authority and resources needed to carry out their duties, including the implementation, maintenance and improvement of the management system, and to identify the occurrence of departures from the quality management system or from the procedures……….. HOKLAS 003 8 th Edition

4. HOKLAS 003 8 th Edition Commentary 1.Duties of managerial and technical personnel are now clearly defined to include implementation, maintenance and improvement of the management system. 2.Introduction of the requirement of “continual improvement” is echoed. HOKLAS 003 8 th Edition

5. HOKLAS 003 8 th Edition 4.1.5 The laboratory shall k) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the objectives of the management system. HOKLAS 003 8 th Edition

6. HOKLAS 003 8 th Edition Commentary Laboratory staff is required to understand how their work relates to achieving the objectives of the management system. Therefore training should not be limited to the trainee’s field of operation but should also include the management system of the laboratory. HOKLAS 003 8 th Edition

7. HOKLAS 003 8 th Edition 4.2.2 The laboratory’s quality management system policies and objectives related to quality, including a quality policy statement, shall be defined in a quality manual (however named). The overall objectives shall be documented in a quality policy statement established, and shall be reviewed during management review. The quality policy statement shall be issued under the authority of the chief executive top management. HOKLAS 003 8 th Edition

8. HOKLAS 003 8 th Edition Commentary 1.The quality manual should contain management system policies related to quality, not just a single quality policy statement. 2.The overall objectives shall be established and reviewed during management review. Review of overall objectives is an integral part of the continual improvement process. HOKLAS 003 8 th Edition

9. HOKLAS 003 8 th Edition 4.2.2 …The quality policy statement….. shall include at least the following: e) the laboratory management’s commitment to compliance with this document comply with this International Standard and to continually improve the effectiveness of the management system. HOKLAS 003 8 th Edition

10. HOKLAS 003 8 th Edition Commentary Laboratory management’s commitment is the corner stone of the process of continual improvement. HOKLAS 003 8 th Edition

11. HOKLAS 003 8 th Edition 4.2.3 Top management shall provide evidence of commitment to the development and implementation of the management system and to continually improving its effectiveness. HOKLAS 003 8 th Edition

12. HOKLAS 003 8 th Edition Commentary Evidence of commitment may take the form of personal involvement of top management, allocation of resources for these specific functions, etc. HOKLAS 003 8 th Edition

13. HOKLAS 003 8 th Edition 4.2.4 Top management shall communicate to the organisation the importance of meeting customer requirements as well as statutory and regulatory requirements. HOKLAS 003 8 th Edition

14. HOKLAS 003 8 th Edition Commentary 1.Some positive means of communication is expected. The effectiveness of such communication will be checked during an assessment. 2.Although meeting statutory and regulatory requirements may not be an accreditation criteria, the top management should effectively communicate the importance of meeting such requirements to the organisation. HOKLAS 003 8 th Edition

15. HOKLAS 003 8 th Edition 4.2.7 Top management shall ensure that the integrity of the management system is maintained when changes to the management system are planned and implemented. HOKLAS 003 8 th Edition

16. HOKLAS 003 8 th Edition Commentary Implication analysis and contingency planning at the planning stage and internal audit after changes to the management system have been implemented are considered effective means of ensuring that the management system will not fall apart as a result of implementing changes. HOKLAS 003 8 th Edition

17. HOKLAS 003 8 th Edition 4.2.H HOKLAS Policy on Quality Management system ….. It shall be available for examination as a part of the accreditation process and the HKAS Executive will be pleased to give comments on draft quality manuals or to review existing manuals. HOKLAS 003 8 th Edition

18. HOKLAS 003 8 th Edition Commentary 1.HKAS is always happy to advise new laboratories in drafting their quality manual and advise existing laboratories in continual improvement by giving recommendations during assessment. 2.However, according to ISO/IEC 17011:2004 HKAS is not allowed to offer any kind of consultancy service to its customers. HOKLAS 003 8 th Edition