HOKLAS

003

8th

Edition

HOKLAS 003

7th Edition Vs. 8th Edition

Major Changes

HOKLAS

003

8th

Edition

HOKLAS

003

8th

Edition

Section 4

Management System

HOKLAS

003

8th

Edition

HOKLAS

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8th

Edition

4.1.5 The laboratory shalla) 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

8th

Edition

HOKLAS

003

8th

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

8th

Edition

HOKLAS

003

8th

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

8th

Edition

HOKLAS

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8th

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

8th

Edition

HOKLAS

003

8th

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

8th

Edition

HOKLAS

003

8th

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

8th

Edition

HOKLAS

003

8th

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

8th

Edition

HOKLAS

003

8th

Edition

Commentary

Laboratory management’s commitment is the corner stone of the process of continual improvement.

HOKLAS

003

8th

Edition

HOKLAS

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8th

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

8th

Edition

HOKLAS

003

8th

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

8th

Edition

HOKLAS

003

8th

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

8th

Edition

HOKLAS

003

8th

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

8th

Edition

HOKLAS

003

8th

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

8th

Edition

HOKLAS

003

8th

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

8th

Edition

HOKLAS

003

8th

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

8th

Edition

HOKLAS

003

8th

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

8th

Edition