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 No significant change

4.7 Service to the customer 4.7.1 The laboratory shall afford clients be willing to cooperate with customers or their representatives cooperation to clarify the client’s request and to monitor in clarifying the customer’s request and in monitoring the laboratory’s performance….clientscustomers.

Commentary There is no significant difference in the requirement, except that a laboratory should show willingness to cooperate. 2. The HKAS policy in this regard is given in HKAS 002 cl. 9.2.3, which remains unchanged.

4.7.2 The laboratory shall seek feedback, both positive and negative, from its customers. The feedback shall be used and analysed to improve the management system, testing and calibration activities and customer service. Note Examples of the types of feedback include customer satisfaction surveys and review of test or calibration reports with customers.

Commentary From recommendation to requirement

4.8 Complaints No significant change

4.9 Control of nonconforming testing and/or calibration work 4.9.1 …. c) Corrective actions are Correction is taken immediately, together with any decision about the acceptability of the nonconforming work;

Commentary (ISO9000 Quality management systems – Fundamentals and vocabulary) Corrective action – action to eliminate the cause of a detected nonconformity, or other undesirable situation. Correction – action to eliminate a detected nonconformity. (A correction can be made in conjunction with a corrective action, i.e. both may be needed.)

Commentary 3. Corrective action is required only in situations described in clause 4.9.2, i.e. nonconforming work could recur. 4. Corrective action requirements given in clause 4.11. (Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent occurrence. The only difference is the time when the action is taken – after or before occurrence of nonconformity.)

Commentary 5. Past assessment experience indicates that laboratories seldom identify the occurrence of nonconforming work. HOKLAS policy clarifies and gives examples of common nonconforming work, and highlights the necessity to adhere to the requirements given in clause 4.9.1.

Commentary 6. Initiation is needed when any aspect of a laboratory’s testing and/or calibration work, or the results of this work, do not conform to its own procedures or the agreed requirements of the customer.

4.10 Improvement The laboratory shall continually improve the effectiveness of its management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.

Commentary A new requirement. The aim is to increase the probability of enhancing the satisfaction of customers (perception of the degree to which customer’s requirements have been fulfilled) and other interested parties. Continual improvement = recurring activity to increase the ability to fulfil requirement (ISO 9000 definition).

Commentary 4. Effectiveness – extent to which planned activities are realised and planned results achieved. 5. Not continuous, but continual. 6. Applies to management system but should be focused on aspects related to quality and technical management.

4.11 Corrective action No significant change

4.12 Preventive action 4.12.1 Needed improvement and potential sources of nonconformances nonconformities, either technical or concerning the quality management system, shall be identified. If When improvement opportunities are identified or if preventive action is required, …

Commentary Stress the importance of improvement opportunities (versus potential nonconformities). No significant change.

4.13 Control of records Commentary No significant change HKAS policy updated and clarified. LIMS – validated and meet requirements of this section. Retention periods of equipment records and training records

4.14 Internal audits No significant change

4.15 Management reviews 4.15.1 In accordance with a …., the laboratory’s executive top management and …review of the laboratory’s quality management system …The review shall take account of: - … recommendations for improvement; ….

Commentary Included a new review item Stress the importance of improvement

5.1 General No significant change

5.2 Personnel 5.2.2 …The effectiveness of the training actions taken shall be evaluated. Commentary Not just provide the training but its effectiveness is required to be evaluated by, for example, competence assessment. Already a HKAS policy. Hence, not new.

Commentary HKAS policy – The continuing competence of technical personnel shall be assessed regularly and records of such assessment shall be kept. Contract Staff - ..training required for contract staff irrespective of duration of contract and whether full-time or part-time basis

5.3 Accommodation and environmental conditions No significant change

Commentary HKAS policy – It should be emphasized that it is the responsibility of the laboratory to ensure that its operation is in compliance with all applicable regulations, particularly those related to laboratory safety. HKAS is not a regulatory authority and assessments will not cover regulatory requirements. Assessors may give general safety advice but should not be regarded as meeting the relevant regulatory requirements.

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 5.10 Reporting of results No significant change

5.9 Assuring the quality of test and calibration results 5.9.2 Quality control data shall be analysed and, where they are found to be outside pre-defined criteria, planned action shall be taken to correct the problem and to prevent incorrect results from being reported.

Commentary Imply in last edition but now stating it explicitly. Not entirely new. Some HOKLAS Supplementary Criteria already stated this explicitly, e.g. No. 6, 8, 12, 20, 21, 22.