HKQAA ISO9001:2015 QMS Lead Auditor Transition Training Course

Hong Kong Quality Assurance Agency (HKQAA) organized ISO 9001:2015 QMS Lead Auditor Transition Training Course held from 9th to 10th Dec 2015. Mr. Derrick Choong was IRCA approved trainer and two day training included ISO/IEC Directives Annex SL and ISO 9001:2015 clauses.

Mr. Derrick Choong explained the ISO/IEC Directives Part 1 – Consolidated ISO Supplement – Procedures specific to ISO in which contained Annex SL (normative) – Proposals for management system standards. Annex SL is included Appendix 1 (Justification criteria questions), Appendix 2 (High level structure (HLS), identical core text, common terms and core definitions) and Appendix 3 (Guidance on high level structure, identical core text, common terms and core definitions). The following diagram showed that future ISO management standard structure would be Annex SL (HLS) plus Discipline specific text (e.g. QMS, EMS, SMS, EnMS, ISMS, etc.) & enhancement. He also mentioned that Type A of MSS providing requirements (e.g. ISO 9001) and Type B of MMS providing guidelines (e.g. ISO 9004).

Then he introduced three pillars of Sustainable Development and they were “Economic Growth”, “Environmental Integrity” and “Social Responsibility”. After that he stated new framework of management system included ISO 9001:2015 and ISO 14001:2015 which both used PDCA model.

One of important concept was Organization Context. He suggested us to reference tool named “PESTLE” which stand for Political, Economic, Social, Technological, Legal and Environmental.

In every session, we had team work exercises to discuss our findings. Those activities in day-one were Understanding Terms & Definitions, Document Review, Checklist, Auditing Risk and Opportunities, Checklist for Communication, Management Review, Improvement, Audit Planning, On-site Audit Plan and Simulated Audit.

One of interested part was to address risk and opportunities. Mr. Derrick Choong showed us the relationship of each clauses and steps in the clause 6.1 in logic flow.

He explained risk has positive or negative results. Positive result is Opportunity and Negative result is Risk (Threat). He used the cause and effect process approach to explain it.

During the audit part, he asked us to think “How to audit” and gave a hints that i) Ask method, ii) Check high risk item, iii) Check how action is taken (integrated into which process). We also needed to consider its effective and next review/update. Before end of day-one training, he briefed the significant impact to audits under the new ISO/IEC Annex SL – HLS.

Finally, we practiced as lead auditor to audit the GM of Food Company and Mr. Choong played the role of auditee (GM of that company). At the end, we needed to take an exam for MC and short questions within 1/2 hr (past grade 21/30).

In day two, the topic focused on QMS under new standard ISO 9001:2015. In the beginning, Mr. Derrick Choong introduced the history and evolution of ISO 9001 standard.

The new part of discipline specific & enhancement was in red color and shown as follow diagram.

I would like to record some clauses which I think special in the new standard such as understanding the needs and expectations of interested parties. Moreover, he mentioned the communication to be considered on “When”, “What”, “Who”, “With Whom” and “How” for both internal and external communication.

In clause 4.4 – QMS and its processes, Mr. Choong introduced a Turtle Digram to show the QMS process in which * referred to Risk and Opportunities (R&O) source and ∆ referred to Risk and Opportunities (R&O) effect.

One new item in Design and Development (D&D) of Products and Services were D&D changes in clause 8.3.6. During discussion, many classmates shared D&D change only recorded the beginning and the last change. It was messy in the middle stage.

During day-two, we practiced several exercises included Auditing Top Management, Preparing audit trail & checklist, Audit for QMS Planning, Auditing the Organization Knowledge, Auditing the QA process, Management Review and Improvement. For continual improvement, we needed to check suitability, adequacy and effectiveness of QMS.

At the end, we also needed to take an exam for MC and short questions within 1/2 hr (past grade 21/30).

It is a very condensed course. However, I still recommend people to attend in which you would understand more about ISO 9001:2015 in auditor point of view.

Reference:
HKQAA - http://www.hkqaa.org/en_index.php