HKQAA Seminar on the Latest Development of ISO 9001 Revision

HKQAA 35^th Anniversary Presents Seminar performed entitled “Latest Development of ISO 9001 Revision” held on 13^th Mar 2024 in the Hong Kong Federation of Youth Groups. Before the seminar, I took a photo with Dr Nigel Croft. We had four years without face-to-face meeting because of Covid. 

We also took a formal photo for memory.

I also met GP friends including Dr Percy Chan, Mr. Larry Lee and Mr. Johnny Sung.

We also took a group photo with Dr. Nigel Croft after the seminar.

(Left: Mr. Johnny Sung, Dr. Percy Chan, Dr. Nigel Croft, Mr. Larry Lee, Mr. Victor Lau and I)

In the beginning, Dr. Nigel Croft introduced the rundown included the story of the evolution of ISO 9001, latest trends in QM, rationale for the 2024 amendment, timescale for revision, etc.

The evolution of ISO 9001 had started since 1987. Then Nigel mentioned two major revisions that 2000 version introduced process approach and continual improvement, and 2015 version employed High Level Structure (HLS) and risk-based thinking. It might be minor revision on 2025.

And then he briefed background of ISO Technical Committee TC 176. The mission of ISO/TC176/SC2 is to develop, maintain and support a portfolio of products that enable organizations to improve their performance and to benefit from the implementation of a robust QMS. After that Dr. Nigel Croft discussed the latest trends in quality management such as “Quality 4.0”.

He reviewed the formal definition of quality that related to characteristics fulfils requirements.

Nigel also added that United Nations SDGs and ESG are expected to be involved; not only for product and service quality.

For Quality 4.0, it is an opportunity for digitally-enabled marketplace. Many advanced technologies (e.g. AI, Big Data, Blockchain) are good tools. We need considering the window of opportunity in different time and different technologies tools. But remember that “A fool with a tool is still a fool.” said by Nigel.

The role of Quality 4.0 was discussed that traditional quality methodologies can enhance the traditional organization. Quality 4.0 can interact with both traditional organization and Industry 4.0 employed organization. But we cannot use traditional quality methodologies for industry 4.0.

Finally, Dr. Nigel Croft mentioned the recent amendment of ISO 9001:2015 that all ISO management system standards should relate to climate change. It is started the revision process and expected to be completed by late 2025.

Nigel quoted the ISO 9001 amendment based on “ISO – London Declaration on Climate Action” to support “Net Zero” initiatives in three ways that are changes all ISO MSS organization context, needs & expectation; ISO Annex SL guideline to be changed; and extended to other specific ISO MSS.

In Oct 2023, changes to the “identical text” of the harmonized structure had issued.

And then Nigel briefed the tentative schedule of coming 2 years for revision of ISO 9001. 

Lastly, he concluded that ISO 9001:2015 amendment had been published in Feb 2024. ISO 9001 revision is on the way and aligned with latest version of “Annex SL”. 

At the end, I took a photo with Nigel again. He said he will come to Hong Kong again in Q4 2024 for updating the progress.

I also met a new friend Mr. Godwin SY Tam (GM, Samson Innovation Co., Ltd.) and he was studied in Chemistry.

Reference:

www.hkqaa.org

www.hksq.org

Previous HKQAA Symposium:

20231130: HKQAA International Symposium 2023 – Sustainable Finance, ESG and Climate Resilience • Hong Kong 2023 - https://qualityalchemist.blogspot.com/2023/11/hkqaa-international-symposium-2023.html

20230825: HKQAA Symposium 2023 – Build the Livable City, Shape a Sustainable Community - https://qualityalchemist.blogspot.com/2023/08/hkqaa-symposium-2023-build-livable-city.html

20191018: HKQAA 30th Anniversary Forum cum Celebration Cocktail Reception - https://qualityalchemist.blogspot.com/2019/10/hkqaa-30th-anniversary-forum-cum.html

20190325: HKQAA Green Finance Certification Scheme Presentation Ceremony cum Forum 2019 - https://qualityalchemist.blogspot.com/2019/03/hkqaa-green-finance-certification.html

2018: Part 1 - https://qualityalchemist.blogspot.com/2018/05/hkqaa-symposium-2018-part-1.html

2018: Part 2 - https://qualityalchemist.blogspot.com/2018/05/hkqaa-symposium-2018-part-2.html

2017: Part 1 - https://qualityalchemist.blogspot.hk/2017/05/hkqaa-symposium-2017-part-1.html

2017: Part 2 - https://qualityalchemist.blogspot.hk/2017/05/hkqaa-symposium-2017-part-2.html

2016: HKQAA Symposium – Startups Registration Scheme Kicks off - https://qualityalchemist.blogspot.hk/2016/05/hkqaa-symposium-startups-registration.html

2015: Part 1 - https://qualityalchemist.blogspot.hk/2015/05/hkqaa-symposium-2015-part-1.html

2015: Part 2 - https://qualityalchemist.blogspot.hk/2015/05/hkqaa-symposium-2015-part-2.html

2014: HKQAA 25th Anniversary Forum & Celebration Cocktail Reception - http://qualityalchemist.blogspot.hk/2014/11/hkqaa-25th-anniversary-forum.html

2013: http://qualityalchemist.blogspot.hk/2013/11/hkqaa-symposium-2013-esg-management.html

2012: Part 1 - http://qualityalchemist.blogspot.hk/2012/12/hkqaa-symposium-2012-part-1.html;

2012: Part 2 - http://qualityalchemist.blogspot.hk/2012/12/hkqaa-symposium-2012-part-2.html

2011: http://qualityalchemist.blogspot.hk/2011/11/hkqaa-symposium-2011-performing-your.html

2010: Part 1 - http://qualityalchemist.blogspot.com/2010/11/hkqaa-symposium-2010-sustainability.html ;

2010: Part 2 - http://qualityalchemist.blogspot.com/2010/11/hkqaa-symposium-2010-sustainability_26.html

2009: http://qualityalchemist.blogspot.com/2009/11/smaller-carbon-footprint-hkqaa.html

2008: http://qualityalchemist.blogspot.com/2008/12/hkqaa-symposium-2008-green-day.html

HKIE Seminar on Risk Management for ISO 9001:2015

The Hong Kong Institution of Engineers (HKIE) –Materials Division organized the seminar named “Risk Management for ISO 9001:2015” on 18th Jan 2016. ISO 9001:2015 was issued on 15 Sep 2015 and it is a revolutionary change of the 2008 version which focuses on the “Risk Management” of organizations. Ir. CK Cheung (Lead Assessor of the USA’s International Accreditation Service (IAS)” was our guest speaker and he would like to share his experience for achieving the new standards implementation in the coming three years.

In the beginning, Ir. CK Cheung said the most important of quality system was “Integrity”. Then he introduced the new version of ISO 9001:2015 in which emphasized “Risk” & “Opportunity”. He also quoted Albert Einstein statement that “If you can’t explain it simply, you don’t understand it well enough.” So he try to explain risk management in the simply way.

Then Ir. CK Cheung briefed the ISO 31000:2009 – Risk Management as reference to fulfill ISO 9001:2015 new requirements. The most fundamental of Risk Management included “Communication and Consultation (5.2)”, “Establishing the context (5.3)” and “Risk Assessment (5.4)” with “Risk Identification (5.4.2)”, “Risk Analysis (5.4.3)” and “Risk Evaluation (5.4.4)”; and “Risk Treatment (5.5.)”, as well as, “Monitoring and Review (5.6)”.

Ir. CK Cheung also mentioned the treatment of risk in the project if identified. Those Risk could be “Avoid”, “Mitigate”, “Transfer” and “Accept”.

Ir. CK Cheung discussed that there would be no Quality Manual but just had Risk Management Manual in which identified all processes of the organization. No longer single manual for all companies existed. Risk associated with company was depended on its scale.

He summarized the quality development from QC to QA to QM and ultimately to Quality Risk Management.

Then Ir. CK Cheung explained how to define risk management through Risk Assessment plus Risk Control and then through Risk Management Planning, Risk Resolution and Monitoring.

He also introduced four types of Business Risk included Operation Risk, Financial Risk, Hazard Risk and Strategic Risk in the following diagram.

Finally, he summarized several requirements related to “Risk” in the ISO 9001:2015 as follows:
- Determination of the processes taking under consideration risks & opportunity (4.4f)
- Risks & opportunity that can affect conformity of products & services and the ability to enhance customer satisfaction should be determined & addressed (5.1.2b)
- When planning for the QMS, the organization shall determine the risks & opportunity (6.1.1)
- The organization shall plan actions to address risks & opportunity (6.1.2)
- Determining type & extent of control of external provision (8.4.2) (It doesn’t use the word “risk”, but meaning is that risk is present.)
- In determining the extent of post-delivery activities the organization shall consider the risks associated with the products & services (8.5.5a)
- The management review shall be planned and carried out taking into consideration the effectiveness of actions taken to address risks & opportunities (9.3.1d)

Ir. CK Cheung used a project management & construction of a High Speed Railway Train as example to explain different issues such as political resistance, financial implication, environmental impact, labor & worker supply, etc. Lastly, he used the Risk Management Process diagram as a conclusion.

After the talk, HKSQ members took a photo with the speaker for memory.

(Left: I, Ir. CK Cheung (Director, WCC Engineering Ltd.) and Mr. Thomas Tsang (Manager, Leading Edge Construction Materials Testing Co., Ltd.))

Reference:
HKIE-Material Division – http://mt.hkie.org.hk/

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

HKQAA Seminar on “A New Era of Management System Standard - ISO 9001:2015”

Hong Kong Quality Assurance Agency (HKQAA) organized the seminar named “A New Era of Management System Standards – Common Myths, Truths and Lies about ISO 9001:2015” on 3rd Dec 2015. The seminar aimed to explore some of the common misconceptions about new ISO 9001:2015 standards including the role of ISO; the Quality Management Principles, Risk-based thinking, and the role of ISO 9001 in Sustainable Development, etc. Mr. Peter Fung (Chairman, HKSQ) had attended the seminar and took some photos for sharing.

Before the seminar, Mr. Edmond Fung (Assistant General Manager, HKQAA) introduced HKQAA Hong Kong Registration – Personnel Series. There were several types of registered personnel for individual applicant included Registered Quality/Environment Management Professional/Officer/Auditor for applicant who had competence and comprehensive working knowledge in Management Systems. Organizations which committed to the improvement of their employees’ competence could join as “Companions”. Then he mentioned some benefits to be a Registered Personnel.

Dr. Nigel Croft (Chairman, ISO Subcommittee responsible for ISO 9001 and ISO 9004 standards) was the guest speaker. Firstly, he joked that ISO stands for “International Sightseeing Organization” – Myth, truth or lie? “Lie!” He said ISO stands for “International Organization for Standardization” which based in Geneva.

Then he asked the second question “ISO 9001:2015 will revolutionize quality management” – Myth, truth or lie? It was Myth! He told us ISO 9001 was evolution but not revolution.

Dr. Nigel Croft also asked “ISO 9001 is ISO’s biggest selling standard of all time” – Myth, truth or lie? It was truth! ISO 9001 was the top of the list and others in the “top 10” included ISO 14001, ISO 9000, ISO 9004, IOS/IEC 17025, ISO/IEC 27001, ISO 19011, etc.

After that Dr. Nigel Croft briefed he was coached by Dr. Edwards Deming and recognized that there must be a method to achieve an aim. Management System was the method to achieve different aims through ISO 9001 (Consistent, Conforming Products), ISO 14001 (Prevention of Pollution), ISO 45001 (Safe Working Conditions), ISO 50001 (Efficient Energy Usage), ISO 22000 (Safe Food), etc.

He also asked “ISO 9001:2015 has abandoned the Process Approach” – Myth, truth or lie? The answer was Lie! Because 3 core concepts for ISO 9001:2015 were i) to identify the processes needed to achieve the planned results; ii) to continually monitor the risk (Risk-based thinking) and iii) to manage the processes and the system using PDCA.

Another question was “ISO 9001 does not guarantee business excellence” – Myth, truth or lie? It was Truth! ISO 9001 was fundamental level to ensure reliable products. Company needed increasing their QMS maturity to business excellence.

Dr. Nigel Croft mentioned new standard was changed in focus from Old “A” (Correction, Corrective Action and Preventive Action) in “PDCA” cycle to “P” & “A” in “PDCA” cycle. “P” was focused on “Risk Identification and Treatment/Mitigation” (Prevention) and “A” was for “Containment, Correction, Corrective Action (to prevent recurrence!), and Improvement (included Kaizen, but also breakthrough improvements and innovation).

After questions answered, Dr. Nigel Croft briefed summary of some other changes to ISO 9001:2015 which was similar he presented in the ITC & HKCTC Conference on ISO 9001:2015.

At the end, Dr. Nigel Croft concluded that ISO 9001 had undergone a “Major Revision” and he encouraged us to prepare transition NOW.

Reference:
ISO - http://www.iso.org/iso/home.html
HKQAA - http://www.hkqaa.org/en_index.php
HKSQ - http://www.hksq.org/
20151125 – ITC & HKCTC Conference on ISO 9001:2015 - http://qualityalchemist.blogspot.hk/2015/11/itc-hkctc-conference-on-iso-90012015.html