HKSQ Seminar on ISO 9001, ISO 14001 & ISO/CD 45001 New Requirements & Implementation

The seminar entitled “ISO 9001, ISO 14001 & ISO/CD 45001 New Requirements & Implementation” was co-organized by Hong Kong Society for Quality (HKSQ), BSI, Department of Industrial and Systems Engineering (ISE), PolyU and ASQ Hong Kong (ASQ-HK) on 20th Nov 2015. The seminar aimed to explain the key changes to the requirements of the new standards and implementation tips for an effective transition. Before the seminar, we took a group photo for memory.

(Left: I, Mr. Michael Li (Client Manager, BSI), Mr. Coleman Tse (Sales & Marketing Director, BSI), Mr. Peter Fung (Chairman, HKSQ) and Mr. Ben Chiu (Senior Business Development Manager, BSI))

In the beginning, Mr. Peter Fung (Chairman, HKSQ) introduced HKSQ Vision, Mission and Values as well as World Quality Month activities in November 2015.

Mr. Coleman Tse (Sales & Marketing Director, BSI) was the first speaker. Firstly, Mr. Tse briefed the background of BSI which has a Royal Charter Status to focus on the development of standards, training and certification activities designed to improve performance, manage risk, reduce cost and enable sustainable growth.

Then he mentioned BSI is pioneer for different ISO standards such as ISO 9001 (BS 5750), ISO 14001 (BS 7750), OHSAS 18001 (BS 8800), ISO/IEC 27001 (BS 7799), etc. He also introduced their transition package and training courses for new standards.

Mr. Michael Li (Client Manager, BSI) was the second speaker and he introduced the main changes of those standards. All new standards would adopt New High Level Structure (HLS).

For ISO 9001:2015 standard, the new changes were identified as “Leadership”, “Risk”, “Context of Organization”, “Quality Importance”, “Process Approach” and “Documented Information”. The implementation of this new standard was followed PDCA cycle where Plan included clauses 4, 5, 6 & 7; Do included clause 8; Check was clause 9 and Act was clause 10.
Some points were elaborated as below.
“Leadership” – more top management involvement
“Risk thinking” – prioritize process and proactive for prevention
“Quality Importance” – strategy direction
“Planning of changes” – using systematic approach

Mr. Li said there were 3 year transition period upto September 2018.

For ISO 14001:2015, it was same as ISO 9001:2015 using PDCA cycle. New ISO 14001 focused on three purposes: i) Enhance Environmental Performance, ii) Fulfill and compliance the obligation and iii) Achieve Environmental Objectives. Moreover, one of new concepts was to consider product life cycle perspective. It was not talking about standards for Product Life Cycle Assessment (e.g. ISO 14040 & ISO 14044).

Then Mr. Li briefed the OHSAS 18001 transform to ISO 45001 (CD). It was also adopted to the High Level Structure (HLS)

Mr. Li showed the ISO 45001 timeline but he received a updated schedule that the standard would be delayed to 2017.

The ISO 45001 (CD) Process Model was showed and discussed. It was similar to both ISO 9001:2015 and ISO 14001:2015.

Q&A

At end of the seminar, Mr. Peter Fung (Chairman, HKSQ) presented a souvenir to Mr. Michael Li.

Reference:
HKSQ - www.hksq.org
HKSQ World Quality Month - http://www.hksq.org/world_quality_month.htm

HKSQ Seminar on ISO 9001:2015 & ISO 14001:2014 – Executive Overview

The seminar named “ISO 9001:2015 & ISO 14001:2015 – Executive Overview” was organized by Hong Kong Society for Quality (HKSQ) and co-organized with SEEM Dept., CityU & HKIE – MID and held on 13th Aug 2015. Since FDIS of ISO 9001:2015 & ISO 14001:2015 has been issued, the seminar aimed to share the view from ISO expert and certification body to senior executive, management representatives and quality management professionals. In the beginning, Mr. Peter Fung (Chairman, HKSQ) presented the appreciation certificates to our guest speakers.
(Left: Mr. Cliff Poon, Mr. Peter Fung and Dr. Aaron Tong)

The first speaker was Ir. Dr. Aaron Tong (Managing Director & Principal Consultant, TQM) and he shared the Changes and Challenges of ISO 9001:2015 & ISO 14001:2015. In the beginning, he briefed his ISO background included the 1st one obtained ISO 9001 in Hong Kong & PRC in 1991; TC-176 Hong Kong Observer, Past Chairman of HKIE-MIE Division, Former Chairman of HKSQ and ASQ trainer for Six Sigma Black Belt, etc.

Then Dr. Aaron Tong introduced the journey of ISO 9001 from 1987 to 2015. He said the critical change was the 3rd Edition in 2000 in which introduced the management model based on PDCA. He added the key of model management was “close-loop feedback system”.

ISO 14001 Journey also mentioned from 1996 to 2015. Both standards were transferred by BS that BS 5750 to ISO 9001 and BS 7750 to ISO 14001. Aaron said the top number of certificate on ISO 9001 and ISO 14001 was China which granted 337033 and 104735 in 2013, respectively.

The process approach was discussed and he explained the different of continuous improvement and continual improvement. He said continuous improvement was “Today better than Yesterday” for short period of time. However, we couldn’t ensure improvement every time. So “Continual improvement” was used for longer period of time such as quarterly or yearly.

After that Aaron described the process approach model of ISO 9001:2015 & ISO 14001:2015 and shared the major changes below:

For ISO 9001,
i) Adopt New High Level Structure (HLS)
ii) Leadership insert “Management Responsibility”. However, Aaron disagree this change because leader and manager was in different role. No mention on MR. He discussed the right person for MR who should be GM rather than QA.
iii) Context of the Organization stated interested parties
iv) Focus on Internal and External forces
v) Remove Preventive Actions. Aaron said preventive action was different to verify and ISO 9001 standard is designed for audit assessment which avoid subjective in nature.
vi) Risk-Based Thinking was adopt from other standards such as ISO 14001 (Environmental Aspect)
vii) Documented Information (where Manual is no longer necessary and more flexible)
viii) Organization knowledge. Aaron said it may be referred from Malcolm Baldrige National Quality Award (MBNQA) model.
ix) Separated Products and Services again
x) External Providers insert Suppliers
xi) Externally Provided Products and Services insert Purchased Products

For ISO 14001,
i) Environmental Performance such as determine criteria to evaluate it using appropriate indicators
ii) Focus on Protection of Environment rather than prevention of pollution
iii) Life Cycle and Value Chain Perspective was added.

Finally, Aaron said the name of ISO 9001 – Quality Management System was not appropriate. It could be better named “Management System’s Quality”.

The second speaker was Mr. Cliff Poon (SGS Certification Manager) and he shared the transition to ISO 9001:2015 & ISO 14001:2015 in Certification Body perspectives.

In the beginning, he introduced the Annex SL and High Level Structure (HLS), which consisted of 4 appendices and proposes 10 clauses in Management Systems development, issued in 2012. Unitl new, there were four standards followed this HLS included ISO 22301:2012, ISO/IEC 27001:2013, ISO 9001 (FDIS) and ISO 14001 (FDIS). There were several benefits using Annex SL below:
i) Based on the same format
ii) Have the same structure, core text, terms and conditions
iii) Have discipline specific requirements
iv) Will be consistent
v) Smoother integration of standards

Then Mr. Cliff Poon shared the changes in external audit such as top management involvement and leadership demonstration, risk based consideration and probably lesser reliance on system documentation. About Risk-Based Thinking, it could go through the standards in the following clauses. PDCA was also found Plan (Clause 6), Do (Clause 8), Check (Clause 9), Act (Clause 10); Clause 7 is Support to the whole process.

After that Cliff stated there was 3 years transition from official publication of the international standards (ISO 9001 and ISO 14001). Some transition arrangements were mentioned such as “ISO 9001:2008 + ISO 9001:2015” and “ISO 14001:2004 + ISO 14001:2015”. The “To-Do-List” for preparation of transition was shared.

Finally, he shared the “Guidance for Preparation of Transition Arrangement” from IAF ID09 and ID 10:2015 as follows:
i) Identify organization gaps which need to be addressed to meet new requirements
ii) Develop an implementation plan
iii) Provide appropriate training and awareness for all parties that have an impact on the effectiveness of the organization
iv) Update the existing management systems (QMS & EMS) to meet the revised requirements and provide verification of effectiveness
v) Liaise with SGS for transition arrangements

Q&A Session:
I asked how many items from risk management to be enough for new ISO 9001 standard. Cliff said there was no passing level for enough or not. It depended on organization processes. Aaron added he would observe company’s customer complaint and defect rate to verify their risk assessment to be effective or not.
Cliff had mentioned their new training series of Management Skill for Top Management such as “2-Days Empowering Leadership in Management Systems and Standard”. I queried that C-suite could only expense (not invest) half or one hour for ISO new requirement. Eventhough second level of top management, I estimated that they would like to attend only half-day seminar. Cliff would consider my suggestion if any executive summary of such training.

At end of the seminar, HKSQ exco took a group photo with guest speakers.
(Left: Mr. Peter Fung, Dr. Aaron Tong, Mr. Chiff Poon and I)

Reference:
HKSQ - www.hksq.org

SEEM, CityU – http://www.cityu.edu.hk/seem/ 

HKIE-MI Division – http://mi.hkie.org.hk/ 

Other related seminars:

20120519: HKQAA Seminar on the next version of ISO 9001:2015 - http://qualityalchemist.blogspot.hk/2012/05/hkqaa-seminar-on-next-version-of-iso.html
20141201: HKQAA Seminar on ISO 9001 & ISO 14001 Revisions - http://qualityalchemist.blogspot.hk/2014/12/hkqaa-seminar-on-iso-9001-iso-14001.html
20150529: HKQAA Symposium 2015 (Part 1) - http://qualityalchemist.blogspot.hk/2015/05/hkqaa-symposium-2015-part-1.html
20150529: HKQAA Symposium 2015 (Part 2) - http://qualityalchemist.blogspot.hk/2015/05/hkqaa-symposium-2015-part-2.html
20150710: HKQAA Seminar on the Next Generation of Management System Standards (ISO 9001:2015) - http://qualityalchemist.blogspot.hk/2015/07/hkqaa-seminar-on-next-generation-of.html

HKQAA Seminar on the Next Generation of Management System Standards (ISO 9001:2015)

The seminar entitled "The Next Generation Management System Standards – Preparing for ISO 9001:2015 – Due out in September!" was organized by Hong Kong Quality Assurance Agency (HKQAA) on 10 July 2015. Dr. Nigel Croft (Chair of ISO/TC176/SC2 - the ISO subcommittee responsible for ISO 9001 and ISO 9004) was invited to provide an update on the background to the key changes to both ISO 9001 and ISO 14001 standards, their implications and potential benefits and the actions organizations should be taking as the official publication date approaches. I would like to summarize Dr. Nigel Croft to share the most new information about the idea of the ISO FDIS 9001:2015 below.

HKSQ representatives were attended the seminar and took a photo with Dr. Nigel Croft. (Left: Mr. Karson Chui (Former Chairman, HKSQ), I, Dr. Nigel Croft and Ms. Angela Wong (Vice Chairman, HKSQ))

In the beginning, Dr. Nigel Croft would like us to think WHY ISO 9001 to be changed and WHAT you should do, as well as Underline Concepts. Dr. Croft presentation outline included “Background”, “ISO Directives – Annex SL”, “ISO 9001:2015”, “ISO 14001:2015” and “Transition arrangements”. He mentioned the Mission of ISO was to support sustainable and equitable economic growth, promote innovation and protect health, safety and the environment. He added ISO 9001:2015 encourage Innovation for looking opportunities to be better quality of life for future generation. Then the background of ISO Technical Committees TC 176 (QMS) and TC 207 (EMS) were briefed.

Dr. Nigel Croft was dreaming of a sustainable future which included Economic Growth, Environmental Integrity and Social Responsibility. He said simply dreaming was not enough and we should have method to achieve it. Dr. W. Edwards Deming’s philosophy was quoted.

Then Dr. Nigel Croft stated management system aimed to achieve those objectives which were Results Focused. Different results from different management system were mentioned included ISO 9001 (Consistent, Conforming Products), ISO 14001 (Prevention of Pollution), OHSAS 18001 (Safe Working Conditions), ISO 50001 (Efficient Energy Usage) and ISO 22000 (Safe Food), etc. The Management System involved the interaction among "Hardware", "Software" and "Humanware" (Ref. 1).

Results Focus was key “Output Matter”. The following “Cause and Effect” diagram demonstrated QMS and EMS key elements and their outcome with effectiveness. After that Dr. Croft discussed 3 core concepts below:
i) Process Approach: Identify the processes needed to achieve the planned results
ii) Risk-based Thinking: Continually monitor the risks and understanding “Cause and Effect”
iii) PDCA cycle
Generic Process with PDCA cycle was stated (Ref. 2). The system of processes was demonstrated on the following model.

Then Dr. Croft summarized the positioning of some ISO (and other) standards in one diagram of Sustainable Development.

The ISO Directives Part1:2012 “Annex SL” High Level Structure was recommended to align different ISO Standards (approx. 30% or more of each standard would be identical text) (Ref. 1); and the Matrix structure of Management System Standards was explained (Ref. 4).

After the break, Dr. Croft told us approximate 1.1 million certifications to ISO 9001 worldwide. He then pointed out the global Challenges for QMS in the following diagram.

Dr. Croft also showed the ISO/FDIS 9001 QMS standards which had just issued on 9 July 2015 for voting (within 60 days).

The key inputs into ISO 9001:2015 included 7 Quality Management Principles (Customer Focus, Leadership, Engagement of People, Process Approach, Improvement, Evidence-based Decision Making and Relationship Management), topics from Future Concepts Task Group (Ref. 1), some changes based on FDIS.

I would like to compare the change of ISO 9001 and ISO 14001 FDIS as follows.
“Framework (Ref. 3) and clauses change”

Finally, Dr. Croft mentioned some changes from DIS to FDIS below.
- Terms and definitions were taken out of ISO 9001
- ISO 9000 become a “normative reference” again
- Simplification of Introduction (e.g. New and simpler figures)
- A lot of discussion about how to address the question of “Innovation”
(ISO 9001 must not inhibit innovation; it should encourage innovation but must not require innovation.)

At the end, Dr. Nigel Croft concluded that ISO was aligning its portfolio of management system standards and aimed to facilitate integration. ISO 9001 and ISO 14001 were both undergoing a “Major Revision” such as significant change in structure, “Process Approach + PDCA + Risk-based Thinking”. In addition, he asked us needed to prepare for the transition now.

I would like to introduce the venue named Moon Chun Multi-Function Hall in CityU Student Residence.

Outside the venue, there were some sculptures such as Albert Einstein.

Reference:
Ref.1 - 20120519: HKQAA Seminar on the next version of ISO 9001:2015 - http://qualityalchemist.blogspot.hk/2012/05/hkqaa-seminar-on-next-version-of-iso.html
Ref. 2 – 20141201: HKQAA Seminar on ISO 9001 & ISO 14001 Revisions - http://qualityalchemist.blogspot.hk/2014/12/hkqaa-seminar-on-iso-9001-iso-14001.html
Ref. 3 –20150529: HKQAA Symposium 2015 (Part 1) - http://qualityalchemist.blogspot.hk/2015/05/hkqaa-symposium-2015-part-1.html
Ref. 4 –20150529: HKQAA Symposium 2015 (Part 2) - http://qualityalchemist.blogspot.hk/2015/05/hkqaa-symposium-2015-part-2.html
Hong Kong Quality Assurance Agency (HKQAA) - http://www.hkqaa.org/en_index.php
Hong Kong Society for Quality (HKSQ) - http://www.hksq.org/index.asp

HKQAA Seminar on ISO 9001 & ISO 14001 Revisions

The Seminar entitled “ISO 9001 & ISO 14001 Revisions – What Changs Will Be and Why?” was organized by Hong Kong Quality Assurance Agency (HKQAA) and support by Hong Kong Science & Technology Parks on 1st Dec 2014. The seminar aimed to explain the next revision to ISO 9001 and ISO 14001 about their further alignment between the structure and content of these two quality and environmental management system standards.

Before the seminar, we arranged “Technologies from Science Park” Show Case – Incubatees’ Technology Solution.
Our Incubation Program team
(Left: I, Mr. Peter Mok (Head of Incubation Program), Mr. Antony Chan (Manager) and Mr. Gallen Leung (Assistant Manager))

We took a photo with our guest speaker Dr. Nigel Croft (Chairman, ISO Technical Subcommittee on Quality Systems (ISO/TC176/SC2)).
(Left: I, Mr. Peter Mok, Dr. Nigel Croft, Mr. Antony Chan and Mr. Bryan Peng (Assistant Director, HKQAA))

HKSQ exco members supported the show cases and seminar.
(Left: Ms. Angela Wong (Vice Chairman), I, Mr. Simon Tong (Coop Member) and Mr. Karson Chui (Former Chairman))

Before seminar start, I visited Vitargent (International) Biotechnology Limited and took a photo for memory.
(HKSTPC supports Vitargent to achieve laboratory accreditation)

Then Bryan and I tried the B-Free Chair Product which is the new patented invention by B-Free Tech Ltd.
(https://www.youtube.com/watch?v=WzZwkE910f0&feature=youtu.be )

Dr. Nigel Croft (Chairman, ISO Technical Subcommittee on Quality Systems (ISO/TC176/SC2)) is our guest speaker and he would provide insights into what changes Will Be and Why. In the beginning, Dr. Croft briefed ISO background and mentioned Dr. W. Edwards Deming questioned “By What Method to achieve the aim?”

Then Dr. Croft stated his 3 core concepts below:
1. Identify the processes needed to achieve the planned results
2. Continually monitor the risks (Risk-based Thinking)
3. Manage the processes and the system using “PDCA”
He told us a joke about PDCA to be “Please Don’t Check Anything”.

After that he explained the Generic Process through Plan-Do-Check-Act for different aspects included Quality, Environment, Safety, Social and Energy.

One of major change of all ISO standards was followed a new ISO Directive Part 1:2012 “Annex SL” which was significant impact on revisions of ISO 9001 and ISO 14001. The high level structure was shown as follows.

During the break, HKSQ exco team took a photo with Dr. Nigel Croft.
(Left: Mr. SW Lam, I, Mr. Simon Tong, Dr. Nigel Croft, Mr. Karson Chui and Ms. Angela Wong)

It is our new hall in Science Park Phase 3 and capacity is upto 750.

Dr. Nigel Croft introduced what to expect in ISO 9001:2015. He said “Certification to ISO 9001” should be a result of a well-implemented quality management system but not just “certification”.

The timeframe of ISO 9001:2015 was shown in the following diagram. The FDIS would be issued in Apr 2015 and expected the new standard published in Sep 2015. Then Dr. Croft briefed the key objectives for ISO 9001:2015 included to apply Annex SL of ISO Directives to enhance compatibility and alignment with other ISO management system standards. Dr. Croft also said QMS principles was reviewed by joint SC1/SC2 Task Group which was led by Prof. Y. Iizuka (Deming prize winner). New 7 Quality Management Principles included “Customer Focus”, “Leadership”, “Engagement of People”, “Process Approach”, “Improvement”, “Evidence-based Decision Making” and “Relationship Management”.

Some changes in DIS of ISO 9001 were showed below.
Changes:
- Align with Annex SL
- Using “Products and service” rather than “Product”
- “External provision of products and service” instead of “Purchasing”
- “Documented information” instead of “Documented procedures and records”
New:
- Clause 4.1 “Context of the Organization”
- Identification of “Interested Parties”
- “Actions to address risk & opportunities”
- Organizational knowledge
- “Improving products and services to meet known and predicted requirements”
Deleted:
- Elimination of the term “Preventive action”
- Elimination of A “Quality Manual” and A “Management Representative”
And the overall structure and model of ISO 9001:2015 were demonstrated using PDCA cycle.

Dr. Nigel Croft introduced what to expect in ISO 14001:2015. It also based on “Annex SL structure”. Some key changes were discussed below.
Changes:
- Context of the organization
- Interested parties
- “Risk & Opportunities”
- Reinforced requirements for Leadership
- Need to integrate EMS into business operations
- “Documented information”
New:
- Address “Processes and their interactions”
- “Compliance obligations”
- Policy included “Other specific commitment(s)”
- Environmental aspects to include Life-Cycle perspective
- And the model of ISO 14001:2015 was demonstrated using PDCA cycle.

Finally, Dr. Croft said 3-year transition period we had for new standards. Both ISO 9001 and ISO 14001 were undergoing a major revision such as “Process Approach + PDCA + Risk-based thinking”. He asked us to prepare for the transition now.

After the seminar, whole HKSQ team took a photo with Mr. PC Chan (COO, HKQAA).
(Left: Mr. SW Lam, Ms. Angela Wong, Mr. Simon Tong, Mr. PC Chan, Mr. Humphrey Lee (Former Vice-Chairman) and Mr. Karson Chui)

I met Mr. Thomson Wong (General Manager/Principal Consultant, BPI Consultants International Limited) and took a photo. We had cooperated in EPA Centre, CityU when he was in TQM Consultants Co., Ltd.

We then had lunch in Science Park.

Reference:
HKSTPC - http://www.hkstp.org/en-US/Homepage.aspx
HKQAA - http://www.hkqaa.org
HKSQ - http://www.hksq.org/