Revision of ISO 9001:2008 QMS Standard – Working Draft ISO 9001:2015 refers to ‘Context of the Organization’ in Clause 4

Clause 4 of ISO 9001:2008 QMS Standard mentions requirements of ‘quality management system’ that has following sub-clauses:

4 Quality management system
4.1 General requirements

4.2 Documented requirements
4.2.1 General
4.2.2 Quality manual
4.2.3 Control of documents
4.2.4 Control of records

Now the working draft for forthcoming ISO 9001 mentions clause 4 as ‘Context of the organization’ instead of ‘Quality management system’ as in ISO 9001:2008 QMS Standard. Clause 4 of the working draft issued by ISO/TC 176 Sub-committee 2 mentions requirements of ‘context of the organization’ that has following sub-clauses:

4 Context of the organization
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management system
4.4 Quality management system

Understanding the organization and its context

This is a new addition that requires:
- Organization to determine internal and external issues relevant to the organization’s purpose and that can affect organization’s ability to achieve desired results
- Organization to consider such issues for determining risks and opportunities

Understanding the needs and expectations of interested parties

This time understanding the needs and expectation of interested parties is included that requires:
- Organization to determine interested parties relevant to organization’s quality management system
- Organization to determine QMS related requirements of such interested parties

Determining the scope of the quality management system

Clause 1.1 of ISO 9001:2008 QMS Standard discusses the scope in general but now to determine the scope for the QMS will be a requirement to establish organization’s QMS scope. Organization needs to determine boundaries and applicability of its QMS by considering internal and external issues, needs and expectations of interested parties. It is now a requirement to mention the scope and also any exclusion in the documented information.

Quality management system

Requirements mentioned in the working draft is more or less similar to clause 4.1 of ISO 9001:2008 QMS Standard, however following additional requirements have been added in the working draft:

- Organization to determine risks to quality performance where unintended output is produced and/or process interaction is not effective.
- Organization to allocate responsibilities and authorities for particular processes or set of processes.
- Organization to ensure that (new or revised) processes continue to deliver desired results.

We will post more articles on ISO 9001 QMS Standard revision.

Please also read my earlier articles ‘Revision of ISO 9001:2008 QMS Standard’ and ‘Revision of ISO 9001:2008 QMS Standard – Working Draft has 10 clauses’ posted in this blog. I will be happy to have your comments and reaction to the write-up.

With best wishes,

Keshav Ram Singhal




I need Training or Consultancy help. Can you help?
Yes, we can certainly help you. We are expertise in implementation steps and can help you fast track your way to an effective and profitable QMS. We can provide you online training and/or consultancy help. If you need help in developing or implementing your ISO 9001:2008 QMS, please email us at keshavsinghalajmer@gmail.com giving details of your requirements.

Feedback is valuable
If you feel this article is informative or if you would like to provide us your feedback, do send us an email with your comments or write your comments in the space provided below the article. If you feel this blog could help your supplier, customer or other business associate, feel free to refer this blog to them.

Revision of ISO 9001:2008 QMS Standard – Working Draft has 10 clauses

'ISO/TC 176 Sub-committee 2' has issued working draft for ISO 9001 and it contains ten clauses instead of eight as in ISO 9001:2008 QMS Standard.


In short, clauses in the working draft are as under:
1. Scope
2. Normative reference
3. Terms and definitions
4. Context of the organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evaluation
10. Improvement


ISO 9001:2008 QMS Standard contains eight clauses as under:
1. Scope
2. Normative reference
3. Terms and definitions
4. Quality management system
5. Management responsibility
6. Resource management
7. Product realization
8. Measurement, analysis and improvement


Looking to the working draft, we come to a conclusion that there will be too many changes in the forthcoming ISO 9001 QMS Standard. ISO 9000 series had undergone major revision with the arrival of ISO 9000:2000 series in the year 2000 and ISO 9001:2000 certifiable standard contained requirements of quality management system to be implemented by organizations. Thereafter in the year 2008, a revised standard ISO 9001:2008 was issued, but with minor and editorial changes. But this time we will see major revision.

ISO 9001:2015 Working Draft also suggests PDCA (Plan-Do-Check-Act) methodology. Requirements in clause 4, 5 and 6 related to 'Plan', requirements in clause 7 and 8 relate to 'Do', requirements in clause 9 relate to 'Check' and requirements in clause 10 related to 'Act' of the PDCA methodology.


We will post more articles on ISO 9001 QMS Standard revision.


Please also read my earlier article ‘Revision of ISO 9001:2008 QMS Standard’ posted in this blog on 25 March 2013.


With best wishes,


Keshav Ram Singhal




I need Training or Consultancy help. Can you help?
Yes, we can certainly help you. We are expertise in implementation steps and can help you fast track your way to an effective and profitable QMS. We can provide you online training and/or consultancy help. If you need help in developing or implementing your ISO 9001:2008 QMS, please email us at keshavsinghalajmer@gmail.com giving details of your requirements.

Feedback is valuable
If you feel this article is informative or if you would like to provide us your feedback, do send us an email with your comments or write your comments in the space provided below the article. If you feel this blog could help your supplier, customer or other business associate, feel free to refer this blog to them.

Making Effort to Create Awareness – Need Your Guidance and Support

Dear Reader,

Greetings!


I am glad to inform you that I am actively involved in creating awareness on management systems through various activities.


I have created a group ‘Management Systems Professionals and Users’ at www.linkedin.com that has a membership of more than 1200 members including professionals engaged in awareness, consulting, guidance, auditing and/or training of any of the management systems (such as ISO 9001, ISO 14001, ISO 13485, AS9100, OHSAS 18001 etc.) and users of any documented management systems. The group also invites prospective users of any of the management systems. The purpose of the group is to interact, discuss and share knowledge and information about management systems.


I am regularly writing articles for creating awareness. My blog ‘Quality Concepts and ISO 9001:2008 QMS Awareness’ at http://iso9001-2008awareness.blogspot.in is a popular blog being visited by people in more than 140 countries/economies. It has crossed more than 105,000 visitors, which I feel is a milestone achievement.


I am also developing ‘ISO 9001 Awareness’ blog at http://iso9001awareness.blogspot.in (in Hindi) with a clear objective to create awareness among Hindi speaking people and hope that this blog will also become a popular blog in near future.


A book ‘Implementing ISO 9001:2008 Quality Management System – A Reference Guide’ jointly authored by Dr. Divya Singhal and me has been published by PHI Learning Private Limited, New Delhi (India), a renowned publisher of management books. Details of this book may be seen at http://phindia.com/bookdetails/implementing_iso_9001_2008_quality_management_system_a_reference_guide_by-singhal_divya_singhal_k_r_-isbn-978-81-203-4574-4.


In addition to the above, I have been involved in training and consulting activities for ISO 9001 QMS from time to time.


I am also compiling ‘Awareness Series on QMS’ containing more than 50 articles, which will be available to subscribers at a nominal fee.


I would request you to please see contents of my blog and if you feel my blog is informative or if you would like to provide me your feedback, do send me an email with your comments or write your comments in the space provided below the article in the blog. If you feel my blog could help your supplier, customer or other business associate, feel free to refer my blog to them.


I need your guidance and support to continue my awareness efforts.


With warm best wishes,


Keshav Ram Singhal
keshavsinghalajmer@gmail.com

Your Email Motivates Me

Email dated 26 February 2013 from Dr. R. H. G. Rau, Past President, National Centre for Quality Management

"Congratulations. It sure is a milestone achievement. Warm personal regards, Rau"


Email dated 27 March 2013 from Asgar Uddin Sirdar (IRCA Registered Lead Auditor)
Qualification: BE Metallurgy, Company: Larsen & Toubro Ltd., Designation: QAQC manager

"I am a supporter of your blog. It is good."

Signing of Quality Policy

Dr. Divya Singhal
&
Keshav Ram Singhal



One reader raised a question - Whether Quality policy can be signed for Chairman and Managing Director by a General Manager who is not even a part of team of Directors? This question indicates the doubt about the signing of the quality policy.

Clause 5.3 of ISO 9001:2008 QMS standard mentions requirements for quality policy that mentions certain requirements to be ensured by the top management of the organization. Top management has been defined as ‘person or group of people who directs and control an organization at the highest level.’

The above clause requires top management to ensure the following:
• Quality policy is appropriate to the purpose of the organization.
• Quality policy includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system.
• Quality policy provides a framework for establishing and reviewing quality objectives.
• Quality policy is communicated and understood within the organization.
• Quality policy is reviewed for continuing suitability.

What is further required (in addition to the above) with regard to the quality policy is that as a document it must be duly approved for adequacy prior to issue as per organization’s documented procedure for control of documents. In this connection requirements of clause 4.2.3 of ISO 9001:2008 QMS standard are required to be followed as quality policy is also a part of organization’s quality management system documentation.

A statement of quality policy is a part of the quality management system documentation. (please refer to clause 4.2.1 in this regard.) Accordingly, 'overall intentions and direction of an organization related to quality as formally expressed by the top management' (quality policy) may be communicated by issuing a documented statement of quality policy, which must be approved for adequacy prior to issue as per organization's documented procedure on 'control of documents'.

Here it is important to mention that ISO 9001:2008 QMS Standard does not state any requirement for signing of the quality policy by particular authority or designated personnel. People generally get confused with the meaning of the word ‘ensure’ and may think that top management formulates the quality policy and that it is a requirement for the top management to sign the quality policy.



Top management is required to ensure such a quality policy that is appropriate to the purpose of the organization, that includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system, and that provides a framework for establishing and reviewing quality objectives. In most organizations, QMS documentation (including quality policy and quality objectives) are generally developed by a team of people and then approved for adequacy prior to issue as per organization’s own documented procedure on ‘control of documents’. Here it is immaterial who signs the quality policy or other documentation, while issuing QMS documentation. Important point is the documentation must be issued only after the same is approved for adequacy prior to issue as per organization’s procedure on ‘control of documents’. Different organizations may have different procedures for control of documents. Where a duly approved ‘quality policy’ or any other QMS documentation, as per the provisions of organization’s procedure on ‘control of documents’, is issued, communicated and understood within the organization, that will serve the purpose and intent of the quality management system as mentioned in ISO 9001:2008 QMS Standard. Further, we should note that top management of the organization reviews the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. Such review must include assessing opportunities for improvement and the need for changes to the quality management system, including quality policy and quality objectives.

Relevant clauses of ISO 9001:2008 QMS Standard in this article – 4.2.1, 4.2.3, 5.3




Where can I get more articles?
This article is included in ‘Awareness Series on QMS’ containing more than 50 articles edited by KESHAV RAM SINGHAL. You can get this series by sending your subscription that is very nominal. You should send an email to keshavsinghalajmer@gmail.com asking subscription details of the Awareness Series on QMS.

I need Training or Consultancy help. Can you help?
Yes, we can certainly help you. We are expertise in implementation steps and can help you fast track your way to an effective and profitable QMS. We can provide you online training and/or consultancy help. If you need help in developing or implementing your ISO 9001:2008 QMS, please email us at keshavsinghalajmer@gmail.com giving details of your requirements.

Your Feedback is valuable
If you feel this article is informative or if you would like to provide us your feedback, do send us an email with your comments or write your comments in the space provided below the article. If you feel this blog could help your supplier, customer or other business associate, feel free to refer this blog to them.

Revision of ISO 9001:2008 QMS Standard

ISO 9000 Standards were first published in 1987. ISO Standards are reviewed periodically and accordingly ISO 9000 series was reissued in July 1994 as ISO 9000:1994 series. ISO 9000 series have undergone major revision with the arrival of ISO 9000:2000 series standards in the year 2000. A set of three standards (ISO 9000:2000, ISO 9001:2000 and ISO 9004:2000) were published on 15 December 2000. ISO 9000:2005, ISO 9001:2008 and ISO 9004:2009 (revised standards) have been published in the year 2005, 2008 and 2009 respectively.


Accordingly, there have been four editions to certifiable ISO 9000 series standards:
- ISO 9001/2/3:1987
- ISO 9001/2/3:1994
- ISO 9001:2000
- ISO 9001:2008



ISO 9000 series has consistently been ISO’s most popular series of standard. With 25 years of success and as ISO standards are periodically reviewed, ISO Technical Committee ISO/TC 176, Quality management and quality assurance, subcommittee SC2, Quality systems, is doing the groundwork for reviewing and revising the quality management standards.


Both ISO 9001:2008 and ISO 9004:2009 are currently based on a set of eight quality management principles. ISO/TC 176/SC2 in collaboration with its counterpart ISO/TC 176/SC1 has undertaken a full review of quality management principles and a few minor adjustments may be there to update the quality management principles for the upcoming quality management standards. ISO/TC 176/SC2 is carrying out extensive research and preparation for the next major revision that is expected in 2015.


The first meeting of the working group on ‘Revision of ISO 9001’ ISO/TC 176/SC2/WG 24 was held in Bilbao (Spain) in June 2012. The meeting developed an item proposal for the revision of ISO 9001, a draft design specification and project plan. The group also developed a preliminary draft of the new standard. The meeting’s outputs have been circulated to ISO member bodies for ballot. As expected, drafting work is in progress and it is expected that:

- The new standards will provide a stable core set of requirements for the next ten years or more.
- The new standards will remain generic.
- The new standards will be relevant to all types and sizes of organization operating in any sector.
- The new standards will maintain focus on effective process management to achieve desired outcomes.
- The new standards will take account of changes in quality management system practices; as such there will be major change.
- The new standards will facilitate effective implementation in the organization as well as effective conformity assessment.
- The new standards will use simplified language and writing styles for better understanding and consistent interpretations of standards’ requirements.



The proposed timeline for the development of ISO 9001:2015 is as under:

- June 2012 – Draft design specification and WDO
- December 2012 – Approved design specifications and WD1
- April 2013 – CD for comment and ballot
- March 2014 – DIS for ballot
- November 2014 – Draft FDIS
- January 2015 – FIDS for ballot
- September 2015 – Publication ISO 9001:2015

With best wishes,

Keshav Ram Singhal




I need Training or Consultancy help. Can you help?
Yes, we can certainly help you. We are expertise in implementation steps and can help you fast track your way to an effective and profitable QMS. We can provide you online training and/or consultancy help. If you need help in developing or implementing your ISO 9001:2008 QMS, please email us at keshavsinghalajmer@gmail.com giving details of your requirements.

Your Feedback is valuable
If you feel this article is informative or if you would like to provide us your feedback, do send us an email with your comments or write your comments in the space provided below the article. If you feel this blog could help your supplier, customer or other business associate, feel free to refer this blog to them.

Use of ISO, Certification Body or Accreditation Body Logo

One professional raised a question on Any Tips for usage of ISO, Certification Body and Accreditation Body Logos for ISO 9001:2008.

Any organization, implementing ISO 9001:2008 QMS Standard (whether it is certified or not) should not use any other organization's logo without their specific permission. Certification body generally grants permission to the organization, who takes certification from the certification body.

As regards use of ISO name and logo, it is suggested to see the link at ISO Website at http://www.iso.org/iso/name_and_logo.htm. It should be noted that use of ISO logo is restricted to ISO members and technical committees only.

With best wishes,

Keshav Ram Singhal