Understanding Management Systems Auditing - Introduction

Understanding Management Systems Auditing

Article - 1

Introduction

ISO 19011 auditing guidelines standard was first published in the year 2002 as ISO 19011:2002, Guidelines for quality and/or environmental management systems auditing. The ISO 19011:2002 standard provides guidance for auditing two management systems standards – (i) Quality management system, and (ii) Environmental management system. After publication of ISO 19011 in the year 2002, International Organization for Standardization (ISO) has published a number of new management systems standards, such as ISO 22000: 2005, ISO/IEC 27001:2005, ISO 50001:2011. As a result ISO considered it necessary to widen the scope of auditing guidelines standard. Accordingly, ISO has published the revised standard ISO 19011:2011, Guidelines for auditing management systems.

In the year 2006, the CASCO (ISO Committee for Conformity Assessment) developed and published ISO/IEC 17021:2006, Conformity assessment – Requirements for bodies providing audit and certification of management systems. This standard has also been revised in 2011 as ISO/IEC 17021:2011, Conformity assessment – Requirements for bodies providing audit and certification of management systems. ISO/IEC 17021:2011 was extended to transform the guidance offered in ISO 19011 into requirements for management system certification audits.

Following modifications have been made by the revision process in the ISO 19011:2011 standard:
- The scope of the ISO 19011:2011 standard has been broadened from auditing quality management system and environmental management system to auditing any management systems
- Remote audit methods have been introduced in ISO 19011:2011
- The concept of risk has been introduced in ISO 19011:2011
- Confidentiality has been added as a new principle of auditing in ISO 19011:2011
- Requirements of clauses 5, 6 and 7 of the earlier standard have been reorganized
- A new annex A (Guidance and illustrative examples of discipline-specific knowledge and skills of auditors) has been added in ISO 19011:2011, thus providing additional guidance on auditing management systems
- A new annex B (Additional guidance for auditors for planning and conducting audits) has been added in ISO 19011:2011, thus providing additional guidance on auditing management systems
- ISO 19011:2011 has strengthened the competence determination and evaluation process

The title of the standard has been modified. ISO 19011:2002 standard title ‘Guidelines for quality and/or environmental management systems auditing’ has been modified in ISO 19011:2011 as ‘Guidelines for auditing management systems’.

A quick reference journey to ISO 19011:2011 standard is given below:

1. Scope
2. Normative reference
3. Terms and definitions
4. Principles of auditing
5. Managing an auditing programme
6. Performing an audit
7. Competence and evaluation of auditors
Annex A – Guidance and illustrative examples of discipline-specific knowledge and skills of auditors
Annex B – Additional guidance for auditors for planning and conducting audits

Next article …. Scope and vocabulary in ISO 19011:2011

Awareness Literature on 'ISO 9001:2008 QMS Implementation in School'

'Singhal Institute for Training and Education Trust' has released an awareness literature on 'ISO 9001:2008 QMS Implementation in School' with an objective to create awareness among employees of educational institutions about ISO 9001QMS. Principal / Management of a School interested to get copy of the literature should send an email to site.ajmer@gmail.com giving details (address, email, website) of the School.

With best wishes,

Keshav Ram Singhal

New Blog on "जोखिम प्रबंधन जागरूकता Risk Management Awareness"

...... जोखिम प्रबंधन जागरूकता ...... Risk Management Awareness: Preface: Dear readers, Greetings! I am starting a new blog on 'Risk Management Awareness' with an objective to create awareness ...

NCR and CAR

NCR = Non-Conformance Report
CAR = Corrective Action Request

NCR is a report that provides details of non-conformity encounters.

CAR is report that requests to review non-conformity and take action to eliminate the causes of nonconformity.

The observer (generally an auditor) of non-conformance raises a NCR (non-conformance report) and ask for a CAR (corrective action request) to the person responsible for the NC (non-conformance). The corrective action initiated can be part of NCR/CAR.

A few other related abbreviations -
PAR = Preventive Action Request
SCAR = Supplier Corrective Action Request
CAPA = Corrective Action Preventive Action
CPAR = Corrective Preventive Action Request
NCN = Non-conformance Note

With best wishes,

Keshav Ram Singhal

Revision of ISO 9001:2008 QMS Standard – ISO has issued Committee Draft for ISO 9001:2015

A new version of ISO 9001 QMS Standard is expected to be published in 2015 as ISO 9001:2015. International Organization for Standardization (ISO) has released ISO/CD 9001 on 3 June 2013 and thus ISO 9001 revision reaches Committee Draft stage. In accordance with the approved project plan for the revision of ISO 9001 QMS Standard, Secretariat of ISO/TC 176/TC 2 has sent the committee draft of ISO 9001 to its members. The same has been circulated to members for commenting and ballot. The last date for submission of comments and votes is 10 September 2013. It is expected that next meeting of ISO/TC 176 will be held in November and work for developing ISO/DIS 9001 will start. It is expected that ISO/DIS 9001 will be circulated to members by April 2014. ISO/FDIS is expected to be released around July 2015 and publication of ISO 9001:2015 QMS Standard is expected by the end of 2015.

If you wish to get a copy of ISO/CD 9001, you may get it from the sales counter of International Organization for Standardization (ISO) for which you should visit http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=62085.

DIS = Draft International Standard
FDIS = Final Draft International Standard

With best wishes,

Keshav Ram Singhal

IMPLEMENTING ISO 9001:2008 QUALITY MANAGEMENT SYSTEM : A REFERENCE GUIDE [Kindle Edition]

Details of 'IMPLEMENTING ISO 9001:2008 QUALITY MANAGEMENT SYSTEM : A REFERENCE GUIDE [Kindle Edition]' are available at http://www.amazon.com/IMPLEMENTING-ISO-9001-MANAGEMENT-ebook/dp/B0081XOFHW/ref=pd_sim_kstore_1.

With best wishes,

Keshav Ram Singhal

Preservation of Product

It is the intention and purpose of ISO 9001:2008 QMS Standard that the organization needs to ensure to appropriately handle the product to prevent damages and mix-ups. It is the intention of the Standard that the product, during all stages of product realization from acquiring from the suppliers to the delivery to the intended destination, must be protected. Clause 7.5.5 of ISO 9001:2008 QMS Standard mentions the relevant requirements for preservation of product. According to the requirements of the Standard, during internal processing and delivery to the intended destination (= during product realization processes and also during delivery process), the organization must preserve conformity of product. This preservation must include identification, handling, packaging, storage and protection; and must apply to the constituent parts of the product.



It will be good if following precautions are taken:
(i) Mark designated area for storing product (that conform to requirements)
(ii) Mark designated area for storing nonconforming product (to avoid its mix-up with conforming product)
(iii) Store the conforming product and nonconforming product in their designated area
(iv) Control inward receipt at every stage of the product realization process
(v) Control outward release
(vi) Make proper attention to identification by marking appropriately
(vii) Make proper attention to packaging
(viii) Periodically review storage, packaging and delivery methods to intended destination

With best wishes,

Keshav Ram Singhal

Understanding the meaning – Continual improvement …. Constant improvement …. Continuous improvement

I was addressing a group of participants in a training programme on ‘ISO 9001 QMS Awareness’, while discussing and telling requirements relating to continual improvement, one participant asked me about ‘continual improvement’ phrase used in ISO 9001:2008 QMS Standard and relevant meaning of ‘continual improvement’, ‘continuous improvement’ and ‘constant improvement’ for QMS implementation.



“Continual, constant, continuous all refer to a succession of occurrences. The two adjectives ‘continual’ and ‘continuous’ are synonyms, but not equivalent. The word "continual" incorporates "continuous" and not the other way around. People use ‘continuous’ and ‘continual’ as if they are exact synonyms, but there is difference between them as we have seen from the above and we can understand distinguish between these two. In the eyes of many QMS Consultants there is no difference between ‘continual’ and ‘continuous’. The concept of ‘continual’ improvement has always been used by Deming in reference to the general processes of improvement. Continual improvement is broader in scope than continuous improvement. We can say that ‘continuous improvement’ is a subset of ‘continual improvement’. The word ‘continual’ incorporates ‘continuous’ and not the other way round.” – This opinion is based on the following:


Continual

(adjective)Con-tin-u-al
(1) Happening without interruption or cessation
(2) Continuous in time
(3) Of regular or frequent recurrence
(4) Often repeated
(5) Very frequent
(6) Duration that continues over a long period of time, but with intervals of interruption



Synonyms of Continual
(1) Unceasing
(2) Ceaseless
(3) Incessant
(4) Uninterrupted
(5) Successive
(6) Recurrent
(7) Repetitive
(8) Repetitious

Noun
(1) Continuality
(2) Continualness


Examples:
(1) Continual misunderstanding between nations
(2) Continual improvement is a requirement of ISO 9001:2008 QMS Standard.
(3) The organization must continually improve the effectiveness of the quality management system.
(4) Continual improvement of the system
(5) The continual street repair disrupted traffic for nearly two years.

Constant

Constant implies always recurring in the same way, under uniform conditions, with similar results, and the like.

Examples:
(1) Constant repetition of the same mistakes
(2) Constant pressure


Continuous



(adjective)Con-tin-u-ous
(1) Being in immediate connection
(2) Being in immediate relation
(3) Uninterrupted in time
(4) Without cessation
(5) Duration without interruption

Adjective
(1) Continuously

Noun
(1) Continuousness

Continuous emphasizes the idea that the succession is unbroken, but successive recurrences are not very close together as observed in continual.

Examples:
(1) The continuous life of the universe
(2) A continuous pattern of dots
(3) Continuous coughing during the concert
(4) The continuous humming of the fluorescent lights provided him a headache.

ASQ Basic Concept

ASQ basic concept states, “Continuous improvement is an ongoing effort to improve products, services or processes. These efforts can seek “incremental” improvement over time or “breakthrough” improvement all at once. ….. The terms continuous improvement and continual improvement are frequently used interchangeably. But some quality practitioners make the following distinction: Continual improvement: a broader term preferred by W. Edwards Deming to refer to general processes of improvement and encompassing “discontinuous” improvements—that is, many different approaches, covering different areas. Continuous improvement: a subset of continual improvement, with a more specific focus on linear, incremental improvement within an existing process. ….”

CONCLUSION

Accordingly, following conclusions are relevant for implementing any management systems (such as ISO 9001, ISO 14001 etc.):

(1) “Continual, constant, continuous all refer to a succession of occurrences.
(2) The two adjectives ‘continual’ and ‘continuous’ are synonyms, but not equivalent.
(3) Whether the word ‘continual’ incorporates ‘continuous’ or ‘continuous’ incorporates ‘continual’, it is irrelevant for a management system professional to find the answer.
(4) People use ‘continuous’ and ‘continual’ as if they are exact synonyms.
(5) In the eyes of many Management Systems Consultants there is no difference between ‘continual’ and ‘continuous’.
(6) The concept of ‘continual’ improvement has always been used by Deming in reference to the general processes of improvement.
(7) For all practical purposes for implementing any management systems in any organization, the phrases ‘continual improvement’, ‘continuous improvement’ and ‘constant improvement’ are, to all intents and practical purposes, the same thing.
(8) It may be 'nice' to understand the etymology of these phrases but it has little practical application when implementation is more important.
(9) We often do ourselves no good in the Quality Profession, in managements' eyes, when we (endlessly) debate the correct phrase usage, instead of delivering results.
(10) The important thing is to continually apply an improvement culture. Promote it, support it and move on.

- K. R. Singhal

‘Oxebridge’ Calls for Temporary Halt to ISO 9001:2015 Development

‘Oxebridge’ Calls for Temporary Halt to ISO 9001:2015 Development

Christopher Peris

‘Oxebridge Quality Resource International’ (‘Oxebridge’) is a quality management implementation boutique started by Christopher Peris, a process engineer, in 1998. I am impressed with his passion to quality management implementation as he believes that:

- ISO 9001 QMS implementation should not shut down the operations of the organization that implements the QMS,
- ISO 9001 implementation should not require endless meetings, over-calibration or unnecessary documentation
- ISO 9001 consultants should do the implementation work themselves, not require the client to do it.

His approach to implement QMS is different from others that has a right direction philosophy: 'Implementation should be fast, low-impact and highly effective.'

International Organization for Standardization (ISO) is in the process of developing ISO 9001:2015.and 'ISO/TC 176 Sub-committee 2' has already issued working draft for ISO 9001:2015. Many QMS professionals feel that development work lacks many points; however, Christopher Peris has taken the lead to mention those ‘converging factors’ that will damage the QMS standard. In this connection ‘Oxebridge’ has released a paper ‘A Public Call for Temporary Cessation of Work on the Development of ISO 9001:2015’ on April 15, 2013 citing four ‘converging factors’ that it feels will damage both ISO and the ISO 9001 QMS Standard, if the standard is allowed to proceed. One of the factors is: ‘Failure to fully develop the foundational Quality Management Principles prior to drafting of the Working Draft.’ 'ISO/TC 176 Sub-committee 2' has already issued working draft for ISO 9001:2015 and the foundational quality management principles are yet to be developed.

Those interested to know more in this regard may read the article on the subject at http://www.oxebridge.com/emma/?p=1589 .

With best wishes,

Keshav Ram Singhal

Fundamentals of Quality Management System

ISO 9001:2008 QMS standard is a generic standard that provides requirements for quality management system. It also refers to ISO 9000:2005 as normative reference. ISO 9000:2005 is a standard that belongs to ISO 9000 family and its title is 'Quality management system - Fundamentals and vocabulary'.

ISO 9000:2005 standard describes fundamentals of quality management system and also specifies the terminology used and eight quality management principles. There are twelve fundamentals of quality management system that has been mentioned in ISO 9000:2005 standard. These are:

1. Rational for quality management system
2. Requirements for quality management systems and requirements for products
3. Quality management systems approach
4. The process approach
5. Quality policy and quality objectives
6. Role of the top management within the quality management system
7. Documentation (value of documentation and types of documents used in quality management systems)
8. Evaluating quality management systems (evaluating processes within the quality management system, auditing the quality management system, reviewing the quality management system and self assessment)
9. Continual improvement
10. Role of statistical techniques
11. Quality management systems and other management system focuses
12. Relationship between quality management systems and excellence models

Think about the above twelve fundamentals and make use of them for strengthening your organization's quality management system.

With best wishes,

Keshav Ram Singhal

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 Mr. 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."

Email dated 3 April 2013 from Mr. Vinesh Lachman, Quality Assurance Consultant, Durban, South Africa

"I am extremely delighted to have read your blog, and to see my passion reflected is beyond words. ..."

Email dated 16 April 2013 from Prof. H. C. Patel, Mumbai

"Liked write-up. Good illustration."

Types of audit

I received an email from a QAQC Manager interalia stating, “I want to know what is surveillance audit, periodic audit and any other audit type you know.” Although I replied the email giving some clarification, however I think it would be better if I write a write-up on the subject matter.

First, we should understand what an audit is. International Standard ISO 9000:2005 defines an audit as “systematic, independent and documented process (set of interrelated or interacting activities which transform inputs into outputs) for obtaining audit evidence (records, statements of fact or other information which are relevant to the audit criteria and verifiable) and evaluating it objectively to determine the extent to which audit criteria (set of policies, procedures or requirements relating to audit) are fulfilled.”

Accordingly, an audit is a systematic, independent and systematic process. The purpose of an audit is to obtain audit evidence and evaluating it objectively against the audit criteria.



Audit types

An audit can be categorized as one of the three audit types, which are as under:
- First party audit
- Second party audit
- Third party audit

First party audit is conducted by the organization itself (or conducted on behalf of the organization) for internal verification, review and other purpose. First party audit is also known as ‘internal audit’ and it is an internal management tool, by which an organization check the health of its management system. Organizations implementing management systems (such as ISO 9001:2008 QMS, ISO 14001:2004 EMS) are required to conduct internal audit at planned intervals.

Second party audit is conducted on a supplier or an organization (excepting a customer) by or on behalf of a party (such as a customer) having an interest in the organization. Second party audit is also known as supplier audit and it is a vendor assessment tool.

Third party audit is conducted for certification purpose and this type of audit is also known as certification audit. This type of audit is conducted by an external, independent audit organization (generally known as certification body or certification body). An organization that seeks certification to a management system is required to undergo certification audit. Certification body carries out three kinds of audit for certification purpose – (i) Adequacy audit – An audit of documentation, (ii) Onsite certification audit – Onsite verification of the management system, and (iii) Surveillance audit – Surveillance audit is a periodic audit (conducted from time to time) to ensure that organization still meets the requirements of the management system standard. Periodic audit is an audit for an intermediate period (e.g., one year) or an audit carried out at specified intervals – usually every one year.



Audit in ISO 9001:2008 QMS

ISO 9001:2008 QMS Standard, Clause 8.2.2, requires organization to conduct internal audit at planned intervals. Accordingly, conducting internal audit at planned intervals is must for an organization implementing ISO 9001:2008 QMS Standard. The Standard does not mention any requirement with regard to second party (supplier) audit or third party (certification) audit. Certification is not a requirement of the Standard. An organization may implement ISO 9001:2008 QMS Standard without obtaining its certification.

With best wishes,

Keshav Ram Singhal

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 Mr. 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."

Email dated 3 April 2013 from Mr. Vinesh Lachman, Quality Assurance Consultant, Durban, South Africa

"I am extremely delighted to have read your blog, and to see my passion reflected is beyond words. ..."

Appointing a Consultant for developing and implementing ISO 9001 QMS in your organization and his role

Many executives feel necessity of consultant for developing and implementing ISO 9001:2008 Quality Management System in the organization. A question arises: Whether appointing or engaging a consultant necessary? No, appointing or engaging a consultant is not necessary for implementing any management systems' standard including ISO 9001:2008 QMS Standard, if organization's people are aware of the standard's requirements and they have confidence for implementation. Many organizations in the world have implemented ISO 9001:2008 QMS Standard without engaging or appointing any consultants. As regard appointing/engaging a consultant, the organization should make an assessment and determine whether a consultant is required.



Why organizations appoint or engage consultant? Appointing or engaging a consultant may be worthwhile investment. A good consultant always effect speedy transfer of knowledge and skills to the organization. A consultant is needed to provide guidance to keep the implementation programme on track. A good consultant provides the people power to complete the work when needed, with no further costs or commitment. There are five general reasons to appoint or engage consultants:
- First, the consultants have experience, expertise and time that employees of an organization may not. An organization generally turns to consultant to fill the knowledge and time gaps.
- Second, consultant generally provide flexibility of time. A consultant may work any time - including nights, weekends and holidays and leave when the project is completed.
- Third, Consultant offers the latest knowledge and objective point of view. A good consultant always brings the latest and unbiased ideas from his wide experience.
- Fourth, a consultant is more efficient and focus on assigned project with sincerity.
- Fifth, engaging a consultant may be proof of honest endeavour. An organization may use consultant to show that an effort is being made to correct and fill gaps in compliance with requirements and regulations.

Thus, a consultant may be an important and relevant resource to assist and guide an organization in developing, implementing and maintaining ISO 9001:2008 QMS.



However, it is essential before engaging/appointing a consultant, to check his working experience and knowledge on standards. Costs are important consideration in deciding to engage/appoint a consultant, therefore, the organization should obtain information about the consultant's cost from several consultants. However, it should be clear while deciding engaging/appointing a consultant that the cheapest consultant may always not be the best. Organization should make an emphasis on the consultant's qualification, knowledge and experience.

Role of the consultant: It is necessary to establish the role of the consultant in the organization. Decide: (i) What the consultant is expected to do? and (ii) What the organization people are expected to do or provide? Hiring/engaging/appointing a consultant should not be regarded as an exercise in shifting the responsibility for establishing the quality management system to someone else.

With best wishes,

Keshav Ram Singhal



How 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.

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 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




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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

Don’t Use ‘ISO Certified’ term

Organizations inadvertently use the term ‘ISO Certified’ when they wish to communicate that they have obtained certification to an ISO standard. The fact remains that International Organization for Standardization (ISO) does not perform certification activity. It should be noted that ISO does not assess the conformity of quality management system to ISO 9001:2008 QMS Standard and also ISO does not issue certificate of conformity to ISO 9001:2008 QMS Standard. Certification is carried out by independent certification or registration bodies.

If any organization has obtained Certificate of conformity to ISO 9001:2008 QMS Standard, then it should use ‘ISO 9001:2008 Certified Organization’ or 'ISO 9001:2008 Registered Company' term, not just ‘ISO Certified’ or ‘ISO 9001 Certified’. Please don’t use the term ‘ISO Certified’ or ‘ISO Certification’.

It should be noted that certification to ISO 9001:2008 QMS Standard is a system certification; it is not a certification mark of conformity on products, product labels or product packaging.

Request - Please make your reaction to the write-up. Thanks.

Keshav Ram Singhal

‘Identify processes’ versus ‘Determine processes’

The word ‘identify’ (mentioned in clause 4.1 in ISO 9001:2000 QMS Standard) has been replaced by the word ‘determine’ in the present standard ISO 9001:2008 QMS Standard. Accordingly, as per ISO 9001:2008 QMS Standard, now the organization needs to determine processes needed for the quality management system and their application throughout the organization. ISO 9001:2008 QMS Standard has made the requirement more clearly in meaning.

The changes appeared in ISO 9001:2008 QMS Standard are more editorial improvement. If we look to the intent of the requirements of clause 4.1 in both standards, there has been no change. However, the word ‘identify’ has limited meaning that means ‘to establish the identity’, while the word ‘determine’ means ‘to decide or settle conclusively and authoritatively’, ‘’to give direction to …’.

As people may understand that earlier version of the standard (ISO 9001:2000) wants to establish the identity of processes needed for the quality management system, while the new version (ISO 9001:2008) wants to decide or settle conclusively and authoritatively processes needed for the quality management system and to give direction to such processes.

The difference between ‘identify’ and ‘determine’ appears to be quite large. In identifying processes, just find out and name processes, while in determining processes, it needs to apply some formula or criteria to those processes that may have impact on the quality management system of the organization.

Request - Please make your reaction to the write-up. Thanks.

Keshav Ram Singhal