Your Email Motivates Me

Email dated 20 April 2014 from Mr. Shambhulinga B. H., Quality Executive, AVK Valves India P. Ltd., Kolar (Karnataka)

"I have seen your QUALITY POLICY AND QUALITY OBJECTIVES IN ISO 9001:2008 blog it was too good. It is very easy to learn and establish the Quality Policy and Quality Objectives, I have inspired of your blog and I made Quality Objectives for Our Company as good as my knowledge...."

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."

Significant Changes in ISO 9001 Committee Draft

ISO/CD 9001 was released for submission of comments in June 2013. Significant changes observed in ISO/CD 9001 are as under:

1. The term 'product' (used in ISO 9001:2008) is replaced by the term 'goods and services (in ISO/CD 9001)

2. Two new clauses are added in ISO/CD 9001
- 4.1 - Understanding the organization and its context
- 4.2 - Understanding the needs and expectations of interested parties

3. 'Process approach' is added as requirement (clause 4.4.2) in ISO/CD 9001 - The requirements to use process approach has been more explicit now.

4. ISO/CD 9001 does not include a specific clause for 'preventive action'. ISO 9001:2008 has clause 8.5.3 as requirements for preventive action.

5.ISO/CD 9001 includes requirements for 'actions to address risks and opportunities' (clause 6.1). Risk management , thus, will be part of the QMS.

6. The structure in ISO/CD 9001 has been changed. There are 10 clauses in ISO/CD 9001 instead of eight clauses in ISO 9001:2008.

Eight clauses in ISO 9001:2008 are:
Clause 1 - Scope
Clause 2 - Normative reference
Clause 3 - Terms and definitions
Clause 4 - Quality management system
Clause 5 - Management responsibility
Clause 6 - Resource management
Clause 7 - Product realization
Clause 8 - Measurement, analysis and improvement

Ten clauses in ISO/CD 9001 are:
Clause 1 - Scope
Clause 2 - Normative reference
Clause 3 - Terms and definitions
Clause 4 - Context of the organization
Clause 5 - Leadership
Clause 6 - Planning
Clause 7 - Support
Clause 8 - Operation
Clause 9 - Performance evaluation
Clause 10 - Improvement

7. The terms 'document' and record' (used in ISO 9001:2008) have been replaced by the term 'documented information' in ISO/CD 9001

8. The term 'continual improvement' (used in ISO 9001:2008) has been replaced by the term 'improvement' in ISO/CD 9001.

9. The existing standard ISO 9001:2008 is based on eight quality management principles, while ISO/CD 9001 is based on seven quality management principles.

ISO 9001:2008 standard is based on following eight quality management principles: (i) Customer focus, (ii) Leadership, (iii) Involvement of people, (iv) Process approach, (v) System approach to management, (vi) Continual improvement, (vii) Factual approach to decision making, and (viii) Mutually beneficial supplier relationship.

One principle 'System approach to management' is dropped in ISO/CD 9001. There are some editorial changes also. Seven quality management principles, on which ISO/CD 9001 is based, are: (i) Customer focus, (ii) Leadership, (iii) Engagement of people, (iv) Process approach, (v) Improvement, (vi) Evidence-based decision making, and (vii) Relationship management.

10. Quality manual is not required in ISO/CD 9001.

11. Management representative is not required in ISO/CD 9001. Role of management representative is assigned to the top management.

12. ISO 9001:2008 requires six mandatory documented procedures. No mandatory documented procedure is required in ISO/CD 9001.

- Keshav Ram Singhal

Please share this article on social media for creating awareness on changes coming in forthcoming ISO 9001:2015 QMS. Thanks.

PDCA Cycle

Plan-Do-Check-Act Cycle is a popular tool for implementing ideas or system in a controlled way. This tool is also known as PDCA Cycle , or Deming Cycle. ISO 9001:2008 QMS standard suggests applying PDCA methodology to all processes. When you want to do something, something you wanted to improve, or something wrong you wanted to fix, then PDCA methodology provides you a better solution to achieve your goal.

You should use PDCA methodology:
- when you wish to bring improvement or wish to start a project
- when you wish to develop a new design of process or product
- when you wish to implement any change in your process or product



The four phases in the Plan-Do-Check-Act Cycle involve:
* Plan - Indentifying and analyzing what to do - First you should identify and establish your objectives and processes necessary to deliver your desired results.
* Do - Implement the processes as planned.
* Check - Measuring how effective the implementation has been, and also analyzing whether there could be any improved way. You should measure processes and product.
* Act - Implementing the improved solutions you analyze during the Check

- Keshav Ram Singhal

Understanding Management System Auditing - Six Principles of Auditing

Understanding Management System Auditing

Article - 3

Six Principles of Auditing

Keshav Ram Singhal

ISO 19011:2002 (the earlier version) mentioned five auditing principles - Ethical, Fair presentation, Due professional care, Independence, and Evidence-based approach, however the present version of the standard, ISO 19011:2011, Guidelines for auditing management systems, has mentioned six principles of auditing. First four principles discussed below are related to auditors and other two principles are related to the audit. These six principles are:

1. Integrity
2. Fair presentation
3. Due professional care
4. Confidentiality
5. Independence
6. Evidence-based approach

All above six principles provide basis to make the audit in a proper manner, so that an audit can be conducted inan effective and reliable manner. An audit provides information to the organization, thus providing opportunity to the organization to improve its performance. Audit conclusions will be relevant and sufficient, if audit principles are followed during the audit process.

Integrity



This is the first principle that relates to an auditor. The principle of integrity is the foundation of professionalism. Integrity is essential to auditing. An auditor should perform his auditing with integrity. Accordingly, the auditor should perform his work with honesty, diligence and responsibility. He should observe and comply with applicable legal (statutory and regulatory) requirements. He should demonstrate his competence while performing his work. He should perform his work in an impartial manner. He should remain fair and unbiased in all his dealings. He should be sensitive to any influences that may be exerted on his judgement while carrying out an audit.

Fair presentation

Fair presentation is the second principle that relates to an auditor. Fair presentation is the obligation on the auditor to report audit findings, audit conclusions and audit reports truthfully and accurately. It is expected from the auditor to also report – (i) significant obstacles encountered during the audit, (ii) unresolved diverging opinions between the auditor and the auditee.

Due professional care

Due professional care is the third principle that relates to an auditor. Due professional care requires the application of diligence and judgement in auditing. The application of diligence and judgement in auditing by the auditor reflects due professional care. It is for the auditor to exercise due professional care in accordance with the importance of task he performs. An auditor should exercise care in performing his task as the audit client(s) and other interested parties place confidence in him for doing so. The auditor should have the necessary competence to perform the task. The auditor should have the ability to make reasoned judgement (applying factual approach to decision making) in all audit situations. An auditor should remember that he performs a QMS audit to judge that the quality management system of the organization conforms to the planned arrangements to the requirements of ISO 9001:2008 QMS standard and requirements established by the organization. When an auditor is required to ascertain whether the quality management system of the organization is effectively implemented and maintained, then the application of diligence and judgement (factual approach to decision making) is required.

Confidentiality



Confidentiality is the fourth principle that relates to the security of information acquired during auditing activities. The principle of confidentiality is required to maintain security of information, which are revealed to an auditor during the audit process. ISO 19011:2011 has included this principle as a new auditing principle. It is required that an auditor should exercise discretion in the use and protection of information acquired during the audit process. An auditor should not use any information acquired during audit process for personal gain. Audit information should not be used inappropriately in a manner detrimental to the legitimate interests of the auditee. Proper handling of sensitive or confidential information is required from an auditor to keep the security of information.

Independence

Independence is the fifth principle that is the basis for the impartiality of an audit and the objectivity of the audit conclusions. An auditor should not audit his own work. Accordingly, (i) an auditor should be independent of the activity being audited; (ii) an auditor should be free from bias and conflict of interest, (iii) an auditor should maintain an objective state of mind throughout the audit process, (iv) an auditor should be free from prejudice or partiality that could affect objectivity, (v) an auditor should ensure that audit findings and audit conclusions are based on audit evidences.

Evidence-based approach

Evidence-based approach is the sixth principle that is the rational method for arriving at reliable and reproducible audit conclusions in a systematic audit process. Evidence-based approach as a principle of auditing is similar to the QMS principle ‘factual approach to decision making’. This principle is the rational method for reaching reliable and reproducible audit conclusions in a systematic way. Audit findings and audit conclusions should be based on audit evidences that are verifiable. An audit is conducted during a finite period of time and with finite resources, as such audit evidence should be based on samples of the information available. A QMS audit must be carried out in an objective manner. The auditing exercise mainly concentrates on gathering objective evidences. An appropriate use of sampling should be applied during auditing process.

If above six principles are applied while carrying out a QMS audit (including internal audit), the audit results will be useful to the organization and helpful for continual improvement of the system.

Scope and Vocabulary in ISO 19011:2011

Understanding Management System Auditing

Article - 2

Scope and Vocabulary in ISO 19011:2011

ISO 19011:2011 is an international standard that provides guidance on auditing management systems. Earlier version ISO 19011:2002 was a standard that was providing guidance on auditing quality and/or environmental management systems. There has been a number of other management system standards that have been published since then, therefore it is felt to widen the scope of the auditing guidance standard and as such ISO 19011:2011 has widen its scope. ISO 19011:2011 provides guidance on:
- Principles of auditing (Clause 4)
- Managing an audit programme (Clause 5)
- Conducting management system audits (Clause 6)
- Evaluation of competence of individuals involved in the audit process (Cause 7)

ISO 19011:2011 standard is applicable to all organizations that implement a management system and that require to conduct or manage management system audit (internal or external). The application of ISO 19011:2011 standard is possible to other types of audits, provided that special consideration is given to specific competence needed.

ISO 19011:2011 standard cites no normative reference.

For better understanding of the guidelines given in the standard, ISO 19011:2011 standard provides terms and definitions of following terms:
- Audit (3.1)
- Audit criteroa (3.2)
- Audit evidence (3.3)
- Audit findings (3.4)
- Audit conclusion (3.5)
- Audit client (3.6)
- Auditee (3.7)
- Auditor (3.8)
- Audit team (3.9)
- Technical; expert (3.10)
- Observer (3.11)
- Guide (3.12)
- Audit programme (3.13)
- Audit scope (3.14)
- Audit plan (3.15)
- Risk (3.16)
- Competence (3.17)
- Conformity (3.18)
- Nonconformity (3.19)
- Management system (3.20)

Most of the terms and definitions in ISO 19011:2011 standard have been adapted from ISO 9000:2005 standard.

ISO 19011:2002 (earlier version) included 14 terms and definitions, while the new version (ISO 19011:2011) includes 20 terms and definitions, thus adding following six terms:
- Observer
- Guide
- Risk (adapted from ISO Guide 73:2009)
- Conformity (adapted from ISO 9000:2005)
- Nonconformity (adapted ftom ISO 9000:2005)
- Management system (adapted from ISO 9000:2005)

Personnel involved in managing or conducting auditing should understand above terms. Understanding above terms will enable you to understand the ISO 19011:2011 standard ion a clear manner. We are not discussing these terms in this chapter and readers are advised to refer to the standard.

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