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- Keshav Ram Singhal
krsinghal@rediffmail.com
keshavsinghalajmer@gmail.com
Blog on 'Quality Concepts and ISO 9001: 2008 Awareness' at http://iso9001-2008awareness.blogspot.in

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Saturday, December 5, 2015

Certification/Registration to ISO 9001:2015 QMS - Part 4


Certification/Registration to ISO 9001:2015 QMS - Part 4

CONCLUDING NOTES


Keshav Ram Singhal


What does certification or registration mean?

Certification or registration is not a mandatory requirement of implementing ISO 9001:2015 QMS standard. Certification or registration may be regarded as the formal recognition of your quality management system.

Organizations obtain certification or registration in order to have confidence of their quality management system or the same may be required by their customers. Organizations' decision regarding certification or registration might also be influenced by their competitors or by regulatory or statutory requirements.

Certification is the term most widely used worldwide, although registration is often used in America (most widely in North America) and the two are used interchangeably and having the same purpose.

Certification or registration to ISO 9001:2015 QMS takes place when an accredited third party (Certification or Registration Body) visits and assesses organization's quality management system and issues a certificate to show that the organization meets the requirements of ISO 9001:2015 QMS standard.


Why do customers require their suppliers to have ISO 9001:2015 QMS certification?

The use of quality management system standards has grown since they were first published in 1987. Now ISO 9001:2015 QMS certification has become very important criteria for selecting or identifying suppliers, because customers have confidence that ISO 9001:2015 certified organizations consistently provide product that meet their (customer) and applicable legal (statutory and regulatory) requirements. ISO 9001:2015 QMS is recognized worldwide as a successful management system for ensuring consistent quality. It is a general belief of the customers that the organization, certified to ISO 9001:2015 QMS standard, has a good quality management system in place and provides consistent quality product/service.


How much will certification cost?

This is a general question that organization's people normally ask, when they implement ISO 9001:2015 QMS standard and take decision about certification of their QMS. The cost of certification will depend on the size of the organization, and the particular certification body with whom the organization will choose to work. Certification body may be able to provide details of the cost, if the organization sends them details of the business and size of their organization. It is better to write to certification body to know their certification fee and other costs.


What is accreditation?

It is suggested to obtain accredited ISO 9001:2015 QMS certification. A question may arise in our mind - What is accreditation? Accreditation is a link in the chain of trust. If an organization meets the requirements of ISO 9001:2015 QMS standard, the organization will receive a certificate of conformity from a certification body (also known as assessing body or conformity assessment body) after formal assessment. This certificate has most value if the certification body is professional, impartial, and independent. The accreditation body with the aim of checking the expertise, impartiality and independence of certification bodies carries out accreditation task. If the results is positive, an accreditation mark is issued to certification body.

Accreditation really means 'creating trust'. Accreditation by an authoritative body is the formal recognition of the competence of the certification body to perform a specific task such as analysis, calibration, inspection or certification. Accreditation is the mechanism for indicating that the assessing organization for a demarcated area, the 'scope', justified confidence. Accreditation is the formal recognition that is based upon a series of international standards that focus particularly on the elements of expertise, independence, impartiality and continuity.

Nationally and internationally buyers want to be able to trust blindly the quality and safety of products/services provided by the certified organizations. If these are guaranteed, it not only benefit the buyer but also to the organization that supply the product/service. This strengthens the supplier organization's position in the market. In order to be able to provide an objective guarantee, the organization can have its quality management system assessed by an accredited certification body.

There are a number of accreditation bodies operating in the world that carry out the accreditation work. In India, National Accreditation Board for Certification Bodies (NABCB) grants accreditation to certification bodies with regard to ISO 9001:2015 certification and also a few certification bodies in India have taken accreditation mark from foreign accreditation bodies.

On-site Audit by Certification Body

On-site audit by certification body is also known as 'Implementation audit', 'Compliance audit', or 'Conformance audit'. This is an on-site assessment by the certification body. Certification body sends its auditor/auditors to the site of the organization seeking certification. It is a systematic examination of whether each requirement of ISO 9001:2015 QMS standard is being implemented effectively and the procedures followed. The emphasis is on the objective evidence. The first area generally examined is the findings of the internal audits, management reviews, corrective actions taken, and changes/improvements made in the quality management system. The audit generally consists of the following four steps outlined below:

1. Opening meeting: This is held to introduce the audit team, confirm the audit scope, the timetable, reporting method, and clarify any unclear aspects. Opening meeting is chaired by the auditor-in-charge and attended by audit team members, auditee team leaders including management. Generally an opening meeting is held for a period of 15 to 20 minutes and following matters are communicated during the meeting:
- Introduction of audit team members and their roles in the audit
- Introduction of auditee team leaders and management
- Scope of the audit
- Any guides, if required
- Confirmation about the about the audit process and its reporting
- Confirmation of the auditors' confidentiality about the matters that come to the notice of the auditors
- Any security requirements, if needed
- Information about the closing meeting
- Any other point or question that auditee may

2. Assessment: After the opening meeting auditor will go to the working place of the organization and interview staff at selected locations of the organization to determine how work is carried out in certain areas, establish if it conforms to the organization's policies and procedures, seek objective evidence of the facts and compare the gathered facts with the requirements of ISO 9001:2015 QMS standard. Auditor will then put their observations in writing and ask the auditee to endorse the report. Some of the actions that an auditor may take are as under:
- Ask to see customer complaints and verify actions taken
- Ask to see previous audit reports
- Ask staff how they deal with specific requirements of the standard
- Ask staff why they are performing certain tasks
- Ask staff whether a measuring and monitoring instrument has been checked or calibrated and if so where the evidence is
- Ask management to explain how the quality management system works
- Ask staff about the quality policy and quality objectives.

3. Preparation of assessment report: After the detailed on-site assessment, the auditor will prepare a report detailing observations and identifying nonconformities with the requirements of the standard. The auditor-in-charge of the audit team will draw conclusions from the findings and formulate the recommendations.

4. Closing meeting: At the end there will be a closing meeting to emphasize good points, to explain the audit observations and findings of nonconformities, and to disclose whether or not the organization will be recommended for certification/registration.

Closing meeting is also chaired by the auditor-in-charge and attended by audit team members, auditee team leaders including management. Generally a closing meeting is held for a period of 25 to 30 minutes and following matters are communicated during the meeting:
- Thanks by the audit team for the cooperation extended during audit
- Scope of the audit
- Reconfirmation of the auditors' confidentiality about the matter that came to the notice of the auditors
- Findings of the audit
- Nonconformities and their corrective action timelimit
- The audit is only look at a sample of the quality management system
- Statement of recommendations by the auditor-in-charge, if any
- Invite auditee team leaders including management to place their views
- Auditor-in-charge to thanks each and everyone in the last and close the meeting

Thus we see that the on-site audit is an essential activity carried out by the certification body's auditors to verify that the organization's quality management system is in conformance to the requirements of ISO 9001:2015 QMS standard.


*****

For Training Handbook on ISO 9001:2015 QMS Awareness, please Click Here

For Training Handbook on ISO 9001:2015 QMS Implementation in a School, please Click Here




Monday, November 23, 2015

Certification/Registration to ISO 9001:2015 QMS - Part 3


Certification/Registration to ISO 9001:2015 QMS - Part 3

Certification Procedure for QMS Certification


Keshav Ram Singhal


Generally the certification body follows following procedure for QMS certification:
- Documentation review
- Initial visit
- Initial on-site audit
- Corrective actions and verification, as necessary
- Issue of certificate
- Periodical surveillance audit
- Renewal of certificate

Since you are interested to obtain ISO 9001:2015 QMS certification for your organization, you should ensure that the quality management system of your organization is in accordance with ISO 9001:2015 QMS standard. After selecting a certification body, you should inform your decision to the certification body and complete/submit the necessary prescribed application and necessary contract note with them.

Following the receipt of the prescribed application for certification from an organization, the certification body, at the beginning of the certification process, agrees with the organization on the scope of the organization's quality management system, then it carries out a review of the organization's documentation (the documented information the organization maintains). After review of such documentation the applicant organization is informed of any lapses or nonconformity in the documentation against ISO 9001:2015 QMS standard.

You may ask about what documentation should be submitted to the certification body for documentation review. Now maintenance of a quality manual is not a mandatory requirement of ISO 9001:2015 QMS standard, as it is in ISO 9001:2008 QMS standard, however the organization should make available following documented information to the certification body for their documentation review:
- Scope of the organization
- Information to support the operation of organization's processes
- Quality policy
- Quality objectives
- Information about operational planning and control
- Information on characteristics of the product/service to be provided, activities to be performed and results to be achieved
- Any other documented information determined by the organization as being necessary for the effectiveness of the quality management system

Initial visit by certification body's personnel includes provision for the certification body to plan the initial audit, confirm the basis of certification and discuss the review of documentation. As this stage, the certification body assesses the degree of implementation and any obvious lapses or nonconformity in the quality management system, which requires attention before the audit. Preparing for the audit in advance will be a right approach for which you should make the following preparations:
- Communicate to your employees about the audit, its purpose, date and audit process
- Make sure your premises (all areas of operation) are clean, safe and having good working environment
- Make sure that all current and relevant documented information are available at the point of use
- Make sure that obsolete documents are removed from the workplace
- Make sure that all monitoring and measuring resources are verified or calibrated
- Keep ready a copy of the maintained documented information available for the auditor
- Keep ready a suitable place for auditor to work, such as writing audit findings and reporting

Following the initial visit, rectification of any notified lapses or nonconformities and the establishment of an agreed audit plan, the certification body would carry out the initial audit (also known as a certification audit). On completion of the initial audit, the certification body will issue a report inter alia mentioning nonconformities with ISO 9001:2015 QMS standard. Observations may also be given to define or illustrate the nonconformity.

The applicant organization, seeking the certification, then responds to the nonconformities, and submits for approval, proposed corrective actions to the nonconformities found the quality management system. Thereafter the certification body will confirm completion of the corrective action by a documentation review or follow-up visit, as appropriate.

Upon completion of a satisfactory initial audit, the certification body issues to the applicant a Certificate of QMS Conformity, generally valid for three years, subject to compliance with the conditions of the certificate. For maintenance of the certification, the certification body performs periodical audits (known as surveillance audits) generally at six/nine monthly intervals. Renewal of certificate is carried out after three years and involves a satisfactory re-audit of the quality management system.

.... To be continued

For Training Handbook on ISO 9001:2015 QMS Awareness, please Click Here

For Training Handbook on ISO 9001:2015 QMS Implementation in a School, please Click Here



Sunday, November 22, 2015

Certification/Registration to ISO 9001:2015 QMS - Part 2


Certification/Registration to ISO 9001:2015 QMS - Part 2

Selecting a Certification Body and Applying for Certification/Registration


Keshav Ram Singhal


An organization, preparing for certification/registration of its ISO 9001:2015 QMS, should contact certification/registration bodies at an early stage of its ISO 9001:2015 QMS implementation project. If your organization is new to implement the quality management system, it may be assumed that your organization will need a minimum of 3 to 6 months time to get your quality management system and its implementation in place. The minimum time will also depend upon the number of sites you wish to certify. If your organization has more than one office, you may begin by obtaining QMS certification at one office only or you may have more than one site certified at once. If you choose to obtain certification formore thn one site, then you may require more efforts and time.

The first work is to choose a certification body from which you will obtain the QMS certification. A number of certification bodies are operating in our country, so you have a wide choice to select a certification body.

In India, National Accreditation Board for Certification Bodies (NABCB), linked to Quality Council of India (QCI), grants accreditation to certification bodies. In addition to this, many foreign accreditation bodies have also granted accreditation to certification bodies operating in India. Some of the foreign accreditation bodies are:
- UKAS - United Kingdom Accreditation Service
- RvA - Raad voor Accredatie (The Dutch Council of Accreditation)
- ANAB - ANSI-ASQ National Accreditation Board
- JAS-ANZ - Joint Accreditation System of Australia and New Zealand
- SCC - Standards Council of Canada
- JAB - Japan Accreditation Board
- IAR - IAR Accreditation Service

There are accreditation bodies in neighbouring countries too, some of which are:
- CNAS - China National Accreditation Service for Conformity Assessment
- PNAC - Pakistan National Accreditation Council
- SLAB - Sri Lanka Accreditation Board for Conformity Assessment

Many of the certification bodies are the members of International Accreditation Forum (IAF) and these certification bodies agree to the IAF Multilateral Recognition Agreement (MLA) recognizing the equivalence of other embers' accreditation to their own.

There are more than fifty certification bodies operating in India, which have been granted accreditation either from NABCB or from any other foreign accreditation body. In such a situation, first you should collect information about the certification bodies operating in your country and then you should contact the certification bodies with brief description about your organization, nature of your business and your assessment requirements. You should also find out whether the certification body is accredited to provide certification in your area of business. Since there are too many certification bodies operating in our country, you need to select a certification body, for which you should know the details of certification services and cost of certification. Therefore it is better to write letters or send emails to several certification bodies asking their certification services and cost of certification. Upon receipt of your letter/email, the certification body will advise you the certification process and a quotation for the costs including the certification fee. Accordingly, you will have quotations from several certification bodies and you will be in a position to decide a certification body by hich you will obtain ISO 9001:2015 QMS certification.

Please note that while deciding a certification body, don't just go for a cheap or non-accredited certification. Quotation will normally include a one-time certification fee (covering a period of three years), costs per day of auditing work (before, during and after certification), travel and other expenses. The number of workdays required for each audit will depend on the size of operation and the location of the organization to be audited.

.... To be continued

For Training Handbook on ISO 9001:2015 QMS Awareness, please Click Here

For Training Handbook on ISO 9001:2015 QMS Implementation in a School, please Click Here



Certification/Registration to ISO 9001:2015 QMS - Part 1


Certification/Registration to ISO 9001:2015 QMS - Part 1

Taking the decision to implement ISO 9001:2015 QMS and its certification


Keshav Ram Singhal


Organizations choose to implement ISO 9001:2015 QMS for a number of reasons. Implementing ISO 9001:2015 QMS confers long-term benefits. However, an immediate goal for most organizations is to achieve ISO 9001:2015 QMS certification. It is important to note that International Organization for Standardization (ISO) has developed and published ISO 9001:2015 QMS standard, but ISO itself neither audit organizations nr issues ISO 9001:2015 QMS compliance certificates. The task of ISO 9001:2015 QMS compliance certification / registration is carried out independently by more than 800 certification bodies around the world.

Why organizations decide to implement ISO 9001:2015 QMS and obtain its certification/registration?

Implementing ISO 9001:2015 QMS confers long-term benefits and certification can be a useful tool to add credibility, by demonstrating that the organization's product/service meets the expectation of its customers.

There may be a number of reasons for implementing ISO 9001:2015 QMS and its certification, such as:
- The organization wants improvement in overall product/service quality
- The organization wants consistency of product/service to its customers
- The organization wants improvement in staff productivity
- The organization wants improvement in cost control
- Current and potential customers may require ISO 9001:2015 QMS certification
- The organization wishes to enter new markets that require/may require ISO 9001:2015 QMS certification
- The organization needs to maintain its market position as a leading-edge organization and as an organization competing on the basis of product/service quality
- The organization has a competitive pressure to stay even or catch up by getting to certified

If an organization does not implement ISO 9001:2015 QMS, then the organization may have some negative consequences, such as:
- Inability to participate in bids domestically and/or abroad that require ISO 9001:20-15 QMS certification
- Potential loss of major current and potential customers
- Inability to attract major new customers
- Loss of market image, when most competitors of the organzation are ISO 9001:2015 QMS certified

Certification vis-a-vis Registration

Certification is the term most widely used worldwide, although registration is often used in America (most widely in North America), and these terms 'certification' and 'registration' with regard to ISO 9001:2015 QMS are used interchangeably and having the same purpose.

.... To be continued

For Training Handbook on ISO 9001:2015 QMS Awareness, please Click Here

For Training Handbook on ISO 9001:2015 QMS Implementation in a School, please Click Here


Saturday, November 7, 2015

BOOKS ON ISO 9001:2015 QMS


We wish to publish details of books on ISO 9001:2015 QMS.

Publishers, authors and readers are requested to send details.

Thanks,

Keshav Ram Singhal



QUALITY POLICY IN ISO 9001:2015




Keshav Ram Singhal


Let us begin with the concept of quality policy in a quality management system of an organization. The quality policy shapes an approach of the organization to its commitment. A quality policy must: (i) be appropriate to the purpose of the organization, (ii) be appropriate to the context of the organization, (iii) support strategic direction of the organization, (iv) provide a framework for setting quality objectives, (v) include a commitment to satisfy applicable requirements, (vi) include a commitment to continual improvement of the QMS.

A quality policy of an organization must meet the following minimum criteria:
(a) It should be linked to overall organizational goals,
(b) It should be relevant to the needs and expectations.

Accordingly, the quality policy of an organization must provide a framework for setting organization’s quality objectives.

A quality policy should also include explicit commitments to customer satisfaction and continual improvement. Quality policy of an organization should have a clear statement of outcomes. The policy should have understood within the organization.

Product quality depends both on perceived customer satisfaction and on well motivated persons engaged in QMS activities

There may be a situation when your organization may not have a quality policy, then you should try to develop a quality policy for your organization. It is often useful to first develop the overall organization’s policy, including policies for marketing, sales, production, finance etc. This exercise could make the quality policy easier to prepare. Organization’s commitment to quality should describe organization’s overall vision of what quality means to organization’s business and its customers. Clause 5.2 of ISO 9001:2015 standard requires organization to maintain the quality policy as documented information.

Clause 5.2.1 of ISO 9001:2015 standard frames requirements with regard to quality policy, which requires top management to establish, implement and maintain a quality policy that (i) is appropriate to the purpose of the organization, (ii) is appropriate to the context of the organization, (iii) supports strategic direction of the organization, (iv) provides a framework for setting quality objectives, (v) includes a commitment to satisfy applicable requirements, (vi) includes a commitment to continual improvement of the QMS.

If your organization has a quality policy, then you should evaluate your quality policy. Evaluate, whether your quality policy clearly linked to your overall organizational goals. If quality policy of your organization is not linked to your organizational goals, then you need to re-examine your policy and goals. Also find out answers to following questions:
- Does your quality policy is appropriate to the purpose of your organization?
- Does your quality policy is appropriate to the context of your organization?
- Does your quality policy support strategic direction of your organization?
- Does your quality policy provide a framework for setting quality objectives?
- Does your quality policy include a commitment to satisfy applicable requirements?
- Does your quality policy include a commitment to continual improvement of the QMS?

On the basis of answers to above questions, you may wish to revise the quality policy of your organization.

An illustration of a Quality Policy

…. (name of the organization) …. is committed in achieving customer satisfaction by providing … (the quality characteristics of product provided by the organization) …. For our customers, in context of continual improvement, so that our customers will … (outcomes in relation to customers’ needs / expectations to be met) ….


Another illustration of Quality Policy

We, … (name of the organization) …, manufactures … (name of the products) …. We manufacture and market these products both for domestic and abroad markets. Our purpose is to produce products to satisfy needs of our customers. We continually improve our products and services to satisfy needs of our customers better. Our quality management system is designed to ensure the maintenance of the product quality through evaluation, inspection and verification processes at all stages of production.

We are committed to comply with customer as well as legal requirements and also committed to continually improve the effectiveness of our quality management system. Our organization has decided to achieve quality objectives as set in the documented statement of quality objectives. The top management of our organization in the meeting of board of directors, at least once in every six months, reviews the quality management system of our organization.


Other requirements

ISO 9001:2015 QMS standard mentions following requirements in its clause 5.2.2:

- Availability and maintaining the quality policy as documented information,
- Communicating, understanding and application of the quality policy within the organization,
- Availability of the quality policy to relevant interested parties, as appropriate.


Wednesday, November 4, 2015

Training Handbook on 'ISO 9001:2015 QMS Implementation in a School'


Training Handbook on 'ISO 9001:2015 QMS Implementation in a School'


ISO 9001:2015 QMS standard has replaced the earlier version ISO 9001:2008 QMS standard. Schools, implementing ISO 9001:2008 QMS, are now required to upgrade their quality management systems (QMS) according to ISO 9001:2015 QMS standard before the transition period expires. Even schools, not implementing QMS, can now implement ISO 9001:2015 QMS.

I have designed and developed a Training Handbook on 'ISO 9001:2015 QMS Implementation in a School', for the benefit of the Management executives, Principals, Teachers, Personnel involved in ISO 9001 QMS implementation, Internal auditors and Individuals, who are interested to upgrade their knowledge. The training handbook also provides brief inputs on the Accreditation Standard for Quality School Governance for the benefits of the participants.


Contents of the Training Handbook are:
# 01 - An introduction on 'ISO 9001:2015 QMS Implementation in a School' Training
# 02 - Introduction - Historical background, Standard Development Timeline for ISO 9001:2015
# 03 - Overview - Foreword, Introduction, QMS - Requirements Clauses, Scope, Normative references, Terms and definitions
# 04 - Context of the organization
# 05 - Leadership
# 06 - Planning
# 07 - Support
# 08 - Operation
# 09 - Performance evaluation
# 10 - Improvement
# 11 - Transition Planning
# 12 - Developing and Implementing ISO 9001:2015 QMS
# 13 - Risk-based Thinking - An integral part of ISO 9001:2015 QMS
# 14 - ISO 9001:2015 QMS - Understanding the process approach and PDCA
# 15 - ISO 9001:2005 - Quality Management Principles
# 16 - Change Management in ISO 9001:2015
# 17 - Adding Value to the Audit
# 18 - Educational Institution and Quality
# 19 - The Accreditation Standard for Quality School Governance
# 20 - Role of Standards in Helping Schools
# 21 - Application of ISO 9001:2015 QMS in a School
# 22 - Post-training test details

If you are interested to see the Preview of the Training Handbook, please send me an email. I will send a copy of the same.

Thanking you,

Keshav Ram Singhal

Email
keshavsinghalajmer@gmail.com
or
krsinghal@rediffmail.com

Request - Please share this message with friends in your network, so that more people may know about the Training Handbook.


Monday, November 2, 2015

आईएसओ 9001:2015 गुणवत्ता प्रबंध प्रणाली का मूल मंत्र


आईएसओ 9001:2015 गुणवत्ता प्रबंध प्रणाली का मूल मंत्र
गुणवत्ता प्रबंधन के सात सिद्धांत


आईएसओ 9001:2015 कार्यान्वित करो,
गुणवत्ता सुधार से कभी भी ना डरो !

गुणवत्ता प्रबंध के सात सिद्धांत निभाओ,
व्यवस्था में प्रक्रिया सोच सदा अपनाओ !

ग्राहक पर दो सदा ही अपना ध्यान,
अच्छा नेतृत्व देगा सभी को ज्ञान !

लोगों को उनके सही काम पर लगाओ,
प्रक्रिया व व्यवस्था में सुधार अपनाओ !

सबूत आधारित निर्णय लो सदा-सदा
संबंध प्रबधन से सभी का फायदा !

यही सात मूल मंत्र है ताकत गुणवत्ता प्रबंध प्रणाली,
बनते गुणवत्ता उत्पाद/सेवाएँ और संस्था गुणवत्तावाली !

- © 2015 केशव राम सिंघल

शुभकामना सहित,
केशव राम सिंघल


Thursday, October 29, 2015

Online Consultancy for Developing and Implementing ISO 9001:2015 QMS


Online Consultancy for Developing and Implementing ISO 9001:2015 QMS

- Keshav Ram Singhal

Consultancy so far has been a face-to-face business, where a consultant meet people. He steps into corporate offices. He sit across table. But with the technological advancement, now a consultant sits at his chair across his laptop and guide people across the globe.

There are five general reasons to hire and appoint consultants:
(i) Consultants have appropriate experience, expertise and time that employees may not. An organization turns to a consultant to fill knowledge and time gaps.
(ii) Consultants provide flexibility of time. Consultants work any time - including nights, weekends and holidays. They leave when the project is completed.
(iii) Consultants offer the latest and objective point of view. Consultants bring the latest and unbiased ideas from their vide experiences.
(iv) Consultants are more efficient and they focus on assigned project with sincerity.
(v) Consultants may be proof of honest endeavour. Organizations may use consultants to show that an effort is being made to correct gaps in compliance with regulations.

A consultant may be an important resource to assist and guide an organization in developing, implementing and maintaining ISO9001:2015 QMS and getting its certification from an accredited certification body. But consultant's cost is a factor that sometimes small and medium-sized organizations find it on higher side. My consultancy is cost effective. I can provide you online training and online consultancy for developing and implementing ISO 9001:2015 QMS.

Based on my guidance, I can assure you that your organization can get the certification from the certification body of your preference or alternatively I can suggest you a number of certification bodies, out of which you can select one. I will ensure that your organization achieves ISO 9001:2015 QMS certification.

For further information, please contact by email mentioning your requirements and details of your organization to:

keshavsinghalajmer@gmail.com
or
krsinghal@rediffmail.com


Wednesday, October 28, 2015

Historical Background and Standard Development Timeline for ISO 9001:2015


Historical Background

ISO 9001/2/3 standards series first published in 1987 and then revised in 1994.
Major revision in 2000 with publication of ISO 9001:2000 QMS Standard on 15 December 2000
Fourth edition – ISO 9001:2008 QMS Standard published on 15 November 2008.
Fifth edition – ISO 9001:2015 QMS Standard published on 15 September 2015

More than 25 years journey completed by ISO 9001 QMS, since it was first published in 1987.

International Organization for Standardization (ISO) is the largest developer and publisher of international standards. It is an independent, non-governmental membership organization, having a membership of 162 member countries (as on 15 November 2015). Standard development work in ISO is done by ISO Technical Committees comprising experts nominated by their standards body or liaison organization. ISO/TC 176 is the ISO Technical Committee number 176 for Quality Management and Quality Assurance. ISO/TC 176/SC2 is the subcommittee responsible for ISO 9001 and ISO 9004 standards, among others.

Standard Development Timeline for ISO 9001:2015

May-June 2012 - Proposal stage
June-October 2012 - Preparatory stage
June-September 2013 - Committee stage
ISO/CD 9001 released on 03 June 2013
May-October 2014 - Enquiry stage (DIS)
ISO/DIS 9001 voting started on 10 July 2014 and ended on 10 October 2014.
July 2015 - Approval stage (FDIS)
ISO/FDIS 9001 voting started on 09 July 2015 and ended on 09 September 2015.
80 countries voted on ISO/FDIS 9001 - 75 votes in favour, 5 abstentions, no negative vote.
15 September 2015 - Publication date of ISO 9001:2015 QMS standard.
23 September 2015 - ISO released press note 'ISO 9001:2005 - Just published!' on its website

Preview of Training Handbook on ISO 9001:2015 QMS Awareness

You can see the Preview of Training Handbook.
Ask for a copy by sending an email to keshavsinghalajmer@gmail.com


Saturday, October 24, 2015

Training Handbook on 'ISO 9001:2015 QMS Awareness'


Training Handbook on 'ISO 9001:2015 QMS Awareness'


ISO 9001:2015 QMS standard has replaced the earlier version ISO 9001:2008 QMS standard. Organizations are now required to upgrade their quality management systems (QMS) according to ISO 9001:2015 QMS standard before the transition period expires.

I have designed and developed a Training Handbook on ISO 9001:2015 QMS Awareness, for the benefit of the management executives, personnel involved in ISO 9001 QMS implementation, internal auditors and individuals, who are interested to upgrade their knowledge.

Contents of the Training Handbook are:
# 01 - An introduction on 'ISO 9001:2015 QMS Awareness' Training
# 02 - Introduction - Historical background, Standard Development Timeline for ISO 9001:2015
# 03 - Overview - Foreword, Introduction, QMS - Requirements Clauses, Scope, Normative references, Terms and definitions
# 04 - Context of the organization
# 05 - Leadership
# 06 - Planning
# 07 - Support
# 08 - Operation
# 09 - Performance evaluation
# 10 - Improvement
# 11 - Transition Planning
# 12 - Developing and Implementing ISO 9001:2015 QMS - This includes step-by-step process to develop and implement ISO 9001:2015 QMS. Very useful for organizations.
# 13 - Risk-based Thinking - An integral part of ISO 9001:2015 QMS
# 14 - ISO 9001:2015 QMS - Understanding the process approach and PDCA
# 15 - ISO 9001:2005 - Quality Management Principles
# 16 - Change Management in ISO 9001:2015
# 17 - Adding Value to the Audit
# 18 - Post-training test details

If you are interested to see the Preview of the Training Handbook, please send me an email. I will send a copy of the same.

Thanking you,

Keshav Ram Singhal

Email
keshavsinghalajmer@gmail.com
or
krsinghal@rediffmail.com

One more request - Please share this message with friends in your network, so that more people may know about the Training Handbook.

Saturday, September 26, 2015

TRAINING ON 'ISO 9001:2015 QMS AWARENESS'



AN OPPORTUNITY TO LEARN AND UPDATE YOUR KNOWLEDGE
ON
'ISO 9001:2015 QMS AWARENESS'




LEARNING OBJECTIVES


UNDERSTAND THE IMPACTS OF NEW STANDARD ON YOUR QMS

After attending the training you will be able to understand KEY CHANGES that affect your organization and your quality management system implementation, including the following -
• Structure and terminology
• Context of the organization
• Risk-based thinking
• Knowledge management
• Role of top management
• Management representative's role?
• Documentation impact and requirements for documented information
• Internal audit
• Understanding ISO 9001:2015 QMS requirements
• Transition planning guidance
• Implementation Guidance


WHY SHOULD YOU ATTEND?


ISO 9001:2008 QMS certified organizations are required to comply with major change to ISO 9001:2015 QMS standard. Understanding what is different is the first step in implementing the revised standard. You will require to ensure that the requirements mentioned in ISO 9001:2015 QMS standard are implemented in your organization before recertification.


WHO SHOULD ATTEND?


• Top, middle and junior management executives
• Personnel involved in QMS implementation
• Internal auditor
• Any individual


TRAINER

Keshav Ram Singhal

You will learn from an expert professional and well known writer, who will help you understand the changes and what they mean to you and your organization.

Click Here for Trainer's Profile.

Click Here for his blog on 'Quality Concepts and ISO 9001:2008 QMS Awareness' - Total hits more than 275,000.

Click Here for his blog on 'Quality Concepts and ISO 9001:2015 QMS Awareness' - Total hits more than 4,500.



MODES OF TRAINING


Face-to-face Training
One day duration
For Single Participant
Participant can visit Ajmer with prior appointment.

Group Training
One day duration
For a group consisting 2 to10 participants
Interested participants can visit Ajmer with prior appointment.

In-house Training
One day duration
At Your Place
Sponsoring organization can call the trainer to conduct training programme.
Sponsoring organization needs to arrange venue, photocopy facility and also staying arrangement for the faculty.

Distance Training (To be commenced from 13 October 2015)
For people interested to learn at their home. The learner can study and learn whenever he wants, wherever he wants. Training material and assignments will be sent by email. Learning registration will be valid for one month.

Certificate will be provided to successful candidates after evaluation.
New skills and knowledge makes a learner more valuable.
Contact by email with your requirements and learner's details to:
krsinghal@rediffmail.com
keshavsinghalajmer@gmail.com


Wednesday, September 23, 2015

Name of the Blog Changed



Name of the Blog Changed

International Organization for Standardization (ISO) has since published ISO 9001:2015 QMS standard on 23 September 2015, I have also changed the name of this blog from 'Forthcoming ISO 9001:2015 QMS Awareness' to 'Quality Concepts and ISO 9001:2015 QMS Awareness'.

We hope readers will patronize my efforts of creating awareness. Please share this information on social media (Facebook, Linkedin, etc.), so that more people may know about this blog.

With best wishes,

Keshav Ram Singhal

NEW VERSION 'ISO9001:2015 QMS' STANDARD HAS BEEN PUBLISHED


NEW VERSION 'ISO9001:2015 QMS' STANDARD HAS BEEN PUBLISHED

Please refer to our earlier news mentioning. "As per the latest information, forthcoming ISO 9001:2015 QMS standard has almost come to a conclusion and has been approved for publication. It is expected that the forthcoming standard will be published on 23 September 2015." Click Here for the earlier news link

As per the news from International Organization for Standardization (ISO), the latest edition of ISO 9001 quality management system standard has been published on 23 September 2015.

ISO 9001 revision work by experts from nearly 95 participating and observing countries took over three years time to revise the standard in the present new version - ISO 9001:2015 QMS standard.

More than 1.1 million organizations worldwide have implemented ISO 9001 QMS and obtained certification to its conformance.

The new version, ISO 9001:2015 QMS standard, follows a new, higher level structure to make this standard easier to use in conjunction with other management system standards (such as ISO 14001 EMS etc.), with increased importance to risk-based thinking and understanding the needs and expectations of interested parties.

- Keshav Ram Singhal

Saturday, September 19, 2015

Forthcoming ISO 9001:2015 QMS - OPERATION - Requirements for products and services - Determination and review of requirements



Click Here for the article on " ISO/DIS 9001 - OPERATION - Determination of requirements for products and services - Customer communication"


Forthcoming ISO 9001:2015 QMS - OPERATION - Requirements for products and services - Determination and review of requirements

Keshav Ram Singhal

Clause 8.2.2 requires determining requirements and clause 8.2.3 requires reviewing requirements related to products and services.

Ensure to define:
- Requirements for product and services
- Applicable legal requirements
- Requirements considered necessary

Review (before committing to supply product/service to the customer)
- Requirements specified by the customer
- Requirements for delivery and post-delivery
- Requirements necessary for specified and intended use
- Requirements determined by the organization
- Legal requirements applicable to product/service
- Contract/order requirements changed/differed from previously communicated

Ensure
- To meet claims offered for products and services
- Organization has ability to meet the requirements
- Resolving contract/order requirements changed/differed from previously expressed
- Confirming customer's requirements before acceptance, when customer not providing documented statement of his requirements.

Retain documented information (as applicable)
- Results of review
- Any new requirements for the product/service

Friday, September 18, 2015

Certification Bodies



Certification Bodies Operating in India and Neighbouring Countries

The editor of this blog is collecting details of certification bodies operating in India and Neighbouring Countries. Please send details (name, address, email, website, etc.) by email to:
keshavsinghalajmer@gmail.com
or
krsinghal@rediffmail.com.

Thanks,

Keshav Ram Singhal

Developing and Implementing Forthcoming ISO 9001:2015 QMS ...


Keshav Ram Singhal

From the last post .... - Last post link

Step 5 - Appointing a QMS consultant

A quality management system consultant is a person who assist the organization on quality management system realization, giving advice or information. Appointing a consultant is not a requirement. It is not necessary appointing a consultant, however, appointing a consultant may be a worthwhile investment. A good consultant effects speedy transfer of knowledge and skills to the organization and he may be needed to provide timely guidance to keep the ISO 9001:2015 QMS implementation programme on track. Consultant provides the people power to complete the work when needed, at reasonable cost. Steering committee or top management of the organization should determine whether a consultant is required.

There are five general reasons to hire and appoint consultants:
(i) Consultants have appropriate experience, expertise and time that employees may not. An organization turns to a consultant to fill knowledge and time gaps.
(ii) Consultants provide flexibility of time. Consultants work any time - including nights, weekends and holidays. They leave when the project is completed.
(iii) Consultants offer the latest and objective point of view. Consultants bring the latest and unbiased ideas from their vide experiences.
(iv) Consultants are more efficient and they focus on assigned project with sincerity.
(v) Consultants may be proof of honest endeavour. Organizations may use consultants to show that an effort is being made to correct gaps in compliance with regulations.

Thus, a consultant may be an important resource to assist and guide an organization in developing, implementing and maintaining ISO9001:2015 QMS and getting its certification from an accredited certification body. However, it is essential, before appointing a consultant, to check their competence, education, knowledge and skills with regard to ISO 9000 series and ISO 9001:2015 QMS. He should be well aware of certification and accreditation systems. Costs are an important consideration in deciding to engage a consultant, therefore, the organization should obtain quotations from several consultants. However, please note that the cheapest consultant may not always be the best. Emphasis should on consultant's qualifications, knowledge and experience.

It is necessary to establish what the consultant is expected to do and what the organization people are expected to do or provide. Hiring, engaging or appointing a consultant should not be regarded as an exercise in shifting the responsibility for establishing and maintaining the quality management system to someone else.

International Organization for Standardization (ISO) has published a standard ISO 10019: 2005, which provides guidelines for the selection of quality management consultants and use of their services. Organizations may refer to this standard for detailed guidance.

Step 6 - Obtaining Information about QMS and ISO 9000 Family

The organization should collect information about quality management system and ISO 9000 family. If the organization has appointed a consultant, then it will be easier for the organization. For general information on quality management system, ISO's website is a useful source from which ISO's brochure 'Selection and use of the ISO 9000 family of standards' can be downloaded. Please refer to the link http://www.iso.org/iso/home/standards/management-standards/iso_9000.htm. The organization should download relevant and supporting information from following websites:
- ISO website - http://www.iso.org
- IAF website - http://www.iaf.nu
- ISO TC 176 website - http://isotc.iso.org/livelink/livelink/open/tc176SC2public

The organization should also obtain relevant information from other websites and blogs. The organization should also purchase the following:
- ISO 9000:2015, Quality management system, Fundamentals and vocabulary
- ISO 9001:2015, Quality management system, Requirements
- ISO 9004:2009, Managing for the sustained success of an organization, A quality management approach
- ISO 19011:2011, Guidelines on auditing management systems
- Various other publications and literature providing knowledge on ISO 9001:2015 QMS and related issues


Step 7 - Start 'ISO 9001:2015 QMS Awareness' Programme

The organization should organize 'ISO 9001:2015 QMS Awareness' programme to communicate to the employees: (i) the aim of ISO 9001:2015 QMS, (ii) the advantages quality management system offers to employees, customers and the organization, (iii) how the quality management system will work, and (iv) employees' roles and responsibilities within the system.

This programme can be conducted by a personnel, who is well aware of ISO 9001:2015 QMS standard, an outside consultant or a trainer to talk to different levels of employees. For general awareness, the duration of such programme may be four hours.


Step 8 - Formulate an Action Plan

An action plan should be formulated for the implementation of ISO 9001:2015 quality management system. The action plan should (i) define the responsibilities of different departments and personnel, and (ii) set target dates for the completion of different activities. The following activities can be included in the action plan:
- Establishing steering committee
- Establishing task force
- Assigning responsibilities and authorities
- Appointing a consultant
- Obtaining information about QMS and ISO 9000 Family
- Purchase of standards, books and literature
- Awareness programme: Top management
- Awareness programme : Steering committee
- Awareness programme: Task force
- Awareness programme: Employees
- Training: Internal audit
- Training: Statistical tools
- Training: QMS Documented Information
- Training: .......... (on specific identified subject)
- Initial status survey
- Developing quality policy
- Establishing quality objectives
- Implementation (including retaining documented information) to begin
- Performance evaluation (including internal audit)
- Management review
- Pre-assessment audit
- Certification body selection
- Application for selection
- Certification audit


Step 9 - Training and Guidance

Training is crucial for organizational development and success. It is essential to the achievement of organization's goals and objectives. It is beneficial to both organizations and employees. A trained employee becomes more efficient and productive. An organization can develop the potential of its employees through training.

For better implementation of ISO 9001:2015 QMS, training programmes should be organized for different categories of employees, such as senior managers, supervisors, employees and workers. Training should cover the basic concepts of ISO 9001 2015 QMS and its overall impact on the achievement of the strategic goals of the organization, quality management principles, organizational processes, and the likely work culture implications on the organization's system. In addition, initial training may also be necessary on risk-based thinking, documented information, auditing, performance evaluation, statistical tools etc.

An in-depth training programme covering the following areas (as necessary) should be organized for steering committee and task force members:
- ISO 9001:2015 QMS Awareness
- Internal QMS audit
- Statistical tools
- QMS documented information

The organization can organize such trainings as in-house programmes. The consultant, if appointed, or outside trainer or an external training institution could be invited to conduct in-house training programmes. When in-house capacity to carry out such training programmes is not available, the organization can depute its personnel to external training programmes organized be professional trainers or training organizations.

The task force coordinator can be a key personnel for the implementation of ISO 9001:2015 quality management system. He should obtain guidance on specific topics within the quality management system from time to time. Some topic-specific standards (the latest versions) that may be referred to are mentioned below:
- ISO 10001, Quality management, Customer satisfaction, Guidelines for codes of conduct for organization
- ISO 10002, Quality management, Customer satisfaction, Guidelines for complaints handling in organizations
- ISO 10003, Quality management, Customer satisfaction, Guidelines for dispute resolution external to organizations
- ISO 10004, Quality management, Customer satisfaction, Guidelines for monitoring and measuring
- ISO 10005, Quality management systems, Guidelines for quality plans
- ISO 10006, Quality management systems, Guidelines for quality management in projects
- ISO 10007, Quality management systems, Guidelines for configuration management
- ISO 10008, Quality management, Customer satisfaction, Guidelines for business-to-consumer electronic commerce transactions
- ISO 10012, Measurement management systems, Requirements for measurement processes and measuring equipment
- ISO/TR 10013, Guidelines for quality management system documentation
- ISO10014, Quality management, Guidelines for realizing financial and economic benefits
- ISO 10015, Quality management, Guidelines for training
- ISO/TR 10017, Guidance on statistical techniques for ISO 9001:2000
- ISO 10018, Quality management, Guidelines on people involvement and competence
- ISO 10019, Guidelines for the selection of quality management system consultants and use of their services
- ISO 19011, Guidelines for auditing management systems


Step 10 - Conducting Initial Status Survey

The organization should conduct initial status survey to establish organization's current status and to determine the gaps between the organization's quality management system and the requirements of ISO 9001:2015 QMS standard. The organization may use one or more of the following:
- Self assessment
- Assessment by an external organization or by a consultant

Self assessment can be conducted by task force team members, who are competent and trained in ISO 9001:2015 QMS. Many external (consulting) organizations and consultants also provide initial status survey service.

Initial status survey should be helpful in determining the following:
- Any need of efforts required for the development and implementation of ISO 9001:2015 QMS
- Any need of documented information in compliance to ISO 9001:2015 QMS standard in the organization
- Any need of change in the organizational structure
- Any need of change in the organizational processes
- Any need of change in the action plan
- Any need of additional resources

Checklist questions may be helpful for conducting self assessment. Personnel involved should obtain or prepare checklist questions for proper assessment. After conducting initial status survey, the organization will be in a position to know the gaps between the organization's quality management system and the requirements of ISO 9001:2015 QMS standard. Now the organization knows the clear path of implementation and expected timetable as mentioned in the action plan.


Step 11 - Establishing and Developing Quality Policy and Quality Objectives, and Creating and Updating Documented Information

ISO 9001:2008 QMS standard used the terms 'document', 'documented procedure', 'quality manual' and 'quality plan', however these terms are not used in ISO 9001:2015 QMS standard, instead a new term 'documented information' has been used.

ISO 9001:2015 QMS standard requires: (i) to develop a quality policy, (ii) to establish quality objectives at relevant functions, levels and processes, (iii) to create, update, control and retain documented information. The standard also requires to maintain documented information to support the operation of its processes and retain them to have confidence that the processes are carried out as planned.

ISO 9001:2015 QMS standard requires to maintain following documented information:
- Scope of the organization's quality management system (4.3)
- Information to support the operation of organization's processes (4.4.2)
- Quality policy (5.2)
- Quality objectives (6.2.1)
- Information that defines the characteristics of the products and services to be produced/provided, activities to be performed, and the results to be achieved (8.5.1)
- In addition to the above, the organization should determine documented information (to maintain) as being necessary for the effectiveness of the organization's quality management system. (7.5.1)


ISO 9001:2015 QMS standard also requires to retain following documented information:
- Monitoring and measuring resources - evidence of fitness, and basis used for calibration and verification, where no international or national measurement standard exists (7.1.5)
- Evidence of competence (7.2)
- Operation planning and control (8.1)
- Results of the review of requirements, including any new or changed requirements, for the products and services, and where requirements for products and services are changed, amendment of relevant documented information (8.2.3)
- Confirmation that design and development requirements are met (8.3.2)
- Design and development inputs (8.3.3)
- Design and development controls activities (8.3.4)
- Design and development outputs(8.3.5)
- Design and development changes, results of reviews, authorization of changes, and actions taken to prevent adverse impacts (8.3.6)
- Results of evaluation, monitoring of performance, and re-evaluation activities of external providers and any necessary actions (8.4.1)
- Necessary information to maintain traceability (8.5.2)
- Information regarding property belonging to customers or external provider is lost, damaged or otherwise found to be unsuitable for use and reporting to the customer or external provider (8.5.3)
- Results of the review of changes, personnel authorizing the changes, and any necessary action (8.5.6)
- Traceability to the person(s) authorizing release of products and services for delivering to the customer (8.6)
- Information that describes nonconformity, the actions taken, any concession obtained, and that identifies the authority deciding the action (8.7.2)
- Evidence of results in monitoring, measurement, analysis and evaluation (9.1.1)
- Evidence of the implementation of the internal audit programme, and internal audit results (9.2)
- Evidence of the results of management review (9.3)
- Evidence of nature of nonconformities and subsequent actions, and results of any corrective action (10.2)
- In addition to the above, the organization should determine documented information (to retain) as being necessary for the effectiveness of the organization's quality management system. (7.5.1)

It is better, in the beginning, to formulate the organization's quality policy and quality objectives in line with vision, mission and long-term business goals of the organization. Quality objectives need to be established at relevant functions, levels and processes needed for the quality management system.

Therefore, the members of the task force may be assigned the following work:
- Defining the scope of the organization's quality management system
- Formulating organization's quality policy
- Formulating quality objectives
- Determining documented information to maintain
- Determining documented information to retain

The task force should take decision with regard to the documented information that are not created or updated by the members of task force:
- Who will create or update?
- Who will control?

Created and updated documented information should be reviewed and approved for suitability and adequacy.


Step 12 - Implementation

The organization needs to close the gaps, as identified in step 10, allocate resources to perform actions and implementation, assign roles, responsibilities and authorities and establish a final time schedule to complete the needed actions. For guidance and reference to requirements, please refer to ISO 9001:2015 QMS standard.

It will be a good practice to implement as per the documented information developed and maintained by the organization. In large organizations, implementation may be more effective if implementation done in a phased manner, while in small organizations, the quality management system is often implemented all at once throughout the organization.
Where phased implementation takes place, the effectiveness of the system in selected area can be evaluated. It will be a good idea initially to evaluate areas where the chances of a positive evaluation are high, to maintain the confidence of both management and staff in the merits of implementing the quality management system as per ISO 9001:2015 QMS standard. The steering committee of the organization should monitor the implementation progress on a regular basis.


Step 13 - Conducting Internal Audit

As the quality management system is being installed, its effectiveness should be checked by internal audits conducted at planned intervals. Internal audits are conducted to ensure that the quality management system of the organization conforms to: (i) the organization's own requirements for its quality management system, and (ii) ISO 9001:2015 QMS standard requirements, and also to ensure that the quality management system is effectively implemented and maintained. When a quality management system has been operating for three to six months, an internal audit should be conducted. A few staff members should be trained to carry out internal audit. Even after the quality management system of the organization stabilizes and starts functioning, internal audit should be planned and performed as an ongoing strategy. After conducting the internal audit, the organization is able to know the detected nonconformities. Therefore, appropriate correction and corrective action should be taken promptly to eliminate the detected nonconformities and its verification.

The organization should make sure that information on non-conformance pointed out in internal audit are resolved by ensuring appropriate correction and corrective action and turned to conformance. The organization should make sure to retain documented information as evidence of the internal audit programme implementation and audit results. Please note that ISO 19011:2011 standard provides guidelines for auditing management systems.


Step 14 - Conducting Management Review

When implementation of quality management system has been operating for three to six months and an internal audit has been conducted, a management review should be conducted by the top management of the organization by considering the following inputs:
- Changes in external and internal issues relevant to organization's quality management system
- Information on the performance and effectiveness of the quality management system
- Trends in customer satisfaction
- Trends in feedback from relevant interested parties (customers, users, etc.)
- Achieving quality objectives
- Process performance
- Conformity of products and services
- Nonconformities, corrections and corrective actions
- Monitoring and measurement results
- Audit results
- Performance of external providers
- Adequacy of resources
- Effectiveness of actions taken to address risks and opportunities
- Opportunities for improvement

Management review outputs should include decisions and actions related to the following:
- Improvement opportunities
- Any need for changes
- Resource needs

Actions as decided in the management review should be appropriately implemented. Management review forms an integral part of the quality management system and it should be conducted at planned intervals. In the subsequent management reviews, please also consider the status of actions from previous management reviews. Make sure to retain documented information as evidence of the results of management reviews.

Step 15 - Arranging Pre-assessment Audit

When deficiencies in the organization's quality management system are no longer visible, it is normally time to apply for certification. However, before doing so, a pre-assessment audit should be arranged with an independent and qualified auditor. Organization's consultant or an independent consultant may be able to do such an audit. Sometimes certification bodies also provide this service for a nominal charge. The pre-assessment audit will provide a degree of confidence for finally going ahead with an application for certification.


Step 16 - Going for Certification

Once the quality management system as per ISO 9001:2015 QMS standard has been in operation for a few months and has stabilized and the steering committee is satisfied with the implementation, the organization should make a formal application to a selected certification body. The certification body normally first carries out an adequacy audit and thereafter an on-site audit. If the certification body finds the quality management system to be working satisfactorily and conforming to ISO 9001:2015 QMS standard requirements, it awards the organization a certificate, generally for a period of three years. During a three-year period, the certification body will carry out surveillance audits to ensure that the quality management system of the organization is continuing to operate satisfactorily.

Certification is not a mandatory requirement of ISO 9001:2015 QMS standard. An organization may implement ISO 9001:2015 QMS standard without obtaining its certification. If an organization wishes to obtain ISO 9001:2015 QMS certification, then efforts should be made to obtain the certification from an accredited certification body. Please ensure that the certification body is accredited to grant certification in the area the organization operates.


Friday, September 11, 2015

ISO 9001:2015 QMS Standard Expected To Be Published Soon




As per the latest information, forthcoming ISO 9001:2015 QMS standard has almost come to a conclusion and has been approved for publication. It is expected that the forthcoming standard will be published on 23 September 2015.

Reacting on the news, Keshav Ram Singhal, the editor of this blog, announced, "Every efforts will be made to increase awareness with regard to the revised standard. I will write analytical articles, organize 'ISO 9001:2015 QMS Awareness' trainings and take other steps, all aimed at helping people and organizations to have a smooth transition to the new standards. Organizations can organize in-house trainings by sending an invitation to me or can nominate their staff to training programmes organized in Ajmer. One-to-one training or small group training facility is also available for which organizations can nominate their personnel on a mutually agreed date. Fees will be reasonable and this will not be a major issue. Efforts will also be made to design and develop online training. Let us start our efforts."





Tuesday, September 8, 2015

Transition Planning for ISO 9001:2015 QMS




Keshav Ram Singhal

Many organizations and professional have questions with regard to transition planning for ISO 9001:2015 QMS and validity of ISO 9001:2008 QMS certification.

International Accreditation Forum (IAF), on 12 January 2015, has issued a IAF Informative Document 'Transition Planning Guidance for ISO 9001:2015 - Issue 1', prepared by IAF Technical Committee in cooperation with ISO/TC 176/SC2/WG 23, and approved by IAF members. The objective of the IAF Informative Document is to provide advice to interested parties (such as organizations, certification bodies, accreditation bodies, training bodies, consultants, etc.) on transition arrangements to be considered before implementing ISO 9001:2015 QMS standard.

The IAF Informative Document has identified activities to be considered by relevant interested parties (such as organizations, certification bodies, accreditation bodies, training bodies, consultants, etc.). The informative document is helpful in increasing the understanding of the context of ISO 9001:2015 QMS standard. Forthcoming ISO 9001:2015 QMS standard will be based on Annex SL of Directives, a high-level structure (HLS). This HLS has standardized sub-clause titles, core text of the standard, common terms and core definitions with an objective to increase compatibility and alignment with other management system standards (such as, ISO 14001 EMS, etc.).

ISO 9001:2015 QMS standard has following changes:
- Adoption of the HLS as set out in Annex SL of ISO Directive
- Adoption of risk based thinking
- Improved understanding and application of the process approach
- Fewer prescribed requirements
- Less emphasis on documentation
- Improved applicability of the requirements to service organizations
- Include requirement to determine the scope (boundaries) of the quality management system
- Emphasis on understanding the organization and its context
- Increased requirements for top management
- Greater emphasis on achieving desired outcomes to enhance and improve customer satisfaction

As per the IAF Informative Document, the International Accreditation Forum (IAF) and the ISO Committee on Conformity Assessment have agreed to a three year transition period from the date of publication of ISO 9001:2015 QMS standard. ISO 9001:2015 QMS standard is expected to be published on any date after 9 September 2015. Please note that International Organization for Standardization (ISO) has released ISO/FDIS 9001:2015 for voting to be completed on 9 September 2015 and thereafter ISO 9001:2015 QMS standard will be published

ISO 9001:2008 QMS certifications will be valid during transition period only. After three years from the publication date of ISO 9001:2015 standard, ISO 9001:2008 certifications will not be valid. Accordingly, ISO 9001:2008 QMS certifications issued during the transition period will be valid during the transition period and after three years from the publication date of IS 9001:2015 QMS standard, ISO 9001:2008 QMS certifications will not be valid.

Organization implementing ISO 9001:2008 QMS standard needs to upgrade its quality management system in line with ISO 9001:2015 QMS standard and accordingly the organization should take following actions:
- Conduct initial status survey to identify gaps, which need to be addressed to meet new requirements of ISO 9001:2015 QMS standard
- Prepare an action plan with target dates for implementation of ISO 9001:2015 QMS standard
- Organize appropriate training and awareness programme for people in the organization
- Update the existing quality management system to meet ISO 9001:2015 QMS standard requirements and implement as per ISO 9001:2015 QMS standard
- Conduct internal audit
- Conduct management review
- Contact Certification Body for ISO 9001:2015 Certification (if the organization seeks certification)

The IAF Informative Document also provides guidance to certification and accreditation bodies. This document can be downloaded from the IAF website (iaf.nu).




Friday, September 4, 2015

Developing and Implementing Forthcoming ISO 9001:2015 QMS





Keshav Ram Singhal

It is a strategic decision for an organization to adopt ISO 9001:2015 QMS standard. Once the top management of an organization takes a decision to develop and implement ISO 9001:2015, following step-by-step process may be useful.

Step 1 - Leadership and Commitment from Top Management

Following three things from the top management will facilitate proper development and implementation of ISO 9001:2015 QMS:
- Leadership role
- Commitment
- Active involvement

It is necessary for the top management to demonstrate leadership and commitment to implement ISO9001:2015 QMS standard. Top management of the organization must be convinced that implementing ISO 9001:2015 QMS standard will provide a number of potential benefits to the organization. Top management must know that although certification and registration is not mandatory, however certification and registration will enable the organization to demonstrate a visible commitment to quality, quality management system and sustainable development initiatives. Top management must be aware of the overview of ISO 9001:2015 QMS standard, for which one-day presentation training can be organized covering the following issues:
- ISO 9001:2015 QMS Overview
- Importance of understanding the organization and its context
- Risk-based thinking
- Identification of goals and expectations
- Leadership role
- Quality policy
- Quality objectives
- Engaging persons to contribute QMS effectiveness
- Establishing a steering committee
- Establishing a task force
- Appointing a consultant
- Implementation process

Presentation training covering the above issues can be organized by a personnel, who is well aware of ISO 9001:2015 QMS standard. An outside consultant or trainer may be asked to organize the training.

Top management of the organization should demonstrate leadership, commitment and determination to implement ISO 9001:2015 QMS standard by involving themselves actively in the following tasks:
- Ensuring people in the organization understand the importance of meeting requirements
- Establishing organization's quality policy and quality objectives
- Integrating quality management system requirements into the organization's business processes
- Promoting the use of the process approach and risk-based thinking
- Engaging, directing and supporting people in the organization
- Providing necessary resources
- Promoting improvements
- Performing 'management reviews' at planned intervals to ensure continuing suitability, adequacy, effectiveness and alignment of organization's quality management system with the strategic direction of the organization.

Top management of the organization should identify objectives or goals the organization wants to achieve. Typical objectives or goals of an organization ma b following:
- Providing more efficient products and services
- Be more profitable
- Producing products and services that consistently meet requirements
- Achieving customer satisfaction
- More business for the organization
- Maintaining market share (business)
- Improving processes in the organization
- Improving communication in the organization
- Improving morale in the organization
- Reducing costs
- Reducing liabilities
- Reducing waste
- Reducing rework
- Increasing confidence in the production process
- Technical up-gradation

Top management needs to ensure that intended results are achieved. So, top management must take all possible steps to develop and implement ISO 9001:2015 QMS standard as per the requirements stated in the standard and determined by the organization.

Step 2 - Assigning responsibilities and authorities

ISO 9001:2008 QMS standard has a requirement to appoint a management representative to coordinate quality management systems activities. ISO 9001:2015 QMS standard does not have a requirement to appoint a management representative. However, the standard requires assignment of responsibilities and authorities for relevant roles within the organization. As such, top management of the organization should assign the responsibility and authority for :
- Ensuring that the organization's quality management system conforms to ISO 9001:2015 QMS requirements
- Ensuring that the organization's processes deliver intended outputs
- Reporting quality management system performance to the top management
- Reporting opportunities for improvement to the top management
- Ensuring the promotion of customer focus throughout the organization
- Ensuring maintaining quality management system's integrity while planning and maintaining changes to the quality management system

One or more persons can be selected and assigned above mentioned responsibilities and authorities or the top management can perform such role.

Step 3 - Establishing a steering committee

ISO 9001:2015 QMS standard does not mention requirement for establishing a steering committee, however, it is better a better idea to establish and set up a steering committee. A member of the top management of the organization should head the steering committee and other members of the steering committee should be:
- Persons selected and assigned specified duties as mentioned in step 2
- Department and functional heads
The steering committee should be responsible for the overall planning of the implementation process, giving directions and allocating resources. The members of steering committee should be trained on ISO 9001:2015 QMS by a professional trainer, consultant or training organization.

Step 4 - Establishing a task force

The steering committee should determine whether a task force is required and if determined then it should set up a task force with a coordinator. Its coordinator can be selected from persons selected and assigned duties as mentioned in step 2. The task force should be allocated the work of determining documented information and their creation.. It can also be assigned the job of: (i) identifying organization's risks, (ii) determine how critical each risk is, and (iii) determine actions to be taken.

The task force members should have good understanding of the organization's processes and also good communication-writing skills. The members of the task force should be trained on 'ISO 9001:2015 QMS' and specially on 'QMS Documented Information' by a professional trainer, consultant or training organization.

To be continued .....

Note

Organizations, desirous of conducting or participating 'ISO 9001:2015 QMS Awareness' training, may contact your training and development partner.









Thursday, September 3, 2015

DESIGN AND DEVELOPMENT OF PRODUCTS AND SERVICES IN FORTHCOMING ISO 9001:2015 QMS




K. R. SINGHAL

Design and development is a set of processes that converts or transforms needs and expectations for an object or entity (such as product, service, process, person, organization, system, resources) into more detailed requirements (needs and expectations). The words 'design' and 'development' and the term 'design and development' are sometimes used synonymously. Forthcoming ISO 9001:2015 QMS standard mentions requirements for design and development of products and services in its clause 8.3 that has following sub-clauses:

8.3.1 - General
8.3.2 - Design and development planning
8.3.3 - Design and development inputs
8.3.4 - Design and development controls
8.3.5 - Design and development outputs
8.3.6 - Design and development changes

General

Organization needs to establish, implement and maintain a design and development process consisting of:
- Design and development planning
- Design and development inputs
- Design and development controls
- Design and development outputs
- Design and development changes

Design and development planning

Organization needs to determine stages and controls for design and development for which the organization must consider the following:
- Nature of design and development activities
- Duration of design and development activities
- Complexity of design and development activities
- Required stages for the design and development process
- Applicable design and development reviews
- Verification activities for design and development
- Validation activities for design and development
- Responsibilities and authorities involved in design and development process
- Internal and external resource needs for design and development process
- The need to control interfaces involved between person involved in design and development process
- The need for involvement of customers and users in the design and dvelopment process
- Requirements for subsequent provision of products and services
- What customers expect for the level of control on design and development process
- What interested parties expect for the level of control on the design and development process
- What documented information needed that can demonstrate meeting design and development requirements

Design and development inputs

Consider the following:
- Functional and performance requirements
- Information from previous similar design and development activities
- Legal requirements
- Standards to implement
- Codes of practice to implement
- Potential consequences of failure because of nature of the products and services

Determine:
- Requirements essential for the products and services that are to be designed and developed

Ensure:
- Input requirements to be adequate, complete and unambiguous
- Resolving the conflicting design and development inputs

Retain
- Documented information on design and development inputs


Design and development controls

Apply controls to design and development process

Ensure:
- Defining of results to be achieved
- Conducting reviews to evaluate the ability of results of design and development and meeting requirements
- Conducting verification activities to ensure that the design and development outputs meet the design and development inputs requirements
- Conducting validation activities to ensure that resulting products and services meet the requirements for the specified application and intended use
- Taking any necessary actions on problems determined during design and development control activities (i.e., during review, verification and validation activities)
- Retaining documented information of design and development control activities


Design and development outputs

Ensure the following:
- Design and development outputs meet the input requirements
- Design and development outputs are adequate for the subsequent processes
- Design and development outputs include or mention (i) appropriate monitoring and measuring requirements, and (ii) acceptance criteria
- Design and development outputs specify the characteristics of the products and services (that are essential for their intended purpose and their safe and proper provision)

Retain:
Documented information on design and development outputs


Design and development changes

Indentify:
Design and development changes

Review:
Design and development changes

Control:
Design and development changes to ensure no adverse impact on conformity to requirements

Retain:
- Documented information on identified design and development changes
- Documented information on results of reviews
- Documented information on authorization of the changes
- Documented information of actions taken


Design and development in ISO 9001:2008 vs ISO 9001:2008

Design and development in ISO9001:2008 has following seven sub-clauses:
- Design and development planning (7.3.1)
- Design and development inputs (7.3.2)
- Design and development outputs (7.3.3)
- Design and development review (7.3.4)
- Design and development verification (7.3.5)
- Design and development validation (7.3.6)
- Control of design and development changes (7.3.7)

Requirements of design and development process have been restructured and earlier seven sub-clauses have been reduced to following six sub-clauses in ISO 9001:2015:
- General (8.3.1)
- Design and development planning (8.3.2)
- Design and development inputs (8.3.3)
- Design and development controls (8.3.4)
- Design and development outputs (8.3.5)
- Design and development changes (8.3.6)


Please note:
International Organization for Standardization (ISO) has released ISO/FDIS 9001:2015 for voting to be completed on 9 September 2015 and thereafter ISO 9001:2015 QMS standard will be published. This article is based on the draft versions of the forthcoming standard and there may be some changes after the final standard is published.

Wednesday, September 2, 2015

EXCLUSIONS IN RELATION TO APPLICABILITY OF REQUIREMENTS IN FORTHCOMING ISO 9001:2015




K. R. SINGHAL

ISO 9001:2008 QMS standard referred the exclusions by providing that where any requirement(s) of ISO 9001:2008 QMS standard cannot be applied due to the nature of the organization and its product, this can be considered as exclusion and such exclusions are limited to requirements within clause 7 only and not permitted in other clauses of the standard.

Forthcoming ISO 9001:2015 QMS standard does not refer to exclusions in relation to applicability of its requirements to the organization's quality management system. All the requirements of ISO 9001:2015 are generic and applicable to the organization, regardless of its type or size, or the products and services it provides. However, an organization, implementing ISO9001:2015, needs to determine the boundaries and applicability of the quality management system to establish its scope, that needs to be available and be maintained as documented information.

Accordingly, if an organization determines that any ISO 9001:2015 QMS requirement is not applicable to the organization's scope, then organization (i) needs to provide justification for the non-applicability, and (ii) ensure that the requirements determined as not being applicable do not affect the organization's ability or responsibility to provide products and services that meet requirements to enhance customer satisfaction.

In this way, we see that ISO 9001:2008 allowed the exclusions within clause 7 only, while ISO 9001:2015 does not mention such limitation to non-applicability of requirements.

Please note:
International Organization for Standardization (ISO) has released ISO/FDIS 9001:2015 for voting to be completed on 9 September 2015 and thereafter ISO 9001:2015 QMS standard will be published. This article is based on the draft versions of the forthcoming standard and there may be some changes after the final standard is published.




Saturday, August 29, 2015

Outsourcing or Externally Provided Processes, Products, Services and Property in ISO 9001:2015




Keshav Ram Singhal

'Outsourcing' is an important external source activity for an organization. 'Outsource' can be defined as 'making an arrangement where an external organization performs part of the organization's role, function or process (interrelated and interacting activities).

ISO 9001:2008 QMS standard however mentioned requirements to ensure controls over outsource process, but it was not specific on the externally provided products and services. According to ISO 9001:2008 QMS standard, where an organization chooses to outsource any process, the organization needs to ensure control over such process.

Forthcoming ISO 9001:2015 QMS standard not only deals with externally provided process or processes, but it also mentions detailed requirements of the control on externally provided processes, products, services and property. There may be situations, when:
(i) outsource products and services are intended for incorporation into the organization's products and services,
(ii) an external provider on behalf of the organization provides products and services directly to the customer,
(iii) an external provider provides a process or part of a process to the organization,
(iv) an external provider provides its property for use or incorporation into the organization's products and services.

With respect to the externally provided processes, products, services and property, requirements mentioned in following clauses are relevant:
Clause 8.4 - Control of externally provided processes, products and services
Clause 8.5.3 - Property belonging to customers or external providers

According to the requirements of forthcoming ISO 9001:2015 QMS standard, an organization needs to carry out the following activities:

Consider
(i) Potential impact of externally provided processes, products and services on the organization's ability to meet requirements (customer and legal)
(ii) Effectiveness of the controls applied by external providers

Determine
(i) Controls to be applied to the externally provided processes, products and services
(ii) Criteria for the evaluation, selection, performance monitoring and re-evaluation of external providers
(iii) Verification and other activities to ensure that externally provided processes, products and services meet requirements

Ensure
(i) Externally provided processes, products and services conform to requirements
(ii) Externally provided processes, products and services remain with the organization's control
(iii) Adequacy of requirements to be communicated to the external providers

Define
Controls to be applied to
(i) External providers, and
(ii) Resulting output

Communicate to the external providers adequate requirements for the
(i) Processes, products and services
(ii) Approval of products and services
(iii) Approval of methods, processes and equipment
(iv) Release of products and services
(v) Required competence (including qualification)
(vi) External providers' interactions with the organization
(vii) Control and monitoring of the external providers' performance to be applied
(viii) Verification and validation activities to be performed at the external providers' premises by the organization or its customers

Apply
Determined controls, criteria and other activities


Controls on external providers' property

The organization is also required to exercise care with the property (such as material, components, tools, equipment, premises, intellectual property and personal data) belonging to the external providers while the same is under the organization's control or being used by the organization. The organization needs to identify, verify, protect and safeguard the property provided for the use or incorporation into the products and services.

When any property belonging to an external provider is lost, damaged or otherwise found to be unsuitable for use, the organization must (i) report the same to the external provider, and (ii) retain documented information of the same.

Please note:
International Organization for Standardization (ISO) has released ISO/FDIS 9001:2015 for voting to be completed on 9 September 2015 and thereafter ISO 9001:2015 QMS standard will be published. This article is based on the draft versions of the forthcoming standard and there may be some changes after the final standard is published.