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

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

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.

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.

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 !

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