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

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Wednesday, June 2, 2021

# 02 - A Study of Integrated Management System – IMS - Benefits of Integrated Management System

 

# 02 - A Study of Integrated Management System – IMS

Benefits of Integrated Management System

There are several benefits of implementing an Integrated Management System in an organization. An Integrated Management System refers to the seamless integration of two or more management systems standards into a common management system that meets the requirements of each of the standards integrated to the IMS that allows the organization to work with a holistic approach. While it can be difficult to comply the requirements of two or more management systems standards in a unified system, however organizations use IMS as a panacea of all ills as if the IMS will make the management systems more efficient.  Benefits derived from implementing an IMS may be summarized as under:

-          Improvement of business focus and performance,

-          Meeting two or more management systems requirements with one set of documented information (policies and procedures),

-          Holistic approach to manage business risk,

-          Minimizing duplication of work and bureaucracy,

-          More efficient and effective internal audits as well as external audits,

-          Human resource savings,

-          Decreasing management cost,

-          Time saving,

-          Savings in total implementation cost,

-          Clear understanding of the organization’s overall policy and objectives,

-          Efficiency improvement and effectiveness of the system,

-          Communication (internal as well as external) improvement

-          Reduction in certification cost etc.

 

How you like this article? Any information you like to add, please mention that in comment box.

 

Best wishes,

Keshav Ram Singhal



Hurrah ! I am too happy ...

 Hurrah ! I am too happy ...


More than 75,000 visitors have
visited, seen and read my blog http://qmsawareness.blogspot.com/.

I feel motivated and honoured with the popularity of my blog.


Thanks for the continuous support of the readers of my blog.


I hope that I will get similar support to my other blogs.


Please keep visiting, reading my blogs
and
keep commenting too.

Again Thanks,

Keshav Ram Singhal
Committed for Creating Awareness






# 01 - A Study of Integrated Management System – IMS

 # 01 - A Study of Integrated Management System – IMS

 

An Integrated Management System (IMS) combines or merges all aspects of an organization’s systems, processes and Standards into one smart system. The combination or merger allows the business to streamline its management, save time and increase efficiency by addressing and implementing all requirements of the management systems as a whole. As such, an IMS is known as a system that combines or merges the components of organization’s business into one system by implementing the requirements of two or more management systems standards, such as, ISO 9001:2015 QMS, ISO 14001:2015 EMS, ISO 14001:2018 OH&SMS, ISO 50001:2018 EnMS etc.

 

When an organization implements more than one management systems, it is necessary to reduce duplication of work and eliminate redundancy in the organization’s systems. For this an understanding of common requirements and expectations will save time and manpower.

 

There are a number of common requirements in various Management System Standards, such as:

-          Policy,

-          Objectives,

-          Competence and awareness of personnel,

-          Communication,

-          Documented information,

-          Internal audit,

-          Management review,

-          Continual improvement

-          Non-conformity and corrective action

 

Common requirements of these different standards (ISO 9001:2015 QMS, ISO 14001:2015 EMS, ISO 14001:2018 OH&SMS, ISO 50001:2018 EnMS) may be addressed by a common documented information (e. g. procedures and work instructions).

 

Now a days many organizations, all over the world, are implementing an integration approach by merging QMS, EMS, OH&SMS and EnMS. A few organizations also implement ISO/IEC 27001:2013 ISMS (Information Security Management Systems) in their IMS. However, in this series, we will cover only QMS, EMS, OH&SMS and EnMS.

 

How you like this article? Any information you like to add, please mention that in comment box.

 

Best wishes,

Keshav Ram Singhal

 


 

Thursday, May 6, 2021

Training Handbook on ISO 9001:2015 QMS Awareness

Training Handbook on ISO 9001:2015 QMS Awareness

Dear friends,
Greetings!
I am glad to inform that my work ‘Training Handbook on ISO 9001:2015 QMS Awareness’ (Kindle Edition) is now available at Amazon and that can be read in your laptop, mobile and Kindle book reader. The handbook is priced INR 200 in India and it is also available in other countries at equivalent price in other currencies.
Members of ‘Kindle Unlimited’ can read this book free of charge.
After reading the contents of this training handbook, the reader will be able to understand KEY POINTS that affect your organization and your quality management system implementation, including the following –
- Structure and terminology
- Context of the organization
- Risk-based thinking
- Organizational knowledge
- Role of top management
- Management representative's role?
- Documentation impact and requirements for documented information
- Understanding ISO 9001:2015 QMS requirements including internal audit requirements
- Implementation guidance
- Quality management principles
- Change management
- Adding value to the audit
Hope the information is useful to you.
Regards,
Keshav Ram Singhal
6 May 2021





Monday, May 3, 2021

Revision of ISO 9001:2015 QMS Standard

Revision of ISO 9001:2015 QMS Standard

 

All ISO Standards are revised every five years to establish if a revision is required to keep the standard current and relevant for the users.

 

Typically, ISO 9001:2015 QMS standard gets revised every 6 to 8 years.

 

ISO 9001 standard’s revision history is as under:

First issue published – 1987

First revision – Second issue published – 1994 – after 7 years

Second revision – Third issue published – 2000 – after 6 years

Third revision – Fourth issue published – 2008 – after 8 years

Fourth revision – Fifth revision published – 2015 – after 7 years

 

As per the history of ISO 9001 standard, revision of the standard is due, but following news may surprise you:

 

- Members of the International Organization for Standardization (ISO) Technical Committee 176, Sub-Committee 2 (TC176/SC2) have taken the surprising decision not to proceed with the much-anticipated update of ISO 9001:2015.

 

- TC176/SC2 conducted a systematic review of ISO 9001:2015 “Quality management systems — Requirements”. By the narrowest of margins, they agreed that ISO 9001:2015 should be unchanged.

 

Accordingly, we may not see the next revision of the standard until the year 2030.

 

Best wishes,

Keshav Ram Singhal



 

Saturday, May 1, 2021

Objectives of Documented information

 

Objectives of Documented information

 

ISO 9001:2015 QMS standard requires QMS documentation to include documented information required by ISO 9001:2015 QMS standard and the documented information determined by the organization. Have you ever thought about the purpose of maintaining or retaining documented information?

 

Documented information serves various purposes, the same are stated below:

 

Communication tool – Documented information serves as a communication tool. It transmits information and provides communication. Documented information may serve the purpose of disseminating and preserving the experiences within the organization.

 

Standard’s conformity evidence – Documented information provides evidence of conformity to ISO 9001:2015 QMS requirements. It provides evidence that requirements of the standard are fulfilled.

 

Knowledge sharing tool – Documented information serves as a knowledge sharing tool among people who have access to it.

 

Best wishes,

 

Keshav Ram Singhal

 

To get your copy - CLICK: ‘A Concise Guide on Creating and Updating Documented Information’. Thanks. 

 

For information on Concise Guide, Please CLICK HERE

 

Wednesday, October 14, 2020

Limitations of Why Why Analysis

 

Limitations of Why Why Analysis

In our book 'Implementing ISO 9001:2008 Quality Management System', we mentioned 'Why why Analysis' as a tool for adding value to internal QMS. We clearly mentioned - "Do not see who is responsible. Rather consider why and what caused the problen or nonconformity. ..... Find out fundamental cause of the nonconformity and stop it happening it again. We need to ask WHY? WHY? WHY? We should not ask -- WHO? We provided examples for using Why Why method. Basically Why Why Analysis is a simple and useful technique, however we need to know its limitations.  

Many in the industry know the root cause analysis system called the 5 Whys or Why Why Analysis. It was created at Toyota and has been implemented in many other organizations that use lean manufacturing concepts. Unlike some of the more complex root cause analysis systems, 5 Whys does not require any data segmentation, regression, testing of hypotheses or other high end statistical tools. In many instances, using the 5 Whys can be done without any data collection either.

Five Whys technique is a popular technique for root cause analysis. Many people use it. Is this a suitable technique for teams? Do we have any alternate better technique for the teams? John Allspaw, SVP of Technical Operations at Etsy favors to discard Five Whys approach. He says that using the Five Whys is a good first step toward doing real root cause analysis but asking too many whys end up in blaming people.

The idea is by asking ‘why?’ at least five times, one can peel away many layers of symptoms and get to the root cause at last of a problem. At many organizations, the 5 Whys is still important for solving problems, and is the basis of the scientific approach there. In their experience, repeating ‘why?’ 5 times will usually reveal the nature of the problem.

The idea of solving a problem means that identify the root cause of problems and then come up with and implement solutions to eliminate the root cause and to prevent them from happening again.

 There are following reasons for the criticism of Why Why Analysis:

- Tendency for investigators to stop at symptoms rather than going on to lower-level root causes

- Inability to go beyond the investigator’s current knowledge – cannot find causes that they do not already know

- Lack of support to help the investigator ask the right “why” questions

- Results are not repeatable – different people using 5 Whys come up with different causes for the same problem

- Tendency to isolate a single root cause, whereas each question could elicit many different root causes

- Considered a linear method of communication for what is often a non-linear event

- Problem with the 5 Whys is that it does not always uncover the root cause when the cause is not known. Also, the 5 Whys presumes that each symptom has one cause. This is not always true, so this type of analysis does not always show several sufficient causes that are causing the symptom.

- How well the 5 Whys works depends some on the skill of the person using it. If one why has an incorrect answer, it can throw off the entire analysis. Last, this method is not always repeatable. Three people applying the 5 Whys can often come up with different answers.

- Other disadvantages include the inability of this method to tell between causal factors and the root cause, and a lack of rigor where the user is not mandated to do sufficiency testing.

 

Courtesy Sources 

- Implementing ISO 9001:2008 Quality Management System - A Reference Guide, Dr. Divya Singhal and Keshav Ram Singhal, PHI Learning Private Limited, New Delhi (Available at Amazon)

- Limitations of the Five Whys Technique in Agile Retrospectives, Savita Pahuja - Please CLICK

- Limitations of 5 Whys in CAPA and Root Cause Analysis - Please CLICK 

- Keshav Ram Singhal



 

 

Saturday, June 27, 2020

BIS Permits Relaxations For Covid-19


BIS Permits Relaxations For Covid-19

To promote the supply of quality PPEs during the ongoing pandemic, Bureau of Indian Standards (BIS) has permitted relaxation in its norms of having in-house testing facilities for the following PPEs:

i) Filter Half Masks to Protect against particles of Class FFP2 as per IS 9473:2002
ii) Surgical Face Masks as per IS 16289:2014
iii) Eye Protectors as per IS 5983:1980

This has been done to enable more manufacturers to be brought in the ambit of BIS product certification scheme, which will in turn result in greater quantity of BIS certified PPEs being made available to the users. However, for such manufacturers, testing of samples for conformity to the specified requirements is being done in laboratories of BIS licensees who have in-house testing facilities, or in BIS recognized or empanelled private/government labs.

Those domestic manufacturers who are interested in applying for a BIS licence may register themselves and submit their application online through BIS website (CLICK HERE). The process of certification can be seen on BIS website (CLICK HERE). Here it is important to note that Bureau of Indian Standards (BIS) is providing access to above standards free of cost, which can be accessed free of cost through BIS website (CLICK HERE).

For any additional information, please get in touch with the nearest BIS Branch .

Best wishes,

Keshav Ram Singhal


Sunday, June 21, 2020

Online training on 'ISO 9001:2015 QMS Awareness' in May 2020


Online training on 'ISO 9001:2015 QMS Awareness' in May 2020

Participants successfully completed the online training in May 2020 are:

- Umesh S. Bhagawat, Thane (Maharashtra)
- Rajdeep Arora, Ludhiana (Punjab)
- Ms. Pushpa Sasane, Pune (Maharashtra)

CONGRATULATIONS !

Keshav Ram Singhal

Thursday, June 11, 2020

Accreditation and Selection of Certification Body


Accreditation and Selection of Certification Body

Accreditation

When an organization decides to implement and obtain certification to ISO 9001:2015 QMS standard or any other standard, the first work is to choose a certification body from which the organization will obtain the certification. A number of certification bodies are operating in our country, so you have a wide choice to select a certification body. It is always suggested to obtain accredited 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 to the standard 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, competent 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 are positive, an accreditation mark is issued to certification body. Accreditation is a term widely used in certification industry. It provides us confidence in the certification body that grants us management systems certification, such as ISO 9001 certification, ISO 14001 certification etc. In simple terms, accreditation is the action or process of officially recognizing someone as having a particular status or qualified to perform a particular activity. It is an acknowledgement of someone's responsibility for achievement of something.

Accreditation really means 'creating trust'. Accreditation is the act of granting credit or recognition, especially to an institution that maintains suitable standards. Accreditation is the process in which certification of competency, authority, or credibility is presented. 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.

When an organization opts for the certification of ISO 9001:2015 QMS standard or any other standard, it finds in the initial stage that the certification body is accredited from an accreditation body. There are a number of accreditation bodies operating in the world that carry out the accreditation work. In India, NABCB (National Accreditation Board of Certification Bodies) grants accreditation to certification bodies. There are many accreditation bodies in the world, such as UKAS (United Kingdom Accreditation Service) in UK, RvA (The Dutch Accreditation Council - Raad voor Accreditatie) in Netherlands, ANAB (ANSI-ASQ National Accreditation Board) in USA, JAS-ANZ (Joint Accreditation System) in Australia and New Zealand etc.

RvA Public Report 2016 says, "Accrediting really means: creating trust. Nationally and internationally buyers want to be able to trust blindly the quality and safety of products and services provided. If these are guaranteed, it not only benefits the buyer but also the supplier. This strengthens his position in the market. In order to be able to give an objective guarantee, the supplier can have his products and services assessed by an accredited organization. This also applies to every area imaginable: health, environment, construction, energy, food, transport, finance etc."

The certificate issued by a certification body, which has been accredited by an accreditation body, which is an IAF MLA signatory for the scope covering the certificate, should be acceptable in the world under the principle of international equivalence. This is a very significant reason for making an appropriate choice of a certification body.

International Accreditation Forum (IAF)

The International Accreditation Forum (IAF) is the world association of Conformity Assessment Accreditation Bodies and other bodies interested in conformity assessment in the fields of management systems, products, services, personnel and other similar programmes of conformity assessment. Its primary function is to develop a single worldwide program of conformity assessment which reduces risk for business and its customers by assuring them that accredited certificates may be relied upon. Accreditation assures users of the competence and impartiality of the body accredited.

Accreditation in India

Since 1992 a need had been felt for the establishment of an accreditation body in India to establish internationally acceptable mechanism for recognition of conformity assessment results. As regards laboratories, an accreditation body under the Ministry of Science and Technology was already functioning. A committee which included various interested ministries and stakeholders including industries was established to make suitable recommendations. The work was coordinated by the then Department of Industries (Department of Industrial Policy and Promotion) and the recommendations were submitted to the Cabinet in 1996. Key recommendations included the Need for establishing an organization jointly by the Government and the industry and the need for the organization to be self-sustaining and be away from the government. Accepting the recommendations, the Cabinet Committee decided to set up Quality Council of India (QCI) as a non-profit autonomous society registered under Societies Registration Act XXI of 1860 to establish an accreditation structure in the country and to spread quality movement in India by undertaking a National Quality Campaign. Accordingly, QCI was established as the National body for Accreditation on recommendations of Expert Mission of EU after consultations in Inter-ministerial task force, Committee of Secretaries and Group of Ministers in 1996.

There is a governing council (known as Council) as the apex level body responsible for formulating the strategy, general policy, constitution and monitoring of various components of Quality Council of India (QCI) including the accreditation boards with objective to ensure transparent and credible accreditation system. Following accreditation boards are working under the structure of QCI:

- National Accreditation Board for Certification Bodies - NABCB
- National Accreditation Board for Education and Training - NABET
- National Accreditation Board for Hospitals and Healthcare Providers - NABH
- National Accreditation Board for Testing and Calibration Laboratories - NABL - However, it should be noted that NABL continues to be a separate legal entity.

The National Accreditation Board for Certification Bodies (NABCB) provides accreditation to Certification and Inspection Bodies based on assessment of their competence as per the Board's criteria and in accordance with International Standards and Guidelines. The National Accreditation Board for Certification Bodies (NABCB) is internationally recognized and represents the interests of the Indian industry at international forums through membership and active participation with the objective of becoming a signatory to international Multilateral / Mutual Recognition Arrangements (MLA / MRA).

NABCB is a member of International Accreditation Forum (IAF) and Pacific Accreditation Cooperation (PAC) as well as signatory to its MLAs for Quality Management Systems, Environmental Management Systems and Product Certification. Global G.A.P., Food Safety Management Systems and Information Security Management Systems NABCB is also a full member of International Laboratory Accreditation Cooperation (ILAC) and Asia Pacific Laboratory Accreditation Cooperation (APLAC) as well as signatory to its MRAs for Inspection. 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
- MQA - Maldives Qualifications Authority
- BAB - Bangladesh Accreditation Board
- NAFP - National Accreditation Focal Point - The Bhutan Standards Bureau has established a National Accreditation Focal Point (NAFP) through the SAARC-PTB cooperation framework to facilitate accreditation of conformity assessment bodies in the country and provide access to international recognized accreditation services.

Nepal has yet to establish its own National Accreditation Board to oversee certification and inspection bodies as well as accreditation of testing and calibration laboratories to demonstrate their competence

Many of the accreditation bodies are the members of International Accreditation Forum (IAF) and these accreditation bodies agree to the IAF Multilateral Recognition Agreement (MLA) recognizing the equivalence of other members' 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. In this connection, it is important to check that its accreditation scope includes the technical sector of your organization. The certification bodies are accredited scope wise.

There are 39 scope sectors as mentioned by IAF, a few of them are as under:
- Agriculture, forestry and fishing,
- Mining and quarrying,
- Food products, beverages and tobacco,
- Nuclear fuel,
- Chemicals, chemical products and fibres,
- Pharmaceuticals,
- Transportation, storage and communication,
- Information technology,
- Engineering services,
- Education, etc.

Selection of a certification body

Since there are too many certification bodies operating in our country, you need to select a accredited certification body, for which you should know the details of accreditation, certification services and cost of certification. Therefore it is better to write letters or send emails to several certification bodies asking their accreditation, 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 which you will obtain ISO 9001:2015 QMS 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. Please note that while deciding a certification body, don't just go for a cheap or non-accredited certification. You need to make a wise choice to get maximum benefits out of certification. Always select an accredited certification body.

Best wishes,

Keshav Ram Singhal