Training Handbook on 'ISO 9001:2015 QMS Awareness'

Training Handbook on 'ISO 9001:2015 QMS Awareness'

For details on the training handbook, please CLICK HERE.

Thanks,

Keshav Ram Singhal

Auditing against ISO 9001:2015

Auditing against ISO 9001:2015

- Krishna Gopal Misra
Email: qualitymeter@gmail.com


It is easy doing an audit by records and documents i.e. acts of "doing" but an audit of a process is actually an audit of the "thinking" behind that "doing".

Typical example of operation is that of a dancer who is performing ( doing) on the stage and audiences ( auditor or clients) keep seeing it. But audiences do not at all, see the song writer and musicians playing background music and choreographer. Do not you think that it is the thinking "process" which is behind every successful dance (performance) and dancer( performer)? Actual purpose of management is to set the process ( thinking) and let operators operate ( doing) the dance or whatever ( be it design of machine or producing product or delivering services).

Did not you see that I have been doing it already in opening meeting with top management and kept discussing risks and opportunities in overall business context?

This is the shift in philosophy in mind of writers of standard and their guilt for revisions of standard. ISO 9001: 2008 standard was known more as documentation and records and often people joked at saying that "do what you write and write what you do". Quality management in earlier versions of standards were focused more at operations ( "doing" or performance ) rather than the process ("thinking" goal and roadmap and risk and opportunities).

Quality manual is done away with. It was most neglected document and dust over it was cleaned only when external auditors ask for. In most quality manuals, it was just an answer of requirements of standard by clause by clause. It could be of some help to auditors who go by standard but is none of the business of the organization. Reputation of auditor is lost when their context is not the organization but how clauses of standard were some how addressed.

With doing away of quality manual, mandatory procedures like document control and internal audit and nonconformity control and corrective action, are gone too. These are not actually gone but taken care by competence of people and where errors ( human or process both) could be cause of risks or actual defect (incident). For example, the reason or rationale of scheduling an internal audit is certainly audited but not the procedure as mandated in quality manual. Document control in these days of technology are very different than they once were, in days of paper and pen. Software tools, pictures and reports sent by WhatsApp and video records of meetings are unknown earlier. These are also documents and are more simple and authentic and therefore controls are left to organization to decide and make it goal or purpose oriented rather than procedure oriented.

Management representative is also not necessary to fix. It is a matter to be decided by an organization whether or not management needs such a role in the organization. ISO can not prescribe it for organizations as a requirement of quality management. Mostly, this formality is only to take care of internal coordination and arranging external audit and deal with certification bodies. Frankly speaking management representative gets noticed only temporarily during audits and certification.

Structure of new standard has coined few words like "Leadership". Leader is not a job title. Informal attitude "walk the talk" inspires the organization; whereas, formal titles and printed documents and records are just footprints. Leadership is not just limited to top management but it is a thought process or culture that integrates the organization, and makes it goal oriented. Leadership is demonstrated in the culture of organization rather than formalities. See how do people at helm of affairs keep in touch with other employees in person which instills confidence in them, is a leadership. People felt connected and share freely their voices in interest of organization.

Formalizing management policies, transparency and access to information and real time communication are examples of leadership. Management decisions or polices such as setting rules of business and giving authorization to people are formally implemented using IT enabled ERP enterprise resource planning or project management tool. These electronic instructions should be protected from unauthorized changes. This necessity of document (configuration control) is a safety from forgetfulness and disputes. This degree of formality is unavoidable. Forgetfulness is not always a bad thing as cleaning of memory is an important activity. Memory ( including document and records) is useful only for a recall value. This means, if we cannot go ahead with self confidence; at least, we can return back home. Retreat ( coming back) without records is impossible. Leaders are good at deciding what is needed to be remembered and what must be cleaned up. Use of white board for writing by non-permanent ink is one thing and printed documents like certificates or agreements are another. Retention of memory is context based.

ISO 9001: 2015 also has remodeled its style to meet its structure with other standards such as environmental management and occupation health etc. This is useful because people would not get unduly worried for references of clause numbers in different standards under umbrella of same ISO when they get audited.

The new version refers suppliers as external providers. Similarly, standards such as ASTM used in work are also external. Do not worry. It is not necessary to start calling suppliers, external provider. Standard has no such intent. It is just another name representing a logic or thinking.

Preventive action is eliminated. Any proactive approach which does not let a defect happen, at first chance, is called preventive action. Purpose of quality system such as roles and responsibility, training and competence and suitable equipment and so on are by itself proactive approach and therefore developing and implementing a quality system is itself a preventive action.

Risk based thinking is not about documenting risk. You can think but how can you document thoughts? Nobody is going to ask you a risk register and why this risk is more riskier than another. That would be funny. Standard is clever enough to not cause a confusion in fields of wild imagination in pick and choose risks.

"Quality Objectives" are the outcome of "risk based thinking". In earlier version of standards, there used to be a clause for "quality objectives" but it was not known how should that arrived at. There can be no other way of fixing goal and objectives at different levels in the organization other than the thinking of the risk and opportunities.

This natural behavior of management is included in the revised standard. Risk is unknown consequences. If consequence are known, you either know it that you have it or if you do not like you can plan for getting rid of it in near or long term. This is the way objectives are arrived at. Quality objectives at an organization level and at each process must be good enough to safeguard the quality, and if defects or unpleasant situations occur, that should be limited by defining quality objectives.

What is process ? How is a process different from operations? Process is all about a roadmap to set a goal and achieve it. For example, if you have to go to Delhi from Thimbu Bhutan, the goal is Delhi and various ways ( or valid possibilities) of reaching Delhi are called processes. The goal is product itself or av certain ambition of individual or organization. If there is no product or goal, there is obviously no process. Rice is same but its goals demand processes suitable for it. For example, dosa by one process and idli by another process.

Coming back to earlier scenario, to manage reaching a goal is challenged by constraints such as 1. cost of travel, 2. punctuality (in time arrival) and 3. comfortable journey. As long as goal is fixed, these constraints decide which process one should choose in the given condition. One can use taxi to airport and fly to Delhi. This is a high cost option but it gives comfort and timely arrival. In another case, one can take train to Delhi, which also meets same goal but is less expensive yet uncertain for timely arrival and not very comfortable. There can be an opportunity to buy discount air fare and journey is planned in such a way that cost and time and comfort, all three are favorable. So, there are options in work, and making choice of suitable process is what a manager is expected doing. Manager is setting goal, thinking and planning and takes decisions but not operates. He or she has not to act as taxi driver, or piloting aero plane, or run train. These are operations. Process is goal focused and accordingly, assembly of unit operations and resources takes place. Process is a mental roadmap ( decision making) to achieve a goal within given constraints called risks and opportunities. Operations are acts of implementing a decision. In earlier example of a dancer performing a show is "operation" or act of dancing but "process" is the thinking behind success of the show which involves song writers and musicians and choreographer.

People thought that doing a work as per given procedure was iso 9001. People joked in name of iso that you do what you write and write what you do. Iso did not get right kind of reputation for such an understanding.

New revision is about goal orientation and how best it ( process or decision making) is achieved given the risk and opportunities.

This gives people flexibility and understanding of various difference in approach and applicable risk and opportunities.

Revised standard is more realistic and natural representation of work in a successful organization. Unnecessary things are weeded out at every revision and quality now is given more emphasis than standardization. Quality standard is combination of two words. Quality is moving and standard is standing or keeps sitting. Standard is like safety railings on both sides of a staircase so that you do not fall sideways when moving up. But these standards should not become obstacles for users of stairs. Standards only act as safety or risk prevention and quality is all about Value (usefulness or desirability). Remember !! There are three elements in quality assurance 1. Value ( usefulness), 2. Variation ( consistency or standardized) and 3. Risk ( unknown consequence).

ISO 9001 is a management standard. Can there be any standard for management? It (management) is human understanding and is not a typical enforcement or practice like law or accounting or mechanical engineering. Management is a combination of formal as well as informal. Formal part is just a tip of iceberg. Standards in management have evolved as do writers of standard get insight in actual working of management. This (ISO 9001) is just one of attempts of servicing industry and commercial establishments with certain ideas of meeting customer requirement. It is not a substitute of quality management or quality engineering or such august body of knowledge. Standards provide framework which clients can choose voluntarily but ISO is not liable in anyway for performance of an organization or claims associated with it.

COURTESY NOTE: I am thankful to Shri Krishna Gopal Misra of Gurgaon (Haryana, India) for his kind permission to republish the article. - Keshav Ram Singhal

Use of 'shall', 'should', 'may' and 'can' in Standards?

Standards generally use words, like 'shall', 'should', 'may' and 'can', in mentioning their requirements or guidelines. What these words mean?

Whenever 'shall' is used in a standard, it indicates a requirement that is necessary to follow.

Whenever 'should' is used in a standard, it indicates a recommendation that is recommended to follow the guideline.

Whenever 'may' is used in a standard, it indicates a permission to follow the guideline.

Whenever 'can' is used in the standard, it indicates a possibility or a capability.

With best wishes,

Keshav Ram Singhal

How to determine opportunities?

An opportunity is a time or set of circumstances that makes it possible to do something. Opportunities can lead to something better, such as, adopting new practices, launching or introducing new product/service, opening new markets, addressing new clients or users, building partnership, using new technology, other desirable and viable possibilities to address needs of the organization or its customers. No specific procedure or methodology is mentioned in ISO 9001:2015 QMS standard to determine 'risks and opportunities'. To determine opportunities, I suggest to make a small group (team) in your organization that should consider circumstances that make it possible to do something better in the organization.

With best wishes,

Keshav Ram Singhal

For details on the Training Handbook on ISO 9001:2015 QMS Awareness, please CLICK HERE.

'INTERNATIONAL ORGANIZATION FOR STANDARDIZATION' (ISO) HAS IMPROVED THE DEFINITION OF 'QUALITY'

International Organization for Standardization (ISO) has defined 'quality' from time to time in its documents and standards.

ISO 8402:1994, Quality management and quality assurance - Vocabulary, an ISO standard published in 1994, defined quality as "totality of characteristics of an entity that bears on its ability to satisfy stated and implied needs." In this definition, the meaning of 'entity' refers to include an activity, a process, a product, a service, an organization, a system, a person or combination thereof.

With publication of the revised standards in the year 2000, ISO 9000:2000 standard replaced the ISO 8402:1994 standard. The revised standard ISO 9000:2000 and also its revised edition ISO 9000:2005, Quality management systems - Fundamentals and vocabulary, defined quality as "degree to which a set of inherent characteristics fulfills requirements" together with following clarifications:"
- The term 'quality' can be used with adjectives such as poor, good or excellent.
- 'Inherent', as opposed to 'assigned', means existing in something, especially as a permanent characteristics.

In September 2015, a new version ISO 9000:2015 QMS standard has been published, which has replaced its earlier version and it defines quality as "degree of which a set of inherent (opposed to assigned, means existing in the object) characteristics (distinguishing features) of an object (that may be an entity, item or anything perceivable or conceivable, such as: product, service, process, person, organization, system, resource) fulfills requirements (needs or expectations that may stated, generally implied or obligatory)." It is also clarified that the term 'quality' can be used with adjectives such as poor, good or excellent.

ISO 9000:2015 standard also explains the fundamental concept of quality in its Para 2.2.1 that can be summarised as under:
- An organization, which focuses on quality, promotes a (proactive) culture in the organization.
- The culture of the organization results in certain behaviour, attitudes, activities and processes of the organization.
- Such behaviour, attitudes, activities and processes of the organization deliver value that fulfills the needs and expectations of customers as well as of interested parties.
- The quality of organization's product/service is determined by (i) the ability of such product/service to satisfy customers, and (ii) the intended and unintended impact of such product/service on relevant interested parties.
- The quality of a product/service includes intended functions and performance of such product/service and also perceived value and benefit to the customer.

With the above, we find that although ISO has now improved the definition of quality, however there is no shift in the meaning of quality in the ISO definition and it now pin points an object (means an entity, item or anything perceivable or conceivable), which may be a product, service, process, person, organization, system, resource that can be material (such as, equipment), immaterial (such as, planned schedule) or imagined (such as, future state of a product) with the same earlier meaning.

With best wishes,

Keshav Ram Singhal

The author has posted an article "Need to look afresh on quality" in September 2011 - CLICK HERE to read the article.

For details on the Training Handbook on ISO 9001:2015 QMS Awareness, please CLICK HERE.

Thanks.

REFERENCE TO ISO 9000:2015 QMS STANDARD WHEN IMPLEMENTING ISO 9001:2015 QMS STANDARD

You may ask, why you should make a reference to ISO 9000:2015 QMS standard, when you are implementing ISO 9001:2015 QMS standard?

When we make a reference to ISO 9000:2015 QMS standard, it helps us to understand related fundamental concepts, principles, terms and definitions related to quality management and quality management system standards, including ISO 9001:2015 QMS standard, developed by the ISO Technical Committee ISO/TC 176.

Title of ISO 9000:2015 QMS standard is 'Quality management systems - Fundamentals and vocabulary'. It describes the fundamental concepts and principles of quality management. It also specifies the terms and definitions that are applicable to all quality management and quality management system standards developed by the ISO Committee ISO/TC 176.

ISO 9000:2015 QMS standard can be obtained from International Organization for Standardization (ISO), Geneva (Switzerland) or from the national standards body. Bureau of Indian Standards (BIS) is the national standards body in India, which is a member of ISO.

With best wishes,

Keshav Ram Singhal

For details on the Training Handbook on ISO 9001:2015 QMS Awareness, please CLICK HERE.

Thanks.

Don't raise nonconformities against people!!!

Don't raise nonconformities against people!!!

Nonconformity simply means non-fulfillment of a requirement. You, as an internal auditor, is interested to find out nonconformities for which you may be in search of non-fulfillment of requirements. While carrying out system audits (such as, ISO 9001:2015 QMS audits), don't raise nonconformities against people, rather raise nonconformities against process and system. If your audit looks out for human error issues and mentions them in your audit report, then you will unnecessarily become a targeted critic of organization's people and you will be stamped as 'fault finder', not a proactive auditor who looks for strengthening the quality management system. Looking for a person at fault and mentioning the same in the report is a blame game that should be stopped. There are a few occurrences that issues are caused by people. Faults are more likely to lie with the system/process/procedure and here you have an opportunity to report the non-conformity for improvement.

When you observe a nonconformity, do not see who is responsible. Rather consider why and what caused the problem or nonconformity.

With best wishes,

Keshav Ram Singhal

For details on the Training Handbook on ISO 9001:2015 QMS Awareness, please CLICK HERE

Thanks.

ISO 9001:2015 QMS - Understanding the needs and expectations of interested parties

ISO 9001:2015 QMS
Understanding the needs and expectations of interested parties

Clause 4.2 of ISO 9001:2015 QMS standard deals with the requirements related to the understanding of the requirements of interested parties. According to the requirements of the standard, following needs to carry out:

(i) Determine: Interested parties relevant to the organization
(ii) Determine: Requirements of the determined interested parties that are relevant to the organization
(iii) Monitor and review: Information about the determined interested parties and their determined requirements.

Clarification:
(i) Interested parties = Persons/organizations that can affect, be affected by, or perceive themselves to be affected by a decision or activity.
(ii) Examples of interested parties: Customers, owners, stockholders, employees, workers on contract, contractors, suppliers, bankers, unions, partners, society, competitors, opposite pressure groups, government, regulatory bodies, neighbours etc.
(iii) Why there is a requirement to understand the needs and expectations of interested parties? Because interested parties' needs and expectations can have an effect or potential effect on the organization's ability to consistently provide products/services that meet (fulfill) customer and applicable legal requirements.
(iv) Needs and expectations = Requirements

An understanding of the needs and expectations of interested parties is an important issue as this can affect the organization's quality management system. As such, it is required that the organization remains familiar with the requirements of interested parties and maintain an awareness through monitor and review and thus make the organization to respond to the requirements appropriately. Unwillingness or reluctance to recognize the needs and expectations of interested parties will hamper a robust quality management system.

Step-by-step process:
(i) Make a team of identified persons.
(ii) The team should be asked to determine interested parties and their requirements.
(iii) The team should make a list of all such requirements with necessary details.
(iv) Assign responsibility to monitor and review such requirements to different persons or groups in the organization, so that effective decisions can be taken for the improvement.

Questions
(i) What are the requirements for understanding the needs and expectations of interested parties in ISO 9001:2015?
(ii) Why should an organization determine interested parties and their requirements?
(iii) Who can be the interested parties?
(iv) What may be the step-by-step process for understanding the needs and expectations of interested parties?


(Written for the Forthcoming Book - Implementing ISO 9001:2015 Quality Management System - A Reference Guide - Dr. Divya Singhal and Keshav Ram Singhal. Suggestions and comments invited.)


For details on the Training Handbook on ISO 9001:2015 QMS Awareness, please CLICK HERE

Thanks.

ISO 9001:2015 QMS - Understanding the organization and its context

ISO 9001:2015 QMS
Understanding the organization and its context

Clause 4.1 of ISO 9001:2015 QMS standard deals with the requirements related to the understanding the organization and its context. According to the requirements of the standard, following needs to carry out:

(i) Determine: Internal and external issues (positive and negative factors or conditions) relevant to organization's purpose, strategic direction and that can affect organizational ability to achieve intended results.
(ii) Monitor and review: Information about the determined external and internal issues (positive and negative factors/conditions)

Clarification:
(i) There are many issues that can make easier the understanding the external context of the organization. Such issues may arise from legal, technological, competitive, cultural, social and economic environments and that can be global, national, regional or local.
(ii) There are many issues that can make easier the understanding the internal context of the organization. Such issues may relate to the organization's value, culture, knowledge and performance.

We see that the requirements of ISO 9001:2015 QMS standard starts with asking for determination of all issues that can enhance or interrupt achievement of the quality management system outcomes. The organizational issues may be internal and/or external that may be well defined, substantially subjective or not so well defined. We need to understand them. A subjective issue may be internal issue within and among groups/people in an organization. It is required for the organization to monitor and review all those issues that can affect achievement of defined goals. With monitoring and reviewing internal and external issues, an organization is better prepared to make improvements and thus leads to a success path. The management of the organization should identify persons, who are well-versed with the organization and its processes and who understand the standard's requirements very well,. These persons should be encouraged to create a suitable, adequate and effective quality management system by monitoring and reviewing internal and external issues. The persons in the organization should make their best efforts to understand related issues and process details, so that they may contribute to achievement of the defined goals.

Step-by-step process:
(i) Make a team of identified persons.
(ii) The team should be asked to think and identify all positive/negative factors and conditions that are relevant and that can affect achievement of organizational goals.
(iii) The team should make a list of all such issues with necessary details.
(iv) Assign responsibility to monitor and review such issues to different persons or groups in the organization, so that effective decisions can be taken for the improvement.

Questions
(i) What are the requirements for understanding organization and its context in ISO 9001:2015?
(ii) Why should an organization determine internal and external issues?
(iii) What can be internal issues that can affect organizational ability to achieve intended results?
(iv) What can be external issues that can affec organizational ability to achieve intended results?
(v) What may be the step-by-step process for understanding the organization and its context.

(Written for the Forthcoming Book - Implementing ISO 9001:2015 Quality Management System - A Reference Guide - Dr. Divya Singhal and Keshav Ram Singhal. Suggestions and comments invited.)


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

Thanks.

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