Developing and implementing ISO 9001:2015 QMS – 06 – Obtaining Information about QMS and ISO 9000 Family

Developing and implementing ISO 9001:2015 QMS – 06 – Obtaining Information about QMS and ISO 9000 Family

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The steering committee should collect information about quality management system and ISO 9000 family. If a consultant is there to assist the organization, then it is easier for the organization, as the consultant will be able to provide all such information. For information on quality management system, ISO’s website is a useful source of information from which following brochures / literature may be downloaded:

 

-        ISO 9001 – Debunking the myths – It is an informative brochure to ISO 9001 that clarifies some of the misconceptions around implementation and use

 

-        ISO 9001:2015 – How to use it – This brochure provides useful information to get started with ISO 9001

 

-        ISO 9001 – What does it mean in the supply chain? – This literature is a useful guide to ISO 9001 for those people involved in selection of suppliers, helping them get the most out of the standard as a supply chain tool.

 

In 2016, International Organization for Standardization (ISO) has published a handbook “ISO 9001:2015 for Small Enterprises – What to do?” for SMEs wishing to implement a quality management system based on ISO 9001:2015. It is a priced publication. This handbook provides small and medium enterprises (SMEs) with guidance on developing and implementing an effective quality management system based on ISO 9001:2015 – Quality management systems – Requirements. The handbook focuses on how SMEs could get maximum benefit from the standard. It provides a clear understanding of what a Quality Management System is and what the requirements are before guiding you through the implementation process.

 

ISO/TC 176 is a technical committee on quality management and quality assurance. The committee has been a leader in the development of standards in the fields of quality management systems and tools since 1979. The committee has its own website that provides information on ISO 9001 Auditing Practices Group and a number of guidance papers and presentations on various quality management system auditing topics. It will be a better option if guidance papers and presentations are referred to. These literatures are very useful to people involving in ISO 9001:2015 QMS implementation as well to internal auditors carrying out ISO 9001:2015 QMS internal audit.

 

Collection of following standards and publications may be useful:

 

-        ISO 9000:2015, Quality management systems – Fundamentals and vocabulary (must have)

 

-        ISO 9001:2015, Quality management systems – Requirements (must have)

 

-        ISO/TS 9002:2016, Guidelines on the application of ISO 9001:2015

 

-        ISO SME Handbook 2016 (Details mentioned above)

 

-        ISO 9004:2018, Quality management – Quality of an organization – Guidance to achieve sustained success

 

-        ISO 10005:2018, Quality management – Guidelines for quality plans

 

-        ISO 19011:2018, Guidelines for auditing management systems (must have)

 

-        ISO 9001 Auditing Practices Group – Guidance papers and presentations

 

-        Various other publications / literature providing knowledge on ISO 9001:2015 QMS and related topics  

 

Incidentally, it should be mentioned that following eBooks / Kindle book have been developed by the author, which may also be useful:

 

-        “TRAINING HANDBOOK ON ISO 9001:2015QMS AWARENESS” (ASIN: B093YFFY7Z) 

-   A Concise Guide on Creating and Updating Documented Information (eBook) - Available from Pothi.com 

- Applying Risk-based Thinking in an Organization Implementing ISO 9001:2015 QMS (eBook) - Available from Pothi.com 

 

Best wishes,

Keshav Ram Singhal

Please have your comments / reaction. Thanks.

Developing and implementing ISO 9001:2015 QMS – 05 – Appointing a QMS Consultant

Developing and implementing ISO 9001:2015 QMS – 05 – Appointing a QMS Consultant

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A quality management system (QMS) consultant is a professional competent person, who assist and guide an organization on quality management system realization, providing advice or information. Appointing a consultant, for ISO 9001:2015 QMS implementation, is not a requirement. It is not necessary appointing a consultant, however appointing a consultant may be worthwhile investment. A professionally competent consultant effects speedy transfer of knowledge and skills to the organization and he / she may be needed to provide timely guidance to keep the ISO 9001:2015 QMS implementation programme on track. A consultant provides the people power to complete the work when needed at reasonable cost. The steering committee or the top management of the organization should determine whether a consultant is required.

 

 

There are seven general reasons to hire and appoint a professional competent consultant:

 

(1)   A professional competent consultant has appropriate experience, expertise and time that employees of the organization may not have. An organization turns to a consultant to fill knowledge and time gaps.

 

(2)   A professional competent consultant can provide flexibility of time. A consultant may work any time – including nights, weekends and holidays. A consultant leaves when the project is completed.

 

(3)   A professional competent consultant offers the latest and objective point of view. A professional competent consultant brings the latest and unbiased ideas from his / her vide experience.

 

(4)   A professional competent consultant is more efficient and he / she focuses on the assigned project with sincerity till it is completed.

 

(5)   Engagement of a professional competent consultant may be a proof of honest endeavour. An organization may use consultant to show that an effort is being made to correct gaps in compliance with requirements.

 

(6)   A professional competent consultant can accelerate and expedite the implementation process, leveraging his / her experience and knowledge to avoid common pitfalls and delays.

 

(7)   A professional competent consultant can provide an objective assessment of the organization's existing processes and systems, free from internal biases and preconceptions.

 

Thus, we see, a consultant may be an important resource to assist and guide an organization in developing, implementing and maintaining ISO 9001:2015 QMS and its certification from an accredited certification body. However, it is essential, before appointing a consultant, to check his / her competence, education, knowledge and skills with regard to ISO 9001:2015 QMS. He / she should also be well aware of certification and accreditation systems. Cost is an important consideration in deciding to engage a consultant, therefore, the organization may obtain quotation of consultant fee and other expenses from several consultants. However, please note that the cheapest consultant may not always be the best. Emphasis should be on consultant’s qualification, knowledge and experience.

 

It is necessary to establish (i) what the consultant is expected to do or provide, and (ii) what the organization’s 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, implementing and maintaining the quality management system to someone else. Ownership of the quality management system (QMS) implementation should remain with the organization's people. A consultant's role is to provide guidance, expertise, and support, but the responsibility for the development, implementation, and maintenance of the quality management system (QMS) should be firmly held by the management and employees of the organization. The consultant is an external resource who assists in the process, but the commitment and involvement of the internal team are crucial for the success and sustainability of the quality management system in the organization.

 

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. ISO 10019:2005 standard is intended to assist organizations when selecting a quality management system consultant. An organization may refer to this standard, if wishes to have detailed guidance in the matter. This standard provides valuable guidance and can further enhance the credibility and effectiveness of the consultant selection process.

 

Best wishes,

Keshav Ram Singhal 

 

Please have your comments / reaction.

 

To train your employees with ISO 9001:2015 QMS Awareness, please supply them “TRAINING HANDBOOK ON ISO 9001:2015QMS AWARENESS” (ASIN: B093YFFY7Z), which is available worldwide at Amazon. Please search this Training Handbook in Amazon Website of your country. 

 

 You may also supply your employees following eBooks - (i) A Concise Guide on Creating and Updating Documented Information (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-concise-guide-creating-and-updating-documented-information/ (ii) Applying Risk-based Thinking in an Organization Implementing ISO 9001:2015 QMS (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-applying-risk-based-thinking-organization-implementing-iso-9001-2015-q/

 

Thanks.

Developing and implementing ISO 9001:2015 QMS – 04 – Establishing a Task Force

Developing and implementing ISO 9001:2015 QMS – 04 – Establishing a Task Force

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The top management or steering committee should determine whether a task force is required to carry out certain specific tasks related to the quality management system. If the top management or steering committee determines establishing a task force, then it should be set up by selecting a few persons from the organization. Its coordinator should be the person, who is assigned specified duties as mentioned in Clause 5.3 of ISO 9001:2015 QMS standard. The task force should be allocated the work of determining documented information (documents, written procedures, forms, records etc) required for the quality management system and their creation / updation. The task force should also be assigned the job of determining:

 

-        Organization’s risks and opportunities,

 

-        How critical each risk is, and

 

-        Actions to be taken to address determined risks and opportunities.

 

The task force members should have good understanding of the organization’s processes and they should also have good communication-writing skills. The members of the task force should be trained on ‘ISO 9001:2015 QMS’ specially on ‘Documented information for the quality management system’. The training can be organized with the help of professional trainer, consultant or training organization.

 

Incidentally, I would like to mention that ISO 9001:2015 QMS standard does not mention any requirements for establishing a task force for developing and implementing ISO 9001:2015 quality management system in the organization, however establishing a task force can be beneficial for an organization to implement ISO 9001:2015 QMS effectively because the task force members, having good understanding of organization’s processes, will be able to use their collective expertise and knowledge to ensure ISO 9001:20015 QMS implementation that aligns with the organization’s specific needs and objectives. The task force will be helpful in addressing organization’s determined risks and opportunities and also complete the creation and updation of documented information required for the quality management system. The task force can undertake several other tasks, such as, gap analysis (to identify deviation from ISO 9001:2015 QMS requirements), process mapping, assistance in employee training, assistance in internal audit and assistance in management review. Thus, a task force will provide a structured approach, ensure proper coordination, and engage employees in implementation process that will lead to a smoother implementation of ISO 9001:2015 QMS, including application of risk-based thinking, and improve overall performance of the organization.

 

In conclusion, establishing a task force can be a strategic decision of the steering committee or top management of the organization that may significantly lead to the success of ISO 9001:2015 QMS implementation in the organization.

 

Best wishes,

Keshav Ram Singhal

 

Please have your comments / reaction.

 

To train your employees with ISO 9001:2015 QMS Awareness, please supply them “TRAINING HANDBOOK ON ISO 9001:2015QMS AWARENESS” (ASIN: B093YFFY7Z), which is available worldwide at Amazon. Please search this Training Handbook in Amazon Website of your country. 

 

 You may also supply your employees following eBooks - (i) A Concise Guide on Creating and Updating Documented Information (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-concise-guide-creating-and-updating-documented-information/ (ii) Applying Risk-based Thinking in an Organization Implementing ISO 9001:2015 QMS (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-applying-risk-based-thinking-organization-implementing-iso-9001-2015-q/

 

Thanks.

Developing and implementing ISO 9001:2015 QMS – 03 – Establishing a Steering Committee

Developing and implementing ISO 9001:2015 QMS – 03 – Establishing a Steering Committee

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ISO 9001:2015 QMS standard does not mention any requirements for establishing a steering committee for developing and implementing ISO 9001:2015 quality management system in the organization, however it is a better idea to establish and set up a steering committee. A member of the top management of the organization can be assigned the responsibilities and authorities as head of the steering committee and there may be other members of the steering committee from the following:

 

-        Departmental and functional heads and

 

-        Persons selected and assigned specified duties as mentioned in Clause 5.3 of ISO 9001:2015 QMS standard.

 

The so formed steering committee should be responsible for overall planning of the quality management system implementation process, giving directions and allocating resources. The members of the steering committee should be well versed with ISO 9001:2015 QMS. They may be trained on ISO 9001:2015 QMS by a professional trainer, consultant or training organization. Establishing a steering committee can be beneficial to oversee the implementation process effectively.

 

The formation of a steering committee can bring several advantages to the implementation process of ISO 9001:2015 QMS. Having a steering committee, with a member of the top management as its head, will ensure that quality management system implementation gets necessary resources, guidance and support from the organization’s leadership. As the steering committee will also have members from various departments and functions of the organization, it will ensure representation from various areas of the organization and promote collaboration and coordination during the quality management system implementation. The steering committee members, are generally well-versed in ISO 9001:2015 QMS, can provide consistent direction and expertise insights to quality management system implementation.

 

The steering committee’s presence will yield several benefits that will contribute to the success of ISO 9001:2015 QMS implementation in the organization, including enhanced communication between top management and people of the organization, better control of implementation process, promptly addressing deviations noticed during implementation, increased employee involvement etc.

 

Best wishes,

Keshav Ram Singhal

 

Please have your comments / reaction.

 

To train your employees with ISO 9001:2015 QMS Awareness, please supply them “TRAINING HANDBOOK ON ISO 9001:2015QMS AWARENESS” (ASIN: B093YFFY7Z), which is available worldwide at Amazon. Please search this Training Handbook in Amazon Website of your country. 

 

 You may also supply your employees following eBooks - (i) A Concise Guide on Creating and Updating Documented Information (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-concise-guide-creating-and-updating-documented-information/ (ii) Applying Risk-based Thinking in an Organization Implementing ISO 9001:2015 QMS (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-applying-risk-based-thinking-organization-implementing-iso-9001-2015-q/

 

Thanks.

 

Developing and implementing ISO 9001:2015 QMS – 02 – Assigning Responsibilities and Authorities

Developing and implementing ISO 9001:2015 QMS – 02 – Assigning Responsibilities and Authorities

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A system in an organization can work well when responsibilities and authorities are assigned to its people. In small setup or informal setup, a system may function without assigning responsibilities and authorities, however it is always better to assign responsibilities and authorities in an organization. Such a system, without assigning responsibilities and authorities, would likely be chaotic, inefficient, and prone to conflicts. Organizational structure provides a framework for achieving organizational goals, coordinating efforts of organization’s people, and ensuring accountability. Without clearly defied responsibilities and authorities in an organization, it is difficult to find out who is responsible or accountable for what, and this leads to a lack of direction and coordination in the organization. Assigning responsibilities and authorities in an organization is essential for several reasons. With the assignment of responsibilities and authorities every individual is able to know his / her specific role and what is expected of him / her. When responsibilities and authorities are assigned, it becomes clear who is responsible or accountable for what. Defined responsibilities and authorities in an organization streamlines decision-making process, avoid duplication of work, and enhance overall performance in the organization. Having clear responsibilities and authorities in an organization reduces chances of conflicts that may arise due to overlapping of roles or decision-making conflicts.

 

In the absence of assigned responsibilities and authorities in an organization, there are chances of confusion or chaos. Employees may not know for what work they are responsible or accountable and such situation may lead to confusion and inefficiency.

 

Assigning responsibilities and authorities in an organization offers several benefits, including (i) functioning smoothly with minimal confusion and overlaps, (ii) enhanced productivity, (iii) better performance, (iv) efficient decision making, and (v) promoting job satisfaction among employees.

 

As regards implementation of ISO 9001:2015 QMS in the organization, the standard mentions requirements in connection with organization roles, responsibilities and authorities (Clause 5.3).

 

ISO 9001:2008 QMS standard had a requirement to appoint a management representative to coordinate quality management system activities, but the current ISO 9001:2015 QMS standard does not require a person to be specially appointed as a management representative. The explicit requirement for the appointment management representative is not mentioned in the current ISO 9001:2015 QMS standard, however the activities that a management representative was undertaking earlier, are still required. The responsibilities of all such activities are required to be fulfilled through the top management. The current ISO 9001:2015 QMS standard lays down more emphasis on the involvement of top management and the standard requires assignment of responsibilities and authorities for relevant roles within the organization. As such, the top management of the organization should assign the responsibilities and authorities for (1) Ensuring conformance of ISO 9001:2015 QMS requirements, (2) Ensuring processes deliver intended outputs (what is expected), (3) Reporting quality management system performance and opportunities for improvement, (4) Ensuring promotion of customer focus throughout the organization, and (5) Ensuring maintaining quality management system integrity when changes are planned and implemented. Such responsibilities and authorities may be assigned to one or more persons or the top management itself can perform such role.  

 

In conclusion, assigning responsibilities and authorities in an organization is crucial for organization’s functioning, improved productivity, and overall success. And here the top management of the organization has to play its role well.

 

Best wishes,

Keshav Ram Singhal

Developing and implementing ISO 9001:2015 QMS – 01 – Leadership and Commitment from Top Management

Developing and implementing ISO 9001:2015 QMS – 01 – Leadership and Commitment from Top Management 

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It is a strategic decision for an organization to adopt and implement ISO 9001:2015 QMS standard. Once the top management of an organization takes a decision to develop and implement ISO 9001:2015 QMS standard, following three things from the top management will facilitate proper development and implementation of ISO 9001:2015 QMS standard:

 

-        Leadership role

 

-        Commitment

 

-        Active role

 

It is necessary for the top management to demonstrate leadership and commitment to implement ISO 9001:2015 QMS standard. The top management of the organization must be convinced that implementing ISO 9001:2015 QMS standard will provide a number potential benefits to the organization. The top management must know that although certification is not mandatory or a requirement of the standard, however certification will enable the organization to demonstrate a visible commitment to quality of product, quality of service, quality management system and sustainable development initiatives. The top management must be aware of the overview of ISO 9001:2015 QMS standard, for which the top management should attend a presentation training that covers 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 for contribute to the quality management system’s effectiveness

 

-        Establishing a steering committee

 

-        Establishing a task force

 

-        Appointing a consultant

 

-        Implementation process

 

Presentation training covering the above issues can be organized by personnel, who is well aware of ISO 9001:2015 AMS standard and is able to interpretate and explain the requirements of ISO 9001:2015 QMS standard. An outside consultant or trainer may be asked to organize such training. If the top management is not able to attend an overview training, then it can read relevant literature, books and publications. In this connection, reading of ‘Training Handbook on ISO 9001:2015 QMS Awareness’ (ASIN - B093YFFY7Z, available at Amazon) is suggested. In the year 2015, International Organization for Standardization (ISO) has published an informative free brochure to ISO 9001 "ISO 9001 - Debunking the myths" that clarifies some of the misconceptions around its implementation and use. It can be downloaded from the ISO's website. Its reading will be useful. There are many other books and publications available.

 

The 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 the 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

 

The top management of the organization should identify objectives or goals it wants to achieve. Typical objectives or goals may be as under:

 

-        Providing more efficient product and service

 

-        Be more profitable

 

-        Producing product and service that consistently meet requirements

 

-        Achieving / enhancing customer satisfaction

 

-        More business for the organization

 

-        Maintaining / enhancing market share (business)

 

-        Improving processes in the organization

 

-        Improving communication

 

-        Improving morale of the people in the organization

 

-        Reducing cost

 

-        Reducing liabilities

 

-        Reducing waste

 

-        Reducing rework

 

-        Increasing confidence in the production process

 

-        Technical upgradation

 

The top management needs to ensure that intended results are achieved, so the top management must take all possible steps to develop and implement quality management system in the organization according to ISO 9001:2015 QMS standard. In this connection, requirements stated in the standard and requirements determined by the organization need to be fulfilled.

 

In nutshell, the top management should have overview knowledge of ISO 9001:2015 quality management system and it should actively involve itself in ISO 9001:2015 QMS implementation process in the organization by guiding, directing and motivating its people. Focusing on leadership and commitment from top management is a crucial aspect of successfully implementing a QMS, and it sets the tone for the entire organization's commitment to quality and continual improvement.

 

Best wishes,

Keshav Ram Singhal

 

Please have your comments / reaction.

 

To train your employees with ISO 9001:2015 QMS Awareness, please supply them “TRAINING HANDBOOK ON ISO 9001:2015QMS AWARENESS” (ASIN: B093YFFY7Z), which is available worldwide at Amazon. Please search this Training Handbook in Amazon Website of your country. 

 

 You may also supply your employees following eBooks - (i) A Concise Guide on Creating and Updating Documented Information (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-concise-guide-creating-and-updating-documented-information/ (ii) Applying Risk-based Thinking in an Organization Implementing ISO 9001:2015 QMS (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-applying-risk-based-thinking-organization-implementing-iso-9001-2015-q/

 

Thanks.