ISO 9001:2015 QMS Awareness – Planning – Change Management For The Quality Management System

ISO 9001:2015 QMS Awareness – Planning

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Change Management For The Quality Management System

      

Change management is a collective term for all approaches to prepare, support, and help individuals, teams, and organizations in making organizational change.

 

Change management = The management of change and development within a business or an organization

 

ISO 9001:2015 QMS standard addresses management of changes to the quality management system of an organization. Change and continual improvement are supplementary to each other. In this regard, please have a look to the following clauses and their requirements:

 

4.4 – Quality management system and its processes – Continually improve the quality management system including processes.

 

5.3 – Top management to assign responsibilities and authorities for ensuring maintaining integrity of the quality management system when changes are planned and implemented.

 

6.3 – Planning of changes – Change planning in a planned manner by considering purpose of change, potential consequences of the change, integrity of the quality management system, availability of resources, allocation / re-allocation of responsibilities and authorities. A reference to clause 4.4 is also mentioned for planning.

 

8.1 – Operational planning – (i) Control planned changes, (ii) Review consequences of unintended (not planned) changes, and (iii) Taking necessary actions to mitigate (reduce) any adverse effects, as necessary.

 

8.3.6 – Design and development changes – Identify, review and control design and development changes to ensure no adverse impact to the conformity of product / service.

 

8.5.6 – Control of changes – Review and control changes for production / service provision to ensure continuing conformity to requirements. Retain documented information (= Keep records) describing results of the review of changes, personnel authorizing changes and any necessary action arising from the review.

 

9.2 – Internal audit – Consider importance of changes during planning, establishing and implementing an audit programme.

 

9.3 – Management review – Inputs of management review to consider external and internal issues relevant to the quality management system. Outputs of management review to take decisions and actions related to any need for changes to the quality management system.

 

10.2 – Nonconformity and corrective action – When a nonconformity occurs, make changes to the quality management system, as necessary.

 

Thus, we see that addressing changes becomes an increasingly important component for the quality management system in ISO 9001:2015 QMS standard.

 

Changes are part of the system. No one can avoid changes. Changes may be needed. Changes can be related to any element of a process. Changes are planned to be beneficial. Changes need to be carried out as planned. It is better to consider risks and opportunities associated with the change.

 

An organization can have a better change management to achieve the benefits associated with changes. The organization should consider all types of changes that may need to happen in the organization’s quality management system. Changes may be generated in processes, documented information, resources, competence, awareness, operation, performance evaluation, improvement initiatives, and many more. Plan-Do-Check-Act (PDCA) methodology will be effective for a successful change management that may include following steps:

 

Plan – (i) Define – What need to be changed? Specific tasks to determine. (ii) Make a plan – How to do? What resources you need for the change? What information you need? Who will supervise? What will be the budget? What will be the timeline? Also develop a communication plan, etc.

 

Do – Engage people, train them, use resources, make proper communication and carry out the desired change.

 

Check – Measure the effectiveness of the change.

 

Act – Based on check, correct and improve, if needed.

 

Think of the following Questions

 

(1)   Why change is needed for the quality management system?

 

(2)   What changes you may need in the quality management system of your organization?

 

(3)   What strategy will you implement for change in the quality management system?

 

(4)   What are the requirements of ISO 9001:2015 QMS standard for Planning of change?

 

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.

 

 

ISO 9001:2015 QMS Awareness – Planning – Why the planning step important in a quality management system?

ISO 9001:2015 QMS Awareness – Planning

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Why the planning step important in a quality management system?

Planning in ISO 9001 QMS is the method of deciding what's most important and most critical aspects to the ISO 9001:2015 QMS during the planning stage, so we can make sure that everything goes according to plan.

 

Here are some points highlighting the importance of planning in a quality management system (QMS):

 

(1) Planning ensures consistency. Planning helps to establish a consistent approach to quality management system by determining the activities, processes, and resources required to achieve desired outcomes / results.

 

(2) Planning helps in managing risks. Through planning, potential risks and opportunities can be determined and addressed proactively, reducing the likelihood of quality issues and nonconformities.

 

(3) Planning helps in defining objectives and targets. Planning enables organizations to set objectives and targets for their QMS that are aligned with their overall business strategy, ensuring that quality is embedded in all aspects of the organization.

 

(4) Planning helps in resource allocation. Planning helps to ensure that resources, including time, money, personnel and infrastructure, are allocated efficiently and effectively to achieve desired outcomes.

 

(5) Planning facilitates continuous improvement. By establishing a framework for planning, monitoring, and evaluating quality activities, planning can help to identify areas for improvement and enable organizations to continually enhance their QMS.

 

Overall, planning is a critical component of a quality management system (QMS), helping organizations to achieve consistent, efficient, and effective quality management practices while enabling continuous improvement over time.

 

Requirements for planning 

Requirements for planning are mentioned in clause 6 of ISO 9001:2015 QMS standard. The relevant sub-clauses of Clause 6 of the standard are as under:

6 Planning

 

6.1 Actions to address risks and opportunities

6.2 Quality objectives and planning to achieve them

6.3 Planning of changes

 

Actions to address risks and opportunities

 

The organization needs to consider determined external and internal issues related to the organization and its context and determined needs and expectations of interested parties as determined in terms of clause 4.1 and clause 4.2 of the standard.

 

The organization needs to determine risks and opportunities that need to be addressed to give assurance that the quality management system of the organization can (1) achieve organization’s intended results, (2) enhance desirable effects, (3) prevent or reduce undesirable effects, and (4) achieve improvement.

 

The organization needs to plan: (1) Actions to address determined risks and opportunities, (2) Procedure / way to integrate and implement planned actions into the organization’s quality management system processes, (3) Procedure / way to evaluate effectiveness of planned action.

 

The organization needs to ensure that the actions taken to address determined risks and opportunities must be proportionate to the potential impact on product / service conformity.

 

Here while implementing above requirements, we must understand that options to address risk may vary, such as, avoiding the risk, converting the risk into opportunity, eliminating risk source, changing the likelihood or consequences, risk sharing, retaining risks by informed decisions. Opportunities can lead to something better, such as, adopting new practices, launching / introducing new product / service, opening new markets, addressing new clients / users, building partnerships using new technology, other desirable and viable possibilities to address needs of the organization or customer.

 

A few real-life examples to address risk are given below:

 

Avoiding the risk into opportunity – A restaurant may avoid the risk of losing customers and low sales during slow business periods by offering special promotion deals to attract new customers and increase sales.

 

Eliminating risk source – A manufacturer may eliminate risk source of producing defective product by finding out the risk source by implementing monitoring and measuring control processes at every stage of production.

 

Changing the likelihood or consequences – An airline company may change the likelihood of flights’ delay by better maintenance and repair of their aircrafts and hiring of trained skilled pilots and ground staff.

 

Risk sharing – A company may share the risk of project’s delays and cost overruns with their subcontractors by including penalty clause in their contracts.

 

Retaining risk by informed decision – A hospital may choose to retain the risk of treating a high-risk patient with a complex medical condition by conducting thorough medical check-ups, assessments and consultations with specialists and such risk is informed to the patient party. Quality

 

Quality objectives and planning to achieve them

 

Objective = Something that the organization is trying to achieve = Aim

 

Quality objectives are specific, measurable goals that an organization sets to improve its quality management system. Quality objectives are typically derived from the organization's quality policy and are aligned with its strategic objectives. Businesses use quality objectives to improve their products, services, and operations.

 

The organization needs to establish quality objectives at relevant functions, levels and determined processes needed for the quality management system.

 

The organization needs to ensure that quality objectives must be consistent with the quality policy, measurable, take into account applicable requirements, relevant to product / service conformity, relevant to customer satisfaction enhancement.

 

To achieve established quality objectives, the organization needs to determine:

 

(1) Ways, procedures and processes,

(2) Resource needs,

(3) Personnel responsible,

(4) Time targets for completion,

(5) Evaluation method / procedure

 

The organization needs to communicate the established quality objectives to relevant personnel.

 

The organization needs to monitor the established quality objectives.

 

The organization needs to update the established quality objectives, as appropriate.

 

The organization needs to maintain a documented information (document) on quality objectives.

 

Planning for changes

 

The organization needs to consider:

 

(1) Purpose of change,

(2) Potential consequences of the change,

(3) quality management system integrity,

(4) Availability of resources,

(5) Allocation / re-allocation of responsibilities and authorities.

 

The organization needs to carry out change in a planned manner. (Please also refer to clause 4.4 of the standard.)

 

A change to a quality management system may be a result of anything from customer complaints or product failures to identified opportunities for improvement or innovation. Change management is a systematic approach to dealing with such change. Please also read a write-up on “Change management in ISO 9001:2015 QMS”.

 

Think of the following Questions

 

(i)             What are the requirements for planning in clause 6 of ISO 9001:2015 QMS standard?

(ii)            What actions will you plan to address risks and opportunities in the quality management system of an organization?

(iii)           Why quality objectives necessary for a quality management system?

(iv)           Why change is needed for the quality management system?

 

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.

 

ISO 9001:2015 QMS Awareness – Role of the Top management

ISO 9001:2015 QMS Awareness – Role of the Top management

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What is the role of the top management in a quality management system?

In organizations, leadership role is on the top management.

 

Top management = Leaders of the organization = Individual or group of people, at the highest level in the organization, who directs and control the organization.

 

According to ISO 9000:2015 QMS standard on terms and definition, top management is defined as a person or group of people who directs and controls an organization at the highest level. Top management has the power to delegate authority and provide resources within the organization. In view of this fact, it is noticed that role of top management is important and relevant in implementing ISO 9001:2015 QMS standard. For developing and implementing an effective quality management system, following three things facilitate proper implementation:

 

(1) Leadership,

(2) Top management commitment, and

(3) Active involvement of the top management. 

 

Through leadership and actions, the top management is able to create an environment in the organization where people are fully involved in their activities as per their defined responsibilities and authorities in the organization. The top management should also be able to create a proactive internal environment in the organization in which a quality management system can operate effectively and people are fully involved in achieving the organization’s objectives.

 

ISO 9001:2015 QMS standard is based on seven quality management principles, namely (i) Customer focus, (ii) Leadership, (iii) Engagement of people, (iv) Process approach, (v) Improvement, (vi) Evidence-based decision making, and (vii) Relationship management. The top management of the organizationshould use these seven quality management principles in developing and implementing ISO 9001:2015 quality management system in the organization. 

There are a few common challenges and obstacles to effective leadership in the context of a quality management system. These are:

 

(1) Lack of top management commitment and involvement,

 

(2) Lack of leadership motivation or guidance to the resistance to change among employees,

 

(3) Limited resources provided,

 

(4) Lack of people engagement in quality management system activities,

 

(5) Inadequate communication and feedback mechanism,

 

 

To overcome above challenges and obstacles and to have an effective quality management system in an organization, effective leadership practices on the part of the top management within a quality management system context may be:

 

(1) Commitment and involvement to the quality management system,

 

(2) Ensuring that the quality management system is aligned with the organization’s overall strategy and objectives,

 

(3) Ensuring establishing and maintaining quality policy in the organization,

 

(4) Setting clear expectations and goals for the quality management system (quality objectives),

 

(5) Promoting the quality policy and quality objectives throughout the organization to increase awareness, motivation and involvement of people,

 

(6) Encouraging engagement of people and empowerment of activities related to the quality management system,

 

(7) Encouraging a culture of continual improvement and innovation,

 

(8) Ensuring focus on customer requirements throughout the organization and regularly communicating with employees about the importance of the quality management system and its impact on the organization,

 

(9) Ensuring implementation of appropriate processes, so that customer and other requirements are fulfilled and quality objectives are achieved,

 

(10) Ensuring to establish, implement and maintain an effective quality management system so that quality objectives are achieved,

 

(11) Ensuring availability of necessary resources including personnel, time, budget,

 

(12) Ensuring review of quality management system periodically at defined intervals and regularly monitoring and evaluating performance of the quality management system,

 

(13) Providing adequate communication and feedback mechanism,

 

(14) Deciding actions regarding the quality policy and quality objectives,

 

(15) Deciding on actions of improvement of the quality management system.

 

 

Requirements related to leadership are mentioned in clause 5 of ISO 9001:2015 QMS standard, but the top management should not limit its role to only such requirements, but it should more actively participate in the development and maintenance of the quality management system of the organization.

 

Think of the following Questions

 

(1) What are the challenges and obstacles you find in your organization for development, implementation and maintenance of the quality management system?

 

(2) What is the role of the top management in your organization for quality management system implementation and maintenance?

 

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.

 

ISO 9001:2015 QMS Awareness - Leadership

ISO 9001:2015 QMS Awareness - Leadership

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What does leadership matter in a quality management system?

Leadership matters much in a quality management system. It is in the core of the system. Leadership is one of the quality management principles on which ISO 9001:2015 QMS standard is based. If we read the standard, we note that clause 5 of the standard mentions requirements related to leadership requirements.

Leaders establish unity of purpose, direction and engagement of people in the organization that align organization's strategies, policies, processes in achieving quality objectives. Leaders focus on communication by listening to the people and defines a strategic plan or direction of the organization. Leaders help people to work in a team.

Leaders in an organization should create and maintain the internal environment in which people can fully engage themselves to achieve organization's quality objectives. For this top management of the organization needs to play leadership role through its commitment, action and communication. They should communicate to the people in the organization the importance of meeting requirements. They need to establish quality policy, ensure ensuring establishing quality objectives at relevant functions, levels and processes, ensure availability of resources and conduct management reviews.

The leaders of the organization should:
- be proactive,
- understand and respect to changes that are visible in the industry environment,
- establish clear vision of the organization,
- build trust, eliminate fear and motivate people.

Benefits that may be derived from the use of 'leadership' principle include:
- Employee's motivation towards organization's goals and objectives
- Better understanding of organization's objectives
- Better communication within the organization

In this connection a leader should practice 5-E of leadership, which are as under:

1. Equality: Everyone is equal. Don't be Biased. Be fair in your acts.
2. Expectations: Be realistic at setting expectations, objectives and goals. Have an eye on expectations, objectives and goals. Understand the strengths, weaknesses and areas of improvement of your team.
3. Emotional Intelligence: Understand that people have emotions and even you do. Use them intelligently.
4. Empower: Empower your people. Be a catalyst for your team members. Be their coach and mentor.
5. Evolve: Evolve every one of your team to work as a team member. And when they are evolved as a team, you are evolved as a leader.

Clause 5 of ISO 9001:2015 QMS standard deals with the requirements related to leadership that describes what the top management's role should be. All requirements in this section are meant for the top management. ISO 9001:2015 QMS standard requires increased role for the top management. Leadership is the central theme of the quality management system and Plan-Do-Check-Act (PDCA) cycle that is applied to the quality management system.

In organizations, leadership role is on the top management.

Top management = Leaders of the organization = Individual or group of people, at the highest level in the organization, who directs and control the organization.

Requirements for leadership 

Requirements for leadership are mentioned in clause 5 of ISO 9001:2015 QMS standard. The relevant sub-clauses of Clause 5 of the standard are as under:

5 Leadership

5.1 Leadership and commitment
5.1.1 General
5.1.2 Customer focus

5.2 Policy
5.2.1 Establishing the quality policy
5.2.2 Communicating the quality policy

5.3 Organizational roles, responsibilities and authorities

Leadership and commitment

 

Top management needs to demonstrate – (1) Leadership and commitment with respect to the quality management, and (2) Leadership and commitment with respect to the customer focus.

 

Top management needs to take accountability for the effectiveness of the quality management system being implemented in the organization.

 

Top management needs to ensure – (1) Establishing quality policy and quality objectives (compatible with the organization’s context and strategic direction), (2) Integrating quality management system requirements into the organization’s business processes, (3) Availability of resources needed for the quality management system, and (4) the quality management system (QMS) achieves intended results (i.e., what is expected).

 

Business = Activities that are carried out in the organization and are basic to the purpose of the organization’s existence.

 

Top management needs to ensure determining, understanding and consistently meeting – (1) Customer requirements, and (2) Applicable legal requirements.

 

Legal requirements = Statutory and regulatory requirements

 

Top management needs to promote – (1) Use of process approach, (2) Use of risk-based thinking, and (3) Improvements.

 

Top management needs to communicate – (1) Importance of effective quality management, and (2) Importance of meeting quality management system requirements.

 

Top management needs to engage and direct – Persons in the organization to contribute to the quality management system effectiveness.

 

Top management needs to support – (1) Persons in the organization to contribute to the quality management system effectiveness, and (2) Other relevant management roles.

 

Policy

 

Top management needs to establish, implement and maintain – Quality policy (that is appropriate to organization’s purpose and context, that supports organization’s strategic direction, that provides framework for setting quality objectives, that includes commitment to satisfy applicable requirements and continual improvement of the quality management system.

 

Top management needs to communicate – Quality policy within the organization.

 

Top management needs ensure – (1) Understanding of quality policy within the organization, (2) Application of quality policy within the organization, and (3) Availability of quality policy to relevant interested parties, as appropriate.

 

Interested parties may include employees, customers, suppliers etc.

 

Top management needs to make available – Quality policy.

 

Top management needs to maintain documented information – Quality policy.

 

Organizational roles, responsibilities and authorities

 

Top management needs to ensure – (1) Assignment of responsibilities and authorities for relevant roles, (2) Communication of responsibilities and authorities for relevant roles, and (3) Understanding of responsibilities and authorities for relevant roles within the organization.

 

Top management needs to assign responsibility and authority 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.

 

Management representative in ISO 9001:2015 QMS?

 

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 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 top management involvement.

 

As per requirements mentioned in clause 5.3 of ISO 9001:2015 QMS standard, top management needs to assign organizational roles, responsibilities and authorities. (Please see previous Para.)

 

Thus, the top management can assign the responsibilities and authorities to one or more persons and such person(s) may be called by any designation name.  

 

Think of the following Questions

 

(i)             What are the requirements for quality management system and its processes in clause 5 of ISO 9001:2015 QMS standard?

(ii)            Who is top management in your organization?

(iii)           What is the established quality policy of your organization?

(iv)           What are the established quality objectives in your 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.