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.

 

ISO 9001:2015 QMS Awareness - Quality Management System And Its Processes

ISO 9001:2015 QMS Awareness - Quality management system and its processes

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Quality management system (QMS) is a systematic approach to managing quality throughout an organization. It involves identifying customer needs, designing and delivering products (and services) that meet those (customers’) needs, and continually improving processes to enhance customer satisfaction. Clause 4.4 of ISO 9001:2015 QMS standard mentions requirements on the establishment, implementation, maintenance, and continual improvement of the QMS processes. According to the requirements of clause 4.4 of the standard, the organization needs to:

 

-        Establish, implement, maintain and continually improve the organization’s quality management system, including the processes needed and their interactions.

-        Determine processes needed for the quality management system and application of determined processes throughout the organization.

-        Determine inputs required and output expected from determined processes.

-        Determine sequence and interaction of determined processes.

-        Determine criteria and methods as well as monitoring, measurement and related performance indicators for effective operation and control of determined processes.

-        Determine resources needed for the determined processes.

-        Ensure availability of determined resources needed.

-        Assign responsibilities and authorities for determined processes to people in the organization.

-        Apply determined criteria and methods and also monitoring, measurement and related performance indicators needed for the effective operation and control of determined processes.

-        Address risks and opportunities as determined as per clause 6.1 of ISO 9001:2015 QMS standard.

-        Evaluate determined processes to ensure achieving intended results.

-        Implement any changes needed to ensure achieving intended results.

-        Continually improve determined processes.

-        Continually improve the quality management system of the organization.

-        Maintain documented information (procedures) that support the operation of organization’s processes.

-        Retain documented information (records) that provide confidence that the processes being carried out as planned.

 

To meet requirements as mentioned in clause 4.4 of the standard, organizations must also look to the requirements mentioned in clause 5 to clause 10.

 

Examples of documented information (procedures) that are required to maintain may be:

 

-        Process maps

-        Flow charts

-        Procedures

-        Work instructions

-        Manual

-        Quality policy

-        Quality objectives and targets

 

Examples of documented information (records) required to retain may be:

 

-        Records of process performance and effectiveness

-        Internal and external audit reports

-        Management review records

-        Fitness of monitoring and measuring resources

-        Basis used for calibration / verification when no measurable standard exists

-        Competence evidence of persons

-        Corrective action reports

 

The above examples are indicative, there may be more.

 

In conclusion, ISO 9001:2015 QMS standard provides a framework for establishing, implementing, maintaining, and continually improving a quality management system and clause 4.4 of the standard requires organizations to establish, implement, maintain and continually improve quality management system processes.  

 

Think of the following Questions

 

(i)             What are the requirements for quality management system and its processes in clause 4.4 of ISO 9001:2015 QMS standard?

(ii)            Why an organization needs to maintain certain documented information?

(iii)           Why an organization needs to retain certain documented information?

 

 

Best wishes,

Keshav Ram Singhal

 

Please have your comments / reaction.

 

To train your employees with ISO 9001:2015 QMS Awareness, please supply them “TRAIING HANDBOOK ON ISO 9001:2015 QMS 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)  (ii) Applying Risk-based Thinking in an Organization Implementing ISO 9001:2015 QMS (eBook)  

 

Thanks.

 

ISO 9001:2015 QMS Awareness - Scope Of The Quality Management System

ISO 9001:2015 QMS Awareness - Scope of the quality management system

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What does scope mean?

 

Scope = Chance or opportunity to do something

Scope = Variety of subjects that are being discussed, considered or looked into

 

Scope refers to the combined objectives and requirements needed to complete a project. The term is often used in project management, management systems and in consulting. Properly defining the scope of a project allows managers to estimate costs and the time required to finish the project. But in establishing the scope of a management system, including the quality management system (QMS), the organization needs to determine boundaries and applicability of the management system.

 

Scope of the quality management system of an organization = The boundaries or the areas of the organization that are included and controlled within the quality management system of the organization including the applicability of ISO 9001:2015 QMS standard requirements within those boundaries or areas of the organization

 

Why an organization needs to define the scope of its quality management system? An organization needs to define the scope of its quality management system because clear defining and understanding the scope of the organization’s quality management system is vital to successfully implementing ISO 9001:2015 QMS standard’s requirements in that organization

 

 

What is required to do for determining the scope in case of the quality management system? Following need to be done:

 

(1) Consider - (i) Consider determined external and internal issues (Please refer to clause 4.1 of the standard), (ii) Consider determined needs and expectations of interested parties (Please refer to clause 4.2 of the standard), and (iii) Organization's product and services. And also think the standard's requirements not applicable to your organization.

 

(2) Determine - (i) Determine boundaries and applicability of the QMS by considering the above, and (ii) Determine if any requirements of ISO 9001:2015 QMS standard is not applicable to the scope of the organization's QMS, then provide justification.

 

(3) Apply - Apply all requirements of ISO 9001:2015 QMS standard, if applicable within the scope of the organization.

 

(4) Maintain - Maintain documented information of organization's QMS scope, product and services covered and justification if any ISO 9001:2015 QMS standard requirement(s) not applicable to the scope. Making QMS scope statement of the organization's QMS simple and easy to read can help to focus your QMS efforts.

 

(5) Make available - Make available the documented information that states the determined scope of the organization's QMS.

 

Before establishing the scope of the QMS, if all requirements of the standard are applicable then well and good, but in case any requirements cannot be applied, think about it and provide its justification. Here important point is that conformity to ISO 9001:2015 QMS may only be claimed if determined requirements as not being applicable do not affect the organization's ability / responsibility to ensure the conformity of organization's products and services and the enhancement of customer satisfaction.

 

Can you think of a situation where any ISO 9001:2015 QMS standard’s requirements may not be applicable to an organization? Yes, there may be such situations. There may be many organizations (for example, organizations involved in only trading activities, small organizations having very limited business activities), which may not be involved in design and development processes as part of their business activities, then the requirements of clause 8.3 of ISO 9001:2015 QMS standard have no use for such organizations. However, important point here is to provide the suitable justification for not applying the particular requirements to the organization’s QMS.

 

Please Note

 

ISO 9001:2015 QMS standard does not use the term 'exclusion' or refer to 'exclusions' in relation to the applicability of the standard's requirements to the organization's QMS. It is for the organization to review the applicability of ISO 9001:2015 QMS standard's requirements due to (i) the organization's size, (ii) the organization's complexity, (iii) the management model adopted by the organization, (iv) the range of organization's activities, and (v) the nature of risks and opportunities the organization encounters. However, please note that conformity to ISO 9001:2015 QMS may only be claimed if determined requirements as not being applicable do not affect the organization's ability / responsibility to ensure the conformity of organization's products / services and the enhancement of customer satisfaction.

 

Both Clause 1 and Clause 4.3 of ISO 9001:2015 QMS standard speak about the scope. What the difference between these two? Clause 1 provides the scope of the standard itself. This clause is for informational purpose. Clause 1 does not include any requirements to be met by an organization, while clause 4.3 deals with specific requirements to be met for determining the scope of the organization’s QMS. Clause 1 states – (i) ISO 9001:2015 QMS standard specifies requirements for a quality management system, (ii) Requirements mentioned in this standard are generic and applicable to any organization regardless of its type, size and product / service. In fact, requirements of ISO 9001:2015 QMS standard are mentioned in clause 4 to 10.

 

Think of the following Questions

 

(i)             What do you understand by QMS scope?

(ii)            What do understand by the scope of the standard?\

(iii)           What do you need to do for determining the QMS scope?

(iv)           What will you do if any ISO 9001:2015 QMS requirements not applicable to your organization?

(v)            Is maintaining documented information of QMS scope necessary?

 

 

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 9001:2015 QMS 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) (ii) Applying Risk-based Thinking in an Organization Implementing ISO 9001:2015 QMS (eBook)

Thanks.

ISO 9001:2015 QMS Awareness - Understanding Needs And Expectations Of Interested Parties

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

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The concept of understanding needs and expectations of interested parties was not mentioned in the earlier versions of ISO 9001 standards. Organizations that want to implement ISO 9001:2015 QMS standard need to meet the requirements of interested parties. These requirements are outlined in clause 4.2 of the standard. This clause 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 by an organization:

 

(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, certification body, 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 (fulfil) 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.

 

Here are a few examples of the needs and expectations of interested parties that can potentially hamper a robust quality management system:

 

(1) Customer: One of the most critical interested parties in any organization is the customer. The organization needs to be aware of their requirements and expectations to ensure that the product or service provided meets their needs. If the organization does not understand or fails to meet customer requirements, it can lead to customer dissatisfaction, complaints, and ultimately, a loss of business.

 

(2) Employees: Employees are critical stakeholders who have a significant impact on the success of the organization. They may have expectations regarding their working conditions, compensation, career development, and opportunities for growth. If these needs are not met, it can lead to a decline in employee morale and productivity.

 

(3) Supplier: A supplier is another important stakeholder who can impact the quality of the final product or service. A supplier may have expectations regarding timely payment, clear communication on quality and quantity of the materials or services it provide etc. If supplier's needs are not met, it can lead to delays, quality issues, and ultimately, decline in production.

 

(4) Contractor: Contractors are also important stakeholders who carry out certain tasks according to the organization’s needs. Contractors may have expectations regarding timely payment terms, clear communication of the benchmarks of services they provide etc. If contractor's needs are not met, it can lead to delays, quality issues, and ultimately, decline in production.

 

Overall, failure to recognize the needs and expectations of interested parties can lead to a breakdown in communication, inadequate planning and execution, and ultimately, a weak quality management system. Therefore, organizations should remain vigilant in monitoring and reviewing the needs and expectations of interested parties and be prepared to respond appropriately.

 

Think of the following 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 needs ans expectations?

(iii) Who can be the interested parties and what can be their needs and expectations?

(iv) What may be the step-by-step process for understanding the needs and expectations of interested parties?

 

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 9001:2015 QMS AWARENESS” (ASIN‏: ‎B093YFFY7Z), which is available worldwide at Amazon.

Thanks.