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Seven principles of Quality management as per ISO 9001:2015

Seven principles of Quality management

Introduction:

In my first post I had written about the Eight principles of quality management on which the standard of ISO 9001:2008 was based. As we are all aware that fifth edition of ISO 9001( ISO 9001:2015) was published in month of september 2015. This fifth edition (ISO 9001:2015) cancels and replaces the fourth edition( ISO 9001:2008). This document was being prepared by Technical committee of ISO “ISO/TC 176/SC 2-Quality Management and Quality Assurance/ Quality Systems” also know as ISO/TC 176 in short. The process of preparing the ISO 9001:2015 went through stage_codes. Organizations have been granted a three-year transition period after the revision has been published to migrate their quality management system to the new edition of the standard.

The key changes in the standards are

  1.  There is no quality manual.
  2. It emphasis on organization context and risk based thinking,
  3. There is no requirement of management representative
  4.  The standard does not include a specific clause for “Preventive Actions”.
  5. The terms “document” and “records” have been replaced with the term “documented information”. Documented procedure in iso 9001:2008 have been replaced by maintained documented information and Documented record in iso 9001:2008 have been replaced by retained documented information.
  6. In 2008 version of the standard the term “product” was used. This term also included services. This term has been  changed to Product and Services
  7. In addition to the term “continual improvement” another term “improvement” have been introduced
  8. Outsourcing is now an external provision.The term “purchased product” has been replaced with “externally provided products and services”.The term “supplier” has been replaced with “External provider”.Control of external provision of goods and services address all forms of external provisions.
  9. The new standard does not make any reference to  the exclusions which was for only for clause 7 in ISO 9001:2008, but in ISO 9001:2015 after proper justification any of the requirement of this international standards may not be included in the scope, provided it does not affect the organization’s ability or responsibility to ensure the conformity of its product and services and the enhancement of customer satisfaction
  10. The term “work environment” used in ISO 9001:2008 has been replaced with “Environment for the operation of processes”.

The  ISO 9000:2015 and ISO 9001:2015 standard is based on the following Seven principles of Quality management.7 quality principle

1 – Customer Focus

The primary focus of quality management is to meet customer requirements  and to strive to exceed customer expectations.

Rationale

Sustained success is achieved when an organization attracts and retains the confidence of customers and other interested parties on whom it depends. Every aspect of customer interaction provides an opportunity to create more value for the customer. Understanding current and future needs of customers and other interested parties contributes to sustained success of an organization

Key Benefits (As per ISO 9000:2015)
  • There is an increase  in customer value;
  • There is an increase in customer satisfaction;
  • There is an improvement in customer loyalty;
  • It enhances in  repeat business;
  • It enhances in  reputation of the organization;
  • There is an expansion  of customer base;
  • There is increase in revenue and market share.
Possible actions (As per ISO 9000:2015)

Some of the possible actions that an organization can take to increase Customer Focus can  include:

  1. To identify and recognize the direct and indirect customer of the organization who receive value from the organization.
  2. To understand customers’ current and future needs and expectations;
  3. The organization must link it’s objectives to customer needs and expectations;
  4. It must communicate customer needs and expectations throughout the organization;
  5. It must plan, design, develop, produce, deliver and support products and services to meet customer needs and expectations;
  6. It must measure and monitor customer satisfaction and take appropriate actions;
  7. It must determine and take action on relevant interested parties’ needs and appropriate expectations that can affect customer satisfaction;
  8. It must actively manage relationships with customers to achieve sustained success.
Explanation: 

This is the first of the Seven principles of Quality management and there is  no change in the heading of  this principle. The Eight principle definition stated “Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.” The Seven principle definition states “The primary focus of quality management is to meet customer requirements and to strive to exceed customer expectations.“. First and foremost the organization must have a clear understanding of who are its direct customer and who are its indirect customers.  Customer focused means putting your energy into satisfying customers and understanding that profitability comes from satisfying customers.There should be researching ,establishing and understanding current   and future customer needs and expectations. The organization should ensure that the objectives of the organization are linked to customer needs and expectations. The top Management should communicate customer needs and expectations throughout the organization. There should be measuring customer satisfaction and acting on the results. the organization should  ensure a balanced approach between satisfying customers and other interested parties.

2 – Leadership

Leaders at all levels establish unity of purpose and direction and create conditions in which people are engaged in achieving the quality objectives of the organization.

Rationale

Creation of unity of purpose, direction and engagement enable an organization to align its strategies, policies, processes and resources to achieve its objectives.

Key Benefits (As per ISO 9000:2015)
  • It increases the effectiveness and efficiency in meeting the organization’s quality objectives;
  • There is a better coordination of the organization’s processes;
  • There is improvement in communication between levels and functions of the organization;
  • It develops and improves the capability of the organization and its people to deliver desired results.
Possible actions (As per ISO 9000:2015)

Some of the possible actions that an organization can take includes:

  • It can communicate the organization’s mission, vision, strategy, policies and processes throughout the organization;
  • It can create and sustain shared values, fairness and ethical models for behaviour at all levels of the organization;
  • It can establish a culture of trust and integrity;
  • It can encourage an organization-wide commitment to quality;
  • It can ensure that leaders at all levels are positive examples to people in the organization;
  • It can  provide people with the required resources, training and authority to act with accountability;
  • It can  inspire, encourage and recognize the contribution of people.
Explanation:

This is the second of the Seven principles of Quality management and there is  no change in the heading of  this principle. The Eight principle definition stated “Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives.” The Seven principle definition states “Leaders at all levels establish unity of purpose and direction and create conditions in which people are engaged in achieving the quality objectives of the organization.“Leadership is providing role model behaviors consistent with the values of the organization.  Behavior that will deliver the organizations objectives.  Internal environment includes the culture and climate, management style, shared, trust, motivation and support. The leadership should Consider the needs of all interested parties including customers, owners, employees, suppliers, financier, local communities and society as whole. The leadership should establish a clear vision of the organization’s future. The leadership should set a challenging goals and targets. The leadership should create and sustain a shared values, fairness and ethical role models at all levels of the organization. The leadership should Establish trust and eliminate fear. The leadership should provide people with the required resources training and freedom to act with responsibility and accountability. The leadership should  Inspire, encourage and recognize people contributions.

3 – Engagement of People

It is essential for the organization that all people are competent, empowered and engaged in delivering value. Competent, empowered and engaged people throughout the organization enhance its capability to create value.

Rationale

To manage an organization effectively and efficiently, it is important to involve all people at all levels and to respect them as individuals. Recognition, empowerment and enhancement of skills and knowledge facilitate the engagement of people in achieving the objectives of the organization.

Key Benefits (As per ISO 9000:2015)
  • It improves understanding of the organization’s quality objectives by people in the organization and increased motivation to achieve them;
  • It enhances involvement of people in improvement activities;
  • It enhances personal development, initiatives and creativity;
  • It enhances people satisfaction;
  • It enhances trust and collaboration throughout the organization;
  • It increases attention to shared values and culture throughout the organization.
Possible actions (As per ISO 9000:2015)

Some of the possible actions that an organization can take includes:

  • It can communicate with people to promote understanding of the importance of their individual contribution;
  • It can promote collaboration throughout the organization;
  • It can facilitate open discussion and sharing of knowledge and experience;
  • It can empower people to determine constraints to performance and to take initiatives without fear;
  • It can recognize and acknowledge people’s contribution, learning and improvement;
  • It can enable self-evaluation of performance against personal objectives;
  • It can  conduct surveys to assess people’s satisfaction, communicate the results and take appropriate actions.
Explanation:

This is the third of the Seven principles of Quality management and the term “Involvement of People” has been change to “Engagement of People“. The Eight principle definition stated “People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit.” The Seven principle definition states “It is essential for the organization that all people are competent, empowered and engaged in delivering value. Competent, empowered and engaged people throughout the organization enhance its capability to create value.” Engaging people means  employees are committed to their organisation’s goals and values, motivated to contribute to organisational success, and are able at the same time to enhance their own sense of well-being.An engaged employee experiences a blend of job satisfaction, organisational commitment, job involvement and feelings of empowerment. When we talk of engagement of people it means that all the employees are competent, empowered and they are delivering value. An engaged employee will have a better perception of job importance. An engaged employee will have better clarity of job expectation. There will be more improvement opportunities. There will be regular feedback and dialog with supervisors. The Quality of working relationships of an engaged employee with peers, superiors, and subordinates is much improved. There is effective employee communication.

4 – Process Approach
Consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as a coherent system.

Rationale

The quality management system is composed of interrelated processes. Understanding how results are produced by this system, including all its processes, resources, controls and interactions, allows the organization to optimize its performance.

Key Benefits (As per ISO 9000:2015)
  • It enhances ability to focus effort on key processes and opportunities for improvement;
  • There is a consistent and predictable outcomes through a system of aligned processes;
  • It can optimize performance through effective process management, efficient use of resources and reduced cross-functional barriers;
  • It enables the organization to provide confidence to interested parties related to its consistency, effectiveness and efficiency.
Possible actions (As per ISO 9000:2015)

Some of the possible actions that an organization can take includes:

  • It can define objectives of the system and processes necessary to achieve them;
  • It can establish authority, responsibility and accountability for managing processes;
  • It can understand the organization’s capabilities and determine resource constraints prior to action;
  • It can determine process interdependencies and analyse the effect of modifications to individual processes on the system as a whole;
  • It should manage processes and their interrelations as a system to achieve the organization’s quality objectives effectively and efficiently;
  • It can ensure the necessary information is available to operate and improve the processes and to monitor, analyse and evaluate the performance of the overall system;
  • It should manage risks which can affect outputs of the processes and overall outcomes of the QMS.
Explanation:

This is the fourth of the Seven principles of Quality management and there is  no change in the heading of  this principle. The Eight principle definition stated “A desired result is achieved more efficiently when activities and related resources are managed as a process.” The Seven principle definition states “Consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as a coherent system.” Processes are dynamic-they cause things to happen.processes within an organization should be structured in order to achieve a certain objective in the most efficient and effective manner.It helps us in systematically defining the activities necessary to achieve/obtain desired results.It helps us in establishing clear responsibility and accountability for managing key activities.It helps us in analyzing and measuring of the capabilities of key activities. It helps us in identifying the interfaces of key activities within and between the functions of the organization.It helps us in evaluating risks,consequences and impacts of activities on customers,suppliers and other interested parties. Quality Management System are constructed by connecting interrelated processes together to deliver the system objectives which is the satisfaction of the interested parties.  This helps us in structuring a system to achieve the organizations objectives in the most effective and efficient way and understanding the interdependencies between the processes of the system. It also helps us in providing a better understanding of the roles and responsibilities necessary for achieving common objectives and thereby reducing cross functional barriers and  targeting and defining how specific activities within a system should operate.

5 – Improvement

Successful organizations have an ongoing focus on improvement.

Rationale

Improvement is essential for an organization to maintain current levels of performance, to react to changes in its internal and external conditions and to create new opportunities.

Key Benefits (As per ISO 9000:2015)
  • There is improved process performance, organizational capability and customer satisfaction;
  • There is enhanced focus on root cause investigation and determination, followed by prevention and corrective actions;
  • There is enhanced ability to anticipate and react to internal and external risks and opportunities;
  • There is enhanced consideration of both incremental and breakthrough improvement;
  • There is improved use of learning for improvement; There is enhanced drive for innovation.
Possible actions (As per ISO 9000:2015)

Some of the possible actions that an organization can take includes:

  • It can promote establishment of improvement objectives at all levels of the organization;
  • It can educate and train people at all levels on how to apply basic tools and methodologies to achieve improvement objectives;
  • It can ensure people are competent to successfully promote and complete improvement projects;
  • It can develop and deploy processes to implement improvement projects throughout the organization;
  • It can track, review and audit the planning, implementation, completion and results of improvement projects;
  • It can integrate improvement consideration into development of new or modified products and services and processes;
  • It can  recognize and acknowledge improvement.
Explanation:

This is the fifth of the Seven principles of Quality management and can be mapped to the sixth of the Eight Quality principle which is “Continual Improvement”.  The term “Continual Improvement” has been change to “Improvement“. The fifth principle of the Eight Quality principle “System approach to management” no longer exist in the Seven principle of quality management.The Eight principle definition stated “Continual improvement of the organization’s overall performance should be a permanent objective of the organization.” The Seven principle definition states “Successful organizations have an ongoing focus on improvement.” Improvement is the  improvement in organizational efficiency and effectiveness. The organization should Employ a consistent organization-wide approach to  improvement of the organizations’ tools of  improvement. The organization should Provide people with the training in the methods and tools of improvement. The organization should Make improvement of products, processes,and the system an objective for every individual in the organization. The organization should Establish the goals to guide and lead.

6 – Evidence-based Decision Making.

Decisions based on the analysis and evaluation of data and information are more likely to produce desired results.

Rationale

Decision-making can be a complex process, and it always involves some uncertainty. It often involves multiple types and sources of inputs, as well as their interpretation, which can be subjective. It is important to understand cause and effect relationships and potential unintended consequences. Facts, evidence and data analysis lead to greater objectivity and confidence in decisions made.

Key Benefits (As per ISO 9000:2015)
  1. There is an improvement in decision making processes;
  2. There is an improvement in  assessment of process performance and ability to achieve objectives; 
  3. There is an improvement in operational effectiveness and efficiency;
  4. There is an increased ability to review, challenge and change opinions and decisions;
  5. There is an increased ability to demonstrate the effectiveness of past decisions.
Possible actions (As per ISO 9000:2015)

Some of the possible actions that an organization can take includes:

  • It should determine, measure and monitor key indicators to demonstrate the organization’s performance;
  • It can make all data needed available to the relevant people;
  • It should ensure that data and information are sufficiently accurate, reliable and secure;
  • It can analyse and evaluate data and information using suitable methods;
  • It should ensure people are competent to analyse and evaluate data as needed;
  • It can make decisions and take actions based on evidence, balanced with experience and intuition.
Explanation:

This is the sixth of the Seven principles of Quality management and can be mapped to the seventh  of the Eight Quality principle which is  “Factual approach to decision making “.  The term “Factual approach to decision making “ has been change to “Evidence-based Decision Making“. The fifth principle of the Eight Quality principle “System approach to management” no longer exist in the Seven principle of quality management.The Eight principle definition stated “Effective decisions are based on the analysis of data
and information.”
 The Seven principle definition states “Decisions based on the analysis and evaluation of data and information are more likely to produce desired results.” Evidence is information that shows or proves  that something exists or is true. Evidence can be collected by performing observations, measurements, tests, or by using any other suitable method. Any decision making should away be based on evidences. The organization should ensuring that data/information is sufficiently accurate and reliable. The organization should make data accessible to those who need them. The organization should analyze data using appropriate tools.The organization should make decision and take actions based on  analysis  of data,balanced with experience and intuition.

7 – Relationship Management

For sustained success, organizations manage their relationships with interested parties, such as suppliers.

Rationale

Interested parties influence the performance of an organization. Sustained success is more likely to be achieved when an organization manages relationships with its interested parties to optimize their impact on its performance. Relationship management with its supplier and partner network is often of particular importance

Key Benefits (As per ISO 9000:2015)
  • There is an enhanced performance of the organization and its relevant interested parties through responding to the opportunities and constraints related to each interested party;
  • There is a common understanding of objectives and values among interested parties;
  • There is an increased capability to create value for interested parties by sharing resources and competence and managing quality related risks;
  • There is a a well-managed supply chain that provides a stable flow of products and services.
Possible actions (As per ISO 9000:2015)

Some of the possible actions that an organization can take includes:

  • It can determine relevant interested parties (such as providers, partners, customers, investors, employees or society as a whole) and their relationship with the organization;
  • It can determine and prioritize interested party relationships that need to be managed;
  • It can establish relationships that balance short-term gains with long-term considerations;
  • It can gather and share information, expertise and resources with relevant interested parties;
  • It can measure performance and provide performance feedback to interested parties, as appropriate, to enhance improvement initiatives; It can establish collaborative development and improvement activities with providers, partners and other interested parties;
  • It can encourage and recognize improvements and achievements by providers and partners.
Explanation:

This is the seventh of the Seven principles of Quality management and can be mapped to the eighth  of the Eight Quality principle which is  “Mutually beneficial supplier relationships “.  The term “Mutually beneficial supplier relationships “ has been change to “Relationship Management“. The fifth principle of the Eight Quality principle “System approach to management” no longer exist in the Seven principle of quality management.The Eight principle definition stated “An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value The Seven principle definition states “For sustained success, organizations manage their relationships with interested parties, such as suppliers.“An interested party is a person or group that has a stake in the success or performance of an organization. Interested parties may be directly affected by the organization or actively concerned about its performance. Interested parties can come from inside or outside of the organization. Examples of interested parties include customers, suppliers, owners, partners, employees, unions, bankers, or members of the general public. Interested  parties are also referred to as stakeholders. Relation management with interested parties meaning sharing knowledge,vision,values, understanding and suppliers are not treated as adversaries.The organization establishes a relationships that balance short-term gains with long term considerations. There is  pooling of expertise and resources with partners. The Organization identifying and selecting key suppliers. There is clear and open communication with the stake holders. There is sharing of  information and future plans. The organization establishes a  joint development and improvement activities. The organization inspiring,encourages and recognize improvements and achievement by suppliers.

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