Developing Integrated World-Class QMS Using ISO 9001:2015

By Jay P. Patel, ASQ Fellow, MBB, Lean Expert, SCRUM Master, CEO and President of Quality & Productivity Solutions, Inc.

Since the first release ISO 9001 over 30 years ago, by ISO (International Organization for Standardization), more than one million organizations worldwide have adopted the principles and achieved certification to the requirements of ISO 9001, Quality Management System.

Today’s version provides organizations with a comprehensive process – focused framework upon which you can build business processes that lead to the successful achievement of organizational objectives.

Organizations that implement an effective business management system create a confidence among their stakeholders in the capability of their processes and the reliability of their products and or services; while at the same time, benefiting from improved risk management. In addition, an effective business management system serves to create the basis for continual improvement leading to increased customer satisfaction and ultimately to the success of the organization.

Why These Radical Changes Now to 9001:2008?

ISO 9001 2015 will bring in many core changes to earlier standards with specific focus to:

• Harmonize Management System Standards Such as QMS, EMS, EnMS, ISMS, FSMS, ITMS and OHMS
• Eliminate Unnecessary Documented Procedures Requirement
• Introduce Risk Based Thinking
• Introduce Common Text, Common Structure and Common Terms

These changes will further lead to an integrated world-class QMS by introducing risk base thinking, Evidence Focused Documents with three Components viz. Requirement, Responsibility and Evidence of Conformity to develope evidence Providing Documents/Forms/ Checklist.

Why ISO 9001 2015 delivers world-class QMS?

An ISO standard is developed by a panel of experts, within a technical committee.

There are 4 key principles in this standard development:

• ISO standards respond to a need in the market: Typically, an industry sector or group communicates the need for a standard
• ISO standards are based on global expert opinion : Subject experts negotiate all aspects of the standard, including its scope, key definitions and contentand methodology and hence it provides a global benchmark
• ISO standards are developed through a multi-stakeholder process: As includes multi stakeholders, it brings a common agreed platform
• ISO standards are based on a consensus: Since there is a consensus, its implementation by all stakeholders is easy

One of the strengths of ISO standards is that they are created by the people that need them. Getting involved in this process can bring significant advantages to your business.

Process approach-Basis for sound QMS:

At the outset, there are many different ways of applying these quality management principles. The nature of the organization and the specific challenges it faces will determine how and to what degree to implement them. Many organizations will find it beneficial to set up quality management systems based on these principles.

The basis for the quality management is to adopt a process approach in the organization.

ISO 9001 2015 has elaborated on the process approach in the clause where specific requirement has been laid down as to what would be the process approach stating:

The organization shall:

• Determine the processes needed for the quality management system and their application throughout the organization;
• Determine the inputs required and the outputs expected from each process;
• Determine the sequence and interaction of these processes;
• Determine the risks to conformity of goods and services and customer satisfaction if unintended outputs are delivered or process interaction is ineffective;
• Determine criteria, methods, measurements, and related performance indicators needed to ensure that both the operation and control of these processes are effective;
• Determine the resources and ensure their availability;
• Assign responsibilities and authorities for processes;
• Implement actions necessary to achieve planned results;
• Monitor, analyse and change, if needed, these processes ensuring that they continue to deliver the intended outputs; and
• Ensure continual improvement of these processes.

The process approach work like as shown in the diagram:

The process approach facilitates lower costs and shorter cycle times through effective use of resources, improved, consistent and predictable results and focused and prioritized improvement opportunities.

It typically aims to achieve systematically defining the activities necessary to obtain a desired result, establishing clear responsibility and accountability for managing key activities, Analysing and measuring of the capability of key activities, Identifying the interfaces of key activities within and between the functions of the organization, Focusing on the factors –such as resources, methods, and materials –that will improve key activities of the organization and evaluating risks, consequences and impacts of activities on customers, suppliers and other interested parties.

8 Quality management principles:

Here are the eight quality management principles on which the quality management system standards of the ISO 9000 series are based. These principles can be used by senior management as a framework to guide their organizations towards improved performance.

The principles are derived from the collective experience and knowledge of the international experts who participate in ISO Technical Committee ISO/TC 176, Quality management and quality assurance, which is responsible for developing and maintaining the ISO 9000 standards.

• Customer focus
• Leadership
• Engagement of people
• Process approachas discussed above
• Continual improvement
• Factual approach to decision making
• Mutually beneficial supplier relationships

Customer focus:

Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.

Applying the principle of customer focus typically leads to:

• Researching and understanding customer needs and expectations
• Ensuring that the objectives of the organization are linked to customer needs and expectations
• Communicating customer needs and expectations throughout the organization
• Measuring customer satisfaction and acting on the results
• Systematically managing customer relationships
• Ensuring a balanced approach between satisfying customers and other interested parties (such as owners, employees, suppliers, financiers, local communities and society as a whole).

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.

Leadership:

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.

Principle of leadership typically leads to:

• Considering the needs of all interested parties including customers, owners, employees, suppliers, financiers, local communities and society as a whole
• Establishing a clear vision of the organization’s future • Setting challenging goals and targets
• Creating and sustaining shared values, fairness and ethical role models at all levels of the organization
• Establishing trust and eliminating fear
• Providing people with the required resources, training and freedom to act with responsibility and accountability
• Inspiring, encouraging and recognizing people’s contributions.
• Activities are evaluated, aligned and implemented in a unified way

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

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.

By engaging people, organizations stand to gain in:

• Motivated, committed and involved people within the organization
• Innovation and creativity in furthering the organization’s objectives
• People being accountable for their own performance
• People eager to participate in and contribute to continual improvement.

This typically leads to their understanding the importance of their contribution and role in the organization, identifying constraints to their performance, accepting ownership of problems and their responsibility for solving them, evaluating their performance against their personal goals and objectives, actively seeking opportunities to enhance their competence, knowledge and experience, freely sharing knowledge and experience and openly discussing problems and issues.

Recognition, empowerment and enhancement of skills and knowledge facilitate the engagement of people in achieving the objectives of the organization.

Improvement

Needless to say improvement of the organization’s overall performance should be a permanent objective of the organization.

Continual improvement philosophy makes organization have performance advantage through improved organizational capabilities, alignment of improvement activities at all levels to an organization’s strategic intent and flexibility to react quickly to opportunities. 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.

The world now recognizes, an effectively developed QMS with built-in simplicity, improvement focused and results oriented, will realize continued benefits.

This philosophy leads to employing a consistent organization wide approach to continual improvement of the organization’s performance, providing people with raining in the methods and tools of continual improvement, making continual improvement of products, processes and systems an objective for every individual in the organization, establishing goals to guide, and measures to track continual improvement while recognizing and acknowledging improvements.

Factual approach to decision making:

As rightly the ISO 9001 2015 states decisions based on the analysis and evaluation of data and information are more likely to produce desired results. Effective decisions are always based on the analysis of data and information.

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 heir 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.

Factual approach facilitates an increased ability to demonstrate the effectiveness of past decisions through reference to factual records, increased ability to review, challenge and change opinions and decisions.

The approach to be successful organization needs to ensuring that data and information are sufficiently accurate and reliable, making data accessible to those who need it, analysing data and information using valid methods and making decisions and taking action based on factual analysis, balanced with
experience and intuition.

Mutually beneficial supplier relationships:

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.

An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.

Organization will have increased ability to create value for both parties, flexibility and speed of joint responses to changing market or customer needs and expectations and optimization of costs and resources.

Applying the principles of mutually beneficial supplier relationships leads to:

• Establishing relationships that balance short-term gains with long-term considerations
• Pooling of expertise and resources with partners
• Identifying and selecting key suppliers
• Clear and open communication
• Sharing information and future plans
• Establishing joint development and improvement activities
• Inspiring, encouraging and recognizing improvements and achievements by suppliers.

Some useful tools of excellence:

The PDCA cycle:

The Plan – Do – Check – Act (PDCA) cycle is the foundation of all ISO management system standards. The cycle ensures development, continuous improvement and control of the management system in question. It is a simple tool that ensures constant monitoring of your organization’s effectiveness.

Plan

Establishing the architecture of your quality management system is covered in clause 4.1 of the standard where it requires the identification of the processes, their success criteria, the inter-relationship between processes and the system for checking your results

Do

Implementing the plans and using the quality management system

Check

Reviewing whether the results are satisfactory at appropriate intervals against the ISO 9001 requirements

Act

Improving the quality management system or acting on the challenges and issues found in the reviews.

Other tools useful in a world-class QMS are:

It is most likely that an organization already has an effective quality management system but it is probably informal and not well documented. ISO 9001 provides a more systematic approach to achieving organization’s objectives. It should not result in excessive bureaucracy or paperwork and lack
of flexibility nor should it be a financial burden. Quality management systems should be considered an investment as the return on investment will be in terms of the previously mentioned benefits and improvements.

About the author:

Jay P. Patel is an ASQ Fellow, Master BB, Lean Expert, PMP, Risk Management Professional with 10 ASQ Certifications, and many other certifications. He has over 30 years’ experience in improving processes, people and achieving breakthrough performance at many companies.

For more information or questions, contact jayp@qpsinc.com. (Website: www.qpsinc.com)