ISO 9001 is the internationally recognized standard for Quality Management Systems (QMS). It is the most widely used QMS standard in the world, with over 1.1 million certificates issued to organizations in 178 countries. ISO 9001 provides a framework and set of principles that ensure a common-sense approach to the management of your organization to consistently satisfy customers and other stakeholders. In simple terms, ISO 9001 certification provides the basis for effective processes and effective people to deliver an effective product or service time after time.
The key to any successful business is strong quality control. If you want your operation to thrive, your potential consumer base must be confident that the goods or services you offer meet or exceed expected standards. ISO 9001 is a quick and easy way for potential consumers to see if your company has put the time and effort into making sure your product or service is the best it can possibly be.
The purpose of the ISO 9001 standard is to help organizations to provide products and services that meet all relevant customer needs and expectations and comply with all relevant regulatory and statutory requirements. According to ISO 9001, any organization can achieve these objectives if it establishes a quality management system (QMS) and if it continually tries to improve the suitability, adequacy, and effectiveness of this system.
A quality management system (QMS) is a set of interrelated or interacting elements that organizations use to formulate quality policies and quality objectives and to establish the processes that are needed to ensure that policies are followed and objectives are achieved. These elements include structures, programs, procedures, practices, plans, rules, roles, responsibilities, relationships, contracts, agreements, documents, records, methods, tools, techniques, technologies, and resources.
ISO 9001 applies to all types of organizations. It does not matter what size the organization is or what the organization does. It can help any organization to achieve standards of quality that are recognized and respected throughout the world.
ISO 9001 requirements are underpinned by universal management principles which help your organization with
Customer Satisfaction
Pre-Qualification and Requests for Quotation
Risk Management
Product Improvement
Internal Auditing
Brand and Reputation
Process Improvement
Operational Efficiency
Training and Competence
Use ISO 9001 if your organization needs to be able to demonstrate that your organization can meet customer requirements and enhance customer satisfaction. Use it if:
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Your organization needs to be able to show that your organization is consistently capable of providing products and services that meet customer requirements and comply with all relevant statutory and regulatory requirements.
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Your organization needs to be able to demonstrate that your organization can enhance customer satisfaction because it is consistently capable of continually improving both its products and services and its practices and processes.
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Your organization needs to be able to assess your organization's ability to consistently provide products and services that meet customer requirements and
comply with all relevant statutory and regulatory requirements.
If your organization does not already have a quality management system (QMS), the ISO 9001 standard can be used to establish one. And once your organization has established your organization’s QMS, you can use it to demonstrate that your organization is capable of meeting customer requirements, enhancing customer satisfaction, and continually improving both its products and services and its practices and processes.
The ISO 9001 standard is based on seven quality management principles. These principles were chosen because they can be used to enhance corporate performance and achieve sustained success. They form the conceptual foundation for the ISO portfolio of quality management standards and were used to guide the development of the ISO 9001 standard.
Focus on customers and interested parties
To enhance corporate performance and achieve sustained success, organizations must focus on both their customers and their interested parties. Organizations can establish this focus by trying to understand the current and future requirements and expectations of both their customers and their interested parties and by constantly trying to meet these requirements and exceed these expectations
Provide leadership for your organization
To enhance corporate performance and achieve sustained success, organizations must ensure that suitable leadership is provided at all levels.
Suitable leadership is provided whenever leaders at all levels establish a unity of purpose and whenever they create an environment that encourages people to pursue a common direction and achieve a common set of objectives. By establishing a common purpose, leaders can help ensure that all strategies, policies, processes, and resources are aligned and being used to pursue a common direction and to achieve a common set of objectives.
Engage and involve your people
To enhance corporate performance and achieve sustained success, organizations must be able to create and deliver value. In order to do so they must have people who are competent, they must enhance their knowledge and skills, and they must manage them effectively by empowering them, by encouraging their involvement and engagement at all levels, and by recognizing their achievements.
Use a process approach
To enhance corporate performance and achieve sustained success, organizations must use a process approach to manage their activities. The process approach is a management strategy. When managers use a process approach, it means that they manage and control the processes that make up their organizations, the interactions between these processes, and the inputs and outputs that tie these processes together. It also means that they manage these interactions as a system. When this approach is applied to quality management, it means that they manage their processes and their process interactions as a coherent quality management system.
Encourage improvement
To enhance corporate performance and achieve sustained success, organizations must encourage and support improvement. If they wish to maintain current levels of performance, if they wish to respond to changing conditions, and if they wish to identify, create, and exploit new opportunities, organizations must establish and sustain an ongoing focus on improvement.
Use evidence to make decisions
To enhance corporate performance and achieve sustained success, organizations must establish an evidence-based decision-making process. Decision making is evidence-based whenever multiple types of input are gathered from multiple sources, whenever facts are identified, whenever data is analyzed objectively, whenever cause and effect relationships are examined, whenever potential unintended consequences are considered, and whenever all of this is used to make decisions.
Manage your corporate relationships
To enhance corporate performance and achieve sustained success, organizations must manage their relationship with suppliers, partners, and other interested parties. Relationships must be carefully managed because suppliers, partners, and other interested parties can influence corporate performance and undermine corporate success.
The ISO 9001 Standard is comprised of 10 clauses/sections which describe the universe of requirements that must be met by an organization seeking certification of their organization’s QMS.
Clause / Section | Clause / Section Objective |
|---|---|
1 | Introduction |
2 | Definitions |
3 | Overview |
4 | Context |
4.1 | Understand your organization and its unique context |
4.2 | Clarify the needs and expectations of interested parties |
4.3 | Define the scope of your quality management system (QMS) |
4.4 | Develop a QMS and establish documented information |
5 | Leadership |
5.1 | Provide leadership by focusing on quality and customers |
5.2 | Provide leadership by establishing a suitable quality policy |
5.3 | Provide leadership by defining roles and responsibilities |
6 | Planning |
6.1 | Define actions to manage risks and address opportunities |
6.2 | Set quality objectives and develop plans to achieve them |
6.3 | Plan changes to your quality management system |
7 | Support |
7.1 | Support your QMS by providing the necessary resources |
7.2 | Support your QMS by ensuring that people are competent |
7.3 | Support your QMS by explaining how people can help |
7.4 | Support your QMS by managing your communications |
7.5 | Support your QMS by controlling documented information |
8 | Operations |
8.1 | Develop, implement, and control your operational processes |
8.2 | Determine and document product and service requirements |
8.3 | Establish a process to design and develop products and services |
8.4 | Monitor and control external processes, products, and services |
8.5 | Manage and control production and service provision activities |
8.6 | Implement arrangements to control product and service release |
8.7 | Control nonconforming outputs and document actions taken |
9 | Evaluation |
9.1 | Monitor, measure, analyze, and evaluate QMS performance |
9.2 | Use internal audits to examine conformance and performance |
9.3 | Carry out management reviews and document your results |
10 | Improvement |
10.1 | Determine improvement opportunities and make improvements |
10.2 | Control nonconformities and take appropriate corrective action |
10.3 | Enhance the suitability, adequacy, and effectiveness of your QMS |
Clause / Section 4.
Context
Context asks you to start by understanding your organization and its context before you develop its process-based quality management system (QMS). It asks you to consider the external and internal issues that are relevant to your organization's purpose and strategic direction and to think about the influence these issues could have on its QMS and the results it intends to achieve. This means that you need to understand your organization's external environment, its culture, its values, its performance, and its interested parties before you develop its QMS. Why? Because your QMS will need to be able to manage all these influences. Once you have considered all of this, you are ready to define the scope of your QMS and to begin its development.
Clause / Section 5.
Leadership
Leadership asks your organization's top management to provide leadership for its QMS by showing that they support it, by expecting people to focus on quality and on customers, by expecting them to provide compliant products and services, and by expecting them to manage risks and opportunities. Section 5 also expects top management to establish a quality policy and to assign QMS roles, responsibilities, and authorities.
Clause / Section 6.
Planning
Planning asks you to plan the development of your QMS. It asks you to address the risks and opportunities that could influence your organization's QMS or disrupt its operation and to consider how its context and its interested parties could affect its QMS and the results it intends to achieve. Section 6 also asks you to set quality objectives and to develop plans to achieve them. Finally, it asks you to control changes to your QMS.
Clause / Section 7.
Support
Support asks you to support your QMS by managing communications and by providing the necessary resources. It asks you to provide competent people, to provide an appropriate process infrastructure and environment, to provide suitable monitoring and measuring technologies, to provide the knowledge that is needed to facilitate process operations, and to provide documented information.
It asks you to start by figuring out how extensive your documented information should be and then asks you to select and include all the documentation your organization needs in order to ensure that its processes are being carried out as planned and all the documentation it needs in order to comply with the ISO 9001 standard. It asks you to manage the creation and modification
of this documentation and to control how it is used.
Clause / Section 8.
Operations
Operations asks you to develop, implement, and control the operational processes that your organization needs to provide products and services and to manage risks and opportunities. It asks you to clarify how product and service requirements will be managed and how customer communications will be handled.
Section 8 also asks you to establish a product and service design and development process (when necessary), to monitor externally provided products and services, to manage production and service provision, to supervise product and service release,
and to control nonconforming outputs in order to prevent unintended use.
Clause / Section 9.
Evaluation
Evaluation asks you to monitor, measure, analyze, and evaluate the performance of your organization's QMS. It asks you to monitor customer satisfaction, to evaluate monitoring and measuring results, to audit conformance and performance, and to review the suitability, adequacy, and effectiveness of your QMS.
Clause / Section 10.
Improvement
Improvement asks you to identify opportunities to improve your organization's processes, products, and services, and to enhance customer satisfaction. It also asks you to control nonconformities, to take corrective actions, and to enhance the suitability, adequacy, and effectiveness of your QMS.