ISO 9001:2015 Quality management systems – Part 1

ISO 9001:2015 sets out the criteria for a quality management system and is based on several quality management principles including a strong customer focus, the motivation and implication of top management, the process approach, and continual improvement. Using ISO 9001:2015 helps ensure that customers get consistent, good-quality products and services, which in turn brings many business benefits. For more information, please visit www.iso.org.

 

ISO 9001:2015 Quality management systems — Requirements

What is ISO 9001:2015 Quality management system (QMS)?

The quality management system is defined as a set of interrelated or interacting elements to establish policies, objectives, and processes to achieve those objectives about quality.

ISO 9001:2015 Quality Management System (QMS( is part of the overall management system, based on a business risk approach, to establish, implement, operate, monitor, review, maintain, and improve quality.

ISO 9001:2015 specifies requirements to plan, establish, implement, operate, monitor, review, maintain, and continually improve a documented management system used to manage quality. The requirements set in ISO 9001:2015 are generic, flexible, and useful to all types of organizations. Thus, this ISO Management System Standard can be aligned and integrated with other Management Systems such as Energy Management, Business Continuity Management, and other management systems, due to their similar structure.

Quality management standardization evolves with ISO 9001:2015 Quality management system by adding:

• Greater emphasis on process approach, risk management, monitoring performance and metrics;
• Better focus on interested parties.
• More careful analysis of the organization’s context is needed to ensure quality improvement.

ISO 9001:2015 Quality management system applies to all types and sizes of organizations that wish to:

1. establish, implement, maintain, and improve a QMS.
2. assure conformity with the organization’s stated quality policy;
3. demonstrate conformity to others.
4. seek certification/registration of its QMS by an accredited third-party certification body; or
5. make a self-determination and self-declaration of conformity with this International Standard

Key clauses of ISO 9001:2015

 

Following the new structure of the Annex SL, ISO 9001:2015 Quality management system is organized into the following main clauses:

 

Clause 1: Scope

Clause 2: Normative references

Clause 3: Terms and definitions

Clause 4: Context of the organization

Clause 5: Leadership

Clause 6: Planning for the quality management system

Clause 7: Support

Clause 8: Operation

Clause 9: Performance evaluation Clause

Clause 10: Improvement

 

Clause 4: Context of the organization

The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its QMS such as:

• issues arising from the technological, competitive, market, cultural, social, and economic environments.
• issues related to values, culture, knowledge, and performance of the organization;
• the identified needs and expectations of relevant interested parties;
• applicable legal, regulatory, and other requirements to which the organization subscribes.

Defining the scope of the QMS, taking into account the organization’s strategic objectives, key products and services, risk tolerance, and any regulatory, contractual, or stakeholder obligations is also part of this clause.

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https://www.iso.org/obp/ui/#!iso:std:62085:en