ISO 9001:2015 Standard and Its Clauses

The ISO 9001:2015 standard is a globally recognized quality management system (QMS) standard that provides a framework for organizations to improve their quality and efficiency. The standard consists of 10 clauses, each addressing a specific aspect of quality management.

Clauses 1-3: General Information

The first three clauses of the ISO 9001:2015 standard provide general information and are not specific to actions or requirements.

• Clause 1: Scopedefines the purpose and scope of the standard.
• Clause 2: Normative Referenceslists the other standards that are referenced in the ISO 9001:2015 standard.
• Clause 3: Terms and Definitionsprovides definitions for key terms used in the standard.

Clauses 4-10: Mandatory Requirements

The remaining seven clauses of the ISO 9001:2015 standard contain the mandatory requirements for the QMS.

• Clause 4: Context of the Organizationrequires organizations to understand their external and internal context and to determine the scope of their QMS.
• Clause 5: Leadershiprequires top management to demonstrate leadership and commitment to the QMS and to establish a quality policy.
• Clause 6: Planningrequires organizations to plan for the QMS, including identifying risks and opportunities and setting quality objectives.
• Clause 7: Supportrequires organizations to provide the resources necessary to support the QMS, including human resources, infrastructure, and work environment.
• Clause 8: Operationrequires organizations to control their processes, including product and service design, production, and delivery.
• Clause 9: Performance Evaluationrequires organizations to monitor, measure, and analyze their QMS performance and to conduct internal audits.
• Clause 10: Improvementrequires organizations to continually improve their QMS.

Each clause is further divided into subclauses, resulting in a total of 56 subclauses that define over 300 individual requirements.

Conclusion

The ISO 9001:2015 standard is a comprehensive framework for organizations to improve their quality and efficiency. The standard consists of 10 clauses, each addressing a specific aspect of quality management. The first three clauses provide general information, while the remaining seven clauses contain the mandatory requirements for the QMS.

References

• https://the9000store.com/iso-9001-2015-requirements/
• https://www.iso-9001-checklist.co.uk/how-many-clauses-are-in-ISO-9001(hint-there-are-10).htm
• https://advisera.com/9001academy/knowledgebase/iso-9001-requirements-and-structure/

FAQs

How many clauses are there in the ISO 9001:2015 standard?

There are 10 clauses in the ISO 9001:2015 standard.

Which clauses in ISO 9001:2015 are mandatory?

Clauses 4 to 10 in ISO 9001:2015 are mandatory.

What do the first three clauses of ISO 9001:2015 cover?

The first three clauses of ISO 9001:2015 provide general information, including the scope of the standard, normative references, and terms and definitions.

What is the purpose of Clause 4: Context of the Organization?

Clause 4 of ISO 9001:2015 requires organizations to understand their external and internal context and to determine the scope of their QMS.

What does Clause 5: Leadership require from top management?

Clause 5 of ISO 9001:2015 requires top management to demonstrate leadership and commitment to the QMS and to establish a quality policy.

What is the focus of Clause 6: Planning in ISO 9001:2015?

Clause 6 of ISO 9001:2015 requires organizations to plan for the QMS, including identifying risks and opportunities and setting quality objectives.

What does Clause 7: Support cover in ISO 9001:2015?

Clause 7 of ISO 9001:2015 requires organizations to provide the resources necessary to support the QMS, including human resources, infrastructure, and work environment.

What is the purpose of Clause 10: Improvement in ISO 9001:2015?

Clause 10 of ISO 9001:2015 requires organizations to continually improve their QMS.