How many clauses are there in ISO 9001?

There are a total of 10 clauses in iso 9001:2015; however, the audit is carried out against clause 4 to 10. these are described as follows:

4) Context of the organization

The main requirements include

  • Context (background)
  • Needs and expectations of the interested parties
  • Scope of the QMS
  • Processes, both for production and service provision as well as the processes for QMS itself e.g. management review, internal audit, corrective action etc.

5) Leadership

The main requirement include

  • General requirements pertaining to leadership and commitment
  • Customer focus
  • Policy
  • Organizational roles, responsibilities and authorities

6 planning

The main requirement include

  • Risks and opportunities and actions to address them
  • Objectives, targets, and planning to achieve them
  • Management of change

7 Support

The main requirement include

  • Resources: human, infrastructure, and environment for the operation of processes, monitoring and measuring resources, organizational knowledge
  • Competence
  • Awareness
  • Communication
  • Documented information

8 Operation

The main requirement include

  • Planning and control of operations including ‘requirement for products and services
  • Design and development of products and services
  • Third-party services including processes
  • Production and service provision
  • Identification and traceability
  • Controls for the property belonging to customers or external providers
  • Preservation
  • Post-delivery activities
  • Product release
  • Control of nonconforming product

9 performance evaluation

The main requirements include

  • monitoring and measuring
  • analysis
  • evaluation
  • customer satisfaction
  • internal audit
  • management review

10 Improvement

improvement in management systems comes through the following (but not limited to)

  • effective (thorough and in-depth) internal audit
  • root cause analysis and corrective action
  • data analysis and evaluation
  • effective management review
  • awareness and training etc.