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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.