ISO 9001:2015 | Quality Management Systems Requirements

ISO standards are reviewed and revised on a regular cycle, typically every 5-10 years, and 2015 sees ISO 9001:2008 reaching the end of that review process. The ISO 9001:2015 standard was published in September 2015.

It introduces the requirements of a quality management system which supports the delivery of a product or service, through the application of effective and continually improving systems, assuring conformity to customer and applicable legal requirements, whilst enhancing customer satisfaction.

1. Scope

2. Normative References

3. Terms and Definitions

4 Context of the organization

4.1 Understanding the organization and its context

4.2 Understanding the needs and expectations of interested parties

4.3 Determining the scope of the quality management system

4.4 Quality management system and its processes

5 Leadership

5.1 Leadership and commitment

5.2 Policy

5.3 Organizational roles, responsibilities and authorities

6 Planning

6.1 Actions to address risks and opportunities

6.2 Quality objectives and planning to achieve them

6.3 Planning of changes

7 Support

7.1 Resources

7.2 Competence

7.3 Awareness

7.4 Communication

7.5 Documented information

8 Operation

8.1 Operational planning and control

8.2 Requirements for products and services

8.3 Design and development of products and services

8.4 Control of externally provided processes, products and services 8.5 Production and service provision

8.6 Release of products and services

8.7 Control of nonconforming outputs.

9 Performance evaluation

9.1 Monitoring, measurement, analysis and evaluation

9.2 Internal audit

9.3 Management review

10 Improvement

10.1 General

10.2 Nonconformity and corrective action

10.3 Continual improvement