The ISO 9001:2015 standard is designed to help organisations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product or program.
It deals with the fundamentals of quality management systems, and more specifically, the requirements that organisations wishing to meet the standard must fulfill.
Confirmation that organisations meet the requirements of ISO 9001 is provided by independent third-party certification bodies.
The standard specifies that the organisation shall issue, maintain and communicate:
• Documented procedures
• A quality policy
• A quality manual
• Numerous records
• The effectiveness of the quality management system
• Examples of implementation
The ISO 9001:2015 standard follows the Plan, Do, Check, Act cycle in a process based approach. Outline requirements for ISO 9001:2015 are as follows:
Section 4: Context of the Organization
Section 5: Leadership
Section 6: Planning
Section 7: Support
Section 8: Operation
Section 9: Performance Evaluation
Section 10: Improvement