ISO 9001:2015 – Quality Management Systems (QMS)

ISO 9001:2015 is an international standard dedicated to Quality Management Systems (QMS). It outlines a framework for improving quality and a vocabulary of understanding for any organization looking to provide products and services that consistently meet the requirements and expectations of customers and other relevant interested parties in the most efficient manner possible.  

ISO 9001:2015 applies to any organization, regardless of size or industry.

Key changes in ISO 9001:2015  

1. ISO 9001:2015 Has 10 Clauses:

• Introduction
• Scope
• Normative references
• Terms and definitions
• Context of the organization
• Leadership
• Planning
• Support
• Operation
• Performance evaluation
• Improvement

2. ISO 9001:2015 Follows the New High Level Structure (HLS) Guidelines

The new High Level Structure places these requirements under identical chapter numbers, making it much easier to integrate different ISO standards.

3. Some Terminology Is Different in 2015

• Products – Products & Services
• Documentation, quality manual, documented procedures, records – Documented Information
• Work environment – Environment for the operation of processes
• Monitoring and measuring equipment – Monitoring and measuring resources
• Supplier – External Provider

4. ISO 9001:2015 Is Process-Based

The entire focus of the ISO 9001:2015 requirements is to encourage a comprehensive process approach to quality management. The ISO 9001:2015 process approach is all about integration.

5. ISO 9001:2015 Puts More Focus on Input and Output

The concept of input and output is closely related to the process approach. In the context of ISO 9001:2015, “input” and “output” refer to the starting point and the results of activities.

6. Risk-Based Thinking Is at the Core of ISO 9001:2015

The concept of risk-based thinking is actually only an expansion of preventive action (a term no longer used in the text of the ISO 9001: 2015 standard). It’s also interesting to note that the opposite of risk, opportunity, is also part of risk-based thinking.

7. Context of the Organization Important in ISO 9001:2015

Understanding the context of the organization refers to reviewing and understanding the internal and external environment and influences that shape a company. An alternative term for “context of the organization” could be “environment in which the company operates”. ISO 9001:2015 groups this environment into internal environment, external environment and interested parties.

8. Leadership and Commitment in ISO 9001:2015

Companies whose top management had delegated ISO 9001 to others will find that ISO 9001:2015 requires significant involvement of executive management. Top managers will put the QMS in line with the overall strategic direction of the business, and top managers will “walk the talk”.

9. Better Integration with Other ISO Standards

ISO 9001:2015 is designed from the top down to be more compatible with other ISO management standards. This is more than just adhering to the new High Level Structure.