Main Changes of ISO 9001:2015

Posted by Integrated Safety Inspection System on 1:40 AM with 9 comments
The transition of ISO 9001:2008 to ISO 9001:2015 is mainly to emphasize on the following subjects;

High level structure and core text from „annex SL“

The new format of ISO 9001 standard is providing identical structure, text and common terms to be applied to the system user. It consist 10 elements of the requirement to simplify and to be easily understood by the system implementer (see details of ISO 9001:2015 Standard Requirement)

There is also explanatory item to clarify the new structure, terminology and concepts of this ISO 9001. It addressed as per Annex A of the standard.

Besides, ISO 9000:2015 specifies the terms and definitions that apply to all quality management and quality management system standards developed. It provides the answer of the term that repeatedly being used in ISO 9001:2015 Standard Requirement and Annex A.

Increased requirements for top management commitment and involvement.

It has been defined specifically in the section 5 of the standard. This requires involvement of top management to ensure maintenance of the QMS. It can be realized through demonstrates of leadership and commitment (clause 5.1.1),  lead to the team in focusing on customer requirement (clause 5.1.2), Generation of Quality Policy (clause 5.2.1) and assigning the right person to manage the organization's QMS (clause 5.3).
Top management also must take part in reviewing and evaluating the effectiveness of their QMS through Management Review process (clause 9.3)

Emphasis on risk-based thinking

Details explanation of risk based thinking has been elaborated in A.4 of Annex A.
The concept of risk based thinking is also being part of responsibility of top management for promoting them in the operation (see clause 5.1.1 of ISO 9001:2015)

Increased emphasis on achieving value for the organization and its customers (“output matters”)

'Internal customer' requirement should be respected for assuring good output to be produced. It has been explained in clause 4.4.1 of the standard.
Proactive measures can be seen in the new version of standard where the control of nonconforming products is now used the phrase of controlling the nonconforming output to emphasize effective implementation and preventing the defect to be generated in the operation (see clause 8.7.1 of the standard)

Need to understand the context of the organization and the needs and expectations of interested parties

The new standard emphasizes for organization to look potential issues that may effected to product conformity besides it hall meet with customer requirement. That is including legal requirement aspect, internal and external issue that may influence the smoothness of company's activities.
Broader views has put into the attention for company to identify, manage and maintain as it was addressed in the standard requirement in clause 4.1, 4.2, 6.1.1 and 6.1.2.
Most of the system users interpret this new requirement are replacing the clause of preventive action in ISO 9001:2008. However, the scope and coverage of the risk management in new standard are comprehensively described in wider range than focusing on product quality only.

Increased flexibility on the use of documentation

The used of documented information to integrate the terminology of procedure, document and record under one application without significant change being shown. This aspect has been specifically explain in A.6 of Annex A.