ISO9001:2015 Final Draft update
ISO has officially published the Final Draft International Standard (FDIS) for both ISO 9001 and ISO 14001, signalling the penultimate stage of the revision process for the world’s most widely adopted Quality and Environment Management System standards. The final standards for both ISO 9001 and ISO 14001:2015 are currently due for publication in September-Dec 2015.
Below are summary of changes
- Compared to the FDIS and DIS, changes are relatively minor.
- The Introduction and figures have been simplified
- The terms and definitions have now been removed from the standard.
- Top management must now promote the use of risk-based thinking in addition to a process approach.
- Explanations about the process environment applied to service organizations have been added.
- Included requirements for production and service activities to prevent human error.
Following are the key changes in this draft from ISO 9001:2008:
1. New Structure
The new standard has 10 clauses(external link).
2. Process Approach
ISO 9001:2015 promotes the process approach beyond the existing requirements of ISO 9001:2008.Clause 4.4 (Quality management system and its processes)of the FDIS provides specific requirements for adopting a process approach.
3. Preventive Action vs Risk Management
One of the key purpose of implementing a quality management system is to act as a preventive tool. As a result the formal requirement related to preventive action is no more existing in the current draft. This is being replaced with risk based thinking.
Although it is required by the organization to determine and address risks, there is no requirement for implementing a formal risk management process.
4. Context of the Organization
Two new clauses have been added to the draft standard.
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties.
5. Quality Management Principles
These are listed in the clause 0.2 of the standard.
6. Products and Services:
In 2008 version of the standard the term "product" was used. This term also included services. In this FDIS the term used is "Products and Services".
7. Documented Information:
2008 version of the standard had two separate terms: "documents" and "records". In the Committee Draft and Draft Internal Standard issued earlier it was combined together and called "documented information". The same term is maintained in the recently issued Final Draft International Standard.
Annex A of the FDIS clarifies that where ISO 9001:2008 would have referred to documented procedures, it is now expressed as a requirement to maintain documented information.
8. No Exclusions:
The new standard does not make any reference to exclusions. However in Annex A, the standard clarifies that the organization can not decide a requirement to be not applicable if it falls under the scope of its QMS. Also non-applicability is not allowed if that could lead to failure to achieve the conformity or to enhance customer satisfaction.
9. Work Environment:
The term "work environment" used in ISO 9001:2008 has been replaced with "Environment for the operation of processes".
10. Purchased Product:
The term "purchased product" has been replaced with "externally provided products and services".
The term "supplier" has been replaced with "External provider".