ISO 9001:2015 Final Draft International Standard (FDIS)

<Page updated on 10 July 2015>



ISO 9001:2015 Final Draft International Standard (FDIS) has been issued on 09 July 2015. ISO member countries have 2 months to form a national position and vote on the latest draft of the standard before the 9 September deadline.

View the standard revision timeline here.

Compared to the DIS issued earlier, here are the key changes in the recently released FDIS.

- Compared to the DIS, changes are relatively minor.
- The Introduction and figures have been greatly simplified
- The terms and definitions have now been removed from the standard and added to ISO 9000.
- 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.

ISO is in process of harmonizing all management system standards. For this a harmonized structure (Annex SL) has been developed. Some standards such as ISO 30301:2011 (Information and documentation – Management systems for records), ISO 22301:2012 (Societal security – Business continuity management systems), ISO 20121:2012 (Event sustainability management systems) have already been changed to this new structure and some other are in process of being revised to this new structure.

 

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

So far the standard was based on eight quality management principles. In this standard the earlier existing eight principles have been reduced to seven 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 the Committee Draft issued in June 2013, this term was proposed to be changed to "Goods and 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.



And where ISO 9001:2008 would have referred to records this is now expressed as a requirement to retain documented information.



8. No Exclusions:

ISO 9001:2008 version allows organizations to exclude the standard requirements under the following conditions:

• Exclusions are allowed for the requirements which can not be applied due to the nature of the business.
• Exclusions are limited to clause 7 (Product Realization)of the standard.
• Such exclusions do not affect the organization's ability to provide products which meet the customer requirements and also the applicable legal requirements.

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".

11. Supplier

The term "supplier" has been replaced with "External provider".

This does not meet that organizations would need to change this term in their QMS as well. Organizations can still maintain the term "supplier", "vendor", "contractor", "consultant" etc. as per their own need.