ISO 9001:2015 Draft International

Standard (DIS) - Key Changes

Following are the key changes in this draft:
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
DIS 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 approach.
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.

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 DIS the proposed term is "Products and
Services".
7. Documented Information:
2008 version of the standard had two separate terms: "documents" and "records". In
the Committee Draft issued earlier it was combined together and called
"documented information". The same term is maintained in the recently issued
Draft International Standard.
See the list of mandatory documents and records required by clicking here.
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 mean 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.
Clause by clause comparison of ISO 9001:2008 and the Draft International Standard
is available here.
View the standard revision timeline here.