Quality Management News

Newsletter
January 2016 Volume 1, No. 1

ISO 9001:2015 Special Issue

10 Clauses
1. Scope

2. Normative references

3. Terms and definitions

4. Context of the organization

5. Leadership

6. Planning

7. Support

8. Operation

9. Performance evaluation

10. Improvement

Key Changes in ISO 9001:2015

Why this revision? from ISO 9001:2008

Following are the key changes in this
newly released ISO 9001:2015.
All ISO standards are revised every
5 years to keep these current and 1. New Structure
relevant. ISO 9001 standard was first
published in 1987. Since then it is The new standard has 10 clauses.
revised every 6 to 8 years.
ISO is in process of harmonizing all
Here is the timing of all revisions of ISO management system standards. For
9001 standard. this a harmonized structure (Annex SL)
has been developed. Some standards
Revision 1 - 1987 such as ISO 30301:2011 (Information
Revision 2 - 1994 and documentation – Management
Revision 3 - 2000 systems for records), ISO 22301:2012
Revision 4 - 2008 (Societal security – Business continuity
Revision 5 - 2015 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 standard provides
specific requirements for adopting a
process approach.

QualityGurus.com Monthly Newsletter 1

 ISO 9001:2015 - What is new?

Key Changes in ISO 9001:2015

from ISO 9001:2008
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.
7 Quality
Management Although it is required by the organization to determine and address risks, there is no
requirement for implementing a formal risk management process.
Principles
4. Context of the Organization

QMP 1: Two new clauses have been added to the standard.

Customer Focus
4.1 Understanding the organization and its context
QMP 2: 4.2 Understanding the needs and expectations of interested parties.
Leadership

QMP 3: 5. Quality Management Principles

Engagement and Competence of
People 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
QMP 4: management principles.
Process Approach
6. Products and Services:
QMP 5:
Improvement In 2008 version of the standard the term “product” was used. This term also included
Principle services. In the new standard the term used is “Products and Services”.

QMP 6:
Informed Decision Making

QMP 7:
Picture of Drumheller
Relationship Management
Alberta badland.

2 QualityGurus.com Monthly Newsletter

 ISO 9001:2015 - What is new?

A picture capured at Drum-

heller Alberta.

Key Changes in ISO 9001:2015

from ISO 9001:2008

7. Documented Information: 8. No Exclusions:

2008 version of the standard had two separate terms:
“documents” and “records”.
In the newly issued revision these two terms have been
combined together and called “documented information”.
The standard clarifies that where ISO 9001:2008 would have
referred to documented procedures, it is now expressed as a
requirement to maintain documented information.
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.

Documented procedures in ISO 9001:2008 Such exclusions do not affect the organization’s
= ability to provide products which meet the
Maintain documented information in ISO 9001:2015 customer requirements and also the applicable legal
requirements.

And where ISO 9001:2008 would have referred to records

this is now expressed as a requirement to retain documented The new standard does not make any reference to
information. exclusions. However in Annex A, the standard clarifies
that the organization can not decide a requirement to
Records in ISO 9001:2008 be not applicable if it falls under the scope of its QMS.
= Also non-applicability is not allowed if that could lead
Retain documented information in ISO 9001:2015 to failure to achieve the conformity or to enhance
customer satisfaction.

QualityGurus.com Monthly Newsletter 3

 A picture captured at
Drumheller Alberta.

Key Changes in ISO 9001:2015 from ISO

9001:2008

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”.

Buy ISO 9001:2015
This does not meet that organizations would need to change Transition Training
this term in their QMS as well. Organizations can still maintain
the term “supplier”, “vendor”, “contractor”, “consultant” etc. as per Course. Click Here.
their own need.

4 QualityGurus.com Monthly Newsletter