Quality Progress - March 2018 - 8

Subject matter experts take on your quality-related queries

THIS MONTH'S QUESTION

My organization would like to request
an exclusion to ISO 9001:2015 for one
of its locations due to the nature of the
business conducted at that location.
What is the best way to request an
exclusion from a certification body?

OUR RESPONSE

As stated in ISO 9001:2015 Annex Table A.1, the term
"exclusions" is no longer used in the standard. Instead,
you must determine which requirements don't apply to your
organization's quality management system (QMS) based
on the organization's size, complexity, management model,
activities, and risks and opportunities.1
The requirements for applicability are stated in Clause
4.3-Determining the scope of the quality management
system, "which defines conditions under which an organization can decide that a requirement cannot be applied to any
of the processes within the scope of its quality management
system. The organization can only decide that a requirement is not applicable if its decision will not result in failure
to achieve conformity of products and services."2
After you determine the scope of your organization's QMS
and analyze the applicability of the standard's requirements
within the determined scope:
"The scope of the organization's quality management
system shall be available and maintained as documented
information. The scope shall state the types of products and
services covered, and provide justification for any requirement of this International Standard that the organization
determines is not applicable to the scope of its quality
management system.
Conformity to this International Standard may only be
claimed if the requirements determined as not being applicable do not affect the organization's ability or responsibility

8 QP

March 2018 ❘ qualityprogress.com

to ensure the conformity of its products and services and
the enhancement of customer satisfaction."3
Considering these requirements, if the scope of your
organization's QMS is already documented in a quality
manual, quality plan or handbook, for example, clearly
describe in this document the nature of the business at
the excluded location and justify why the requirements
do not apply.
You also should state in this document that the
exclusion does not affect your organization's ability or
responsibility to ensure the conformity of products and
services, or the enhancement of customer satisfaction.
Typically, certification bodies ask for the scope of an
organization-including any exclusions-during the new
application and certification renewal stages, but you can
declare an exclusion to the documented scope of your
QMS to the certification body at any time.
REFERENCES
1. International Organization for Standardization (ISO), ISO
9001:2015-Quality management systems-Requirements,
Annex A, clause A.5.
2. Ibid.
3. Ibid, clause 4.3.

This response was written by M. Onur Artan, quality
coordinator, STAR Rafineri, Turkey.


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Table of Contents for the Digital Edition of Quality Progress - March 2018

Seen and Heard
Expert Answers
Progress Report
Mr. Pareto Head
Career Coach
My Quality Story
In the Right Direction
A Different Kind of BBQ
Gaining Ground
Impeding Progress
Innovation Imperative
Statistics Spotlight
Standard Issues
Marketplace
Footnotes
Back to Basics
Quality Progress - March 2018 - INTRO
Quality Progress - March 2018 - cover1
Quality Progress - March 2018 - cover2
Quality Progress - March 2018 - 1
Quality Progress - March 2018 - 2
Quality Progress - March 2018 - 3
Quality Progress - March 2018 - 4
Quality Progress - March 2018 - 5
Quality Progress - March 2018 - Seen and Heard
Quality Progress - March 2018 - 7
Quality Progress - March 2018 - Expert Answers
Quality Progress - March 2018 - 9
Quality Progress - March 2018 - Progress Report
Quality Progress - March 2018 - 11
Quality Progress - March 2018 - 12
Quality Progress - March 2018 - Mr. Pareto Head
Quality Progress - March 2018 - Career Coach
Quality Progress - March 2018 - 15
Quality Progress - March 2018 - My Quality Story
Quality Progress - March 2018 - 17
Quality Progress - March 2018 - In the Right Direction
Quality Progress - March 2018 - 19
Quality Progress - March 2018 - 20
Quality Progress - March 2018 - 21
Quality Progress - March 2018 - 22
Quality Progress - March 2018 - 23
Quality Progress - March 2018 - A Different Kind of BBQ
Quality Progress - March 2018 - 25
Quality Progress - March 2018 - 26
Quality Progress - March 2018 - 27
Quality Progress - March 2018 - 28
Quality Progress - March 2018 - 29
Quality Progress - March 2018 - 30
Quality Progress - March 2018 - 31
Quality Progress - March 2018 - Gaining Ground
Quality Progress - March 2018 - 33
Quality Progress - March 2018 - 34
Quality Progress - March 2018 - 35
Quality Progress - March 2018 - 36
Quality Progress - March 2018 - Impeding Progress
Quality Progress - March 2018 - 38
Quality Progress - March 2018 - 39
Quality Progress - March 2018 - 40
Quality Progress - March 2018 - 41
Quality Progress - March 2018 - 42
Quality Progress - March 2018 - 43
Quality Progress - March 2018 - Innovation Imperative
Quality Progress - March 2018 - 45
Quality Progress - March 2018 - 46
Quality Progress - March 2018 - 47
Quality Progress - March 2018 - Statistics Spotlight
Quality Progress - March 2018 - 49
Quality Progress - March 2018 - 50
Quality Progress - March 2018 - 51
Quality Progress - March 2018 - 52
Quality Progress - March 2018 - 53
Quality Progress - March 2018 - Standard Issues
Quality Progress - March 2018 - 55
Quality Progress - March 2018 - 56
Quality Progress - March 2018 - 57
Quality Progress - March 2018 - Marketplace
Quality Progress - March 2018 - 59
Quality Progress - March 2018 - Footnotes
Quality Progress - March 2018 - 61
Quality Progress - March 2018 - 62
Quality Progress - March 2018 - 63
Quality Progress - March 2018 - Back to Basics
Quality Progress - March 2018 - cover3
Quality Progress - March 2018 - cover4
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