2019

EXPERT ANSWERS

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."

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 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.



I agree with the position - we just concluded a third-party audit, and the auditors found that we had just introduced a new product. We argued that we thought it was premature to include it in the scope until it stabilized. The auditors claimed that was an adequate reason, and there have been issued with nonconformity because of that.
--Margaret Kola, 03-02-2018

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