To Document, or Not To Document?

Case Study

- October 2015

Abstract: The term “documented information” in ISO 9001 is likely to continue confusing organizations after the 2015 revision eliminated the need for a manual and the six required procedures. Standards experts Robert Freeman and Jennifer Drown, members of U.S. TAG 176, explain three criteria for determining the need for documentation, and they discuss what the path to a successful transition may look like for many organizations.

Keywords: ISO 9001:2015 - revision - quality management system - documented information - documentation

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Thank you for your question about this "Standards Connection" article. One of the authors, Robert Freeman, provided the following response to the ASQ Knowledge Center:

"While some of the definitions related to conformance and compliance can be seen as stating very similar things, in the world of standards, specifications, rules, and regulations conformance and compliance tend to be seen as having differing meanings. The definitions we will key in on are:

Conform - to be or become similar in form, nature, or character.
Comply - to act or be in accordance with wishes, requests, demands, requirements, conditions, etc.

Using the definitions shown, the key words are 'similar' and 'in accordance with.' I chose these particular definitions because they most closely represent the thought process of organizations and agencies who live up to, assess against, and act on requirements, standards, specifications, rules, and regulations.

A simplified example of a compliance document would be a contract. Contracts tend to spell out specific language and in most cases provide the person choosing to fulfill the contract with what is needed to deliver the exact thing being asked for (i.e., 'in accordance with'). If the contract says to deliver 100 parts of a given part number and revision, the organization will need to comply with those specific conditions to be in a position to get paid for the work performed. While you could argue that the parts conform to the contractual requirements, the parts are in compliance with the requirements instead of simply being like (similar) the requirements.

Another and more directly related example of compliance, as seen through the definitions shown above, would be trade compliance. When an organization ships to customers outside of the United States, that organization has to make sure there are no sanctions or embargoes limiting their ability to ship to that country. The rules/regulations describing what can be shipped and any particular details the packaging/paperwork must include tends to be very specific and it is expected that the rules/regulations will be complied with. In essence, the actions taken by the organization have to correctly adhere to (comply with) the specific requirements or conditions set out by the applicable compliance document. Additional examples of this would be EPA, OSHA, and FDA regulations.

On the other hand, ISO 9001:2015 does not state exactly what has to be done, but rather the need for something that is similar or matches/is equal to the requirements. In essence, the scope in ISO 9001:2015 states, 'All the requirements of this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.' The use of the word generic tells us ISO 9001:2015 is not stating what has to be done. Instead, it is telling us what the management system needs to account for in whatever way the organization chooses to address (conform with) the requirements included within the standard."

Again, thank you for question. We hope this additional information is useful.
--ASQ Knowledge Center team, 11-05-2015


Great article, I am confused however.
In the article, it is stated: "First, ISO 9001:2015 is a conformance standard, not a compliance standard."
To clarify, I looked up the meanings for both conformance and compliance. My interpretation is that they are one in the same. What are the differences? Thank you.
--Kristina Essinger, 10-30-2015

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