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ISO 9001 documentation requirements

The ISO 9001 documentation is at the core of any ISO 9001 quality management system (QMS). What makes the ISO 9001 documentation so important? There are two important aspects:

(1) your company has to document its entire ISO 9001 QMS (the ISO 9001 standard contains both explicit and implicit requirements for the various documents); and

(2) your company has to actually do everything that is contained in your company's ISO 9001 documentation.

Because your company not only needs to have a pretty set of ISO 9001 documents but also needs to actually conduct its business according to these documents, it is crucial that the ISO 9001 documentation not only meets ISO 9001:2015 requirements but that the ISO 9001 documentation is efficient and doesn't increase bureaucracy at your company. This is a very important consideration as we have seen far too many companies that unnecessarily spend many employee hours and much money just to maintain an overly complicated and bureaucratic ISO 9001 QMS. We, therefore, urge you to keep your documentation as simple and efficient as possible. If you use templates for your ISO 9001 documentation, please choose wisely!


What documents are required?

ISO 9001:2015 requires the following documents:

Procedures

The procedures are the essence of the ISO 9001 documentation. The ISO 9001 procedures explicitly describe how numerous processes within the company must be performed, and who is responsible for them. Ideally, the procedures are combined in a single user-friendly document (a "procedures manual" or "quality management manual" or similar.

ISO 9001:2015 sets the requirements on the procedures and their content in many clauses; the requirements are not always explicit. We recommend you have procedures covering most or all applicable ISO 9001:2015 requirements.

Quality Policy

The quality policy is the company's policy defining its stance towards quality and customer satisfaction. As such, the ISO 9001 quality policy is the overall guiding principle.
The content of the quality policy must meet the requirements of ISO 9001:2015 section 5.2.

Quality Objectives

Process Flowchart

The process flowchart is a description of how the various processes of the ISO 9001 QMS interact with each other. The process flowchart is required in ISO 9001:2015 section 4.4.

Scope Statement

The scope statement defines the application and boundaries of the ISO 9001 quality management system within the company. The scope statement is required in ISO 9001:2015 section 4.3.

Work Instructions

Work instructions are the most detailed and most company-specific of all ISO 9001 documents. Work instructions describe in detail how particular tasks must be performed. Work instructions are typically written by the people who perform the actual work. ISO 9001:2015 requires work instructions only where they add real value to the company; it is a common misconception that every task in the company needs to be documented.
Work instructions are required by ISO 9001:2015 section 8.5.1.

Records

Records are different from the above documents, all of which provide directions on how to conduct business. Records, on the other hand, are evidence of things done. ISO 9001:2015 contains numerous explicit requirements on records plus requirements for many more undefined records.

Forms are optional

ISO 9001:2015 does NOT contain requirements on using forms. In fact, it would not be a violation of ISO 9001:2015 requirements not to have any forms at all. However, good forms provide many benefits to any business, ranging from time savings to consistency. Using forms can be a tremendous help creating the various records that ISO 9001:2015 requires. The best forms even act as instructions when they guide the user through the process of providing the requested information.

How about the Quality Manual?

Previous revisions of ISO 9001 required a quality manual which contained the overall description of the company's ISO 9001 quality management system. ISO 9001:2015 no longer requires a quality manual. However, some companies choose to develop an ISO 9001 quality manual for marketing purposes and to provide external parties with general information on their ISO 9001 quality management system without revealing their proprietary processes.


Format and content

There are many requirements in ISO 9001:2015 regarding the content of the above mentioned documents. On the other hand, there are many things that ISO 9001:2015 does NOT require, for example:

ISO 9001:2015 does not require any particular format or layout;

referencing every document and form to each other is not required;

there are no requirements regarding introductory paragraphs to procedures;

and there are certainly no requirements in ISO 9001:2015 saying that the documentation needs to be complicated and hard to understand!


Remember that the ISO 9001 documentation is supposed to provide instructions on how to operate your company's ISO 9001 quality management system. The best documentation is easy to understand and user-friendly; the easier it is to follow the instructions, the better.

We have seen many companies making the mistake of creating various different documents and then referencing in each document all the other pertinent documents. This approach not only causes redundancies, but it is also simply burdensome and not user-friendly. Creating the ISO 9001 documentation in this way is usually the beginning of a cumbersome and bureaucratic ISO 9001 quality management system.

We recommend to create user-friendly ISO 9001 documentation by combining the different documentation requirements (i.e., procedures, quality policy, scope and process flowchart) as much as possible into one comprehensive manual (an "ISO 9001 QMS manual" or "procedures manual" or "quality management manual" etc). This reduces repetition and bureaucracy, and it saves time implementing the ISO 9001 quality management system.

Good ISO 9001 documentation always keeps the user of the document in mind, and different users have different preferences. Some users prefer instructions in form of pictures, others like flowcharts. Not many like long and convoluted text.

A word of caution...

In case you chose templates for your ISO 9001 documentation, take a look at samples. If they seem complicated and hard to understand, they will not be useful to your company and employees. If an ISO 9000 consultant insists on writing ISO 9001 documentation that you don't understand, chances are that this documentation will be useless at best or a burden to your company's performance at worst.