QMS Documentation Explained

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As we progress through a better understanding of QMS Implementation, I’ve shared what a QMS is and how it is built on Standards. To meet those Standards, an operation needs to create documents and records, and quite honestly, a lot of them.

            For review:

A Quality Management System (QMS) is a documentation of an operator’s processes, functions and policies necessary for the continuous improvement of quality to ensure customer expectations and requirements are met or exceeded. 

            The following are some of the key terms from ISO 9001–2015 you will need to understand when referring to documents and records.

• “Shall” indicates a requirement 

• “Should” indicates a recommendation 

• “May” indicates a permission

• “Can” indicates a possibility or capability

You will “maintain” documents and “retain” records 

Documents & Records

   As you begin to create your documents and records, it is also helpful for you to understand the difference between Policies and Procedure (SOP’s).

Policies are the overarching principles that guide how you make decisions and operate on a day-to-day basis. A policy can be thought of as a framework that expresses the why behind certain strategies and objectives. Remember that policies aren’t etched in stone, and they are flexible, meaning they can and should be updated as your operation evolves and grows.

Procedures describe, in detail, the steps that should be taken in specific situations. They have a defined beginning and end and are often repeated to achieve certain outcomes. Procedures are more about the how related to a certain area of compliance.

Because documentation is so important to implementing a QMS, we always recommend to our clients to look at Clause 7.5.3 which describes the key information that a document should provide, before addressing other Clauses. Having a Document Template will make your QMS journey much easier.

If you are a client of The Advisory Academy, you know that we have provided customizable templates for you to implement your QMS.

“If you can’t explain it simply, you don’t know it well enough.” Albert Einstein

Thank you for joining our learning community. As always, if you have any questions about Regulatory Compliance, do not hesitate to contact us.

We are here to help you simplify your operations.