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Getting started with a QMS from scratch: What are records and where and how do I store them?

As mentioned in the previous blog posts of this series, the main idea behind a QMS is the Plan-Do-Check-Act principle.

This means that you PLAN what you want to do, implement it and generate an output. Based on this output, you evaluate whether some things need to be improved.

Records are output from your QMS. They are a result from the DO phase and allow you to CHECK. Not only you can check and evaluate the effectiveness of your implementation.

Also auditors will check the records during their audits as it's most of the time the only way to proof you actually implemented your procedures.

A lot of records are completed templates. Using templates is a good way to make sure that you:

  • Record the necessary information in a harmonized way

  • Don't forget to record information

  • Save time, as you don't have to create a specific structure every time

Templates and records are documents and therefore they should be controlled.

In a classical paper-based QMS, you would have your template approved and then use this approved template to create records from it.

Same as with procedures and work instructions, you have the risk that the wrong version of a template is used to create records.

When using a software tool like MatrixQMS, document control is integrated.

MatrixQMS has a workflow which separates the creation and approval of a template from the actual use of that template to create records.

In the QMS project, templates can be created with a predefined structure, containing different sections and fields. This template can be approved and is then published to specific projects where it serves as a basis to create records.

What's the advantage?

  1. One centralized place to create and approve templates

  2. Only the latest approved/published version of a template is available for use

  3. Only relevant templates are available in specific projects

If you'd like to have a demo on how templates and records work in MatrixQMS and MatrixALM, don't hesitate to contact us.

About the Author
Ann Vankrunkelsven
RA/QA Manager