Documentation of QMS processes, quality events, and workflows is critically important. Sometimes the notion of documentation can create angst within a company. Sometimes the idea of documentation is viewed as overly burdensome and often times unnecessary with little value added.

In my experience, most companies do create quite a few burdens and obstacles regarding documentation. And it doesn’t have to be this way.

Documentation should be about defining processes and maintaining the records required to demonstrate these processes are being followed. Documentation is key for objective evidence. Objective evidence to support your employees through design, development, manufacturing, and support of medical devices. Objective evidence to demonstrate that requirements are being addressed.

Establishing thorough, yet functional, document management practices for your business is one of the most important foundational elements of a QMS.

Your need:


A key part of your quality management system is your quality manual.

Your quality manual must meet the following criteria:

  • Describe the scope of your QMS. Include any clauses that are excluded or non-applications supported with justification.
  • List or reference the procedures comprising the QMS.
  • Describe interactions of QMS processes.
  • Outline the structure of QMS documentation.


Every medical device type or device family must have a medical device file.

The contents of a medical device file shall include:

  • Description of the product, including intended use and indications for use.
  • Product labeling and instructions for use.
  • Specifications for the product.
  • Specifications and procedures for manufacturing, inspection, labeling, packaging, storage, handling, and distribution.
  • Specifications for measuring and monitoring.
  • Specifications and procedures for product installation (if applicable).
  • Procedures for product servicing (if applicable).


Documentation is a necessary aspect of a quality management system.

A document control procedure shall define your company’s criteria for document control. This includes ensuring documents are reviewed and approved prior to implementation, means to revise documents and identify changes, and ensure current versions are available at point of use.


Records require similar controls as documents. And sometimes the distinction between a document and record can be a bit confusing.

Records are evidence that certain processes have been followed. Throughout this guide, there are additional notes related to records.

The same type of criteria is applicable regarding review and approval. Records, however, are typically not versioned.

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