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ISO 13485: What does it require from Quality manual?

Author: John Mills
by John Mills
Posted: Oct 20, 2019

Sometimes organizations go too far with quality manual, creating a huge, unusable book that is pretty much just the ISO 13485 standard and just rewritten it with do some modification. Technically suppose that, this would show written proof that the organization is committed to meeting every single requirement the standard lists for their Quality Management System (QMS) – but a document like this is much too long and difficult to understand to be of any use to employees. Many modern companies like to go with a short with its ISO 13485 manual that’s easy to read and understand.

The actual requirement to include in ISO 13485 quality manual that is mainly understands. So here are the requirements of a quality manual, and the thinking behind each requirement:

1. The QMS scope:

The QMS scope is a description of what company does for example we can say Distribution of Medical Devices, Software Design for MRI Machines, etc. and the boundaries of your Quality Management System. It requires to be agreed upon with the certification body, as it will be stated on the ISO 13485 certificate.

Now you are capable to understand what’s included in your scope and what’s not, you required to list any exclusions from the standard. Mostly, there won’t be any to list, but a common exclusion is the "Design and Development" clause of the ISO 13485 standard, because many companies manufacture products according to customer specifications, and don’t actually design any products.

2. ISO 13485 Documented procedures:

There are quite a lot of procedures that ISO 13485 requires an organization to document or require at least reference in the quality manual. Mandatory documented procedures include:

  • Control of documents
  • Control of records
  • Internal audit
  • Control of non-conforming products
  • Corrective and preventive actions
  • Validation of computer software
  • Customer specifications such as manufacturing, inspection, packaging, and delivery
  • Monitoring and measurement
  • Servicing and installation (if applicable)
  • Management review
  • Work environment and contamination control
  • Design and development
  • Validation of sterilization and sterile barrier systems (if applicable)
  • Identification and traceability
  • Preservation of product
  • Calibration or verification for measuring equipment
  • Feedback and complaint handling
  • Reporting to regulatory authorities
  • Advisory notices, reworks, data analysis
  • Additionally to the required documents, there is a requirement for companies to develop ISO 13485 documentation for any procedures that are likely to have non-conformances were they not considered or forgot to write. Basically, if you require a ISO 13485 documented procedure to prevent mistakes from occurring, then you require a good documented procedure.

    The Documented Procedures that are shown graphically such as in form of flowcharts can be included right in the quality manual. For longer procedures it requires more written information, it is easy to include references to these documents in the quality manual. In this way, the quality manual can serve as a kind of quick-reference guide to company procedures.

    3. Descriptions of processes and interactions: The easiest way to accomplish descriptions of processes is with a simple, top-level flowchart illustrating the basics of organization’s processes, with arrows determining how they interact. There is no requirement to go into great detail for this in the quality manual.


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    Author: John Mills

    John Mills

    Member since: Aug 30, 2013
    Published articles: 42

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