QMS development

PharmOut frequently implements ISO 13485 Quality Management Systems (QMS) in medical device & IVD companies, compliant with ISO 13485:2016 and / or FDA QSR 820.

ISO 13485 Quality Management Systems Products and services

Our products and services include:

  • High level consulting – How should you structure your Quality Management System? What resources and systems will you need to have in place to make the quality system work? How can you be sure your QMS will pass a regulatory audit?
  • ISO 13485 quality management system templates – our own consultants use these everyday to develop systems for different companies, so we are continually refining them based on our experiences.
  • Experienced technical document writers – they are working in this area constantly, so have a vast library of QMS documents they can draw upon to create your QMS.
  • Training courses on technical writing, Good Documentation Practice and how to implement an ISO 13485 QMS.

Our recommendations for a successful QMS implementation

Here are some key points to consider when implementing a QMS in regulated company or a Quality Critical facility:

Depending on the complexity of your operations, aim for 6 to 12 months to achieve ISO 13485 registration.

It’s best to get the people in your organisation who own the process to write the documents. However, often they don’t have the time or the writing skills to do it. Try using professional technical document writers to extract the information and turn it into effective documents.

It’s common in regulated companies that the majority of changes will either be to quality documents or will require document changes, some sources report this to be as high as 96% of all changes. To ensure you have an effective change control system in place and invest in a document management system if you have more than 50 documents in your QMS. Auditors often focus on change control and document management processes as they are frequent sources of non-compliance and often looking for the most obvious large project that everyone thought had a change request raised.

Invest in getting your QMS document templates right, PharmOut sells a set of templates, based on the modest cost it is well worth investing in templates, however a template pack from a ISO consultant will never work out the box in your facility. Unfortunately, one must spend time detailing how your business and quality processes should work and then modifying them. Either spend time developing them or buy templates from somewhere. Make the templates easy to use and train your document writers. Your QMS documents should look like a consistent set of documents, not a collection of disparate files (that’s a red flag to an auditor).

Consider having a compliance audit performed by a third party when you’ve finished your QMS. You want to know about any deficiencies before a regulatory auditor arrives.

More information

If you would like a quote or would need to ask questions, please contact us.