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ISO 13485 Quality Management System Development

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

ISO 13485 Quality Management Systems Products and Services

Our products and services include:

  • High level consulting – How should you structure your QMS? 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 – over years of working with different companies, our consultants have developed sophisticated and detailed QMS templates. These templates are continually refined and updated based on our ongoing experiences and any changes in regulation.
  • Experienced technical document writers – our document writers are experts at writing in plain English and they also have a vast library of QMS documents they can draw upon.
  • Training courses – PharmOut provides numerous industry-relevant training courses, including 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:

The majority of changes in regulated companies will be to quality documents. With this in mind, if you have more than 50 documents in your current QMS (or fewer but are looking to expand) it is paramount to invest in a document management system and ensure you have an effective change control system in place. Document management and change control are frequent sources of non-compliance especially if the system has been set up in a haphazard way – an easy target for auditors!

In an ideal situation, the people in your organisation who own the processes and are subject matter experts should write the documents – however, in reality, often they don’t have the time or technical writing background to do it! PharmOut’s professional document writers will work closely with your team to extract the crucial information and translate it into effective and compliant documents.

PharmOut sells QMS templates which will help to set you up with good Quality foundation on which you can structure the rest of your company. Based on the modest cost, the templates are well worth investing in, however, a template pack will never work straight out of the box and they will require a degree of specification and customisation to detail how your business, facility and quality processes should work. In this regard, if you are short on time and resources, we are also able to provide consultants and document writers to your site to assist.

We can customise and make the templates easy to use and also train your staff in document writing so that in the future your QMS documents look like a consistent set of documents instead of a collection of disparate files (a common problem as well as a red flag to an auditor!).

It is also worth considering having a compliance audit performed by a third party when you’ve finished your QMS to see if everything has been covered. You’ll want to know about any deficiencies or gaps in the system before a regulatory auditor arrives!

Depending on the complexity of your operations, our recommendation is to aim between 6 to 12 months to achieve ISO 13485 registration.

More Information

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