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Bespoke Quality Management Systems; Implemented, Trained and Operational Within 1 Week

Bespoke Quality Management Systems – A Tailored Service

 

After understanding the clients product, business and company requirements, we will create a bespoke and tailor-made Quality Management System that is fully compliant to ISO 13485:2016. The system can normally be created within one week, once we have all your information.

 

The next step is to provide training to ensure the client understands how to use the system provided. Full on-site training is included in the price of the system and will be tailored to match the existing level of regulatory knowledge and understanding within your organisation. 

 

The Process

Gap Analysis & Fact Finding

  • We will investigate your company, people, products and any existing QMS to establish the gaps and to ensure the most appropriate QMS is provided.
 

Quality Procedures

  • Following the results of the Gap Analysis, we will develop the Quality Policy and a Quality Manual appropriate to your business and write all necessary procedures.
  • A typical QMS includes approximately 50-70 procedures and associated forms.
 
Duration & Training
  • On completion of the fact finding and gap analysis, a bespoke QMS can typically be installed 1 week later. Training and implementation of the new system can then begin immediately.
  • The amount of training required (and the level of future support) will depend on your internal structure, staffing levels, the experience of your current employees and the package you purchase. However, on-site training of the QMS usually takes 3 days and is included in the price of the QMS.
  • The majority of clients take both the QMS and the TFT, in which case, training on both systems can be integrated and normally takes 5 days to complete.
  • For companies based in the UK, training and payment may be staggered over several months to fit in with your product development cycle and to provide the right documents at the right time. Training outside the UK is typically performed over a 5 day block with further training over video conference in the months that follow.

 

What is ISO 13485?

ISO 13485 is a standard that describes the Quality Management System for design and manufacture of Medical Devices (including IVD’s).

 

Why gain certification to ISO 13485?

Both the Medical Device Regulation (EU MDR 2017/745) and the In Vitro Medical Device Regulation (EU IVDR 2017/746) require a company to show conformity to the Essential Requirements by developing new products within a Quality Management System. Although they do not specifically mention ISO 13485, it is the route taken by most companies.

ISO 13485 is applicable to any company developing, manufacturing and/or marketing medical devices. Gaining this standard helps companies demonstrate they understand the relevant regulatory requirements and so can be an important tool for increasing the value of a company or product and this in turn can lead to increased investment if this is necessary.

 


Contact us today to see how we might help you!.