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

Bespoke Quality Management Systems – A Tailored Service

After understanding your 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.
  • A Gap Analysis Report will detail our findings and recommend future action.
 

Quality Procedures

  • Following the results of the Gap Analysis, we will develop the Quality Policy and a Quality Manual that is appropriate to your business and write all necessary procedures.
  • A typical QMS includes approximately 50 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 and the experience of your current employees. However, on-site training of the QMS usually takes between 1-3 days and is included in the price of the QMS.
  • For companies based in the UK, training can be staggered across one month and would normally be performed 1 day / week. Training outside the UK is typically performed over a 3 day block.

 

What LRQA reported about our QMS following a successful ISO 13485 audit for one of our clients:

"The functioning of the QMS is considered in no small way to have supported the organisation’s success in its two years of existence.  The primary goal of achieving customer satisfaction to secure repeat business is underpinned by a commitment by the staff to a system that works for them.  The structure and organisation of the QMS has no doubt assisted the small team in achieving a lot in a relatively short space of time." (LRQA Stage II Audit, July 2015)

 

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 accreditation to ISO 13485?

Both the Medical Device Directive (MDD 93/42/EEC) and the In Vitro Medical Device Directive (IVDD 98/79/EC) 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!.