Quality Management Representative

Once your Quality Management System (QMS) is certified, there are requirements for you to ensure you pass your yearly surveillance audits and maintain, monitor and improve your system to the certified standard.

It is easy to fall behind on the administration and a progressive struggle to find an in-house Quality Assurance (QA) Manager to effectively oversea the processes involved with your QMS. With this in mind, Patient Guard offer a Management Representative service where we would act as your 3rd party QA Manager, to work with you on your QMS and to ensure you are compliant/adhering to the ISO standard.

It is very common for many start up, micro or small companies to only have 1 employee, struggle to find a suitable person for this particular role or do not require a QA Manager on full-time payroll. Having Patient Guard as your appointed Management Representative allows you to utilise an expert in Quality Assurance on a monthly basis and to ensure your continuous compliance.

Here are a few commonly asked questions regarding our ISO 13485 Implementation service;

Q: What areas of the QMS are you able to help us manage?

A: Some of the aspects of your QMS we would aid you on include:

  • Management review meetings
  • Raising non-conformances and issuing CAPAs
  • Working on continual improvements issued against the system
  • Logging and reviewing customer feedback and complaints
  • Keeping up to date records
  • Setting and achieving ‘SMART’ quality objectives

Q: How is this service delivered each month?

A: We deliver this service to suit your company’s individual needs and ways of working. Methods of delivery may include:

  1. Virtual meeting platforms
  2. Granted access to your e-QMS system
  3. E-mail and telephone communications
  4. Reviewing documents offline
  5. Recurring weekly workshops with our QA experts

Our Management Representative service offers support and assistance with the above and the overall standard of your QMS. You will receive expert advice and support with this monthly service.

If you would like to discuss this service with us, then please contact us for more information.