QMS Support Services

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 oversee the processes involved with your QMS. Patient Guard offer a QMS Support Service 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 one employee, struggle to find a suitable person for this role or do not require a QA Manager on full-time payroll. Having Patient Guard’s continued support allows you to utilise an expert in Quality Assurance monthly and to ensure your continuous compliance.

We offer two QMS support packages which can be chosen by clients to meet the level of support they require within their businesses.

QMS Support Level 1

A yearly Quality Assurance plan will be drawn up at the start of the service.

The time spent with our QA specialists can be allocated to assist you with any of the following areas as needed:

  • Assistance with your Management Review Meetings
  • Reviewing your QMS procedure to ensure they are up to date
  • Administrative tasks such as document and change control
  • Implementing risk management methods for QMS and business risk monitoring
  • One full system Internal Audit per year
  • Assistance with your annual certification body surveillance audit

QMS Support level 2

A yearly Quality Assurance plan will be drawn up at the start of the service to ensure we cover all grounds required to meet your QMS obligations. You may choose to focus on different areas with us each month, no matter what challenges you may be facing with your QMS we are here to help.

The time spent with our QA specialists can be allocated to assist you with any of the following areas as needed:

  • Assist you with your Management Review Meetings
  • Help with CAPA implementation and resolution
  • Assisting with non-conformance reporting, investigation, and closure
  • Working on achieving your continual improvements issued against the system
  • Logging, reviewing, and investigating customer feedback and complaints
  • Keeping up to date records
  • Setting and achieving ‘SMART’ quality objectives
  • Reviewing your QMS procedure to ensure they are up to date
  • Conducting GAP assessments
  • Assistance with supplier evaluation and monitoring
  • Supporting you through the requirements for Measurement and Analysis and Post Market Surveillance
  • Assisting with QMS and Quality training needs
  • Administrative tasks such as document and change control
  • Implementing risk management methods for QMS and business risk monitoring
  • Assisting with design and development documentation requirements
  • Multiple Internal Audits against your system
  • Support during your External Audits

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

Get your free consultation today