ISO 13485 implementation | Plan & Guide

Do you require a reliable and experienced partner to implement your ISO 13485 Quality Management System (QMS)?

ISO 13485 is the QMS standard for medical device manufacturers, distributors (MDR Requirement), importers and designer/developers. Our Quality Assurance (QA) consultants have the background, experience, and qualifications necessary for implementing Quality Management Systems, that can be customised to any organisation.

At the beginning of your ISO 13485 implementation, we are able to provide a clear and concise Project Management Plan to assist you with the process from start to finish.

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

Q: How does the ISO 13585 implementation service work?

A: The service is flexible, and we pride ourselves on our ability to adjust our working style to fit our customer’s needs. As a standard, we set up weekly virtual meetings, update/review the project management plan and communicate via email/phone when/if further information is required by both parties.

Q: How long does implementing the QMS take?

A: We usually set the timeframe of 8 to 12 weeks for full implementation. This gives you, the client, and the assigned QA representative enough time to ensure adherence to the ISO 13485 standard.

Q: Will you be able to aid us on the Certification/Notified Body process?

A: Yes – we have helped multiple companies with the certification process and notified body application. Patient Guard aim to deliver the highest level of customer satisfaction and aftercare support on all our services, to ensure you are confident for your external audit.

Q: What are the main aspects to consider when implementing ISO 13485?

A: The main areas of your business’ activities that are covered in the scope of ISO 13485 include:

  • Establishing a quality manual, the management of software used within the QMS and defining your document/ change control processes (Clause 4)
  • Review of management responsibilities and QMS planning, such as setting a quality policy and objectives. This also sets out the process required for management review meetings (Clause 5)
  • Management of employee training and qualifications, ensuring your HR records are sufficient for compliance (Clause 6)
  • Monitoring the product/ service or software related activities such as goods in inspection, supplier evaluation, purchasing activities, design and development, risk management etc… (Clause 7)
  • Continual improvement via non-conformances and CAPAs, handling customer complaints/ feedback and your internal audits (Clause 8)

If your company requires ISO 13485 Implementation, please get in touch for more information.

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