Attributes
| Name: | ISO 13485 Assurance Program |
| Criteria: | ISO 13485 and Client Charter |
| Market: | All organizations involved with medical devices |
| Scope: | International |
| Output: | Certificate of Confidence |
| Validity: | 3 years, subject to on-going requirements |
| Outcome: | Certification gives confidence to the organization, its customers, regulators and/or other interested parties in the ability to effectively manage the design, manufacturing, supply and distribution of medical devices. |
Background
ISO 13485 is the international standard for quality management systems (QMS) for medical devices, establishing a framework for organizations to demonstrate their ability to consistently provide medical devices and related services that meet customer and regulatory requirements. It is a foundational standard for market access globally, helping ensure patient safety and product quality through a rigorous, process-based approach that covers the entire medical device life cycle.
The process
As an organisation, the steps involved for you are:
- Applying for certification:
Review and accept our customised Proposal, and you’re underway! - Achieving certification:
Firstly, a pre-certification audit or “test run” will be conducted either on-site (at your premises) or off-site (at our premises) or both, to see whether your management systems are suitable. Areas of concern will be reported. Once concerns have been actioned, an on-site certification audit will be conducted, where we will examine the extent to which you address the program criteria. Areas of concern will be reported. Once we are satisfied there are no outstanding issues that present an unacceptable risk to you, your employees, customers, regulators, Equal Assurance or others, we can proceed to issue a Certificate of Confidence. Well done! - Maintaining certification:
Depending on the level of risk, we will conduct a series of surveillance audits (and in some cases special and follow-up audits) and tri-ennial re-certification audits, to examine the extent to which you continue to address the program criteria. Areas of concern will be reported. So long as we continue to be satisfied there are no outstanding issues that present an unacceptable risk to you, your employees, customers, regulators, Equal Assurance or others, your certification remains valid.
Your next step
Click the link below to contact one of our Account Managers who will prepare a Proposal Form at no cost.