Certification Body / Approved Body services
As a start-up Certification or Approved Body, it can be a tough ask to develop your legal entity, open an office, hire staff AND implement a fully compliant, accredited quality management system (QMS).
Fully versed in ISO/IEC 17021 and ISO/IEC 17065 series of standards and with an in-depth knowledge of UKAS processes, Peritus can help you navigate the path to accreditation. Choose from any combination of the following services:
- Full QMS implementation
- Gap analysis of a draft/existing QMS
- Document review and approval service as part of your document control procedure
- Internal audit
- Facilitation of a management review
- Auditor training (Internal and 3rd party)
- Support during a UKAS audit
Manufacturers QMS services
When trying to design a QMS to meet the requirements of either ISO 9001, ISO 13485, MDSAP as well as UK and EU regulatory requirements, it can be a challenge to balance the needs of the regulators with the pragmatic needs of the business.
Peritus have many years of hand-on operational and 3rd party audit experience of medical device manufacturers. We can ensure that your QMS is streamlined and simple to use whilst meeting the requirements of the selected standards.
You can combine any of the services listed below with additional services from our technical selection
- Full QMS implementation
- Gap analysis of a draft/existing QMS
- Document review and approval service as part of your document control procedure
- Internal audit
- Facilitation of a management review
- Internal auditor training (service under development)
- Support during a Certification Body audit