Audit and Assessment of Compliance with ISO 13485 (2016) Medical devices — Quality management systems

Professional Healthcare Audit and Advisory Services

Across the UK and Ireland, National standards recommend that central decontamination units (CDU) maintain accreditation with EN ISO 13485 (2016).

Medical Audits Clinical Team can provide your organisation with an independent, professional audit of your compliance with ISO 13485(2016), Quality Standards.

This International ISO 13585 Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

While this is a stand-alone standard, it is based on ISO 9001:2008, which has been superseded by ISO 9001:2015

Decontamination Audit Requirements for Acute Hospitals

The ISO 13485 standards require organisations to carry out regular audits of the Central Decontamination Unit and Endoscopy unit to ensure standards are met and to identify any risks in either processing or management of invasive medical devices.

These internal decontamination audits should be carried out using an audit based on the most up to date best practice standards and guidelines.

All the relevant stages of the decontamination life cycle of reusable invasive medical devices should be included in the audit process to ensure compliance with best practice.

Staff Resources relating to ISO 13485 Decontamination standards Auditing

For organisations who have resource issues related to completing decontamination audits or have staff training needs in the ISO 13585 decontamination standards, our External auditing services are hugely advantageous.

External audits of decontamination standards also further quality assure the decontamination process and decontamination audits.

' We used the services of Medical Audits to carry out a full audit of our ISO13485 quality system and processes. This was the first time we used them and the entire process was very professional and the feedback / reports provided were very detailed and provided assurances of our systems.

The auditor was very knowledgeable and the software used to carry out the audit was extensive and provided all the key information required.

The supporting documentation received after the audit was excellent and will be critical when providing evidence to our Notified Body. Will be more than happy to use their services again. '

Neville Fowler MIDSc (Chtd)
Technical Manager , Sterile Services
Guy's and St Thomas' NHS Foundation Trust

External Decontamination Audits of ISO 13485 Quality standards for Medical Device Decontamination Units

This external decontamination audit will assist identification of risks and training requirements, assess practice in relation to safe management of reusable invasive medical devices and help you evidence your compliance with relevant endoscopy unit and Reusable Invasive Medical Device (RIMD) standards.

The audit will include:

✔ Role of decontamination officer
✔ Infection Control oversight of decontamination processes
✔ Standards for endoscopy unit layout
✔ Standards for Central Decontamination Unit layout
✔ Management of reusable invasive devices across the facility
✔ Cleaning of reusable invasive medical devices
✔ Disinfection and sterilisation of medical devices
✔ Traceability standards for medical devices
✔ Staff training and education
✔ Maintenance of washer /disinfectors and autoclaves
✔ Monitoring compliance in clinical and procedure rooms

Included in our Decontamination Audit is Assessment of Compliance with other Relevant Decontamination Standards Including:

  • Health Service Executive Standards and Recommended Practices for Central Decontamination Units (HSE, 2011)
  • Code of Practice for Decontamination of Reusable Invasive Medical Devices (HSE,2012).
  • BSG guidance on decontamination of equipment for gastrointestinal endoscopy : the report of a working party of the British Society of Gastroenterology Endoscopy Committee (British Society of Gastroenterology, 2014)
  • Guidelines for the Prevention and Control of Infection from Water Systems in Healthcare Facilities ( Health Protection Surveillance Centre, Ireland, 2015)
  • Standards of infection prevention in reprocessing flexible gastrointestinal endoscopes, (Society of Gastroenterology Nurses, 2016)
  • Joint Advisory Group on Gastrointestinal Endoscopy (JAG) accreditation standards for endoscopy services 2015
  • Health Technical Memorandum 01-01: Management and decontamination of surgical instruments (medical devices) used in acute care (2016)
  • Health Technical Memorandum 01-06: Decontamination of flexible endoscopes (2016)

Medical Audits Also Provide Decontamination Audit Software Systems – For information on these systems, click the links below: