Audit Software to enable local assessment of compliance with ISO 13485 (2016) Medical devices — Quality management systems

Medical Audits Provide Quality Assurance for Decontamination Processes

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

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.

Decontamination Audit Requirements for Acute Hospitals

The ISO 13485 standards require organisations to carry out regular audits of the Central Decontamination Unit, Sterile services departments 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.

Carry out your own Decontamination Audits of Standards Related to the Management of Reusable Medical Devices

The audit software has been developed by Healthcare Professionals and experts in decontamination standards to assist you to:

  • Identify risks and training requirements related to decontamination of reusable invasive medical devices (RIMD)
  • Assess practice in relation to safe management of reusable invasive medical devices
  • Evidence your compliance with relevant endoscopy unit, sterile services and Reusable Invasive Medical Device (RIMD) standards.

The audit system includes:

✔ 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 reusable invasive medical devices
✔ Traceability standards for reusable invasive medical devices

Providing you with local evidence of compliance with decontamination standards as well as a method of identifying risks and non-conformances related to Sterile services and Endoscopy services.

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

  • BS EN ISO 14971:2019: Medical devices – Application of risk management to medical devices.
  • HBN13 – Health Building Note 13 for Sterile Services
  • BS EN ISO 13485:2016 Quality Management Systems - Requirements for regulatory purposes.
  • BS EN ISO 15883 Parts 1 & 2 Washers Disinfectors
  • UK MDR 2002 (amended).
  • IDSc Standards and Practice Guide to Good Manufacturing for the NHS.
  • BS EN 285 – Porous load sterilizers (Validation)
  • HTM 01:01 Management and decontamination of surgical instruments (medical devices) used in acute care (2016)
  • HTM 01-06 Decontamination of flexible endoscopes (2016)
  • BS EN ISO 14644 Clean Rooms and Associated Controlled Environments. (Part 1 2015, Part 2 2015, Part 4 2001)
  • 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

For more information on Medical Audits services related to Decontamination click the links below:

Community Care

Medical Audits Systems Support
Safe Decontamination Practices


Health Service Executive Code Of Practice For Decontamination Of Reusable Invasive Medical Devices
Health Technical Memorandum 01-06: Decontamination Of Flexible Endoscopes
Health Technical Memorandum 01-01: Management And Decontamination Of Surgical Instruments (Medical Devices) Used In Acute Care