Our ISO Services range from
Assistance with ISO Quality Manual preparation
Preparation of
ISO 13485: 2016 Internal Audit Services for Hospitals
We can provide a full on site audit of your compliance with ISO 13485: 2016 including:
- Document review
- Observational audit of process flow and compliance with standards
- Advice on ISO 13485 : 2016 documentation wording
- List of mandatory documents to evidence compliance with ISO 13485: 2016
- Detailed report of compliance with percentages, RAG charts and identification of non-conformities
- Gap analysis and action plan to achieve full compliance
Experienced ISO 13485: 2016 Auditors
Our auditors have a working knowledge of the most up to date NHS guidelines and standards and will provide advice and guidance with reference to:-
- 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)
- 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
This internal audit will assist identification of risks and training requirements, assess practice in relation to safe the safe management of reusable invasive medical devices and evidence your compliance with ISO 13485:2016 standards.
Medical Audits ISO 13485:2016 compliance audit of management of reusable invasive medical devices (RIMDs) also includes:
✔ Standards for unit layout
✔ Water quality management
✔ Cleaning of RIMDs
✔ Inspection of RIMDs
✔ Storage of RIMDs
✔ Auditing of tracing and tracking processes
✔ Staff training and education assessment
✔ Maintenance programmes for washer /disinfectors and autoclaves
✔ Physical observational audit of compliance in the department
See more information about other services and audit software from Medical Audits
Professional Services
Independent cleaning audits
Pre accreditation auditing services – HIQA, JCI, CQC etc.
Infection Prevention consultancy services
Specialist Infection prevention training programmes
Tender support and preparation for cleaning and Infection Prevention services
Bespoke audit software design service
Audit Software
Decontamination Standards audit tools
Endoscopy standards audit system
Audit and Quality Assurance Software for hospitals
Environmental Hygiene audit tools
Hand hygiene auditing software
Clinical Audit software