ISO 13485 is an international standard which details the requirements for a quality management system (QMS) for organisations involved in one or more stages of the life-cycle of a medical device.
With over 35 years’ expertise, and ISO 13485 consultants across the UK, our tailored medical device consultancy services provide support implementing, maintaining and continually improving QMS management systems in line with ISO 13485.
The standard is designed to allow organisations who provide medical devices and related services to demonstrate that they will consistently meet customer and regulatory requirements.
Organisations which may conform to ISO 13485 include those who design, develop, produce, store, install and dispose of medical devices. The standard can also be used by suppliers or external parties who provide products to organisations, for example those supplying raw materials or components of a medical device or calibration services.
- consistently providing products and services which meet customer expectations and regulatory requirements
- continually improving processes, products and services by identifying improvement opportunities and acting upon them
- effectively managing risks
- ensuring traceability, for example by records of materials and work conditions
- securing more contracts due to enhanced credibility
Risk Analysis and FMEA for Medical Devices – based on ISO 14971 – This two day course examines examines all steps of the risk management process focusing on risk analysis and Failure Mode and Effects Analysis (FMEA) for medical devices and the requirements of ISO 14971.
Root Cause Analysis Training – Designed to teach delegates tools and techniques to investigate the root causes of problems or failures and evaluate solutions to prevent chronic and recurring problems.
Leadership and Management Training Courses – Highly beneficial for organisations seeking to ensure their management team are equipped with the skills to influence and implement change effectively, our leadership and management courses can be tailored to meet your organisations requirements.
How we can help
One of the first steps to achieving ISO 13485 certification is to assess how closely your current system meets the requirements of ISO 13485. This can be achieved by performing a gap analysis.
When undertaking a gap analysis our consultant will provide a full written report with the findings which can then be used to develop an ISO 13485 implementation plan.
Internal audits and pre-assessment audits can determine whether your management system is effectively implemented and maintained.
Our medical device consultants can undertake the full audit process for you, from preparing for and conducting the audit to providing a report highlighting nonconformities and opportunities for improvement.
ISO 13485 requires organisations to develop documentation including a quality policy and document procedures such as procedures for the management review.
Our ISO 13485 consultants can provide support in creating and reviewing your documentation and provide guidance on additional documentation which can assist in the continual improvement of your management system.
Providing employees with an understanding of ISO 13485 and the skills to audit against ISO 13485 can assist with the successful implementation of the QMS.
Our ISO 13485 training courses include our Introduction to ISO 13485 for Medical Devices and our ISO 13485 Internal Auditor training courses which are available at your premises, online and at venues across the UK.
Nonconformities & Corrective Action
During a certification audit the level of an organisation’s conformity to ISO 13485:2016 is determined.
If nonconformities were identified during your audit our consultants can provide support identifying the root cause and recommend corrective actions to ensure the results of these actions meet with the ISO 13485 requirements.
Speak to us
If you would like to speak to someone about how we can support your organisation call our team on 0333 123 9001 or contact us.
Sheffield Hallam University|30th Jul, 2021
Omega Diagnostics Group Plc|29th Jul, 2021
Scapa Healthcare Ltd|29th Jul, 2021
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Agilitas IT Solutions Limited|27th Jul, 2021