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 consultants across the UK, our tailored consultancy services provide support implementing, maintaining and continually improving management systems in line with ISO 13485 requirements.

ISO 13485:2016 outlines a framework for organisations within the medical device sector, inclusive of suppliers and external parties. The QMS requirements are designed to compliment the technical requirements of the product.

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. ISO 13485, which is based upon ISO 9001, encourages a process approach to quality management.

Implementing ISO 13485 within an organisation has various benefits including, but not limited to:

  • 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

In addition to providing ISO 13485 Consultancy and ISO 13485 training courses, we offer a variety of business improvement and related training courses aimed at helping organisations to improve their management systems, products and services including:

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

ISO 13485 Gap Analysis

ISO 13485 Gap Analysis

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 we will provide a full written report with the findings which can then be used to develop an ISO 13485 implementation plan.

Auditing ISO 13485

Auditing Against ISO 13485

Internal audits and pre-assessment audits can determine whether your management system is effectively implemented and maintained.

Our 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.

Developing ISO 13485 Documentation

Developing Documentation

ISO 13485 requires organisations to develop documentation including a quality policy and document procedures such as procedures for the management review.

Our 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.

ISO 13485 Auditor Training

ISO 13485 Training Courses

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.

Continually Improving the QMS

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.

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