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ISO 13485:2016

ISO 13485 is the medical industry’s optimal medical device standard, which ensures that all medical devices meet the proper regulatory compliance laws and customer needs.  This standard allows companies to reduce safety and legal risks while creating more economical work environments.

Turnstone will liaise with available certification companies to find the best option for your organisation, we will take all the fuss out of seeking ISO 13485 certification by helping you through every step of the process.

Our team will carry out an internal ISO 13485 Compliance Audit, specifically adhered to each clause within the ISO 13485 standard in which you are applying for. This internal audit will measure the performance of your existing systems and procedures. We will then provide you with a comprehensive report of our findings, together with easy-to-understand guidance on how to deal with any shortcomings we identify and make ongoing support available to help you implement any necessary improvements prior to the external ISO 13485 certification audit.  We can also integrate this system with your existing systems or any of the other ISO standards you wish to become certified to.

We can help you with the development, edits, and/or implementation of:
  • ISO 13485 Bespoke Management System and Procedures
  • ISO 13485 Gap Analysis
  • Scope of the Business
  • Organograms Charts
  • Policy Statement
  • Medical Device Document
  • Contamination Control
  • Supplier Documentation Review
  • Measuring and Monitoring Documents
  • Risk & Opportunities Registers
  • Emergency Response Plans
  • Bespoke customer schedule to manage equipment and resource expiry dates
  • Training Records and Matrixs
  • Bespoke Training Programme
  • ISO 13485 Awareness training
  • Liaise with external and 3rd parties on behalf of the client.
  • Audit programme and internal audits including compliance and process-based audits
  • Continual improvement reviews i.e., implementing improvement suggestions in relation to efficiency and compliance which will add value to the business
  • Identify nonconformances and assign preventative and corrective actions
  • Chairing and minuting of Management Review meetings
  • Client Portal for easy access to all documents
  • Forms as required by the company, on the requested forum.