Back in march we wrote a blog discussing our aspirations to obtain the ISO 13485: Medical Devices standard. The tasking process behind obtaining this is testament to the effort we put in to our systems management and quality policy.
What is ISO 13485:Medical Devices?
ISO 13485 specifies standards and requirements for a quality management system that can be used by any organisation that has anything to do with the design / manufacture of a medical device in any stages of it’s life cycle. This also ensures that an organisation conforms to the regulations of the standard set by the body. These regulations must be identified in the QMS (Quality Management System).
What is considered a Medical Device in ISO 13485?
For a business to successfully comply with the regulations outlined in ISO 13485, there are aspects of the business that must be relevant to the standards being set. Any development, manufacture, design of medical devices at any point in it’s lifestyle can be justified to implement this accreditation into your QMS. Organisations looking to comply with the regulations are required to plan and outline a complete product realisation plan, ensuring this identifies requirements for design and development of product procedures. Other aspects covered by this accreditation are as follows:
- In-vitro reagents
What regulations do we have to comply with?
Any regulatory standard is heavily integrated into an effective quality management system. This system is managed by a quality manager, in our case, Graham Bayliss. Grahams job is to ensure that procedures carried out at ReAgent that are relevant to our multiple accreditation outlined in our QMS. Carrying out these activities needs to show how activities are implemented and controlled using a risk based approach. The QMS must be documented in a Quality Manual, and each accreditation is documented separately within that.
We must establish our commitment to the quality management system, this includes outlining quality objectives for the whole company. Management have to define responsibilities and authorities to organise and manage these systems, in accordance with the regulations set.
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