Introduction:
A Hertfordshire business, specialising in plastic injection moulding and associated tooling production had ambitions to win work in the medical device market. To achieve this, the management recognised that compliance and certification of their quality management system to ISO 13485 was required. WLP were asked to help carry out the necessary changes and position the business for certification by a UKAS accredited certification body.
What We Did:
- Conducted a baseline gap analysis against BS EN ISO 13485:2016 to identify improvement areas. Based on this, we developed an action plan to achieve certification, defining the project scope.
- Provided support to ensure understanding of key concepts and assisted in implementing and modifying documented procedures and records as required by the standard. Changes were introduced to the management system, covering design and development planning, inputs and outputs, review, verification, validation, and change management.
- Introduced new processes and documentation related to the work environment and contamination control, including sterilisation and cleanliness records. A review of regulatory requirements was conducted, and a new integrated quality manual was created to streamline documentation. We remained engaged throughout, offering continuous support until certification was successfully achieved.
Results:
Having the certification, the company is able to demonstrate a commitment to high-quality production and compliance, and has made the company a more attractive partner with potential customers in the medical device sector.