What is the opportunity-cost alternative and benefit to conducting a ViVitro Labs supplier external audit?

The ViVitro Labs ISO 17025 accredited QMS combined with proven internal processes enables clients to chose an opportunity-cost benefit that uses an alternative to an external audit and allows them to allocate their external audit resources and efforts towards more risky critical suppliers and processes.

Using the combination of ViVitro’s ISO 17025 accreditation, robust quality agreements with a project specific quality questionnaire is generally sufficient to meet ISO 13485 requirements for evaluating, selecting and monitoring critical suppliers. It sufficiently mitigates risks related to in-vitro performance test data on pre-clinical samples and eliminates the need for a separate critical supplier audit of ViVitro Labs.

The requirements for evaluating, selecting and monitoring critical suppliers are covered in ISO 13485:2016, especially in relation to section 7.4 – Purchasing. ISO 13485:2016 does not explicitly require systematic on-site audits (external audits) of critical suppliers by customers nor does it provide guidance on external audits of critical suppliers. As a result, organizations around the world have put various processes in place to evaluate, select and monitor critical suppliers while maintaining compliance with ISO 13485 requirements.

If the client QMS does not require an audit of critical suppliers and agreeable to using a quality agreement or a quality questionnaire, then evaluation, selection and monitoring of ISO 17025 accredited critical suppliers like VIVITRO LABS can be achieved by referencing the supplier’s accreditation certificate, establishing a quality agreement and responding to a comprehensive quality questionnaire.

VIVITRO LABS works with clients to complete quality questionnaires and develop quality agreements adapted to contract testing laboratory activities.  Details and pricing are included in all ViVitro Quotes and Sales Agreements.

VIVITRO LABS provides test equipment and contract testing services to small and large medical device manufacturers for over 40 yrs. In order to meet the quality levels required by ISO 13485, VIVITRO LABS contract testing services are conducted under an ISO 17025 accredited QMS which is monitored and annually audited by A2LA, a US based, internationally recognized registrar. The scope of VIVITRO LABS ISO 17025 accreditation is covered by two certificates which relate to Victoria and the Marseille laboratories activities, respectively.

Ask your local Business Development Manager for details and options when discussing your project quote and statement of work.

 

 

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