Why use an ISO 17025 Accredited Laboratory?

A common question from new clients is “Do I need to use ISO 17025 accredited laboratory, or can I rely on data from any laboratory?”   Both R&D and regulatory submissions of medical devices require accurate and reliable results. Using a technically competent laboratory minimizes the risk of developing or supplying a faulty medical device due to incorrect testing data or procedures.

Laboratory accreditation provides means of evaluating the technical competence of laboratories to provide specific test as listed on the scope of accreditation.   Accredited laboratory providers need to conform to the technical requirements of ISO 17025.  These include (but are not limited to):

• Suitable testing facilities
• Specific staff qualifications, training and experience
• Equipment fit for the purpose of testing – properly calibrated and maintained
• Traceability of measurements to national standards
• Adequate quality assurance (QA) procedures
• Ongoing internal auditing by independent QA personnel
• Appropriate and validated test methods
• Accurate recording and reporting procedures
• Inspections by accredited bodies every 2 years
• Participation in Proficiency Testing

ISO 17025 accreditation is internationally adopted via Mutual Recognition Agreements (MRA) between countries. This means is the data provided by an ISO 17025 accredited laboratory is more readily accepted in overseas markets then data from a non- accredited laboratory.

Testing of products and materials can be expensive and time consuming, even when done correctly.  If not done correctly, the cost and time involved in re-testing can be even higher if a product has failed to meet specifications. Not only do costs go up, but a manufacturer’s reputation can go down.

Choosing a technically competent and accredited laboratory minimizes the chance of retesting being required or faulty product being shipped.  ViVitro Labs ISO 17025 accreditation helps save time and reduce risk.  Our clients are generally developing heart valves and need to minimize time to the market; or they are testing heart valves already in production and can be held liable for any failure in the field that involves patient safety.