ISO 15189 is designed for medical laboratories to achieve competence.
It is also designed to attain sound scientific practice, in their day to day operations.
Similar in scope to ISO 17025 but adapted specifically for laboratories in medical industries, this standard is relevant whenever your business is relying on taking measurements, conducting experiments and assessing scientific outcomes that relate to your own or others’ operations.
Designing, developing, producing or selling into the medical industry.
If you’re designing, developing, producing or selling into the medical industry and have any involvement in scientific or lab-based work then this standard will help to ensure that your work is demonstrably reliable. This can be essential when selling into the highly regulated medical industry, and holding the standard sends a clear message to your customers that you have your processes in order.
To achieve this accreditation you’ll need to show that your laboratory processes are recorded, repeatable, controlled and error assessed. A regular procedural audit review is a requirement and has to feed into management level reviews.
In a similar fashion to the ISO 17025 standard, the ISO 15189 standard is only assessed and accredited in the UK by the UK Accreditation Service (UKAS).