Laboratory and Medical ISO Accreditation

In an industry tied down with red tape and regulations, laboratory accreditation is vital to prove your processes stand up to scrutiny and your organisation is achieving the highest standards.

Covering the whole gamut of medical testing and research facilities, ISO standards that are specific to this sector can add the magic of certification to the science of your operations. Whether your work features elements of scientific methods, sample analysis or other aspects of a lab setting, ISO medical accreditation can bring tangible benefits.

These include:

• Increasing efficiency for day-to-day tasks
• Proving the quality and competence of your operation
• Delivering reliable and repeatable results in areas such as testing
• Improving the accuracy of the records you make and store.

Proving quality across many branches of science

Our highly skilled team of Qualitators works with organisations that want to achieve accreditation/certification by focussing on three main medical ISO standards covering lab-based science and healthcare organisations.

ISO 17025, also known as Laboratory Competence and Calibration, covers lab testing and creates a standard framework for robust results. Any business that undertakes activities that include science-based measurements in order to determine an outcome – including sampling and calibration – is likely to benefit from achieving ISO 17025. It is therefore equally applicable to engineering companies and not just science-based organisations.

Meanwhile, ISO 15189 – based on ISO 17025 – was specifically designed with medical laboratories in mind. It was devised to uphold standards in medical lab environments, reflecting the importance of high-quality provision of scientific services as part of the treatment of patients.

Related to this is the ISO 14971 “Application of Risk Management to Medical Devices” standard – this focuses on the risk management techniques behind ISO 13485. While it may not always be needed as a separate standard, it is one that supports ISO 13485 and should be created and installed without reference to the ISO 14971 standard

Finally, ISO 13485 covers the market for medical devices. It draws on the quality management standards laid down in ISO 9001 Quality+ with a focus on helping businesses meet customer expectations. Our team can also help set up CE Marking processes for organisations relating to certain medical devices – just ask us for details.

Laboratory and Medical Industries

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