We help you to achieve the ISO 15189 standard

Take a step further along the road to quality in your laboratory.

At GSC we want to work with you side by side, and put our resources and technical team at your disposal to help you achieve UNE-EN ISO 15189 accreditation, an international standard based on the ISO/IEC 17025 and ISO 9001 standards. It enables clinical laboratories, specialised in any field (biological, microbiological, immunological, chemical, immunohaematological, haematological, biophysical, cytological, pathological, etc.), to assess their quality management system and technical competence.

Demonstrate your quality and competence

Achieve UNE-EN ISO 15189 with GSC

At GSC we put our team of consultants with extensive experience in the sector at your disposal. Our own staff have been successfully involved in the implementation of systems in different types of laboratories for more than 25 years through our auditing and consultancy service.

What differentiates us?

  • We adapt to the specific needs of each client, giving them the service they need at all times.
  • Our experience in auditing and consultancy allows us to define, if necessary, a reorientation of your Quality System, giving you practical and simple guidelines to do so.
  • We provide you with up-to-date information on applicable regulations to anticipate changes and help you understand and implement them.

We also help you to achieve other accreditations or certifications through our auditing and consultancy services. We can help you achieve your goals.  

Frequently Asked Questions about UNE-EN ISO/IEC 15189

The accreditation of this standard is applicable to clinical laboratories involved in biological, microbiological, immunological, chemical, immunohaematological, haematological, biophysical, cytological, cytological, pathological analysis etc.

In these cases, accreditation would not be possible because such tests are not considered clinical, but they could be accredited under ISO 17025 standard.  
The two standards include both management and technical requirements, although the main difference is that their scope of application is completely different. The first applies to testing and calibration laboratories and the second applies to clinical laboratories that analyse biological samples of human origin. As such, each of these standards indicates different specific requirements.
For example, ISO 15189 includes requirements for analytical methods, as is the case for ISO/IEC 17025, however, it also includes aspects for pre-analytical methods that ISO/IEC 17025 does not cover.  

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