Organization
A good laboratory should be accredited. There are several organizations that perform the accreditation using international or local standard. Examples of the standards are ISO (International Standard Organization), EN (European Norms). In the country level, examples of accreditation bodies are Belac (Belgium) and CCKL (The Netherlands).
The standards have numbers, for example ISO 15189 which is the standard for clinical laboratory. There are also other standards for laboartory in general.
What does a lab need?
In general two things:
1. Quality hand book.
This is a 'translation' of the standard. It consists of management and technical chapters.
2. Quality coordinator.
How does it work?
A team of 3 to 5 auditors come to visit the lab. They will asses the standard of procedures (SOP), talk to the lab and the quality coordinator and examine the practical aspects (pre-, analysis, and post-analysis). The auditors request the lab beforehand to perform several test that the auditors are going to examine.
How long is an accreditation valid?
The accreditation body can give remarks. For example A (meaning that immediate action is needed), B (action is needed but not immediately) and * (meaning the remarks might be subjective from the auditors. Accreditation is given for in general 3 to 5 years.
A good laboratory should be accredited. There are several organizations that perform the accreditation using international or local standard. Examples of the standards are ISO (International Standard Organization), EN (European Norms). In the country level, examples of accreditation bodies are Belac (Belgium) and CCKL (The Netherlands).
The standards have numbers, for example ISO 15189 which is the standard for clinical laboratory. There are also other standards for laboartory in general.
What does a lab need?
In general two things:
1. Quality hand book.
This is a 'translation' of the standard. It consists of management and technical chapters.
2. Quality coordinator.
How does it work?
A team of 3 to 5 auditors come to visit the lab. They will asses the standard of procedures (SOP), talk to the lab and the quality coordinator and examine the practical aspects (pre-, analysis, and post-analysis). The auditors request the lab beforehand to perform several test that the auditors are going to examine.
How long is an accreditation valid?
The accreditation body can give remarks. For example A (meaning that immediate action is needed), B (action is needed but not immediately) and * (meaning the remarks might be subjective from the auditors. Accreditation is given for in general 3 to 5 years.
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