Accreditation & Validation Flashcards
What two accreditations do labs require?
9001- data management systems
17025- competence testing and calibration
Define accreditation
External validation of methods and correct procedures are being followed. Assessment of how a lab functions by assessing technical competence and integrity of the organisation
What is ISO 9001?
Not scientific competence assessment
Sets out the requirements of a quality systems management for all areas of the business: Facilities Training People Equipment Services
Checks that all paperwork flows through the lab, correctly managed and things in place to deal with complaints
What is ISO 17025?
Requirements for competence of testing and calibration labs.
-mandated by FSR
Ensures you are technically competent and are able to produce precise and accurate test/calibration data.
Appropriate recording of measurements Valid processes Testing of suitable equipment Calibration of equipment Staff competence
Ensures everything has paperwork, it’s being filled out correctly and there are systems to trace things back: such as machine results, who prepared standards that day, what reagents? What batch?
What is now accredited that wasn’t previously? How do you get it?
17025 - opinion can be accredited
As long as you can back up what you have done/said, you meet the criteria.
Define Validation.
Any method used for analysis is fit for the specific purpose it is intended, so results can be relied upon
Who’s responsibility is it to make sure processes are validated?
The forensic service provider, the accreditation service will oversee this
When should the forensic science regulator be informed of the intention to implement. A new method?
If the new method:
Uses science not previously used in the uk
Employs the use of a previous method in a new field
Analysis of the criminal justice system suggests significant change capabilities.
