Accreditation Flashcards
What is accreditation?
The accreditation process determines, in the public interest, the technical competence and integrity of organizations such as those offering testing, calibration and certification services.
Difference between accreditation and certification?
Accreditation provides authoritative assurance of the technical competence of a laboratory to undertake specified tests to the appropriate international standard.
Certification shows an organisations compliance with documented requirements.
Why do laboratories need accreditation?
To ensure that analyses are not fit for purpose, but also demonstrably correct.
Ensure that laboratories are technically competent and impartial
Ensure customer confidence in validity of reports
Government policy and regulation
Benefits of accreditation
Recognition of competence
Marketing advantage
Benchmark of performance
Accreditation is internationally recognised
Who accredits organisations
United Kingdom Accreditation service (UKAS)
Preparation for accreditation
The laboratory must choose the standard that applies to them (ISO 15189:2012)
They must become familiar with the relevant standard
Observe what the lab already has in place
Undertake a gap analysis
Validate all tests to be accredited
Design & implement a quality management system
Quality Manual
The quality manual sets out the quality system:
-Scope of accreditation
-Management and technical responsibilities
-SOPs
-Quality control measures
-System of audit and review
Achieving accreditation
A lab must show amongst other things:
-Full documentation of procedure
-Documentation showing sample traceability
-Evidence and records of calibration
-Data demonstrating method validation
-Evaluation of measurement uncertainty
-Evidence of qualified and trained staff
-Effective programme for quality control of data
Accreditation application
Applications are to UKAS by completing a form
Supply appropriate supporting material as listed in the application (Quality Policy)
UKAS will appoint an
Accreditation manager
Assessment manager
Accreditation Pre-assessment
A pre-assessment visit is optional
This is an informal visit to determine how ready the laboratory is for accreditation
Assessor will identify areas of weakness and ensure that the lab does not put itself forward for assessment unless ready to do so.
Assessment visit
A formal assessment of the lab
Will be conducted by a lead assessor supported by technical assessors
The assessment covers three elements:
-The impartiality of the laboratory
-Technical competence of staff, suitability of equipment and environment, validity of test methods.
effectiveness of management system.
What does the lead assessor focus on?
Higher level quality management procedures
What do the technical assessors focus on?
Technical activities.
They are required to have at least 5 years of experience in the relevant sector of analytical techniques.
What is being checked?
Records, e.g. QMS procedures, training, activities.
Observation of actual work & tests being conducted
Questions will be asked to laboratory staff to check the understanding and adherence to the QMS.
Vertical Audits
A sample is considered from receipt of the laboratory, through examination of items, analysis, interpretation and reporting of findings.
eg. tracking a process from one end to the other with all in-between steps being examined
