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Laboratories are
required to provide objective evidence of quality goals, management
commitment, communication within and outside the laboratory, client
satisfaction, continual improvement through effective QC/QA/quality
management and sound reporting practices.
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The accreditation
program will include periodic surveillance (e.g. follow-up, self assessment)
and re-assessment, and will be linked to EQA monitoring of performance.
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Accreditation will
operate within the context of a quality system and the documentation
requirements thereof. Accreditation policies, processes and procedures will
be documented and accessible.
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Consultants will
advise on all accreditation policies, processes and procedures.
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All advisors and
staff will adhere to confidentiality and conflict of interest rules.
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Accreditation
assessment will ensure that laboratories meet explicit quality management
criteria and will recognize the laboratory’s competency and integrity.
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Accreditation
requirements and the methods of assessment will be defined.
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Accreditation
requirements define quality expectations, set the desired standards of best
practice, and serve as the benchmark against which laboratory quality and
competency are assessed.
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Criteria for
issuing 4-year and 2-year accreditation certificates will
be established, along with guidelines to recommend withdrawal of
accreditation. The assessment process will be non-discriminatory and
impartial.
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Qualified assessors
will be contracted, and records maintained of their qualifications and
expertise including conflict of interest declarations.
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Recipient
laboratories will confirm that assessors appointed, including the team
leader, do not have conflicts that may compromise their impartiality.
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Assessors will
undergo training to ensure their familiarity with requirements, assessment
methods, operating policies and processes, and to enhance their
communication skills.
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Assessors will be
provided with tools to ensure that comprehensive and correct assessments are
conducted.
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Program information
will contain relevant information about the requirements, assessment
process, criteria for assessment and necessary information/documentation to
be provided by the recipient laboratory.
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The assessment date
will be mutually agreed upon by QMP–LS and the applicant laboratory.
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Assessment reports
will be provided in a timely fashion, and shall document the findings along
with any explanation of non-conformance.
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Accreditation
certificates will be issued according to established protocol.
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Staff will aid in
defining and promoting standards-of-practice guidelines.
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Opportunities for improvement of the program
will be identified and monitored.
