introduction to iso 15189
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CPA is a UKAS
company
Introduction to ISO 15189
New and modified requirements
CPA is a UKAS
company
• Identification of the differences
• Key differences (not exhaustive)
• How this might be assessed
• Lessons learned
Introduction
CPA is a UKAS
company
• Aim:
Communicate the gaps (not exhaustive)
• It isn’t….:
To instruct on how to achieve conformity
• Ultimately it is the laboratory’s
responsibility to identify and address the
gaps
Scope of session
CPA is a UKAS
company
• Basically unchanged
• Multiple ways of meeting requirements
• As before, not an audit, but an assessment
• Holistic approach to add value
• Assessment Team looking for conformity
• Much may already have been assessed
under CPA but consistency and depth may
have varied
Basic principles of assessment
CPA is a UKAS
company
New
Modified
Information
management
Validation/
Verification Uncertainty Traceability
EQA/IQC Staff
competence
Evaluation &
Risk management Equipment
records
Laboratory director
& clinical staff
competence
Service
agreements Staff
suggestions
Purchasing
CPA is a UKAS
company
• Clause: 5.10
• Validated by supplier and verified by lab
• Safeguarded against tampering –
authorisations for management,
modification and maintenance of LIMS
• Integrity maintained and system failures
documented
Information management
CPA is a UKAS
company
• Results and records accurately
reproduced
• Contingency plans
• If systems maintained off site,
requirements must still be met –
selection of suppliers
• Links to: 4.1; 4.6; 4.9; 4.13; 5.2; 5.8; 5.9
Information management
CPA is a UKAS
company
• 4.4.1: Each request shall be considered
an agreement
• ‘Agreement’ shall specify the information
needed to ensure appropriate
examination and result interpretation
Service agreements
CPA is a UKAS
company
• Following conditions shall be met:
• Evidence to show that the requirements
of the *customers*, users and provider
(lab) have been understood
• Capability, including skills/expertise
• Methods fit for purpose
• Links to: 4.14; 5.1; 5.4.2; 5.4.3; 5.5.1
Service agreements
CPA is a UKAS
company
• Clause: 5.1
• On-going competency assessment
programme
• Acceptance criteria for performance
• Records of qualifications, experience and
training
Clinical staff competence
CPA is a UKAS
company
• Evidence of incorporation into
management system
• Coverage by internal audit
• Links to: 4.7; 4.12; 4.14; 5.6
Clinical staff competence
CPA is a UKAS
company
• Clause: 4.6
• Equipment, reagents, consumables and
services
• Acceptance criteria
• Evaluation
Purchasing
CPA is a UKAS
company
• Monitoring of performance
• Collaborate with other departments, if
necessary
• Links to: 4.1.1.4; 4.13, 5.3, 5.6
Purchasing
CPA is a UKAS
company
• ISO 15189 definitions:
• Verification – confirmation, through
provision of objective evidence, that
specified requirements have been fulfilled
• Validation – confirmation, through
provision of objective evidence, that the
requirements for a specific intended use
or application have been fulfilled
Validation and verification
CPA is a UKAS
company
• Clause: 5.5.1.2 mainly but mentioned in
13 clauses
• e.g. 5.3.1.2 ‘Equipment acceptance
testing: ‘The laboratory shall verify upon
installation….’
• Can manufacturer's specifications be
met?
Verification
CPA is a UKAS
company
• Use of kit limited to manufacturer’s
specified scope or would need to validate
• Authorisation of outcome by competent
personnel
• Re-verify when the manufacturer or the
composition of reagents change
• Links to: 4.12; 4.14; 5.6
Verification
CPA is a UKAS
company
• Clause: 5.5.1.3
• Defined acceptance criteria
• Documented procedure – as detailed as
required?
• Critical evaluation of manufacturer’s
validation, including traceability
Validation
CPA is a UKAS
company
• Suitable for user demographic
• Validation supplemented where
necessary?
• System to ensure that changes are
evaluated for any impact on validation
• Suitable authorisation
• Links to: 4.12; 4.14; 5.6
Validation
CPA is a UKAS
company
• Clause: 5.3.1.4
• When equipment directly or indirectly
affects results
• Verification at defined intervals
• Records of metrological traceability of
calibration standards
• Manufacturer data may or may not be
sufficient
Traceability
CPA is a UKAS
company
Traceability
http://www.bipm.org/en/committees/jc/jctlm/
CPA is a UKAS
company
• Provenance of reference materials
• Where traceability not possible/relevant,
other means of providing confidence in the
results required
• Links to: 4.14; 5.5; 5.6
Traceability
CPA is a UKAS
company
• Clause: 5.5.1.4
• Performance requirements for each
measurement procedure to be defined
• Regularly reviewed
• Uncertainty estimates to be readily available
• Requirements cover examinations reporting
measured quantity values and those that
include a measurement step
• Links to: 4.14; 5.1; 5.6
Measurement Uncertainty
CPA is a UKAS
company
• Clause: 5.6.3
• Proficiency testing (external quality
assurance) and interlaboratory
comparisons important in demonstrating
competence
• Documented procedure – responsibilities,
plan, participation
EQA
CPA is a UKAS
company
• Acceptance criteria for the scheme, (internal
acceptance criteria)
• TPS 47 (UKAS Policy on Participation in
Proficiency Testing) and ILAC P9
• Links to 4.14; 5.1; 5.5
EQA
CPA is a UKAS
company
• ‘4.3 Laboratories shall formulate and document a
plan for the level and frequency of participation
in PT, the plan shall be regularly reviewed in
response to changes in staffing, methodology,
instrumentation, scope etc. Laboratories should
refer to the EA Publication EA 4/18 TA Guidance
on the level and frequency of proficiency testing
participation for further guidance on how to
establish a plan.’
EQA TPS 47 excerpt
CPA is a UKAS
company
EQA
CPA is a UKAS
company
EQA
https://www.eptis.bam.de/en/index
.htm
CPA is a UKAS
company
• Clause: 5.6.2
• On-going monitoring of performance by
IQC required
IQC
CPA is a UKAS
company
• Needs to be suitably robust
• What is this based on?
• Define rationale for approach to test
assurance – what is the package?
• Including manufacturer material, is there
sufficient to provide confidence in test
results?
IQC
CPA is a UKAS
company
• Documented procedure – responsibilities,
participation
• Links to 4.14; 5.1; 5.5
IQC
CPA is a UKAS
company
• Clause: 5.1.4; 5.1.6; 5.1.8; 5.1.9
• Staff competence - objective evidence
• Separate from training
• Across scope of activities and staff
• On-going reassessment against pre-
defined criteria
Staff competence
CPA is a UKAS
company
• Continuing education and proof of
effectiveness
• Personnel records to include accidents,
work experience
• Links to: 4.1; 5.5; 5.6
Staff competence
CPA is a UKAS
company
• Where does it say what you do?
• Why is it done that way?
• Do staff know what should be done and
why?
• Where is this implemented?
Evidence requirements
CPA is a UKAS
company
• Where is the evidence that this is
implemented?
• Is the evidence objective?
• What does the evidence tell you?
• Does it work?
Evidence requirements
CPA is a UKAS
company
• Individual components of ISO 15189 are
not assessed in isolation
• Elements link together and will be
assessed as such:
Staff competence, test assurance,
uncertainty, validation
Purchasing, equipment, test
assurance, responsibilities
Rationale
CPA is a UKAS
company
• Holistic assessment
• Designed to facilitate continual
improvement
• Not a new concept
Rationale
CPA is a UKAS
company
• Changes are in specific areas but impact on
the whole of ISO 15189
• Different types of changes
• New
• Revised expectations
• Performance should be evaluated at
management review, including review of
suppliers
Summary
CPA is a UKAS
company
• Health and Safety assessment - much
reduced
• Objective evidence critical
Summary
CPA is a UKAS
company
Introduction to ISO 15189
New and modified requirements
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