CPA is a UKAS
company
Introduction to ISO 15189
New and modified requirements
Introduction
• Identification of the differences
• Outputs of the gap analysis
• Outputs of the pilot and early assessments
• Key differences (not exhaustive)
• How this might be assessed
CPA is a UKAS
company
Basic principles of assessment
• Unchanged
• Multiple ways of meeting requirements
• As before, not an audit, but an assessment
• Holistic approach to add value
• Assessment Team looking for conformity
CPA is a UKAS
company
Identifying the differences
CPA is a UKAS
company
• Project Steering Groups: Gap analysis performed between
CPA Standards and ISO 15189
• Reviewed the differences as well as the implementation
and application of respective Standards
• Additional requirements of ISO 15189
• Approach to the assessment and expectations
• Differences in focus
• Possible areas of inconsistency
• May be assessed now but certainly under ISO 15189
Early assessments – key findings
CPA is a UKAS
company
• Initial application documentation was not sufficiently
detailed
• Steering group gap analysis was confirmed – high
numbers of findings around verification, traceability,
uncertainty
• Unable to offer accreditation to 20% of labs
• Some labs clearly under prepared for assessment
Scope
CPA is a UKAS
company
• Aim:
• Communicate the gaps (not exhaustive)
• Not:
• To advise on how to achieve conformity
• Laboratory responsible for identifying and addressing
gaps
Information
management
Staff
suggestions
Evaluation &
Risk management
Equipment
records
Service
agreements
New
Modified
Staff
competence
Validation/
Verification
Uncertainty
Laboratory director
& clinical staff
competence
CPA is a UKAS
company
EQA/IQC
Traceability
Purchasing
Information management
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
• 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
Evaluation
CPA is a UKAS
company
• Clause: 4.14
• Emphasises the need for regular reflection
• Evaluate work process impact and potential failures to
reduce risk
• Established TATs that are reviewed
• Reviews by external organisations
• Links to: 4.10; 4.11; 4.12; 4.15
Staff suggestions
CPA is a UKAS
company
• 4.14.4 & 4.1.2.6
• Communication processes – effective
• Staff to be encouraged to make suggestions to improve
• Evaluated
• Implemented, as appropriate
• Feedback
• Records maintained
• Links to: 4.11, 4.12
Service agreements
CPA is a UKAS
company
• 4.4.1: Each request shall be considered an agreement
• Agreement shall specify the information needed on
request to ensure appropriate examination and result
interpretation
• Following conditions shall be met:
• Requirements of customers, users and provider (lab)
must be understood - evidence
• Capability, including skills/expertise
• Methods fit for purpose
• Links to: 4.14; 5.1; 5.4.2; 5.4.3; 5.5.1
Clinical staff competence
• Clause: 5.1
• On-going competency assessment programme
• Acceptance criteria for performance
• Records of qualifications, experience and training
• Evidence of incorporation into management system
• Coverage by internal audit
• Links to: 4.7; 4.12; 4.14; 5.6
CPA is a UKAS
company
Equipment and Reagents
CPA is a UKAS
company
• Clause: 5.3.1.7 / 5.3.2
• Expanded requirements – records maintained
• Acceptance testing: new lot verification of performance
• Inventory and instructions for use
• Agreements with manufacturer to be informed of
changes?
• Records: identity, condition, instruction, performance
verification
• Links to: 4.13; 5.5.1; 5.6
Purchasing
• Clause: 4.6
• Equipment, reagents, consumables and services
• Acceptance criteria
• Evaluation
• Monitoring of performance
• Collaborate with other departments, if necessary
• Links to: 4.1.1.4; 4.13, 5.3, 5.6
CPA is a UKAS
company
Validation and verification
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
Verification
CPA is a UKAS
company
• Clause: 5.5.1.2 but mentioned in 13 clauses
• Documented procedure to verify competence
• Can manufacturer's specifications be met?
• Use of kit limited to manufacturer’s specified scope or
requirement to validate?
• Have representative staff been involved?
• Authorisation by competent personnel
• When change reagents
• Links to: 4.12; 4.14; 5.6
Validation
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
• Suitable for use within the lab for user demographic
• Validation supplemented where necessary?
• Changes to methods captured for impact on validation
• Suitable authorisation
• Links to: 4.12; 4.14; 5.6
Traceability
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
• 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
Measurement Uncertainty
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
EQA
CPA is a UKAS
company
• Clause: 5.6.3
• Proficiency testing and interlaboratory comparisons
critical in demonstrating competence
• Documented procedure – responsibilities, participation
• Acceptance criteria for the scheme
• Acceptance criteria for the results
• TPS 47 and ILAC P9
• Links to 4.14; 5.1; 5.5
IQC
CPA is a UKAS
company
• Clause: 5.6.2
• On-going monitoring of performance by IQC required
• 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?
• Documented procedure – responsibilities, participation
• Links to 4.14; 5.1; 5.5
Staff competence
CPA is a UKAS
company
• Clause: 5.1.4; 5.1.6; 5.1.8; 5.1.9
• Staff competence - objective evidence
• Specifies list
• Across scope of testing?
• Across scope of staff?
• On-going assessment against pre-defined criteria
• Continuing education and proof of effectiveness
• Personnel records to include accidents, work experience
• Links to: 4.1; 5.5; 5.6
Evidence requirements
• 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?
• Where is the evidence that this is implemented?
• Is the evidence objective?
• What does the evidence tell you?
• Does it work?
CPA is a UKAS
company
Rationale
CPA is a UKAS
company
• Individual components of Standard 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
• Holistic assessment
• Designed to facilitate continual improvement
• Not a new concept
Summary
CPA is a UKAS
company
• Changes are in specific areas but impact on the whole
Standard
• Different types of changes
• New
• Revised expectations
• Performance should be evaluated at management review,
including review of suppliers
• Health and Safety assessment - much reduced
• Objective evidence critical
CPA is a UKAS
company
Introduction to ISO 15189
New and modified requirements