ISO 15189 Clauses Quality Manual Comment

4 MANAGEMENT REQUIREMENTS
4.1 ORGANIZATION AND MANAGEMENT
4.1.1 Legal identity
4.1.2 Laboratory design appropriately to meet the needs
4.1.3 Conformity with relevant requirements for permanent
facilities or at sites and decentralised facilities
4.1.4 Possible conflict of interest, financial or political
considerations
4.1.5
a) Appropriate authority for all personnel, resources to carry
out their duties
b) Possible conflict of interest, financial or political
considerations
c) Protection of confidential information
d) Confidentiality, impartiality and operational integrity
e) Organisational structure, relation with other organisations
f) Function descriptions and interrelationships
g) Staff training
h) Technical management
i) Quality management (authority and responsibilities)
j) Deputies for all key functions

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4.2 QUALITY MANAGEMENT SYSTEM
4.2.1 Documentation, communication and implementation
4.2.2 IQC and EQA
4.2.3 Quality policy statement: content and availability
a) The scope of service the laboratory intends to provide
b) The laboratory management’s statement of the
laboratory’s standard of service
c) The objectives of the quality management system
d) A requirement that all personnel concerned with
examination activities familiarize themselves with the
quality documentation and implement the policies and
procedures at all times
e) The laboratory’s commitment to good professional
practice, the quality of its examinations, and compliance
with the quality management system
f) The laboratory management’s commitment to
compliance with this standard.
4.2.4 Content of the quality manual
a) Introduction
b) Description of the medical laboratory, its legal identity,
resources and main duties.
c) Quality policy
d) Staff education and training
e) Quality assurance
f) Document control
g) Records, maintenance and archiving

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4.2 QUALITY MANAGEMENT SYSTEM (cont.)
h) Accommodation and environment
i) Instruments, reagents and/or relevant consumables
management
k) Safety
l) Environmental aspects
m) Research and development
n) List of examination procedures
o) Request protocols, primary sample, collection and
handling of laboratory samples
p) Validation of results
q) Quality control (including inter laboratory comparisons)
r) Laboratory information system
s) Reporting of results
t) Remedial actions and handling of complaints
u) Communications and other interactions with patients,
health professionals, referral laboratories and suppliers.
v) Internal audits
w) Ethics
4.2.5 Calibration, monitoring and preventive maintenance of
instruments
4.3 DOCUMENT CONTROL
4.3.1 Procedure for document management

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4.3 DOCUMENT CONTROL (cont.)
4.3.2 Procedure shall be adopted to ensure that
a) All documents issued to laboratory personnel as part of
the quality management system are reviewed and
approved by authorized personnel prior to issue.
b) A list, also referred to as a document control log,
identifying the current valid revisions and their distribution
is maintained.
c) Only currently authorized versions of appropriate
documents are available for active use at relevant
locations
d) Documents are periodically reviewed, revised when
necessary and approved by authorized personnel
e) Invalid or obsolete documents are promptly removed
from all points of use, or otherwise assured against
inadvertent use.
f) Retained or archived superseded documents are
appropriately identified to prevent their inadvertent use
g) If the laboratory’s documentation control system allows
for the amendment of documents by hand pending the
re-issue of documents, the procedures and authorities for
such amendments are defined, while amendments are
clearly marked, initialled and dated, and a revised
document is formally re-issued as soon as practicable
h) Procedures are established to describe how changes to
documents maintained in computerized systems are to be
made and controlled
4.3.3 Identification of documents
a) Title
b) Edition or current revision date, or revision number or all
these
c) Number of pages (where applicable)
d) Authority for issue
e) Source identification

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4.4 REVIEW OF CONTRACTS
4.4.1 Procedure for review of contracts
4.4.2 Records of reviews, changes
4.4.3 Review of referral work
4.4.4 Information to clients in case of deviations
4.4.5 Amendments to contracts
4.5 EXAMINATION BY REFERRAL LABORATORIES
4.5.1 Competence of referral laboratories
4.5.2 Periodical review
4.5.3 Register
4.5.4 Reporting of referral tests
4.6 EXTERNAL SERVICES AND SUPPLIES
4.6.1 Procedure selection and use of external services,
equipment, consumables
4.6.2 Verification
4.6.3 Inventory control system and quality records
4.6.4 Evaluation of suppliers
4.7 ADVISORY SERVICES
Information, advice on choice of examinations
Relations with clinical staff
4.8 RESOLUTION OF COMPLAINTS
Policy and procedures for complaint handling
Registration
Traceability and corrective actions

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4.9 IDENTIFICATION AND CONTROL OF NONCONFORMITIES
4.9.1 Policy and procedures for handling non conformities
a) Personnel responsible for problem resolution are
designated
b) The actions to be taken are defined
c) The medical significance of the nonconforming
examinations is considered and where appropriate, the
requesting clinician informed
d) Examinations are halted and reports withheld as
necessary
e) Corrective action is taken immediately
f) The results of nonconforming examinations already
released are recalled or appropriately identified, if
necessary
g) The responsibility for authorization of the resumption of
examination is defined
h) Each episode of nonconformity is documented and
recorded, with these records being reviewed at regular
specified intervals by laboratory management to detect
trends and initiate preventive action
4.9.2 Prevention of reoccurrence
4.9.3 Release of results in the case of non conformities
4.10 CORRECTION ACTION
4.10.1 Procedures
4.10.2 Documentation of changes resulting from corrective
actions investigations
4.10.3 Monitoring results of corrective actions
4.10.4 Additional audits and feedback in management review
4.11 PREVENTIVE ACTION
4.11.1 Identification of needed actions
4.11.2 Planning, effectiveness, trend and risk analysis

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4.12 CONTINUAL IMPROVEMENT
4.12.1 Regular review of operational procedures
4.12.2 Evaluation of effectiveness of actions; submission to lab
management
4.12.3 Review and implementation of action
4.12.4 Monitoring of quality indicators and improvement
activities
4.13 QUALITY AND TECHNICAL RECORDS
4.13.1 Procedures for identification, collection, indexing,
access storage, maintenance and safe disposal of
quality and technical records
4.13.2 Storage, retrievability and prevention for deterioration
4.13.3 Archiving and retention time
4.14 INTERNAL AUDITS
4.14.1 Audit program
4.14.2 Planning, procedures, registration, follow-up
4.14.3 Feedback in management review
4.15 MANAGEMENT REVIEW
4.15.1 Management review: procedure
4.15.2 Management review: content
4.15.3 Management review: evaluation of the quality and
appropriateness to the patient care
4.15.4 Management review: report, actions
5 TECHNICAL REQUIREMENTS
5.1 PERSONNEL
5.1.1 Organizational plan, personnel policies, job descriptions
5.1.2 Records of education and qualification
5.1.3 Supervision and competency
5.1.4 Responsibilities of the laboratory director

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5.1 PERSONNEL (cont.)
5.1.5 Adequate staff resources
5.1.6 Training of personnel in quality assurance
5.1.7 Authorization to perform specific tasks
5.1.8 Use of personnel in quality assurance
5.1.9 Continuing education program
5.1.10 Training to prevent or contain the effects of adverse
5.1.11 Assessment of competency after training and
re-evaluation
5.1.12 Qualification for professional judgements
5.1.13 Confidentiality of information regarding patients
5.2 ACCOMODATION AND ENVIRONMENTAL CONDITIONS
5.2.1 Adequacy and suitability of the lab space (including other
sites)
5.2.2 Risk of injury and protection from hazards
5.2.3 Accommodation for sample collection
5.2.4 Suitable design and environment for task carried out
5.2.5 Control and registration of environmental conditions
5.2.6 Separation of incompatible activities
5.2.7 Access control
5.2.8 Adequate communication system within the facilities
5.2.9 Storage of samples and documents assuring integrity
5.2.10 Housekeeping

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5.3 LABORATORY EQUIPMENT
5.3.1 Availability of adequate equipment inside and
decentralized equipment
5.3.2 Compatibility with performance specifications
Calibration program and program for preventive
maintenance
5.3.3 Unique identification
5.3.4 Records
5.3.5 Instructions for use, maintenance and safe handling
5.3.6 Maintenance in safe working condition
5.3.7 Defective equipment
5.3.8 Measures to reduce contamination
5.3.9 Labelling and calibration status
5.3.10 Check after repair
5.3.11 Computer requirements: validation, procedures,
maintenance, protection of programs and data
5.3.12 Instructions for use, maintenance and safe handling
5.3.13 Use of corrective factors
5.3.14 Safeguarding from adjustments
5.4 PRE-EXAMINATION PROCEDURES
5.4.1 Information on request forms
5.4.2 Specific instructions for proper collection & handling of
primary samples
5.4.3 Sample collection manual- content and doc control
5.4.4 Availability of references, procedures, instruction and
labeling for primary sample
5.4.5 Identification and traceability of primary samples
5.4.6 Monitoring of sample transport
5.4.7 Sample reception

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5.4.8 Acceptance and rejection criteria
5.4.9 Periodical review of sample volume
5.4.10 Request review
5.4.11 Procedures for receipt, labelling, processing and
reporting of urgent samples
5.4.12 Traceability of sample portions
5.4.13 Policy concerning verbal request
5.4.14 Preliminary and temporary
5.5 EXAMINATION PROCEDURES
5.5.1 Examination procedures
5.5.2 Validation
5.5.3 Documentation and availability of procedures,
instructions
5.5.4 Performance specifications
5.5.5 Periodical review of reference intervals
5.5.6 List of current examinations
5.5.7 Information to users when examination procedures are
changed
5.6 ASSURING THE QUALITY OF EXAMINATION PROCEDURES
5.6.1 Appropriateness of internal quality control (IQC)
5.6.2 Uncertainty of results
5.6.3 Program for calibration and verification of trueness
5.6.4 External quality assessment (EQA) – inter laboratory
comparisons
5.6.5 Non-availability of EQA

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5.6.6 Comparability of results by using different
5.6.7 procedures/equipment for the same examination and /or at
different sites
5.7 POST-EXAMINATION PROCEDURES
5.7.1 Clinical validation
5.7.2 Storage and disposal of (primary) samples
5.7.3 Safe disposal of samples: in accordance with local
regulation or recommendation
5.8 REPORTING OF RESULTS
5.8.1 Format of reports (electronic or paper)
5.8.2 Reporting within an agreed-upon time interval
5.8.3 Content of the report
5.8.4
5.8.5 Reporting of sample suitability
5.8.6 Retention and retrieval of reported data
5.8.7 Procedures for emergency reporting
5.8.8 Alert/critical intervals
5.8.9 Interim reports
5.8.10 Records of actions taken in response to results in critical
intervals
5.8.11 Appropriate turnaround time
5.8.12 Results from referral labs
5.8.13 Procedures for release of examination results
5.8.14 Procedures for verbal reporting or reporting by electronic
means
5.8.15 Policies and procedures regarding the alternation of reports
5.8.16 Cumulative reports

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