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LASF10 Checklist for ISO 15189
PAB assessment checklist for ISO 15189
Your Browser Doesn't Support Canvas. Showing the Text Content of the PDF Instead: Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
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LA/SF10
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INTRODUCTION
1.
Purpose
This checklist is prepared for the following purposes:
1.1 To assist both the laboratory staff and the assessment team in checking that all criteria for
accreditation are satisfied.
1.2 To index documentation of the quality system and use as part of the preparation for the
introduction of ISO 15189 and an assessment; and
1.3 To provide essential background information for briefing PAB assessment team and
relevant information during the assessment process.
This checklist provides only a brief summary of the clauses of the Standard.
2.
Structure and Use of the Checklist
2.1 Compliance with PAB General Requirements
2.2 All PAB accredited laboratories are required to comply with the accreditation requirements
and the basic technical and management system requirements for laboratories based on ISO
15189:2012.
2.3 PAB needs to obtain and maintain information on the specific technical resources available in
the laboratory and to be aware of the desired scope of the accreditation by PAB (the
approved examinations or tests) and for approved signatories (the specific people authorized
to sign PAB endorsed test reports).
3.
Preparation of Laboratory Quality Manuals
Each accredited laboratory is required to implement a documented management system as
one of the fundamental conditions for PAB accreditation.
The documented management system includes all of the laboratory’s policies and operational
procedures established to meet the requirements for accreditation.
The manner in which a laboratory’s documented management system is structured is the
choice of the laboratory. The purpose of the documentation is primarily to advice the
laboratory’s staff of the policies and procedures expected by its management to be
implemented by all staff.
Typically, a laboratory’s management system is documented in a Laboratory Quality Manual
and supporting procedures and records. In some cases, a Laboratory Quality Manual includes
supporting procedures. In other cases, some of the subjects of a Laboratory Quality Manual
may be incorporated in an organization’s more general Quality Manual or procedures.
Document ID
Issue Number
Revision Number
Effectivity Date
Page
LA/SF10
01
01
01 August 2018
2 of 48
Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Clause
4
4.1
4.1.1
4.1.1.1
General
4.1.1.2
Legal Identity
4.1.1.3
Ethical conduct
4.1.1.4
Laboratory
Director
4.1.1.4
Laboratory
Director
Requirements of Accreditation/
Description
Management Requirements
Organization and management responsibility
Organization
Does the laboratory management
system cover work carried out in:
- Permanent facilities?
- Sites away from its permanent
facilities?
- Associated temporary facilities?
- Mobile facilities?
Is the laboratory or the organisation
legally responsible?
Does the laboratory/management have
arrangement to ensure that:
a. No involvement in any activities
that would diminish confidence in
the laboratory’s competence,
impartiality,
judgment
or
operational integrity.
b. Management and personnel are
free from
- undue internal and external
commercial pressure?
- financial pressure?
- Other pressure that influences
that may adversely affect the
quality of work?
c. Where potential conflicts in
competing interests may exist,
they shall be openly and
appropriately declared
d. Appropriate procedures to ensure
human samples, tissues or
remains according to relevant
legal requirements?
e. Policies and procedures to
confidentiality of information?
Is the laboratory directed by a person
or persons with competence and
delegated
responsibility
for
the
services provide?
Do the responsibilities of the
laboratory/facility director or designees
include
professional,
scientific,
consultative, advisory, organisational,
administrative,
and
educational
matters?
Does the laboratory director (or
designates for delegated duties) have
the necessary competence, authority
and resources in order to fulfil the
requirements of this international
standard?
Document ID
Issue Number
Revision Number
Effectivity Date
Page
LA/SF10
01
01
01 August 2018
3 of 48
Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Clause
Requirements of Accreditation/
Description
The duties and responsibilities of the
laboratory director (or designate/s)
shall be documented and include the
following:
a) Provide effective leadership of the
medical
laboratory
service,
including budget planning and
financial management.
b) Relate and function effectively with
applicable
accrediting
and
regulatory agencies, appropriate
administrative
officials,
the
healthcare community, and the
patient population served, and
providers of formal agreements,
when required;
c) Ensure that there are appropriate
numbers of staff,
d) Ensure the implementation of the
quality policy,
e) Implement a safe laboratory
environment,
f) Serve as contributing member of
the medical staff,
g) Ensure the provision of clinical
advise,
h) Select and monitor laboratory
suppliers,
i) Select referral laboratories and
monitor the quality of their
services,
j) Provide professional development
programs for lab. Staff,
k) Define, implement and monitor
standards of performance and
quality improvement,
l) Monitor all work performed in the
laboratory,
m) Address any complaints, request
or suggestion from staff and/or
users of lab. Services,
n) Design
and
implement
a
contingency plan to ensure that
essential services are available.
(contingency plan should be
periodically tested)
o) Plan and direct research and
development, where appropriate.
(The laboratory/facility director need
not
perform
all
responsibilities
personally. However, it is the
laboratory/facility
director’s
responsibility for the overall operation
Document ID
Issue Number
Revision Number
Effectivity Date
Page
LA/SF10
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01
01 August 2018
4 of 48
Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Clause
4.1.2
4.1.2.1
Management
commitment
4.1.2.2
Needs of user
4.1.2.3
Quality Policy
Requirements of Accreditation/
Description
and
administration
of
the
laboratory/facility, for ensuring that
quality services are provided for
patients.)
Management responsibility
The laboratory management shall
provide evidences of its commitment
to develop and implement the quality
management
system
and
to
continually improve its effectiveness
by:
a) Communicating
to
laboratory
personnel the importance of
meeting
the
needs
and
requirements of users as well as
regulatory
and
accreditation
requirements.
b) establishing quality policy;
c) ensuring that quality objectives
and planning are established;
d) Defining
the
responsibilities,
authorities and interrelationships
of all personnel.
e) Establishing
communication
processes;
f) Appointment of quality manager;
g) Conducting management review.
h) Ensuring that all personnel are
competent
to
perform
their
assigned activities;
i) Ensuring availability of adequate
resources to enable the proper
conduct
of
pre-examination,
examination and post-examination
activities.
Does the medical laboratory / facility
services,
including
appropriate
interpretation and advisory services
meet :
-the needs of patients and all
personnel responsible for patient care?
Is the Quality Policy:
- defined under the authority of
laboratory/ facility management?
- and include the following:
a) Appropriate to the purpose of the
organization.
b) The laboratory’s commitment to
good
professional
practice,
examinations that are fit for
intended use,
c) Compliance with the requirements
of this International Standards,
Document ID
Issue Number
Revision Number
Effectivity Date
Page
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01
01 August 2018
5 of 48
Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Clause
4.1.2.4
Quality
Objectives and
Planning
Requirements of Accreditation/
Description
and continual improvement of the
quality of laboratory services,
d) A framework for establishing and
reviewing quality objectives,
e) Communicated and understood
within the organization,
f) Reviewed for continuing suitability.
The laboratory management establish
quality objectives that are measurable
and consistent with the quality policy.
Does it meet the needs and
requirements of the users, at relevant
functions and levels within the
organisation?
4.1.2.5
Responsibility,
authority and
interrelationship
s
4.1.2.6
Communication
The
planning
of
the
quality
management system shall meet the
requirements
and
the
quality
objectives.
Ensure that responsibilities, authorities
and interrelationships are defined,
documented and communicated.
Appointment of person(s) responsible
for each laboratory function.
Appointment of deputies for key
managerial and technical personnel.
Are there records of items discussed in
communications and meetings with the
laboratory staff?
Are records kept of items discussed in
communications and meetings?
4.1.2.7
Quality
Manager
Are
appropriate
communication
processes established between the
laboratory and its stakeholders in
relation
to
laboratory’s
preexamination, examination and postexamination processes and quality
management system?
The laboratory shall appoint Quality
Manager.
Does the responsibilities and authority
includes:
a) Ensuring that processes needed
for the quality management
system
are
established,
implemented and maintained,
b) Reporting to the laboratory
management, at a level which
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Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Clause
4.2
4.2.1
General
requirements
4.2.2
4.2.2.1
General
4.2.2.2
Requirements of Accreditation/
Description
decision are made to laboratory
policy, objectives and resources,
on the performance of the quality
management system and any
need for improvement?
c) Promoting the awareness of
users’ needs and requirements
throughout
the
laboratory
organisation?
Quality management system
The
laboratory
shall
establish,
document, implement and maintain
quality management system and
continually improve its effectiveness.
The laboratory shall:
a) Determine the processes needed
for the quality management
system
and
ensure
their
application
throughout
the
laboratory;
b) Determine the sequence and
interaction of these processes;
c) Determine criteria and methods
needed to ensure that both the
operation and control of these
processes are effective.
d) Ensure the availability of resources
and information necessary to
support
the
operation
and
monitoring of these processes.
e) Monitor and evaluate these
processes;
f) Implement actions necessary to
achieve planned results and
continual improvement of these
processes.
Documentation requirements
Quality
management
system
documentation shall include:
a) Statement of Quality Policy and
Quality Objectives
b) Quality manual
c) Procedures and records required
by ISO 15189
d) Documents
and
records,
determined by the laboratory to
ensure the effective planning,
operation and control of its
processes.
e) Copies of applicable regulations,
standards and other normative
documents.
The laboratory shall establish and
Document ID
Issue Number
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Effectivity Date
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Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Clause
Quality manual
4.3
Requirements of Accreditation/
Description
maintain Quality Manual that includes:
a) Quality policy or makes reference
to it
b) Scope of the quality management
system
c) Organization and management
structure
d) Roles and responsibilities of
laboratory management (including
the laboratory director and quality
manager)
e) Document structure
f) Documented policies for the
quality management system and
reference to the managerial and
technical activities.
All laboratory staff shall have access to
and be instructed on the use and
application of the quality manual and
the referenced documents.
Document control
The laboratory shall control documents
required by the quality management
system.
Ensure unintended use of any obsolete
document is prevented.
Shall have documented procedure to
ensure the following conditions are
met:
a) All documents, including those
maintained
in
computerized
system
are
reviewed
and
approved
by
authorized
personnel before issue.
b) All documents are identified to
include:
- title
- unique identifier on each page,
- date of current edition and/or
edition number
- page number to total number of
pages
- authority to issue
c) List of documents with current
authorized editions and their
distributions.
d) Only current authorized editions
of applicable documents are
available at points of use.
e) Procedure and authorities for the
amendment of documents by
Document ID
Issue Number
Revision Number
Effectivity Date
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Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Clause
4.4
4.4.1
Establishment
of service
agreements
4.4.2
Review of
service
agreements
4.5
Requirements of Accreditation/
Description
hand. Amendments are clearly
marked, initialled and dated, and
a revised document is issued
within a specified time period.
f)
Changes to documents are
identified
g) Documents remain legible.
h) Documents
are
periodically
reviewed and updated at a
frequency that ensures that they
remain fit for purpose.
i)
Obsolete controlled documents
are dated and marked as
obsolete.
j)
At least one copy of an obsolete
controlled document is retained
for specified requirements.
Service agreements
The laboratory shall have procedures
established and maintained for review
of agreements.
The following conditions shall be met
when the laboratory enters into an
agreement:
a) The requirements, including the
methods to be used are:
- Defined
- Documented
- Understood
b) Capability and resources meet
the requirements.
c) Laboratory personnel have the
skills and expertise necessary for
the performance of the intended
examination.
d) Appropriate method is selected
and capable of meeting the
customers’ needs.
e) Customers
and
users
are
informed of deviations from the
agreement.
f)
References shall be made to any
work referred by the laboratory.
Are records of these reviews and any
significant changes maintained?
If the contract needs to be amended
after the work commence:
- Is the same contract review
process repeated?
- Are any amendments
communicated to all affected
parties?
Examination by referral laboratories
Document ID
Issue Number
Revision Number
Effectivity Date
Page
LA/SF10
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01 August 2018
9 of 48
Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Clause
4.5.1
Selecting and
evaluating
referral
laboratories
and consultants
4.5.2
Provision of
examination
results
Requirements of Accreditation/
Description
The laboratory shall have documented
procedures available to evaluate and
select:
- Referral laboratories?
- Consultants who provide second
opinions and interpretation for
complex testing in any discipline.
The procedure shall ensure that the
following conditions are met:
a) Laboratory
management
responsible for selecting and
monitoring the quality of referral
laboratories
and
consultants.
Referral laboratory or consultant is
competent
to
perform
the
requested examinations.
b) Arrangements
with
referral
laboratories
and
consultants
periodically
reviewed
and
evaluated.
c) Records of such periodic reviews
are maintained.
d) Maintains register of all referral
laboratories and consultants.
e) Requests and results of all
samples referred are kept for a
pre-defined period.
The referring laboratory, and not the
referral laboratory/facility, shall be
responsible to ensure that examination
results and findings are provided to the
clinician making the request.
The report shall have all the essential
elements of the results if it is reported
by the referral laboratory, without
alterations that could affect any clinical
interpretations.
4.6
The report shall indicate which
examinations were performed by a
referral laboratory or consultant.
The author of any additional remarks
shall be clearly identified.
External services and supplies
The laboratory shall have procedure
for selection purchasing of services,
equipment, reagents and consumable
supplies it uses that affect the quality
of its services.
The laboratory shall
approved suppliers.
select
and
Document ID
Issue Number
Revision Number
Effectivity Date
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LA/SF10
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01
01 August 2018
10 of 48
Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Clause
Requirements of Accreditation/
Description
Criteria for selection of suppliers shall
be established
A list of selected and approved
suppliers of equipment, reagents and
consumables shall be maintained.
4.7
4.8
4.9
Purchasing information shall describe
the requirements for the product or
service to be purchased.
The laboratory shall monitor the
performance of suppliers.
Advisory services
The
laboratory
shall
establish
arrangements for communicating with
users on the following:
a) Advising on choice of
- examination and use of the
services
- required type of samples
- clinical indications
- limitations
of
examination
procedures
- frequency of requesting the
examination
b) Advising on individual clinical
cases,
c) Professional judgments on the
interpretation of the results of
examinations,
d) Promoting the effective utilization
of laboratory services,
e) Consulting on scientific and
logistic matters such as instances
of failure of sample(s) to meet
acceptance criteria.
Resolution of complaints
The laboratory shall have documented
procedure for the management of
complaints or other feedback.
Records of all complaints, investigation
and action taken shall be maintained.
Identification
and
control
of
nonconformities
The laboratory shall have documented
procedure to identify and manage
nonconformities in any aspects of the
quality management system, including
pre-examination, examination or postexamination processes.
The procedure shall ensure that:
Document ID
Issue Number
Revision Number
Effectivity Date
Page
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01
01
01 August 2018
11 of 48
Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Requirements of Accreditation/
Description
Clause
a)
4.10
4.11
Responsible person for handling
nonconformities are designated.
b) Define immediate actions taken.
c) The extent of nonconformity is
determined
d) Examinations are halted and
reports withheld as necessary;
e) The medical significance of the
nonconforming
tests
is
considered
and
requesting
clinicians
informed
where
appropriate.
f)
Non-conforming test results and
examinations already released
are recalled?
g) The
responsibility
for
authorization of the resumption of
work is defined?
h) Details of the non-conformity is
documented and recorded and
reviewed at regular specified
intervals to detect trends and
initiate preventive actions?
If evaluation of the non-conformity
determines recurrence, then are
procedures
established
and
implemented to identify, document and
eliminate the cause(s).
Corrective action to be taken shall be
determined and documented.
Corrective action
The laboratory shall take corrective
actions appropriate to the effects of the
nonconformities encountered.
The laboratory shall have documented
procedure for:
a) Reviewing nonconformities
b) Determining root causes of
nonconformities
c) Evaluating the need for corrective
action
to
ensure
that
nonconformities do not recur.
d) Determining and implementing
corrective actions needed.
e) Recording
the
results
of
corrective action taken
f)
Reviewing the effectiveness of
the corrective action taken.
Preventive action
The laboratory shall determine action
to eliminate the causes of potential
nonconformities
to
prevent
its
occurrence.
Document ID
Issue Number
Revision Number
Effectivity Date
Page
LA/SF10
01
01
01 August 2018
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Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Clause
4.12
Requirements of Accreditation/
Description
The laboratory shall have documented
procedures for:
a) reviewing of laboratory data and
information to determine potential
nonconformities.
b) determining root cause(s) of
potential nonconformities.
c) evaluating of the need for
preventive action to prevent
occurrence of nonconformities.
d) determining and implementing of
preventive action needed.
e) recording of the results of
preventive action taken.
f) reviewing the effectiveness of the
preventive action taken.
Continual improvement
The laboratory shall continually
improve the effectiveness of the quality
management system through the use
of management reviews, corrective
actions and preventive actions with its
intention, as stated in the quality policy
and quality objectives.
Improvement
activities
shall
be
directed at areas of highest priority
based on risk assessments.
Action plans for improvement shall be:
- developed,
- documented,
- implemented, as appropriate?
4.13
The effectiveness of the actions taken
shall determine through a focused
review or audit of the area concerned.
The laboratory management shall
ensure the following:
- the laboratory participates in
continual improvement activities
that encompass relevant areas and
outcomes of patient care?
- where there are opportunities for
improvement, are these issues
addressed regardless of where they
occur?
- improvement plans and related
goals shall be communicated to
staff
Control of records
The laboratory/facility shall establish
and
maintain
a
documented
procedures for:
Document ID
Issue Number
Revision Number
Effectivity Date
Page
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Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Clause
Requirements of Accreditation/
Description
-
identification
collection
indexing
access
storage
maintenance
amendment
safe disposal of quality and
technical records?
Records shall be created concurrently
with performance of each activity that
affects the quality of the examination.
(Records can of any form/ type of
medium as long as they are readily
accessible,
protected
from
unauthorized
alterations
and
in
accordance to local, national, or
regional legal requirements.)
The date and, where relevant, time of
amendments to records captured
along with the identity of personnel
making the amendments.
The laboratory shall define retention
time of all records pertaining to the
quality management system, including
pre-examination, examination and
post-examination
processes.
The
retention time may vary, however,
reported results defined to allow
records to be retrievable for as long as
medically relevant or as required by
regulation.
The facilities shall have suitable
environment for storage of records to:
- prevent damage or deterioration?
- prevent loss?
- prevent unauthorized access?
Records shall include, at least, the
following:
a) supplier selection and performance,
and changes to the approved
supplier list
b) staff qualification, training and
competency records
c) request forms (including the patient
chart or medical record only if used
as the request form),
d) Records of receipt of samples in the
Document ID
Issue Number
Revision Number
Effectivity Date
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Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Clause
Requirements of Accreditation/
Description
laboratory, e.g. accession records
e) Information on reagents and
materials used for examination (lot
documentation,
certificates
of
supplies, package inserts)
f) laboratory work-books or work
sheets,
g) instrument printouts and retained
date and information
h) examination results and reports,
i) instrument maintenance records
including internal and external
calibration records
j) calibration functions and conversion
factors
k) quality control records,
l) incident records and action taken,
m) accident records and action taken
n) risk management records
o) nonconformities
identified
and
immediate or corrective action
taken
p) preventive action taken
q) complaints and action taken
r) records of internal and external
audits
s) interlaboratory
comparisons
of
examination results
t) records of quality improvement
activities
u) minutes of meetings that record
decisions
made
about
the
laboratory’s quality management
system
v) records of management reviews
4.14
4.14.1
General
(All these records shall be available for
laboratory management review)
Evaluation of audits
The evaluation and internal audit
processes shall be planned and
implemented to:
a) demonstrate
that
laboratory’s
processes are conducted in a
manner that meets the needs and
requirements of users? (e.g users’
feedback)
b) ensure conformity to the quality
management system
c) continually
improve
the
effectiveness
of
the
quality
management system
Are the results of evaluation and
Document ID
Issue Number
Revision Number
Effectivity Date
Page
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Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Clause
4.14.2
Periodic review
of requests,
and suitability
of procedures
and sample
requirements
4.14.3
Assessment of
users feedback
4.14.4
Staff
suggestion
4.14.5
Internal Audit
Requirements of Accreditation/
Description
improvement activities included as part
of management review?
Authorized personnel shall periodically
review the examinations provided by
the laboratory to ensure they are
clinically appropriate for the requests
received.
The laboratory shall periodically review
its:
- sample volume
- collection device
- preservative
requirements
for
blood, urine, other body fluids,
tissue and other sample types
to ensure neither insufficient nor
excessive amounts of samples are
collected and samples are properly
collected
to
preserve
the
measurand?
The laboratory shall seek user
feedback
on
the
laboratory’s
performance and whether the service
has met the needs and requirements
of users.
Records of such information and action
taken shall be retained and reviewed.
The laboratory shall encourage staff
make suggestions for the improvement
of any aspect of the laboratory
services.
Suggestions shall be
- evaluated
- implemented, as appropriate
- feedback provided to the staff
Records of suggestions and action
taken shall maintained
The laboratory shall conduct internal
audits at planned intervals and covers
all activities in the quality management
system (including pre-examination,
examination and post-examination
procedures) to determine:
- conformance to the requirements
stated in ISO 15189, relevant PAB
documents and internal laboratory
procedures
- implementation, effectiveness and
maintenance
of
the
quality
management system.
Are such audits carried out by
Document ID
Issue Number
Revision Number
Effectivity Date
Page
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Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Clause
Requirements of Accreditation/
Description
personnel trained to assess the
performance of managerial and
technical processes of the quality
management system?
How does the laboratory ensure
objectivity and impartiality of the audit
process? Are selected auditors,
wherever
resources
permit,
independent of the activity to be
audited?
Does the audit programme include:
- the status and importance of the
processes, the technical and
management areas to be audited
- the results of previous audits
The procedures for internal audit shall
define the criteria, scope, frequency,
methodology,
responsibilities
and
requirements
for
planning
and
conducting audits, and for reporting
and maintaining records.
The
laboratory
shall
have
a
documented procedure to define the
responsibilities and requirements for
planning and conducting audits, and
for reporting results and maintaining
records.
4.14.6
Risk
management
4.14.7
Quality
indicators
The personnel responsible for the area
being audited shall ensure that
appropriate
action
is
promptly
undertaken when non conformities are
identified. Corrective actions shall be
taken without delay to eliminate the
causes
of
the
detected
non
conformities.
The laboratory shall evaluate the
impact of work processes and potential
failures on examination results that
affect patient safety.
The laboratory shall modify processes
to reduce or eliminate the identified
risks and document decisions and
action taken.
The laboratory shall establish quality
indicators to monitor and evaluate the
performance of the critical aspects of
Document ID
Issue Number
Revision Number
Effectivity Date
Page
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Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Clause
Requirements of Accreditation/
Description
pre-examination, examination and
post-examination procedures.
The process of monitoring the quality
indicators shall be planned which
include:
- objectives
- methodology
- interpretation
- limits
- action plan
- duration of measurement
Are
the
reviewed?
indicators
periodically
Are turnaround times for each of its
examinations that reflect clinical needs
established?
Does the laboratory periodically
evaluate its performance to meet the
established turnaround time?
4.14.8
Review of
external
organization
4.15
4.15.1
General
4.15.2
Review input
(The laboratory should establish
quality indicators for systematically
monitoring
and
evaluating
the
laboratory’s contribution to patient
care)
When external organisations indicate
the laboratory has non conformities or
potential
non
conformities,
the
laboratory shall take appropriate
immediate actions and as appropriate
corrective action or preventive action
to ensure continue compliance with
ISO 15189:2012.
The laboratory shall retain records of
reviews by external organizations and
of
the corrective
actions
and
preventive actions taken.
Management Review
The laboratory management shall
review the quality management system
at planned intervals to ensure
continuing suitability, adequacy and
effectiveness in support of patient care
The input to management review shall
include information from the results of
evaluation of at least the following:
a) periodic review of requests,
suitability of procedures and
sample requirements
Document ID
Issue Number
Revision Number
Effectivity Date
Page
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01
01 August 2018
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Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Requirements of Accreditation/
Description
Clause
b)
c)
d)
4.15.3
Review
activities
4.15.4
Review output
assessment of user feedback
staff suggestions
the outcome of recent internal
audits?
e) risk management
f)
use of quality indicators
g) reviews by external organizations
h) interlaboratory
comparison
programmes
(PT/
EQA)
performance
i)
monitoring and resolution of
complaints
j)
supplier evaluation
k) identification and control of nonconformities
l)
results of continual improvement
(including current status of
corrective actions and preventive
actions
m) Follow-up actions from previous
management reviews
n) Changes in volume and scope of
work, personnel and premises
that could affect the quality
management system
o) Recommendation
for
improvement, including technical
requirements
The management review shall:
- analyse
of
the
causes
of
nonconformities,
trends
and
patterns that indicate process
problem
- include assessment of opportunities
for improvement and the need for
changes to the quality management
system, including its quality policy
and quality objectives.
- objectively evaluate the quality and
appropriateness of the laboratory’s
contribution to patient care, to the
extent possible.
The laboratory shall document the
decisions made and action taken
during management review related to:
- Improvement of the effectiveness
of the quality management system
and its processes
- Improvement of services to users
- Resource needs
The findings and actions arising
from the management review shall
be recorded and communicated
to
Document ID
Issue Number
Revision Number
Effectivity Date
Page
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Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Clause
Requirements of Accreditation/
Description
the laboratory staff.
5
5.1.1
General
5.1.2
Personnel
qualification
5.1.3
Job description
5.1.4
Personnel
introduction to
the
organizational
environment
5.1.5
Training
The
actions
from
management
reviews shall be carried out within
an appropriate and agreed timescale.
Technical Requirements
The laboratory/facility management
shall have documented procedures for
personnel management.
The management shall maintain
records for all personnel to indicate
compliance with requirements.
The laboratory management shall
document
document
personnel
qualification for each position.
- The qualification shall reflect
appropriate education, training,
experience and demonstrated skills
needed, and be appropriate for the
tasks performed.
- The personnel making judgments
with reference to examinations shall
have the applicable theoretical and
practical
background
and
experience.
The laboratory shall have job
descriptions
that
describe
responsibilities, authorities and tasks
for all personnel.
The laboratory shall have programme
to introduce new staff to the
organisation, the department or area in
which the person will work, the terms
and conditions of employment, staff
facilities,
health
and
safety
requirements (including fire and
emergency), and occupational health
services.
The laboratory shall provide training for
all personnel in the following areas:
a) The quality management system
b) Assigned work processes and
procedures
c) The
applicable
laboratory
information system
d) health and safety, including the
prevention or contamination of the
effects of adverse incidents
e) Ethics
f) Confidentiality of patient information
Document ID
Issue Number
Revision Number
Effectivity Date
Page
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Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Clause
Requirements of Accreditation/
Description
Personnel undergoing training shall be
supervised.
5.1.6
Competence
assessment
5.1.7
Review of staff
performance
5.1.8
Continuing
education and
professional
development
The effectiveness of the training
programme shall be periodically
reviewed.
The laboratory shall assess the
competence of each trained person to
perform assigned managerial or
technical
tasks
according
to
established criteria.
Reassessment shall take place at
regular interval. Retraining shall be
provided, when necessary.
Competency of laboratory staff can be
assessed by using any combination or
all of the following approaches under
the same conditions as the general
working environment:
a) direct observation of routine work
processes
and
procedures,
including all applicable safety
practices
b) direct observation of equipment
maintenance and function checks
c) monitoring the recording and
reporting of examination results
d) review of work records
e) assessment of problem solving
skills
f) examination of specially provided
samples, such as previously
examined samples, interlaboratory
comparison materials, or split
samples)
Does the laboratory consider the
needs of the laboratory and of the
individual during the reviews of staff
performance in order to maintain or
improve the quality of service and
encourage
productive
working
relationships?
Continuing education program shall be
available for personnel participating in
managerial and technical processes.
Personnel shall take part in continuing
education.
Effectiveness
of
the
education
programme
continuing
shall
be
Document ID
Issue Number
Revision Number
Effectivity Date
Page
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Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Clause
Requirements of Accreditation/
Description
periodically reviewed.
5.1.9
Personnel
records
5.2
5.2.1
General
Personnel shall take part in regular
professional development or other
professional liaison activities.
The laboratory shall maintain the
following records:
a) educational
and
professional
qualifications
b) copy of certification or license,
when applicable,
c) references
from
previous
employment,
d) job descriptions,
e) orientation records
f) training in current job tasks
g) competency assessments
h) records of continuing education and
achievements,
i) reviews of staff performance
j) records of accidents and exposure
to occupational hazards
k) records of immunization status
(when relevant to assigned duties)
Accommodation and environmental conditions
The laboratory workplace shall be
adequate to carry out quality work,
quality control procedures, and safety
of personnel and patient care services.
Is there evidence that the laboratory
director determined the adequacy of
the laboratory’s space?
The laboratory resources shall be
maintained in a functional and reliable
condition
5.2.2
Laboratory and
office facilities
Are provisions made for appropriate
primary
sample
collection
and
examinations sites, which are different
from permanent laboratory facility?
The laboratory and associated office
facilities shall provide an environment
suitable for the tasks to be undertaken,
to ensure the following conditions are
met:
a) access
to
laboratory/facility
controlled;
b) medical
information,
patient
samples, and laboratory resources
safeguarded from unauthorized
access;
Document ID
Issue Number
Revision Number
Effectivity Date
Page
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01 August 2018
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Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Clause
5.2.3
Storage
facilities
Requirements of Accreditation/
Description
c) laboratory/facility for examination
allow correct performance of
examinations?
Example, energy sources, lighting,
ventilation, noise, water, waste
disposal
and
environmental
conditions.
d) communication systems within the
laboratory appropriate to the size
and complexity of the facility to
allow
effective
transfer
of
information;
e) safety
facilities
and
devices
provided and functioning regularly
verified.
Storage space and conditions shall be
provided to ensure continuing integrity
of sample materials, documents,
equipment, reagents, consumables,
records, results and any other items
that could affect the quality of
examination results.
Are clinical samples and materials
stored in a manner to prevent cross
contaminations?
5.2.4
Staff facilities
5.2.5
Patient sample
collection
facilities
Are storage and disposal facilities for
dangerous materials appropriate to the
hazards of the materials and as
specified by applicable requirements?
The laboratory shall have adequate
access to washrooms, supply of
drinking water and facilities for storage
of personal protective equipment and
clothing.
Do the patient sample collection
facilities have separate reception/
waiting and collection areas?
Are
considerations
made
for
accommodating patient disabilities,
comfort, and privacy when primary
sample
collection
facilities
are
provided?
Is the environment in which the
primary sample collection procedures
are performed suitable so that it does
not invalidate the results or adversely
affect the quality of the examination?
Are appropriate first aid materials
Document ID
Issue Number
Revision Number
Effectivity Date
Page
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01
01
01 August 2018
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Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Clause
5.2.6
Facility
maintenance
and
environmental
conditions
Requirements of Accreditation/
Description
available and maintained for both
patient and staff at sample collection
facilities?
The laboratory premises shall be
maintained in a functional and reliable
condition.
Work areas shall be clean and well
maintained.
The laboratory/facility shall monitor,
control and record environment
conditions as required by relevant
specification or where they may
influence the quality of sample, results
and/or the health of staff.
(Due attention shall be paid to light,
sterility, dust, noxious or hazardous
fumes, electromagnetic interference,
radiation, humidity, electrical supply,
temperature, sound and vibration
levels, and workflow logistics, as
appropriate to the activities concerned
so as not to invalidate the results or
adversely affect the required quality of
examination)
There shall be effective separation
between neighbouring areas where
incompatible activities are performed.
Appropriate measures shall be taken
to prevent cross-contamination where
examination procedures pose a hazard
or where the work may be affected or
influenced by not being separated (e.g.
nucleic acid amplifications).
5.3
5.3.1.1
General
The laboratory shall provide a quiet
and uninterrupted work environment
where it is needed.
Laboratory Equipment
Note: Instruments, reference materials,
consumables, reagents, and analytical
systems are included as laboratory
equipment, as applicable.
Does the laboratory has documented
procedure for selection, purchasing
and management of equipment?
Is the laboratory/facility furnished with
all the items of equipment required for
Document ID
Issue Number
Revision Number
Effectivity Date
Page
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01
01 August 2018
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Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Clause
Requirements of Accreditation/
Description
its services (including primary sample
collection, sample preparation and
processing, examination and storage)?
Where the laboratory/facility needs to
use equipment outside its permanent
control,
does
the
laboratory
management
ensure
that
the
requirements of ISO 15189 are met?
5.3.1.2
Equipment
acceptance
testing
5.3.1.3
Equipment
instructions use
The laboratory shall replace equipment
as needed to ensure its quality of
examination results.
The equipment shall be verified upon
installation and before use to shown its
capability to achieve the necessary
performance and compliance with
requirements
relevant
to
any
examinations concerned.
Each item of equipment shall be
uniquely labelled, marked or otherwise
identified.
The
equipment shall be operated
by trained and authorized personnel
at all times.
Are current instructions, issued by
manufacturer, on the use, safety
and
maintenance
of equipment,
including relevant manuals and
directions for use, readily available?
5.3.1.4
Equipment
calibration and
metrological
traceability
The laboratory shall have procedures
for safe handling,
transport,
storage and use
of equipment to
prevent its
contamination
and
deterioration.
The
laboratory
shall
have
documented procedure
for
the
calibration of equipment that directly
or indirectly affects examination results
The procedure includes:
a) reference to conditions of use and
manufacturer’s instructions;
b) recording of the metrological
traceability of the calibration
standard and traceable calibration
of the item of equipment;
c) verification
of
the
required
measurement
accuracy
and
function of the measuring system at
defined intervals;
Document ID
Issue Number
Revision Number
Effectivity Date
Page
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Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Clause
Requirements of Accreditation/
Description
d) recording of the calibration status
and date of recalibration;
e) ensuring that calibration factors are
correctly updated after calibration;
f) safeguards to prevent adjustments
or tampering that might invalidate
examination results.
Metrological traceability shall be to a
reference material or
reference
procedure of the higher metrological
order available.
5.3.1.5
Equipment
maintenance
and repair
Where this is not possible or relevant,
does the laboratory use other means
for providing confidence in the results
such as (but not limited to):
- use of certified reference materials
- examination or calibration by
another procedure
- mutual consent standards or
methods
which
are
clearly
established,
specified,
characterized and mutually agreed
upon by all parties concerned?
Is there documented programme of
preventive maintenance which, at a
minimum,
following
the
recommendation
from
the
manufacturer?
Are equipment maintained in safe
working condition and in working
order?
Are procedures in place to ensure
examination of electrical safety,
emergency stop devices, and safe
handling and disposal of chemical,
radioactive and biological materials by
authorized persons?
Manufacturer’s
specifications
or
instructions or both shall be used, as
appropriate.
Is defective equipment taken out of
service, clearly labeled and not used
until it has been repaired and shown
by verification to meet specified
acceptance criteria?
Is the effect of this defect on previous
examinations examined and institute
Document ID
Issue Number
Revision Number
Effectivity Date
Page
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Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Clause
Requirements of Accreditation/
Description
immediate action or corrective action?
Are reasonable measures taken to
decontaminate equipment prior to
service, repair or decommissioning,
provide suitable space for repairs and
provide appropriate personal protective
equipment?
When equipment goes outside the
direct control of the laboratory/facility,
does the laboratory ensure its
performance is verified before the
equipment is returned to service?
5.3.1.6
Equipment
adverse
incident
reporting
Are adverse incidents and accidents
that can be attributed to specific
equipment investigated and reported to
manufacturer
and
appropriate
authorities, as required?
5.3.1.7
Equipment
records
Are the following records of each item
of equipment contributing to the
performance
of
examinations
maintained:
a) identity of the equipment,
b) manufacturer’s name, model, and
serial number or other unique
identification,
c) manufacturer’s/ supplier’s contact
information,
d) date received and date of entered
into service,
e) location,
f) condition when received (e.g. new,
used or reconditioned),
g) manufacturer’s instructions,
h) records
that
confirmed
the
equipment’s initial acceptability for
use when it is incorporated in the
laboratory,
i) maintenance carried out and the
schedule
for
preventive
maintenance,
j) equipment performance records
that confirm the equipment’s
ongoing acceptability for use,
k) damage
to,
or
malfunction,
modification or repair, of the
equipment.
Does the performance records referred
in
j)
include
copies
of
Document ID
Issue Number
Revision Number
Effectivity Date
Page
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Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Clause
Requirements of Accreditation/
Description
reports/certificates of all calibrations
and/or verifications including dates,
time
and
results,
adjustments,
acceptance criteria and due date of
next calibration and/or verification, to
fulfil part or this entire requirement?
Are the records maintained and readily
available for the life span of the
equipment or for any time period
required by national, regional and local
regulations?
5.3.2
5.3.2.1
General
5.3.2.2
Reagent and
consumablesReception and
storage
5.3.2.3
Reagent and
consumablesAcceptance
testing
5.3.2.4
Reagent and
consumablesInventory
management
5.3.2.5
Reagent and
consumablesInstruction for
Reagents and consumables
Does the laboratory has documented
procedure for reception, storage,
acceptance testing
and inventory
management
of
reagents
and
consumables?
Where the laboratory is not the
receiving facility, does the laboratory
verify that the receiving location has
adequate storage and handling
capabilities to maintain purchased
items in a manner that prevents
damage or deterioration?
Is the storage of received reagents and
consumables
in
accordance
to
manufacturer’s specification?
Is new formulation of examination kits
with changes in reagents or procedure,
or new lot or shipment verified for
performance
before
use
in
examinations?
Are consumables that can affect the
quality of examinations verified for
performance
before
use
in
examinations?
Does the laboratory establish an
inventory control system for reagents
and consumables?
Does the inventory control system
segregate
uninspected
and
unacceptable
reagents
and
consumables for those that have been
accepted for use?
Are instructions for use of reagents
and consumables, including those
provided by the manufacturers, readily
available?
Document ID
Issue Number
Revision Number
Effectivity Date
Page
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Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Clause
use
5.3.2.6
Reagent and
consumablesAdverse
incident
reporting
5.3.2.7
Reagent and
consumablesRecords
5.4
5.4.1
General
5.4.2
Information for
patients and
users
Requirements of Accreditation/
Description
Are adverse incidents and accidents
that can be attributed to specific
reagents or
consumables
investigated
and
reported
to manufacturer and
appropriate authorities, as required?
Are the following records (but not
limited to) of each reagents and
consumables contributing to the
performance
of
examinations
maintained:
a) Identity
of
the
reagent
or
consumable
b) manufacturer’s name, and batch
code/ lot number,
c) manufacturer’s/ supplier’s contact
information,
d) date received, expiry date, and date
of entering into service and, where
applicable, the date the material
was taken out of service,
e) condition when received (e.g.
accepted or damaged),
f) manufacturer’s instructions,
g) records
that
confirmed
the
reagent’s or consumable’s initial
acceptability for use,
h) performance records that confirm
the reagent’s or consumable’s
ongoing acceptance of use.
Where the laboratory uses reagents
prepared or completed in-house, does
the records also include reference to
the persons or persons undertaking
their preparation and the date of
preparation?
Pre-examination Process
Does the laboratory has documented
procedures and information for preexamination activities to ensure the
validity of the results of examinations?
Are the following information available
for patients and users of the laboratory
services:
a) location of the laboratory
b) types of clinical services offered
by the laboratory including
examinations referred to other
laboratories
c) opening hours of the laboratory
d) examinations offered by the
Document ID
Issue Number
Revision Number
Effectivity Date
Page
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Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Clause
Requirements of Accreditation/
Description
laboratory
including,
as
appropriate,
information
concerning samples required,
primary sample volumes, special
precautions, turnaround time,
(which may also be provided in
general categories or for groups
of
examinations),
biological
reference intervals, and clinical
decision values,
e) Instruction for completion of
request form
f)
Instruction for preparation of the
patient
g) Instruction for patient-collected
samples
h) Instruction for transportation of
samples, including any special
handling needs,
i)
any requirement for patient
consent (e.g. consent to disclose
clinical information and family
history to relevant healthcare
professionals, where referral is
needed
j)
the laboratory’s criteria for
accepting and rejecting samples,
k) a list of factors known to
significantly
affect
the
performance of examination or
the interpretation of the results
l)
availability of clinical advice on
ordering of examinations and on
interpretation
of
examination
results,
m) the
laboratory’s
policy
on
protection
of
personal
information,
n) the
laboratory’s
complaint
procedure
Is information that includes an
explanation of the clinical procedure to
be performed available for patients and
users to enable informed consent?
5.4.3
Request from
information
Are importance of provision of patient
and family information, where relevant
(e.g.
for
interpreting
genetic
examination results), explained to the
patient and user?
The request form or electronic
equivalent shall allow space for the
inclusion of, but not limited to:
Document ID
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Revision Number
Effectivity Date
Page
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Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Requirements of Accreditation/
Description
Clause
a)
b)
c)
d)
e)
f)
g)
5.4.4
5.4.4.1
General
patient identification, gender, date
of birth, location/contact details of
the
patient
and
unique
identification of the patient;
name or other unique identifier of
physician or other person legally
authorised to order examinations
or use medical information
together with the destination for
the report. If the requesting
clinician’s address provided as
part of the request form
information;
type of primary sample and the
anatomic site of origin, where
relevant;
examinations requested;
clinical information relevant to the
patient, which should include
gender and date of birth, as a
minimum,
for
interpretation
purposes;
date and time of primary sample
collection; and
date and time of receipt of
samples by the laboratory.
The laboratory shall have documented
procedure to handle verbal requests
for
examinations
that
includes
providing confirmation by request form
or electronic equivalent within a given
time.
The laboratory shall be willing to
cooperate with users or their
representatives in clarifying the user’s
request.
Primary sample collection and handling
The laboratory shall have documented
procedures for proper collection and
handling of primary samples.
The procedure(s) shall be available to
those responsible for primary sample
collection regardless if the collectors
are laboratory staff.
Where the user requires deviations,
exclusions from or additions to, the
documented collection procedure, are
the deviations recorded and included
in
all
documents
containing
Document ID
Issue Number
Revision Number
Effectivity Date
Page
LA/SF10
01
01
01 August 2018
31 of 48
Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Clause
Requirements of Accreditation/
Description
examination results and communicated
to the appropriate personnel?
5.4.4.2
Instructions for
pre-collection
activities
5.4.4.3
Instructions for
collection
activities
In emergency situations, consent might
not be possible; under these
circumstances it is acceptable to carry
out necessary procedures; provided
they are in patient’s best interest.
Does the laboratory have instructions
to include the following:
a) completion of request form or
electronic requests;
b) preparation of the patient (e.g.
instructions to caregivers and
phlebotomists)?
c) type and amount of primary
sample to be collected (e.g.,
phlebotomy, skin puncture, blood,
urine and other body fluids) with
descriptions of the primary sample
containers and any necessary
additives?
d) special timing of collection, if
required?
e) clinical information relevant to or
affecting
sample
collection,
examination performance or result
interpretation (e.g. history of
administration of drugs)?
Does the instructions for collection
activities include the following:
a) positive identification in detail of
the patient from whom a primary
sample is collected?
b) verification that patient meets preexamination requirements [e.g.
fasting status, medication status,
sample collection at predetermined
time or time intervals, etc]?
c) instructions for collection of
primary blood and non-blood
samples, with descriptions of the
primary sample containers and
any necessary additives?
d) where primary sample is collected
as part of clinical practice,
determination and communication
to appropriate clinical staff on the
information and instructions for
primary sample containers, any
necessary additives and sample
transport conditions?
Document ID
Issue Number
Revision Number
Effectivity Date
Page
LA/SF10
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01
01 August 2018
32 of 48
Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Requirements of Accreditation/
Description
Clause
e) instructions for labelling of primary
samples in a manner that provides
an unequivocal link with the
patients from whom they are
collected.
f) identification of the collector and
collection date, and when needed,
recording of the collection time
g) instructions for proper storage
conditions
before
collected
samples are delivered to the
laboratory
h) safe disposal of materials used in
the collection allowed additional
examinations?
5.4.5
Sample
transportation
5.4.6
Sample
reception
Do the laboratory’s instructions for
post-collection
activities
include
packaging
of
samples
for
transportation?
Does the laboratory monitor how the
samples are transported to the
laboratory for the following:
a) within a time frame appropriate to
the nature of the requested
examinations and the laboratory
discipline concerned?
b) within
a
temperature
range
specified in the primary sample
collection manual and with the
designated preservatives to ensure
the integrity of samples?
c) in a manner that ensures the
integrity of the samples and safety
for the carrier, the general public
and the receiving laboratory, in
compliance
with
established
requirements?
The laboratory’s procedure for sample
reception shall ensure that the
following conditions are met:
a)
b)
c)
Samples unequivocally traceable,
by request and labelling, to an
identified patient or site.
Laboratory-developed
and
documented
criteria
for
acceptance
or rejection of
samples applied.
Where there is uncertainty in the
identification of the primary
sample, or sample instability due
Document ID
Issue Number
Revision Number
Effectivity Date
Page
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01
01 August 2018
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Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Requirements of Accreditation/
Description
Clause
d)
e)
f)
to
delay
in
transport
or
inappropriate
container(s),
insufficient sample volume, or
when the sample is clinically
critical or irreplaceable and the
laboratory chooses to process the
sample, does the final report
indicate the nature of the
problem, and where applicable,
that caution is required when
interpreting the result?
All sample received are recorded
in an accession book, worksheet,
computer or other comparable
system and include:
- date and time of receipt and/
or registration of samples
- identity of person receiving the
sample, whenever possible
Authorised
personnel
shall
evaluate received samples to
ensure that they meet the
acceptance criteria relevant for
the requested examination.
Where
relevant,
are
there
instructions for the receipt,
labelling,
processing
and
reporting of samples specifically
marked as urgent?
Do the instructions include:
-
5.4.7
Preexamination
handling,
preparation and
storage
details of special handling of the
request form and the primary
sample?
mechanism of transfer of the
primary sample to be examination
area of the laboratory?
any rapid processing mode to be
used?
any special reporting criteria to be
followed?
All portions of the primary sample shall
be unequivocally traceable to the
original primary sample.
The laboratory shall have procedures
and appropriate facilities to :
- secure patient samples
- prevent deterioration, loss or
damage during pre-examination
activities, and during handling,
preparation and storage
Document ID
Issue Number
Revision Number
Effectivity Date
Page
LA/SF10
01
01
01 August 2018
34 of 48
Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Clause
5.5
5.5.1
5.5.1.1
General
Requirements of Accreditation/
Description
The laboratory procedure shall include
time limits for request of additional
examinations or further examinations
on the same primary sample.
Examination Process
Selection, verification and validation of examination procedure
The laboratory shall select examination
procedures which have been validated
for their intended use.
The identity of persons performing
activities in examination processes
shall be recorded.
Does the specified requirements
(performance specifications) for each
examination procedure relate to the
intended use of that examination.
5.5.1.2
Verification of
examination
procedures
Validated examination procedures
used without modifications shall be
subject to independent verification by
the laboratory before being introduced
in routine use.
The laboratory shall obtain information
from
the manufacturer/ method
developer
for
confirming
the
performance characteristics of the
procedure.
Does the independent verification by
the laboratory, through obtaining of
objective evidence, confirm that the
performance
claims
for
the
examination procedure have been met
and relevant to the intended use?
Is there documented verification
procedure? Is the result obtained
recorded?
5.5.1.3
Validation of
examination
procedures
Are the verification results reviewed by
appropriate authority and is the review
documented?
The laboratory shall validate the
examination procedures derived from:
a) non-standard methods,
b) laboratory designed or developed
methods
c) standard methods used outside
their intended scope
Document ID
Issue Number
Revision Number
Effectivity Date
Page
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01
01 August 2018
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Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Requirements of Accreditation/
Description
Clause
d)
validated methods subsequently
modified
The validations shall be as extensive
as necessary and confirm, through
provision of objective evidence (in the
form of performance characteristics),
that the specific requirements for the
intended use of the examination have
been fulfilled.
Is
there
documented
validation
procedure? Is the result obtained
recorded?
Are the validation results reviewed by
appropriate authority and is the review
documented?
5.5.1.4
Measurement
uncertainty of
measured
quantity values
When changes are made to a
validated examination procedure, are
the impact of the changes documented
and, when appropriate, a new
validation shall be carried out.
The
laboratory
shall
determine
measurement uncertainty for each
measurement procedure used to report
measured quantity values on patient’s
samples.
The laboratory shall define the
performance requirements for the
measurement uncertainty of each
measurement procedure and regularly
review estimates of measurement
uncertainty.
The
laboratory
shall
consider
measurement
uncertainty
when
interpreting measured quantity values.
Upon request, does the laboratory
make its estimation of measurement
uncertainty available to laboratory
users?
Where
examinations
include
a
measurement step but do not report a
measured
quantity
value,
the
laboratory
should
calculate
the
uncertainty of the measurement step
where it has utility in assessing the
reliability of the examination procedure
or has influence on the reported result.
Document ID
Issue Number
Revision Number
Effectivity Date
Page
LA/SF10
01
01
01 August 2018
36 of 48
Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Clause
Requirements of Accreditation/
Description
5.5.2
Biological
reference
intervals or
clinical decision
values
The laboratory shall define the
biological reference intervals or clinical
decision values, document the basis
for reference intervals or decision
values
and
communicate
this
information to users.
Are appropriate changes made, when
a particular biological reference
interval or decision value is no longer
relevant for the population served? Are
the changes communicated to the
users?
When the laboratory changes an
examination
procedure
or
preexamination procedure, are the
associated reference intervals and
clinical decision values reviewed?
5.5.3
Documentation
of examination
procedures
Examination procedures
documented.
shall
be
They shall be written in a language
commonly understood by the staff in
the laboratory. It shall be available in
appropriate locations.
Any condensed document format (e.g.
card files or similar used systems)
shall correspond to the documented
procedure.
Are all documents associated with the
performance
of
examinations,
including
procedures,
summary
documents, condensed documents
format and product instructions for use,
subjected to document control?
In addition to document control
identifiers,
does
documentation
include, when applicable, the following:
a) purpose of the examination
b) principle and method of the
procedure used for examinations
c) performance characteristics
d) type of sample (e.g. plasma,
serum, urine)
e) patient preparation
f)
type of container and additive
Document ID
Issue Number
Revision Number
Effectivity Date
Page
LA/SF10
01
01
01 August 2018
37 of 48
Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Requirements of Accreditation/
Description
Clause
g)
h)
i)
j)
k)
l)
m)
n)
o)
p)
q)
r)
s)
t)
5.6
5.6.1
General
5.6.2
5.6.2.1
General
5.6.2.2
Quality control
materials
required equipment and reagents
environmental and safety controls
calibration
procedures
(metrological traceability)
procedural steps
quality control procedures
interferences
(e.g.,
lipaemia,
haemolysis, bilirubinemia) and
cross reaction
principle
of
procedure
for
calculating results, including,
where relevant, measurement
uncertainty of measured quantity
values
biological reference intervals or
clinical decision values
reportable interval of examination
results
instructions
for
determining
quantitative results when results
is not within the measurement
interval
alert/critical
values,
where
appropriate
laboratory clinical interpretation
potential sources of variation
references
If the laboratory intends to change to
an existing examination procedure
such that results or their interpretations
could be significantly different, the
implications shall be explained to users
of the laboratory services after
validating the procedure.
Ensuring quality of examination results
The laboratory shall ensure that quality
of examinations by performing them
under defined conditions. Appropriate
pre- and post- examination processes
shall be implemented.
The laboratory shall not fabricate any
results.
Quality control
The laboratory/facility shall design
internal quality control procedures that
verify the attainment of the intended
quality of results.
The laboratory shall use quality control
materials that react to the examination
system in a manner as close as
possible to patient samples.
Document ID
Issue Number
Revision Number
Effectivity Date
Page
LA/SF10
01
01
01 August 2018
38 of 48
Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Clause
5.6.2.3
Quality control
data
Requirements of Accreditation/
Description
The quality control materials shall be
periodically examined with a frequency
that is based on the stability of the
procedure and the risk of harm to the
patient from an erroneous result.
The laboratory shall have a procedure
to prevent the release of patient results
in the event of quality control failure.
When the quality control rules are
violated and indicate that examination
results are likely to contain clinically
significant errors, the results shall be
rejected and relevant patient samples
re-examined after the error condition
has been corrected and withinspecification performance is verified.
The laboratory shall evaluate the
results from patient samples that were
examined after the last successful
quality control event.
The quality control data shall be
reviewed at regular intervals to detect
trends in examination performance that
may indicate problems in the
examination system.
5.6.3
5.6.3.1
Participation
The preventive actions taken shall be
recorded when such trends are noted.
Interlaboratory Comparison
The laboratory shall participate in interlaboratory comparison programme(s)
appropriate to the examination and
interpretations of examination results.
The laboratory shall:
- monitor
the
results
of
the
interlaboratory
comparison
programme(s)
- participate in the implementation of
corrective
actions
when
predetermined performance criteria
are not fulfilled.
The laboratory shall establish a
documented
procedure
for
interlaboratory
comparison
participation that include:
- defined
responsibilities
and
instructions for participation?
Document ID
Issue Number
Revision Number
Effectivity Date
Page
LA/SF10
01
01
01 August 2018
39 of 48
Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Requirements of Accreditation/
Description
Clause
-
5.6.3.2
Alternative
approaches
performance criteria that differs
from the criteria used in the
interlaboratory
comparison
programme?
Interlaboratory
comparison
programme(s)
chosen
by
the
laboratory shall, as far as possible,
provide clinically relevant challenges
that mimic patient samples and have
the effect of checking the entire
examination process including preand post-examination procedures,
where possible.
Whenever interlaboratory comparison
is not available, the laboratory shall
develop other approaches and provide
objective evidence for determining the
acceptability of examination results.
Wherever possible, this mechanism
shall utilise appropriate materials.
5.6.3.3
Analysis of
interlaboratory
comparison
samples
Examples of such materials may
include:
- certified reference materials
- samples previously examined;
- material from cell or tissue
repositories;
- exchange of samples with other
laboratories
- control materials that are tested
daily in interlaboratory comparison
programs.
The
laboratory
shall
integrate
interlaboratory comparison samples
into the routine workflow in a manner
that follows, as much as possible, the
handling of patient samples.
The laboratory shall ensure that:
- interlaboratory comparison samples
are examined by personnel who
routinely examine patient samples
using the same procedures as
those used for patient samples.
-
no communication with other
participants in the interlaboratory
comparison
programme
about
sample data until after the date for
submission of the data.
Document ID
Issue Number
Revision Number
Effectivity Date
Page
LA/SF10
01
01
01 August 2018
40 of 48
Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Requirements of Accreditation/
Description
Clause
-
5.6.3.4
Evaluation of
laboratory
performance
5.6.4
Comparability
of examination
results
interlaboratory comparison samples
are not sent for confirmatory
examinations before submission of
the data, although this would
routinely be done with patient
samples.
The performance in interlaboratory
comparisons shall be reviewed and
discussed with relevant staff.
When predetermined performance
criteria are not fulfilled, does the
laboratory:
- involved
the
staff
in
the
implementation and recording of
corrective actions?
- monitored the effectiveness of the
corrective action?
- evaluated the returned results for
trends that indicate potential
nonconformities
and
take
appropriate preventive action?
There shall be defined means of
comparing procedures, equipment and
methods used and establishing the
comparability of results for patient
samples throughout the clinically
appropriate intervals.
This is applicable to the same or
different
procedures,
equipment,
different sites, or all of these.
(In the particular case of measurement
results
that
are
metrologically
traceable to the same reference, the
results are described as having
metrological comparability providing
that calibrators are commutable).
The laboratory shall notify users of any
differences in comparability of results
and discuss any implications for
clinical practice when measuring
systems
provide
different
measurement intervals for the same
measurand and when examination
methods are changed.
The laboratory shall document, record
and as appropriate, expeditiously act
upon
results
from
the
above
comparisons.
Document ID
Issue Number
Revision Number
Effectivity Date
Page
LA/SF10
01
01
01 August 2018
41 of 48
Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Clause
5.7
5.7.1
Review of
results
5.7.2
Storage,
retention and
disposal of
clinical samples
Requirements of Accreditation/
Description
Problems or deficiencies identified
shall be acted upon and records of
actions retained.
Post-examination process
The laboratory shall have procedure to
ensure that
authorised personnel
systematically review the results of
examinations and evaluate them in
conformity of the clinical information
available regarding the patient and
authorise the release of the results.
Review criteria shall be established,
approved
and
documented
for
procedure that involves automatic
selection and reporting.
The
laboratory
shall
have
a
documented procedure for:
- identification
- collection
- retention
- indexing
- access
- storage
- maintenance
- safe disposal of clinical samples
The laboratory shall define the
retention time of clinical samples.
Retention time shall be defined by:
- nature of sample
- the examination
- any
applicable
requirements/
regulation
5.8
5.8.1
General
Safe disposal of samples shall be
carried out in accordance with local
regulations or recommendations for
waste management.
Reporting of Results
The results of each examination shall
be
reported
accurately,
clearly,
unambiguously and in accordance with
any specific instructions in the
examination procedures.
The laboratory shall define the format
and medium of the report (electronic or
paper) and the manner in which it is to
be communicated from the laboratory.
The laboratory shall have procedures
in place to ensure correctness of
Document ID
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Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Requirements of Accreditation/
Description
Clause
transcription of laboratory results.
The reports shall have the necessary
information for the interpretation of the
examination results.
5.8.2
Report
attributes
5.8.3
Report content
The laboratory shall have a process for
notifying the requester when an
examination is delayed that could
compromise patient care.
The laboratory shall ensure that the
following report attributes effectively
communicate laboratory results and
meet users’ needs:
a) comments on sample quality that
might compromise examination
results,
b) comments
regarding
sample
suitability
with
respect
to
acceptance/ rejection criteria,
c) critical results, where applicable
and
d) interpretative comments on results,
where applicable, which may
include the verification of the
interpretation
or
automatically
selected and reported results in the
final
report
are
effectively
communicated and meet the users'
needs.
The report should include but not
limited to:
a)
b)
c)
d)
e)
f)
g)
clear unambiguous identification
of the examination including,
where
appropriate,
the
examination procedure;
the
identification
of
the
laboratory/facility that issued the
report;
Identification of all examinations
that have been performed by a
referral laboratory;
identification and location of the
patient on each page;
name or other unique identifier of
the requester and the requester’s
contact details;
date of primary sample collection,
and time where available and
relevant to patient care;
source and system (or primary
Document ID
Issue Number
Revision Number
Effectivity Date
Page
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01
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Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Requirements of Accreditation/
Description
Clause
h)
i)
j)
sample type),
measurement procedure, where
appropriate;
results
of
the
examination
including SI units or units
traceable to SI units, or other
applicable units;
biological reference intervals,
clinical decision values, or
diagrams/ nomograms supporting
clinical decision values, where
applicable.
(Under some circumstances, it may be
appropriate to distribute lists or tables
of biological reference intervals to all
users and sites where reports are
received).
5.9
5.9.1
General
k) interpretations of results, where
appropriate;
l) other comments such as cautionary
or explanatory notes (e.g., quality or
adequacy of primary sample, which
may have compromised the result,
results/interpretations from referral
laboratories, use of developmental
procedure);
m) Identification
of
examinations
undertaken as part of a research or
development programme and for
which no specific claims on
measurement performance are
available;
n) identification of the person(s)
reviewing
the
results
and
authorising the release of the report
(if not contained in the report,
readily available when needed);
o) date and time of release of report, if
not on the report, shall be readily
accessible when needed;
p) page number to total number of
pages (e.g. “Page 1 of 5”)
Release of Results
The laboratory/facility shall have
documented procedures for the
release
of
examination
results,
including details of who may release
results and to whom.
The procedures shall ensure
following conditions are met:
the
Document ID
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Reference to
Laboratory Document
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Laboratory Accreditation Form
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15189:2012
Clause
Requirements of Accreditation/
Description
a) When quality of the primary sample
received
is
unsuitable
for
examination,
or
could
have
compromised the result, it is
indicated in the report.
b) When examination results fall within
established “alert” or “critical”
intervals,
- immediate
notification
of
physician (or other clinical
personnel responsible for patient
care)
including
referral
laboratories’ results.
- records of actions taken are
maintained including
date and time
responsible laboratory staff
member
person notified
examination results conveyed
any difficulty encountered in
meeting this requirement
c) results are legible, without mistakes
in transcription, and reported to
persons authorised to receive and
use the information.
d) When results are transmitted as an
interim report, the final report is
always forwarded to the requester.
5.9.2
Automated
selection and
reporting of
results
e) There are processes for ensuring
that results distributed by telephone
or electronic means reach only
authorized
recipients.
Reports
provided orally shall be followed by
a written report. There shall be
records of all oral results provided.
If the laboratory implements a system
for automated selection and reporting
of
results,
it
shall
establish
documented procedure to ensure that :
a) criteria for automated selection and
reporting are defined, approved,
readily available and understood by
the staff?
b) criteria are validated for proper
functioning before use and verified
after changes to the system that
might affect their functioning?
c) a process is in place to indicate the
presence of sample interferences
Document ID
Issue Number
Revision Number
Effectivity Date
Page
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01
01 August 2018
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Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Clause
5.9.3
Revised reports
5.10
5.10.1
General
5.10.2
Requirements of Accreditation/
Description
(e.g. haemolysis, iceterus, lipaemia)
that may alter the results of the
examination;
d) a process to incorporate analytical
warning
messages
from
the
instruments into the automated
selection and reporting criteria,
when appropriate;
e) results selected for automated
reporting are identifiable at the time
of review before release and that
date and time of selection are
included;
f) a process for rapid suspension of
automated selection and reporting
is in place.
There shall be written instructions
regarding the revision of reports. So
that:
a) Revised report is clearly identified
as revision and includes reference
to the date and patient’s identity in
the original report.
b) user regarding is made aware of
the revision;
c) the revised record shows the time
and date of change and the name
of person responsible for the
change;
d) the original report entries in the
record when revisions are made.
Results used for clinical decisionmaking revised shall be retained in
subsequent cumulative reports and
clearly identified as having been
revised.
When the reporting system cannot
capture amendments, changes or
alterations, a record of such shall be
kept.
Laboratory Information Management
The laboratory/facility shall have
access to the data and information
needed to provide a service which
meets the needs and requirements of
the users.
The laboratory shall have documented
procedure to ensure confidentiality of
patient information is maintained at all
times.
The laboratory shall ensure that the
Document ID
Issue Number
Revision Number
Effectivity Date
Page
LA/SF10
01
01
01 August 2018
46 of 48
Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Clause
Authorities and
responsibilities
Requirements of Accreditation/
Description
authorities and responsibilities for the
management of the information system
are defined, including the maintenance
and modification to the information
system(s) that may affect patient care.
The laboratory shall
define
authorities
and
responsibilities of all personnel who
use the system, in particular those
who:
a) access
patient
data
and
information;
b) enter patient data and examination
results;
c) change
patient
examination results;
5.10.3
Information
system
management
data
or
d) authorize to release examination
results and reports.
The system(s) used for the collection,
processing,
recording,
reporting,
storage or retrieval of examination data
and information shall be:
a) validated by supplier and verified
for functioning by the laboratory
before introduction, with any
changes
to
the
system
authorised, documented and
verified before implementation?
b) documented to include day to day
functioning of the system and be
readily available to authorised
users?
c) protected
from
unauthorised
access
d) safeguarded against tampering or
loss
e) operated in an environment that
complies
with
supplier
specifications
or
provides
conditions which safeguard the
accuracy of manual recording and
transcription;
f)
maintained in a manner that
ensures the integrity of the data
and information and includes the
recording of system failures and
the appropriate immediate and
corrective actions,
g) in compliance with national or
Document ID
Issue Number
Revision Number
Effectivity Date
Page
LA/SF10
01
01
01 August 2018
47 of 48
Reference to
Laboratory Document
(To be completed by the
laboratory)
PAB Remarks
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
Clause
Requirements of Accreditation/
Description
international
requirements
regarding data protection.
The laboratory shall verify the results
of examinations,
associated
information
and
comments
are
accurately reproduced, electronically
and in hard copy where relevant,
by the information systems external to
the laboratory intended to directly
receive the information (e.g. clinics’
computer systems, fax machines, email, personal web devices or
websites.)
When new examination or automated
comments
are implemented,
the
laboratory shall verify that the changes
are accurately reproduced by the
information systems external to the
laboratory intended to directly receive
information from the laboratory.
The laboratory shall have documented
contingency plans to maintain services
in the event of failure or downtime in
information system that affects the
laboratory’s ability to provide service.
When the information system(s) are
managed and maintained off-site or
subcontracted to an
alternative
provider,
the
laboratory
management shall be responsible for
ensuring that the provider or operator
of the system complies with all
applicable
requirements
of
this
International Standard.
PAB Supplementary Requirements
LA/SR08 (Supplementary Requirements for the
Accreditation of Medical Testing Laboratory)
Philippine Accreditation Bureau
Laboratory Accreditation Form
Assessment Checklist for PNS ISO
15189:2012
PAB Supplementary Requirements
LA/SR 09 (Supplementary Requirements for
Participation to Proficiency Testing)
LA/SR 10 (Supplementary Requirements on
Traceability of Measurement)
LA/SR 11 (Supplementary Requirements on the Use
of PAB Laboratory and Inspection Body
Accreditation Symbol)
Document ID
Issue Number
Revision Number
Effectivity Date
Page
LA/SF10
01
01
01 August 2018
48 of 48
