LQMS-SIP Checklist Final v1 - Jan 12 2016 PDF

CHECKLIST FOR THE
STEPWISE IMPROVEMENT PROCESS FOR

STRENGTHENING LABORATORY QUALITY MANAGEMENT SYSTEMS
(LQMS-SIP)
TOWARDS ACCREDITATION
CHECKLIST FOR THE STEPWISE IMPROVEMENT PROCESS FOR STRENGTHENING LABORATORY QUALITY MANAGEMENT SYSTEMS INDICATING THE EQUIVALENCE
WITH ISO 15189
Version 1 2016
The text taken from the ISO 15189:2012, Medical Laboratories – Requirements for quality and competence, is reproduced with the permission of the International
Organization for Standardization, ISO. This standard can be obtained from any ISO member and from the Web site of the ISO Central Secretariat at the following
address: www.iso.org. Copyright remains with ISO.
The requirements given in the checklist are not the exact clauses in the ISO 15189: 2012; however the numbering corresponds to the relevant sections of the standard. The equivalence with
the CLSI Quality Systems Essentials (CLSI Guideline QMS01-A4 – Quality Management system – A Model for Laboratory Services Approved Guideline – Fourth Edition) is provided as a
separate annex
Instructions for checklist use:
• The Stepwise Improvement Process Checklist contains 15 Management requirements and 10 Technical requirements based upon the ISO 15189 International
Standard.
• In each of the main sections the requirements are separated into 3 distinct tiers, based upon relative importance/complexity.
o Requirements noted in “black” represent Tier 1
o Requirements noted in “blue” represent Tier 2
o Requirements noted in “green” represent Tier 3
• Responses to all questions must be, Yes (Y), No (N) or Not applicable (N/A), to specify whether the laboratory is in compliance or not.
• All the elements of each specific requirement must be satisfactorily present to indicate “Yes”.
• Provide comments for each “N/A” or “No” response
SAFETY REQUIREMENTS
The Safety requirements included are based on the ISO 15190 - Medical Laboratories - Requirements for Safety in the final section.
The results from the safety assessment do not count toward the Laboratory’s final Tier classification.
NOTE: Items that include “tick lists” must receive all “yes” and/or “n/a” responses to be marked “yes” for the overarching question.
Assessors must complete the laboratory assessment using the following techniques to evaluate operations and to document findings in detail:
a) Review laboratory records to verify that the QMS and supporting documents are complete, current, accurate, and annually reviewed.
b) Observe laboratory operations including pre-analytic, analytic and post-analytic phases of laboratory testing;
c) Ask open-ended questions to clarify documentation seen and observations made.
d) Do a vertical audit of a specimen through the laboratory from collection through to reporting.
e) Review Quality Control process and records and ensure traceability of samples and results.
f) Confirm PT results and the results are reviewed and corrective action taken as required.
g) Evaluate the quality and efficiency of supporting work areas (e.g., phlebotomy, reception, drivers, cleaners, IT, etc.).
h) Talk to clinicians and staff to learn the users’ perspective on the laboratory’s performance.
2
CHECKLIST FOR THE STEPWISE IMPROVEMENT PROCESS FOR STRENGTHENING LABORATORY QUALITY MANAGEMENT SYSTEMS INDICATING THE EQUIVALENCE
WITH ISO 15189
LABORATORY PROFILE
Date of Assessment (dd/mm/yyyy)

Assessor name(s)
Laboratory Name
Laboratory Address
Laboratory Telephone Fax Email
Name of Laboratory Head (Manager or

Director)
Name of Deputy Head (Manager or Director)
Name of Quality Manager (Officer)
Name of Safety Officer
Name of Consulting Pathologist:
Print name of Lead Assessor:
Signature of Lead Assessor:
3
CHECKLIST FOR THE STEPWISE IMPROVEMENT PROCESS FOR STRENGTHENING LABORATORY QUALITY MANAGEMENT SYSTEMS INDICATING THE EQUIVALENCE WITH ISO 15189
MANAGEMENT REQUIREMENTS
Status Quality Improvement
Comments
ISO Levels
15189 Requirement What to look for
Clauses Y N NA Tier 1 Tier 2 Tier 3
4.1 Organization and management responsibility
4.1.1.2 Can the laboratory or the organization of which the Company registration, articles of
laboratory is a part, be held legally responsible for its incorporation, license, (liability) insurance, x x x
activities? other relevant legal documentation
4.1.1.3 Ethical Conduct
4.1.1.3 Does the laboratory have arrangements to ensure:

a) No involvement in activities which would diminish Established code of ethics x x x
confidence in laboratory’s confidence, impartiality,
judgement or operational integrity. Documented and Approved staff Ethics
Policy
b) Management and personnel are free from undue
commercial, financial or other pressures Documented and Approved Policy on
declaring conflicts of interest
c) Potential conflicts of interest are openly and
appropriately declared Documented procedure about treatment
and disposal of human samples, tissues
d) Procedures are in place to ensure that human or remains
samples, tissues or remains are treated according to
relevant legal requirements Confidentiality agreements signed by all
staff, outlining requirements and
e) Confidentiality of information is maintained repercussions for breeches
4.1.1.4 Does a competent person(s) with medical, scientific and Job description for Laboratory Director
technical background direct the laboratory? and designees, and evidence of x x x
qualifications, continuing education and
experience
Records of Competency assessment for
Laboratory Director, designees and
Professional staff
4.1.2 Management responsibility
4.1.2.1 Has management provided evidence of commitment to Minutes of staff meetings, Management
the development and implementation of the QMS and its reviews and training on the QMS x x x
continual improvement?
4
Comments
ISO Levels
4.1.2.3 Has an appropriate quality policy defining the intent of Documented and approved Quality policy
the quality management system been established and statement.
documented? x x x
Quality policy signed by appropriate
Does the quality policy include: personnel
a) A commitment to good professional practice, to Quality Manual
conducting examinations fit for intended use,
compliance with the requirements of the
International Standard and continual improvement of
the quality of laboratory services
b) A framework for establishing and reviewing the
quality objectives
c) That it be communicated and understood within the
organization
d) That it be reviewed for continuing suitability
4.1.2.4 Has Management established quality objectives which Documented and approved Quality
address the needs of the users, are consistent with the Objectives x x x
quality policy and are measureable?
Quality Manual
4.1.2.5 Has management defined, documented and Documented Job descriptions and
communicated the responsibilities, authority and Organogram
interrelationships within the organization? x x x
Documented designation of who has
Have deputies for all key functions been appointed? primary and secondary responsibility for
all key functions
4.1.2.6 Has management documented communication and Minutes of staff meetings, memos to staff,
meetings with staff? Documentation of internal communication
regarding the QMS, User Manual x x
Has management established a communication process
with stakeholders about pre-examination, examination Memos, letters, press releases
and post examination processes and the QMS?
4.1.2.7 Has a quality manager been appointed, delegated Documented designation of quality
responsibility and authority for development, manager position or responsibility x x x
implementation and compliance with the QMS?
Job description and organogram
5
Comments
ISO Levels
4.2 Quality Management System
4.2.1 Has Management established, documented, Documented policies, processes and

implemented and maintained a QMS and continually procedures x
improved its effectiveness in accordance with the
International Standard ISO 15189? Evidence of communication of this
information to all staff
Evidence that laboratory management has
ensured that all documents are
understood and implemented
Evidence of Management reviews
Data of corrective and preventive actions
4.2.2 Documentation requirements
4.2.2.1 Does the QMS documentation include procedures and Master list of documents
records required by the International Standard ISO x x
15189? SOP manuals
Does the documentation include copies of applicable Copies of national regulations, ISO
regulations, standards and other normative documents? 15189:2012, other applicable standards
as referenced by the lab in its QMS, e.g.
ISO 15190
4.2.2.2 Quality Manual
4.2.2.2 Has the laboratory established a quality manual that is Established and documented Quality
accessible to and used by staff? Manual x x x
Does the manual include all the requirements of ISO Evidence of sessions to train staff on the
15189:2012 Clause 4.2.2.2?
use and applicability of the manual
6
Comments
ISO Levels
Document hierarchy described in the

Quality manual and supporting
procedures appropriately referenced
Roles and responsibilities of management
and the quality manager referenced in the
Quality Manual
Sign off sheet or information session

records
Evidence of review and/or revision as
required by document control procedure
7
Comments
ISO Levels
4.3 Document Control
4.3 Has the laboratory established and maintained Documented procedures for the control of
procedures to control all documents that form part of its all documents that form part of the QMS x x x
quality system? (internal and external)
Does the document control procedure include all the All hard and soft copy QMS documents are
requirements of ISO 15189:2012 Clause 4.3? reviewed and approved by authorized x x x
personnel.
Quality system documents uniquely
identified in accordance with the stated
criteria
Current master list
Current authorized documents available at
relevant locations
Procedure for amending documents
Procedure for identifying changes in
documents
Records of periodic review, revision and
approval
Obsolete documents labelled as such
Specified document retention times
Archived documents
8
Comments
ISO Levels
4.4 Service Agreements
4.4.1 Does the laboratory have documented procedures for Documented procedure for review of
the establishment and review of agreements to provide service agreements that includes x
services? requirements of Clause 4.4.1.
Do these agreements take into account the request, the User Manual
examination and the report including any information Copies of completed request forms
needed to ensure appropriate examination and result
interpretation? Signed contracts or service agreements
When the laboratory enters into a service agreement Evidence of communication about
deviations from original service agreements
does it meet all the requirements of ISO 15189:2012
Clause 4.4.1? List of referral laboratories and
examinations referred
4.4.2 Are records of these service agreements reviewed and Records of any service agreement reviews
any significant changes maintained? and changes agreed x x
If the service agreement needs to be amended after the Records of review for service agreements
work commences: Is the same review process amended after work commenced
repeated? Are any amendments communicated to all
parties affected? Records of laboratory notification of service
agreement amendments to all affected
parties
9
Comments
ISO Levels
4.5 Examination by Referral Laboratories
4.5.1 Selecting and evaluating referral laboratories and consultants
4.5.1 Does the laboratory have a documented procedure for Documented procedure for the selection
selecting and evaluating referral laboratories and and evaluation of referral laboratories and x x
consultants? consultants to include all the requirements
listed Clause 4.5.1 a) to e)
Does the procedure ensure that the laboratory meets
the requirements of ISO 15189:2012 Clause 4.5.1? Records of reviews of referral laboratories
and consultants and Register of Referral
Laboratories and / or consultants
Record of requests and results for all
samples referred in accordance with
specified retention period
4.5.2 Provision of Examination results
4.5.2 Is the referring laboratory responsible for ensuring that Copies of referral lab/consultants reports. x x X
the examination results from the referral laboratory is Copies of referring laboratory reports.
made available to the person making the request,
unless otherwise specified? Identification of personnel making addition
remarks on the referral report
If the referring laboratory prepares the report, does it
include all essential elements of the results reported, Review of turnaround times, measurement
without alterations that could affect clinical accuracy and transcription errors
interpretation? Code of Ethics, Conflict of interest
Does the report indicate which examinations were procedure
performed by the referral laboratory or consultant?
Is the author of any additional information identified?
Does the laboratory adopt the most appropriate means
of reporting referral lab results?
Are mechanisms in place to ensure that collaboration
between referring and referral laboratories are not
hindered by commercial or financial considerations?
10
Comments
ISO Levels
4.6 External Services and Supplies
4.6 Does the laboratory have a procedure(s) for selection, Procedures(s) for the selection and
purchasing of services, equipment, reagents and purchase of eternal services, equipment, x
consumable supplies? reagents and supplies
Are criteria established for the selection and approval of Criteria for selection and records of
suppliers? Supplier Evaluations
Is this done in collaboration with other organizational Approved Supplier list
departments, where relevant?
Purchasing records with product /service
Is there a current list of approved suppliers of specification
equipment, reagents and consumable supplies?
Does the purchasing information describe the

requirements for the product and / or service?
Is the supplier’s performance monitored to ensure that
purchased services and items consistently meet the
stated criteria?
11
Comments
ISO Levels
4.7 Advisory Services
4.7 Has the laboratory established arrangements for Minutes of meetings and consultations
communicating with users according to the between laboratory director and /or x
requirements of ISO 15189:2012 Clause 4.7? consultant/specialists with clinical
personnel
Documented evidence of advice on
individual clinical cases
Records of qualifications, training and
competency assessment for laboratory
and associated professional staff
4.8 Resolution of Complaints
4.8 • Is there a procedure for the management of Procedure for the management of
complaints or other feedback from patients, complaints or other feedback x x
clinicians, laboratory staff and other parties?
Records of complaints, investigations and
• Are there records of complaints, investigations and corrective actions
corrective actions?
12
Comments
ISO Levels
4.9 Identification and Control of Non-Conformities
4.9.1 Does the laboratory have a documented procedure to Procedures for managing non-conformities
identify and manage non-conformities? that include requirements of Clause 4.9.1 a) x
to h) ISO 15189:2012.
Do these procedures ensure that the laboratory meets
the requirements of ISO 15189 Clause 4.9.1? Records of non-conformities and
investigations
Reports of corrective actions taken
4.10 Corrective Action
4.10 Does the laboratory take appropriate corrective actions Procedure for corrective actions
to eliminate the causes of nonconformities? x
Records of root cause analysis and
Does the laboratory have a documented procedure for corrective actions taken
corrective actions which include all the requirements of
ISO 15189:2012 Clause 4.10?
4.11 Preventive action
4.11 Does the laboratory have a documented procedure for Documented procedure for preventive action
preventive action? that include requirements of Clause 4.11 x
ISO 15189:2012:
Records of preventive actions taken
13
Comments
ISO Levels
4.12 Continual Improvement
4.12 Does the laboratory have a programme for continual Management review minutes
improvement of its quality management system? x
Documented Quality Policy
Does the laboratory conduct risk assessments for the
procedures that it is undertaking? Documented Quality Objectives
Does the laboratory have documented action plans for Risk evaluation reports
improvement? Improvement action plans for priority areas
Does the laboratory communicate improvement plans Evidence that staff is informed of plans and
and goals to the staff? goals e.g. correspondence with staff
4.13 Control of Records
4.13 Does the laboratory have a documented procedure for Procedure(s) for identification, collection,
control of quality and technical records? indexing, access, storage, maintenance, x x x
amendment and safe disposal of quality and
Does the facility have suitable record storage areas? technical records
Retention times of Records
Review records listed in ISO 15189:2012
Clause 4.13 a) to v)
14
Comments
ISO Levels
4.14 Evaluation and Audits
4.14.1 Does the laboratory plan and implement the evaluation Internal audit Plan, Schedule, Associated
and internal audit processes needed to ensure Forms and Reports x x x
conformity to the QMS, improve its effectiveness and
meet user needs?
4.14.2 Periodic review of requests, and suitability of procedures and sample requirements
4.14.2 Do authorized personnel periodically review the Records of review of examinations by

laboratory’s examinations to ensure they are clinically authorized personnel x x
relevant?
Does the laboratory periodically review its sample
collection requirements to ensure the sample is properly Records of review of sample collection and
collected to preserve the measurand? user manuals
4.14.3 Assessment of user feedback
4.14.3 Does the laboratory seek information from users on Customer surveys and reports x X
whether the service has met user needs?
Records of actions taken based on
Do the methods for obtaining and using this information customer feedback
include cooperation with users or their representatives?
Is the information obtained in a manner that ensures
user confidentiality?
Are records of information collected and actions taken
kept?
4.14.4 Staff suggestions
4.14.4 Does Laboratory management encourage staff to make Records of staff surveys and meetings
suggestions for the improvement of the laboratory x x
service? Records of management actions based on
staff feedback
Are suggestions evaluated, implemented as appropriate
and feedback provided to the staff?
Are records of suggestions and action taken by the
management maintained?
15
Comments
ISO Levels
4.14.5 Internal audit
4.14.5 Does the laboratory conduct internal audits at planned Audit schedule
intervals to ascertain whether the QMS: X x
Records of auditor training
a) Conforms to the requirements of the ISO
15189:2012 and the laboratory requirements Records of follow up from previous audits
b) Is implemented, effective, and maintained? Documented procedure for conducting

internal audits which defines the
Are personnel trained to conduct audits which assess responsibilities and requirements for
the performance of managerial and technical processes planning and conducting audits, and for
of the QMS? reporting results and maintaining records
Are the audit criteria, scope, frequency and methods Documented audit criteria, scope,
defined and documented? frequency and methods
Are auditors selected and audits conducted to ensure Audit reports
objectivity and impartiality of the audit process?
Records of Corrective Action Plan,
Does the laboratory have a documented procedure for implementation and verification
conducting internal audits?
Are corrective actions promptly undertaken?
4.14.6 Risk Management
4.14.6 Does the laboratory evaluate the impact of work Risk analysis/impact assessment report(s)
processes and potential failures on examination results
as they affect patient safety? Record of decisions and actions taken with x
respect to process modifications.
Does the lab make modifications to processes to
reduce or eliminate identified risks and document
decisions and actions taken?
16
Comments
ISO Levels
4.14.7 Quality Indicators
4.14.7 Does the laboratory establish quality indicators to List of quality indicators
monitor and evaluate performance?
Description of process and schedule for x x
Does the laboratory have a planned process of monitoring quality indicators which includes
monitoring quality indicators? establishing the objectives, methodology,
interpretation, limits, action plan and
Does the laboratory periodically review their indicators, duration of measurement
to ensure their continued appropriateness?
Periodic indicator review reports
Does the laboratory, in consultation with the users,
establish and monitor turnaround times? Record of agreed turnaround times for
each examination finalized in consultation
with users
Record of evaluation and report on

achievement of established turnaround
times
4.14.8 Reviews by eternal organisations
4.14.8 Does the laboratory take appropriate corrective action Records of the reviews by eternal
or preventive action when reviews by eternal organizations
organizations indicate current or potential X
nonconformities? Records of corrective actions and
preventive actions taken
Are records of reviews and corrective and preventive
action maintained?
17
Comments
ISO Levels
4.15 Management Review
4.15.1 Documented Procedure for Management

Does the laboratory management conduct a review of Review to ensure its continuing suitability,
the quality management system at planned intervals? adequacy and effectiveness and support of x x
patient care
4.15.2 Does the input to laboratory’s management review Management review meeting agenda
include information from the results of evaluations of the
requirements of ISO 15189:2012 Clause 4.15.2? Minutes including decisions and actions on X
results of at least the items listed in Clause
4.15.2 a) to o) of ISO 15189:2012
4.15.3 Does the laboratory’s Management review analyse the Records of the Management review
input information? minutes indicating items outlined in Clause
4.15.3 ISO 15189:2012. X
Does this review include assessment of opportunities
for improvement and need for changes to the QMS, and
where possible, objective evaluations of
appropriateness of the lab’s contribution to patient
care?
4.15.4 Is the output from the management review incorporated Minutes of Management review including a)
into a record that documents any decisions made and to c)
actions taken related to: X
Minutes of staff meetings, emails, bulletins,
a) Improvement of the effectiveness of the QMS its memos, etc.
processes
b) Improvement of services to users Action and Implementation plans
c) Resource needs?
Are the findings and actions arising from management

reviews recorded and reported to laboratory and other
relevant staff?
Does the laboratory management ensure that actions

arising from management review are completed within a
defined timeframe?
18
TECHNICAL REQUIREMENTS
Comments
ISO Levels
5.1 Personnel
5.1.1 Does the laboratory: Documented personnel management

procedure x x x
- have a documented procedure for personnel
management? Personnel records for all staff in the
organisation
- maintain records for all personnel to indicate
compliance with requirements?
5.1.2 Personnel qualifications
5.1.2 Has the laboratory management documented the Qualification and competency
personnel qualifications for each position as appropriate requirements x X x
for the tasks to be performed?
5.1.3 Job Descriptions
5.1.3 Does the laboratory have job descriptions for all Job descriptions that describe
personnel? responsibilities, authorities and tasks x X x
Organisational chart
5.1.4 Personnel introduction to the organizational environment
5.1.4 Does the laboratory have an orientation programme for Documented orientation programme
new staff? x X x
Records of staff orientation
5.1.5 Training
5.1.5 Does the laboratory provide training for all personnel Annual training plan X x
inclusive of the areas listed in ISO 15189:2012 Clause
5.1.5? Employee training plans
Are trainees supervised at all times? Training course outlines and reports
Is the training programme periodically reviewed for Training records

effectiveness? Reviews of training programmes
19
Comments
ISO Levels
5.1.6 Competence Assessment
5.1.6 Does the laboratory assess the competence of each Competency assessment records
person to perform assigned managerial or technical X x
tasks? Established criteria for competency of
managerial and technical tasks
Does the laboratory periodically reassess competence
and retrain when necessary? Training Records
5.1.7 Reviews of staff performance
5.1.7 Do staff performance reviews consider the needs of the Performance reviews
laboratory and the individual in order to maintain or X x
improve the quality of service provided? Evidence of reviews addressing continual
improvement issues and customer service
5.1.8 Continuing education and professional development
5.1.8 Does the laboratory have a continuing education Documented continuing education
programme available to managerial and technical programme X x
personnel?
Evidence of personnel participation in the
Is the programme periodically reviewed for continuing education programme
effectiveness?
Evidence of reviews of continuing
Do personnel regularly participate in professional education programme for effectiveness
development or other professional liaison activities?
Continuing education records, certificates
5.1.9 Personnel records
5.1.9 Are personnel records maintained and accessible for all Personnel records including at least
personnel? requirements stated in ISO 15189:2012 X x
Clause 5.1.9
20
Comments
ISO Levels
5.2 Accommodation and Environmental Conditions
5.2.1 Does the laboratory have work space that is designed to Laboratory layout, space and
ensure the quality and efficacy of the service and the infrastructure in accordance with x x
health and safety of laboratory personnel, patients and international guidelines
visitors?
Has the laboratory evaluated the adequacy of the space
allocated for its work? Records of evaluation
5.2.2 Do the laboratory and office facilities provide a suitable Laboratory and associated facilities
environment that ensures the requirements of ISO layout, safety, confidentiality, and quality X x x
15189:2012 Clause 5.2.2 practices
Evidence of restricted access to
examination spaces
Specimen collection and transport
procedures
Records of environmental monitoring of
specimen collection and examination
areas
Communication Process
Record of performance checks on safety
devices
5.2.3 Are adequate storage spaces and conditions provided? Examine the conditions of storage spaces
for sample materials, documents,
Are clinical samples and materials stored appropriately equipment, reagents, consumables,
to prevent cross contamination? records, results and any other items that X x x
Are storage and disposal facilities for dangerous could affect the quality of examination
materials appropriate to the hazards of the materials? results
Records of monitoring of storage
conditions.
Methods of waste management and
disposal
21
Comments
ISO Levels
5.2.4 Does staff have adequate access to washrooms, Examine condition of staff facilities
drinking water, storage facilities for personal protective X x x
equipment and clothing? Observe use of PPE
5.2.5 When primary sample collection facilities are provided, Layout of specimen collection and
are considerations made for accommodating patient accessioning area X x x
comfort, needs and privacy?
Facilities and accommodation for
Are appropriate first aid materials for both patient and patients with disabilities
staff needs available at collection facilities?
First aid kits and emergency materials
5.2.6 Are the laboratory premises maintained in a functional Clean and well maintained work areas,
and reliable condition? housekeeping schedule and records X x x
Are work areas clean and well maintained? Records of environmental monitoring
Does the laboratory monitor, control and record Laboratory layout
environmental conditions?
Procedure to prevent cross contamination
Is there effective separation between neighbouring areas
where incompatible activities are performed?
Are appropriate measures taken to prevent cross-
contamination?
Is a quiet uninterrupted work environment provided?
22
Comments
ISO Levels
5.3 Laboratory Equipment, reagents and consumables
5.3.1 Equipment
5.3.1.1 Does the laboratory have a documented procedure for Procedure for selection, purchasing and
the selection, purchasing and management of management of equipment x x x
equipment?
Is the laboratory furnished with all the items of equipment
required for its services? Laboratory equipment inventory list
5.3.1.2 Equipment acceptance testing
5.3.1.2 Is equipment shown to be capable of achieving the Equipment verification records

performance required and complies with specifications x x
relevant to the examinations concerned? Equipment List of with unique identifier
Is each piece of equipment uniquely labelled, marked or Labels on each piece of equipment
otherwise identified?
5.3.1.3 Equipment instructions for use
5.3.1.3 Do only trained and authorized personnel operate Training and personnel records and
equipment? competency assessment records X x x
Does the laboratory have procedures for safe handling, Procedures for proper use of equipment
transport, storage and use of equipment to prevent its
contamination/ deterioration? Manufacturers’ equipment manuals, and
directions for use
Are up-to-date instructions on the use and maintenance
of equipment readily available to laboratory personnel?
23
Comments
ISO Levels
5.3.1.4 Equipment calibration and metrological traceability
5.3.1.4 Does the laboratory have a documented procedure for Documented procedure for calibration x
the calibration of equipment that directly or indirectly which includes requirements of Clause
affects examination results? 5.3.1.4 a) to f) ISO 15189:2012
Does the procedure ensure that the laboratory meets the Calibration certificates or Calibration
requirements of ISO 15189:2012 Clause 5.3.1.4? records
Is the metrological traceability to a reference material or
reference procedure of the higher metrological order? Records of use of certified reference
materials
Where not practical, are other methods utilised?
5.3.1.5 Equipment maintenance and repair
5.3.1.5 Does the laboratory have a documented programme of Records of preventive x x

preventive maintenance? maintenance/service of equipment, as
advised by the manufacturer
Are equipment maintained in a safe working condition
and in working order?
Is defective equipment taken out of service and clearly Records of corrective action taken
labelled?
Labels on defective equipment
Is repaired equipment shown by verification to meet
specified acceptance criteria before being placed back in Records of post service verification
operation? Records of review and corrective action
Does the laboratory examine the effect of defects on the on previous examination results
previous examinations? Decontamination records
Are reasonable measures taken to decontaminate PPE policy
equipment prior to service, repair or decommissioning?
Records of performance verification for
Does the laboratory provide suitable space for repairs returned equipment
and appropriate personal protective equipment?
When equipment goes outside the direct control of the
laboratory, is performance verified before resumption of
use?
24
Comments
ISO Levels
5.3.1.6 Equipment adverse incident reporting
5.3.1.6 Does the laboratory investigate adverse incidents and Adverse incident reports and reporting
accidents that can be attributed directly to specific forms
equipment and report this to the equipment manufacturer x
and appropriate authorities?
5.3.1.7 Equipment records
5.3.1.7 Are records maintained for each item of equipment that Records for each piece of equipment, that x x
contributes to the performance of examinations? include aat least the items listed in ISO
15189:2012 Clause 5.3.1.7:
5.3.2 Reagents and consumables
5.3.2.1 Does the laboratory have a documented procedure for Procedures for reception, storage, and x x
management and inventory of reagents and acceptance testing and inventory
consumables? management of consumables and
reagents
5.3.2.2 Does the laboratory verify that the receiving location has Records of verification of conditions at x x
adequate storage and handling capabilities to maintain receiving locations
purchased items in a manner that prevents damage or
deterioration? Examine storage conditions for reagents
and consumables
Are received reagents and consumables stored
according to manufacturer’s specifications?
5.3.2.3 Does the laboratory verify the performance of Records of acceptance testing x
examination kits before use?
5.3.2.4 Does the laboratory have an inventory control system for Inventory records x x
reagents and consumables?
Examine the storage facility for labelling
Does the inventory control system segregate and organisation
uninspected and unacceptable reagents and
consumables from those that have been accepted for Inspection Checklist
use?
25
Comments
ISO Levels
5.3.2.5 Are the instructions for use of reagents and consumables Reagent and Consumable instructions
readily available? x x x
5.3.2.6 Does the laboratory investigate adverse incidents and Adverse incident reports and reporting
accidents that can be attributed directly to specific forms x
reagents and consumables and report this to the
manufacturer and appropriate authorities?
5.3. 2 Reagents and Consumables
5.3.2.7 Does the laboratory maintain records for each reagent Records of reagents and consumables
and consumable that contributes to the performance of including items listed in ISO 15189:2012 x x
examinations? Clause 5.3.2.7
Does the laboratory maintain records for each reagent Identification of persons preparing in-
that is prepared or completed in-house? house reagents and date of preparation
26
Comments
ISO Levels
5.4 Pre examination Processes
5.4.1 Are there documented procedures and information for Procedure for validity of pre-examination
pre-examination activities that ensure the validity of the activities
results of examinations? x x x
User Manual
5.4.2 Information for patients and users
5.4.2 Does the lab provide appropriate information for patients User manual which include items listed in
and users of the laboratory services? ISO 15189:2012 Clause 5.4.2
x x x
Does the laboratory provide information for patients and
users that include an explanation of the clinical
procedures to be performed to facilitate informed
consent?
5.4.3 Request form Information
5.4.3 Does the laboratory have request forms? Request forms with at least the
requirements of ISO 15189:2012 Clause
5.4.3 x x x
5.4.3 Does the laboratory have a documented procedure Procedure for verbal requests for
regarding verbal requests for examinations? examinations
x x
5.4.4 Primary sample collection and handling
5.4.4.1 Does the laboratory have documented procedures for Procedures for the collection and
the collection and handling of primary samples that are handling of primary samples
available to sample collectors within and outside of the x x x
laboratory? Distribution list
5.4.4.2 Does the lab have instructions for pre-collection Instructions for pre-collection activities
activities? that include the items listed in ISO x x x
15189:2012 Clause 5.4.4.2
5.4.4.3 Does the lab have instructions for collection activities? Instructions for collection activities that
include at least the items listed in ISO
15189:2012 Clause 5.4.4.3 x x x
27
Comments
ISO Levels
5.4.5 Sample transportation
5.4.5 Does the lab have instructions for post-collection Procedures (Post-Collection activities) in
activities that address requirements for packaging of User Manual
samples for transportation? x x x
5.4.5 Does the laboratory have a documented procedure for Procedures for monitoring the
monitoring the transportation of samples? transportations of samples that meets the
requirements of ISO 15189:2012 Clause x x
5.4.5
5.4.6 Sample reception
5.4.6 Does the laboratory have a sample reception procedure? Sample reception procedure which
ensures that the requirements of ISO
Are all portions of the sample traceable to the original 15189:2012 Clause 5.4.6 are met. x x
primary sample?
5.4.7 Does the lab have procedures for pre-examination Procedures for pre-examination handling,
handling, preparation and storage? preparation and storage that:
x x
a) ensures security of patient samples
b) prevents deterioration, loss or damage

during pre-examination activities and
during handling, preparation and storage
c) include time limits for requesting

additional examinations on the same
primary sample.
Examine sample storage facilities
28
Comments
ISO Levels
5.5 Examination Processes
5.5.1 Selection, verification and validation of examination procedures
5.5.1.1 Does the laboratory use validated examination Established validated procedures
procedures? appropriate for meeting the needs of x x
users
Is the identity of persons performing activities in the
examination processes recorded? Records of persons performing
examination activities
5.5.1.2 Are validated examination procedures independently Procedures for verifying all examination
verified by the laboratory before being introduced into processes x
routine use?
Has the laboratory obtained from the
manufacturer/method developer information for Records of all verification procedures and
confirming the performance characteristics? results
Has the laboratory confirmed through objective evidence

that the performance claims for the examination Records of review of verification results
procedure have been met?
Are results obtained and the procedure used for
verification recorded? List of staff authorised to review
verification results
Does staff with the appropriate authority review the
verification results and record the review?
5.5 Examination Processes
5.5.1.3 Does the laboratory validate examination procedures Procedure for validation of examination
derived from: procedures x
a) Non-standard methods? Records of all validation results
b) Lab-designed or developed methods?
c) Standard methods used outside their intended Records of review of validation results
scope?
d) Validated methods subsequently modified? List of staff authorised to review and
Has the laboratory confirmed through objective evidence approve validation results
that the performance claims for the examination
procedure have been met?
29
Comments
ISO Levels
Are results obtained and the procedure used for

validation recorded?
Does staff with the appropriate authority review the
validation results and record the review?
Are changes to validated examination procedures

documented and are new validations performed?
5.5.1.4 Measurement uncertainty of measured quantity values
5.5.1.4 Has the laboratory determined measurement uncertainty Measurement uncertainty for each
for each measurement procedure in the examination measurement procedure x
phase which reports measured quantity values on
patients’ samples? Measurement uncertainty performance
requirements
Are performance requirements for measurement
uncertainty defined and regularly reviewed? Records of review of performance
Is measurement uncertainty considered when requirements
interpreting measured quantity values and are these
made available to users? User communications of measurement
uncertainty e.g. in reported results, User
Where there is no measured quantity value, does the Manual, letter/email.
laboratory calculate the uncertainty of the measurement
step in assessing reliability of the examination procedure
on the reported result?
5.5.2 Biological reference intervals or clinical decision values
Are the biological reference intervals or clinical decision SOPs, User Manual x
5.5.2 values:
a) Defined by the laboratory?
b) Documented along with the basis for them?
c) Communicated to users?
Does the laboratory make appropriate changes if a Records of investigations of biological x
particular reference interval is no longer appropriate for reference intervals as necessary
the population served?
User communications e.g. letter/email,
Are such changes in biological reference intervals newsletter, User Manual.
communicated to users?
Are biological reference intervals reviewed, if Records of review of biological reference x
appropriate, when the laboratory changes an intervals when SOPs are changed, if
examination procedure or pre-examination procedure? necessary
30
Comments
ISO Levels
5.5.3 Documentation of Examination Procedures
5.5.3 Are all examination procedures documented in a Controlled examination procedures which
language commonly understood by staff and available includes, as applicable the items listed in x x x
in an appropriate location? ISO 15189:2012 Clause 5.5.3
Do condensed documents correspond to the Document controlled job aids
documented procedure?
Records of communication to users
Are all documents associated with the performance of
examinations subject to document control?
In addition to document identifiers, do procedure
documents contain required information?
If changes are planned to an existing examination
procedure such that results or their interpretations could
be significantly different, are the implications explained to
users after validating the procedure.
31
Comments
ISO Levels
5.6 Ensuring Quality of Examination Results
5.6.1 Does the laboratory ensure the quality of examinations Records of environmental and equipment
by performing them under defined conditions? monitoring. Internal quality control records x x x
for every laboratory examination.
Does the laboratory ensure appropriate pre- and post-
examination processes are implemented? Records for all aspects of testing,
including specimen handling, requests,
Does the laboratory ensure that no results are examinations and reporting
fabricated?
5.6.2 Quality Control
5.6.2.1 Does the laboratory design quality control procedures Quality control procedures including:
that verify the attainment of the intended quality of x x
results? a) Frequency of conduct of internal
quality control
b) Methods of analysis of quality control
data
c) Actions to be taken in the event of
quality control failure
5.6.2.2 Quality Control Materials
Does the laboratory use appropriate quality control Quality control records and
materials? manufacturer’s information and data e.g. x x x
package and kit inserts
Are quality control materials periodically examined to
prevent erroneous results and to ensure continued
suitability?
32
Comments
ISO Levels
5.6.2.3 Quality Control Data
Does the laboratory have a procedure to prevent the Documented procedure for handling QC
release of patient results in the event of quality control failures x x
failure?
Quality control records
Does the laboratory reject results and re-examine patient Quality control corrective and preventive
samples when a quality control performance error is action records
detected that indicates that examination results are likely
to contain clinically significant errors?
Does the laboratory evaluate the results from patient

samples examined after the last successful quality
control event?
Does the laboratory review quality control data at regular

intervals to detect trends and take preventive action as
necessary?
5.6.3 Inter-laboratory comparisons
5.6.3.1 Participation
5.6.3.1 Does the laboratory participate in inter-laboratory Records of participation in eternal quality
comparisons appropriate to the examination and assessment (EQA) programmes x
interpretations of results?
Procedure including responsibilities and
Does the laboratory monitor the results of inter- performance criteria for inter-laboratory
laboratory comparisons and participate in the comparison programme participation
implementation of corrective actions when performance Records of monitoring of results
criteria are not fulfilled?
Records of implementation of corrective
Is there a procedure for inter-laboratory comparison actions where indicated
participation?
Does the programme provide clinically relevant
challenges that mimic patient samples and check the
entire examination process, where possible?
33
Comments
ISO Levels
5.6.3.2 Alternative approaches
5.6.3.2 When inter-laboratory comparison programmes are not Review Records such as those listed in
available, does the laboratory develop approaches for the note under Clause 5.6.3.2 of ISO x x
determining the acceptability of examination results? 15189:2012
Any other suitable programmes
5.6.3.3 Analysis of inter-laboratory comparison samples
5.6.3.3 Has the laboratory integrated inter-laboratory Records for handling and reporting of
comparison samples into the routine workflow in a inter-laboratory comparison samples. x x
manner that follows, as much as possible, the handling
of patient samples?
Are these performed by personnel who routinely
examine patient samples using routine methods?
Does the laboratory avoid collaboration with other
participants about sample data before the deadline for
submission of the data?
Does the laboratory avoid referring inter laboratory
comparison samples before submission of results?
34
Comments
ISO Levels
5.6.3.4 Evaluation of laboratory performance
Is performance in inter-laboratory comparisons reviewed Records of:

and discussed with relevant staff? 1. Review of performance with x x
relevant laboratory staff
When pre-determined performance criteria are not 2. Corrective action
fulfilled, does staff participate in the effective 3. Monitoring of effectiveness of
implementation and recording of corrective action? corrective action
Is preventive action taken where trends in returned 4. Preventive action.
results indicate potential nonconformities?
5.6.4 Comparability of examination results
5.6.4 For examinations performed using same or different Process for periodically verifying the
procedures, equipment, and/or different sites: comparability of results when same or x
different procedures, equipment and/ or
Is there a defined means for comparing procedures, sites are used
equipment and methods and establishing the
comparability of results throughout the clinically Records of comparisons of procedures,
appropriate intervals? equipment and/or sites.
User information bulletins/memos,
Does the laboratory notify users of any differences in meetings.
comparability of results and discuss implications for
clinical practice? Records of actions taken based on
problems or deficiencies identified.
Does the laboratory document and record the results of
the comparisons performed and the actions taken?
35
Comments
ISO Levels
5.7 Post- Examination Procedures
5.7.1 Review of Results
5.7.1 Does the laboratory have procedures to ensure Procedure for the review of results before
authorized personnel review examination results before they are released x x x
release, against internal quality control, clinical
information and previous examination results? Records of authorization of results before
release
5.7.2 Storage, Retention and disposal of clinical samples
5.7.2 Does the laboratory have a documented procedure for Documented procedure for sample
identification, collection, indexing, access, retention, control, retention and storage x x
storage, maintenance and safe disposal of samples?
Does the laboratory have defined sample retention times
with criteria which are based on the nature of the Stored samples
sample, the examination and specified requirements?
Are samples disposed safely and in accordance with Waste Management Regulations applied
regulations or recommendations for waste management? in the safe disposal of samples
36
Comments
ISO Levels
5.8 Reporting of Results
5.8.1 Are results of each examination reported Copies of issued Laboratory Reports
accurately, clearly, unambiguously in x X
accordance with specific instructions in a Documented procedure for verification of
defined format and medium? transcription
Does the laboratory have a procedure to Process for notifying requesters when
ensure the correctness of result transcription? examinations are delayed
Is there a process for notifying requester when
an examination which could compromise Copies of requester notification
patient care is delayed?
5.8.2 Report Attributes
5.8.2 Do the laboratory reports effectively Copies of issued laboratory reports

communicate laboratory results and meet x X
users’ needs in accordance with ISO Feedback from users
15189:2012 Clause 5.8.2?
Criteria for acceptance/rejection
List of critical values
5.8 Report Content
5.8.3 Does the laboratory have a standardized Laboratory reports that include the x x X
reporting format? requirements of ISO 15189:2012 Clause
5.8.3
37
Comments
ISO Levels
5.9 Release of results

5.9.1 Does the lab have documented procedures for the Documented procedure for release of
release of examination results, including who may examination results x X
release results and to whom?
Copies of final reports with notes about
sample quality
Log of actions for critical results reporting
Copies of original results, Copies of

interim and final reports
Logs for telephone and electronic results

transmission, Policy for results distributed
by telephone and other electronic means
5.9.2 Automated Selection and Reporting of Results
5.9.2 Does the laboratory have a documented procedure for Evidence will only be required if this
automated selection and reporting of results? activity is applicable to the laboratory. x
Documented procedure for automated
selection and reporting of results
Refer to requirements of ISO 15189:2012
Clause 5.9.2
5.9.3 Revised Reports
5.9.3 Does the Laboratory have written instructions regarding Procedure for revision or alteration of
the revision of reports ensuring the original report is reports x x
referenced, the user is notified and the action is
recorded? Copies of altered reports
Does the Laboratory keep records of revisions when the

reporting system cannot capture amendments, changes
or alterations?
38
Comments
ISO Levels
5.10 Laboratory information management
5.10.1 Does the Laboratory have a documented procedure to Documented procedure on confidentiality
ensure the confidentiality of patient information is of paper based and/or computer data x x
maintained at all times?
5.10.2 Authorities and Responsibilities
5.10.2 Has the laboratory defined the authorities and

responsibilities for the management of the information Job Descriptions
system, including maintenance and modification affecting List of authorities for Information x x
patient care? Management system according to
requirements of ISO 15189:2012 Clause
Has the laboratory defined the authorities and 5.10.2
responsibilities of the personnel who use the Information IT user manual
Management System?
5.10.3 Information system management
5.10.3 Is there evidence that the Laboratory information system Validation and verification data and x
meets the requirements of ISO 15189 Clause 5.10.3? records including system training checklist
Does the laboratory have a documented contingency LIS User manual and SOPs
plan for maintenance of services in the event of an
information system failure or downtime which affects the Copy of national or international
laboratory’s ability to provide service? requirements for data protection
List of authorized users
Copy of LIS Contingency plan
Corrective Action Reports
39
SAFETY REQUIREMENTS
ref to Status Quality Improvement
Comments
ISO Levels
Section 15190 Requirement What to look for
numbers Y N NA Tier 1 Tier 2 Tier 3
Section 1: Safety Officer, Safety Manual, Safety Programme

6.1
Job description, letter of x x X
Is there an appointed Biosafety Officer (BSO)? appointment
6.2
x X
Has the BSO been trained to perform their duties? Training records
6.3 7.2, 7.4, Is a safety manual specific for the laboratory's needs
8 readily available to all employees?
Safety manual to include (but not
be limited to):
a) fire prevention, electrical safety
b) accidents/incidents
c) chemical, radiation and
biohazards x X
d) hazardous material identification,
labelling, storage, spill clean up
and waste disposal, use of MSDS
sheets
e) detailed instructions for
evacuation
f) health and safety committee
Is there evidence that employees have read the manual? Sign-off sheets
6.4 7.2, 7.4, Documented procedure/instructions
8, 17.1 Are there instructions regarding job hazards that describe
- Use of BSC, Spills, Needle stick
how to carry out tasks safely and what to do if an incident x x
injuries, Blood, Equipment
occurs?
(Centrifuge, Autoclave)
6.5 7.2, 7.4 Documents, binders, texts - E.g.,
Are other essential safety-related procedures, policies MSDS on all chemical and x x
(aside from the safety manual) available in the laboratory? biological agents
6.6 7.3.1, Is the safety program reviewed annually? Safety program review report to
7.5.3 include the following documents
and records:
a) safety and health policy
x
b) written procedures that include
safe work practices
c) education and training
40
SAFETY REQUIREMENTS
Comments
ISO Levels
d) reports of physical inspections

e) hazardous materials and
substances
f) health surveillance
g) first aid services and equipment
h) investigation of accidents and
illnesses
6.7 7.3.2 Is there evidence that work areas are inspected annually Safety inspection report covering
for safety? the following:
(a) fire emergency apparatus,
alarms and evacuation processes,
ready and functioning
(b) hazardous spillage containment
procedures and materials or
x X x
necessary equipment, available
and in good working order
(c) proper storage of flammable
and combustible materials
(d) proper decontamination and
disposal processes
6.8 8 Are hazardous areas and the presence of certain hazards Conspicuously posted
(e.g., flammable) identified? signs/notices and labels for x x x
hazardous materials
6.9 8 Are visitors, non-permanent staff and other workers made Records of visitor briefing
aware of hazards in the laboratory? X x x
6.10 Has the laboratory performed a risk assessment to SOP for Risk Assessment
determine which procedures require the use of a Reports of risk assessment
biological safety cabinet? x x
Section 2: Reporting of Incidents, Accidents and Occupational Illness
6.11 7.5.2, 9 Is there a program for reporting safety-related Procedure and reporting forms
accidents/incidents? Accident/incident Reports X x
41
SAFETY REQUIREMENTS
Comments
ISO Levels
6.12 7.5.2, 9 Are detailed reports filed for all incidents/accidents? Detailed Reports giving persons
involved, time and place,
identification of the cause, and x x
recommendations for prevention
and actions).
6.13 9 Are the accident/incident reports reviewed by laboratory Evidence of review and associated
management to ensure that remedial action(s) is taken to remedial actions
avoid recurrence? X x
6.14 7.5.2 Is there a procedure and process (e.g., vaccination where Documented procedure on control
applicable) regarding occupational exposure to Human occupational exposure
Immunodeficiency Virus, Hepatitis B Virus, Hepatitis C X x X
Virus and tuberculosis?
Section 3: Training
6.15 5.2, Is there evidence that a safety training program is in Manuals and training records of at
7.5.2, place? least the following areas:
9 a) staff orientation and periodic
retraining
b) fire prevention and
preparedness
c) chemical and radiation safety
d) biological hazards
x X
e) standard/universal precautions
f) infection prevention/available
immunization
g) emergency procedures
h) transportation of Dangerous
Goods
i) personal protective equipment
and clothing
6.16 9, 14.1 Is there evidence that all staff have been trained in the Training Records
safe handling, use and disposal of sharp instruments and
devices? x x x
6.17 9, 14.1, Is there evidence that staff are trained to be aware of the Training Records
15 hazards associated with the handling of body fluids? X x x
42
SAFETY REQUIREMENTS
Comments
ISO Levels
6.18 Are lab employees trained to ensure that all applicable Records of staff trained in
regulations are followed when transporting or offering for dangerous goods transport.
x x
transport biological material and dangerous goods?
Section 4: Personnel Responsibilities and Safe Work Practices

6.19 5.2, 14.1, Do staff consistently practice standard precautions to Direct observation
14.2, 15 ensure the protection of themselves, co-workers, patients,
and the public from exposure to sources of danger? X x x
6.20 Are all samples, control materials, biologically sourced SOP for safe handling of
calibrators, cultures and waste assumed to contain viable pathogens
pathogens and handled in a safe manner? x x x
6.21 11.1 Are food and drink prohibited in the laboratory where Signs and policy on handling food
specimens are stored and handled and from and drink in the lab, direct
specimen/reagent refrigerators? observation X x x
6.22 Is the use of cell phones prohibited in the lab (unless Signs and policy on cellular
authorized)? telephone use in the lab x x x
6.23 11.1 Is smoking prohibited in the laboratory? Lab policy prohibiting smoking in
the lab X x x
6.24 11.1 Is there evidence that the application of cosmetics and the Signs and policy on cosmetic use
handling of contact lenses are prohibited in the and contact lenses in the lab x x x
laboratory?
6.25 11.1 Are arrangements in place to warn of hair, beards, loose Lab policy on safety precautions for
clothing and jewellery being caught in equipment or long hair, beards, loose clothing
contaminated by infectious substances? and jewellery X x x
6.26 11.4 Is personal property stored where it cannot become Direct observation
contaminated? x x x
43
SAFETY REQUIREMENTS
Comments
ISO Levels
6.27 6.2, 12.7, Are workers and visitors required to wash their hands Lab policy on handwashing and
14.2 immediately after contact with infectious substances, hygiene
patients or when leaving the lab? X x x
6.28 6.2, Are dedicated hand-washing sinks available and located Sinks with appropriate signage
12.9e in areas where biological materials are handled or close to
x x x
exits?
6.29 14.1 Is there evidence that mouth pipetting is prohibited? Lab Policies on mouth pipetting
and direct observation X x x
6.30 14.1, 23 Has the laboratory management determined and Procedure for handling and
implemented a procedure for handling sharps, including disposal of sharps and direct
use of puncture-resistant containers? observation of WHO approved x x x
sharps containers
6.31 15 Are samples centrifuged safely? Written instructions for use and
safety with centrifuges to include
lockable lids, rotor cover, bucket X x x
covers
Section 5: Personal Protective Clothing and Equipment
6.32 12.1, Is PPE provided to staff, visitors, and patients as Procedure for distribution and use
12.3, required? of PPE
X x x
14.2,
17.1
6.33 12.1, Is PPE changed when necessary and removed when Protective clothing changed when
12.2 leaving the lab? necessary and immediately if
X x x
contaminated with hazardous
materials - direct observation
6.34 12.1 Has the laboratory management determined and Procedure for transport and
implemented the criteria for the transport and washing of washing of contaminated
contaminated clothing? PPE/clothing x x x
6.35 12.4 Has the laboratory management provided appropriate Direct observation, Policy on
gloves for those staff that suffer from allergies or handling latex allergies X x x
reactions?
44
SAFETY REQUIREMENTS
Comments
ISO Levels
6.36 12.5 Is there evidence that shoes with open toes are prohibited Direct observation, Policy on lab
in the laboratory? approved footwear x x x
Section 6: First Aid and Emergency Practices

6.37 12.9f Are appropriately trained personnel and appropriate Training Records and procedure on
equipment available to provide first aid, if required? administering first aid x x
6.38 20 Is there a plan for emergency evacuation? Documented emergency plan

x x
Section 7: Good Housekeeping

6.39 13 Are laboratory work areas tidy and uncluttered, exits, Direct observation of areas clean,
aisles and corridors unobstructed? trash disposed X x x
6.40 6.3.1, Are there exit signs and adequate lighting at the point of Appropriate signage
6.3.7 exit from the laboratory? x x x
6.41 13 Is there documented evidence that work surfaces and Decontamination logs, Records of
equipment are cleaned and disinfected when required spills and actions taken, Procedure
(whenever spills or contaminations occur) and laboratory for decontamination
benches disinfected at the end of each shift? X x x
6.42 13,23 Is a person designated to oversee good housekeeping Duty roster, Terms of reference
practices? X x x
Section 8: Biological Hazard Containment

6.43 16 Have biological safety cabinets been certified by a Certificates of inspection (Class I
qualified person before being placed into service, when and II), maintenance log
HEPA filters are changed, when moved or after
maintenance, and at least annually to ensure that they X x
function as designed?
45
SAFETY REQUIREMENTS
Comments
ISO Levels
6.44 Does the laboratory employ an appropriate containment Training records, Procedure for
level for their operational practice and are staff familiar operation in BSL 2,3 or higher x x
with required operational guidelines?
Section 9: Chemical Safety (Including Gases and Liquid Nitrogen)

6.45 17.1 Are hazardous liquids and gas cylinders appropriately Proper (Appropriate storage)
stored? cabinets, restraints for gas X x
cylinders
6.46 12.1, Does the lab have eye wash stations? Eye wash station(s), maintenance
17.2 log X x
6.47 12.11, Are emergency showers available where needed, are they operational Shower and
17.2 tested periodically and is documentation kept? documentation of inspection X x
6.48 13, 17.2, Are chemical spill kits available? Spill kits, checklist of items
19.4 included X x
6.49 13, 17.3 Is there a process defined for the disposal of chemicals? Procedure for disposal of
x x
chemicals
Section 10: Electrical and Fire Safety
6.50 21 Is there evidence that power cords and plugs are regularly Records of electrical inspection and
inspected for damage and fraying? procedure for checking electrical X x
safety
6.51 20 Is there a complete fire safety plan? Fire safety plan
x
6.52 19.7 Are portable fire extinguishers visible and accessible, and Fire extinguishers, guidance on use
do they have the correct rating for the hazards present? of Class A,B,C,D extinguisher for x x
different fires
6.53 19.6, Is there evidence that all personnel participate in an Records of fire drill, evacuation
19.7, 20 annual fire drill or other emergency evacuation training? training X x
6.54 19.5 Are containers for flammable liquids as small as possible, Appropriate safety containers, SOP
appropriately stored and closed when not in use and are for transport, use and disposal of
they transported in safety containers? flammable liquids x x x
46
SAFETY REQUIREMENTS
Comments
ISO Levels
6.55 19.4 Are areas well-ventilated where flammable gases and Direct observation, Policy on use of
liquids are used? flammable gases and liquids X x x
6.56 19.4 Are flammable gases and liquids kept away from sources Procedure for storage of flammable
of heat or ignition including electric motors and direct liquids x x x
sunlight?
Section 11: Waste Disposal
6.57 18.3, 23 Are staff familiar with the requirements for the handling Training Records
and disposal of hazardous waste? X x x
6.58 23 Is waste disposed of on a regular basis and not allowed to Procedure for disposal of
accumulate? hazardous wastes x x x
47
General comments:
END OF DOCUMENT
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CHECKLIST FOR THE

STEPWISE IMPROVEMENT PROCESS FOR

Instructions for checklist use:

Date of Assessment (dd/mm/yyyy)

Laboratory Telephone Fax Email

Name of Laboratory Head (Manager or

Name of Quality Manager (Officer)

Name of Safety Officer

Name of Consulting Pathologist:

Print name of Lead Assessor:

Signature of Lead Assessor:

4.1 Organization and management responsibility

4.1.1.3 Ethical Conduct

4.1.1.3 Does the laboratory have arrangements to ensure:

4.1.2 Management responsibility

4.2 Quality Management System

4.2.1 Has Management established, documented, Documented policies, processes and

4.2.2 Documentation requirements

4.2.2.2 Quality Manual

Document hierarchy described in the

Sign off sheet or information session

4.3 Document Control

4.4 Service Agreements

4.5 Examination by Referral Laboratories

4.5.1 Selecting and evaluating referral laboratories and consultants

4.5.2 Provision of Examination results

4.6 External Services and Supplies

Does the purchasing information describe the

4.7 Advisory Services

4.8 Resolution of Complaints

4.9 Identification and Control of Non-Conformities

4.10 Corrective Action

4.11 Preventive action

4.12 Continual Improvement

4.13 Control of Records

4.14 Evaluation and Audits

4.14.2 Do authorized personnel periodically review the Records of review of examinations by

4.14.3 Assessment of user feedback

4.14.4 Staff suggestions

4.14.5 Internal audit

b) Is implemented, effective, and maintained? Documented procedure for conducting

4.14.6 Risk Management

4.14.7 Quality Indicators

Record of evaluation and report on

4.15 Management Review

4.15.1 Documented Procedure for Management

Are the findings and actions arising from management

Does the laboratory management ensure that actions

5.1.1 Does the laboratory: Documented personnel management

5.1.3 Job Descriptions

5.1.4 Personnel introduction to the organizational environment

Is the training programme periodically reviewed for Training records

5.1.6 Competence Assessment

5.1.7 Reviews of staff performance

5.1.8 Continuing education and professional development

5.1.9 Personnel records

5.2 Accommodation and Environmental Conditions

5.3 Laboratory Equipment, reagents and consumables

5.3.1.2 Equipment acceptance testing

5.3.1.2 Is equipment shown to be capable of achieving the Equipment verification records

5.3.1.3 Equipment instructions for use

5.3 Laboratory Equipment, reagents and consumables

5.3.1.4 Equipment calibration and metrological traceability