Preparing Your Laboratory to Certify or Accredit Under ISO 15189

Preparations and Considerations 

When Seeking Laboratory 

Accreditation Under ISO 15189 

Particular Requirements for Quality and 

Competence 

Presenter: Greg Cooper 

Manager, Clinical Standards and Practices 

Bio-Rad Laboratories

Introduction 

• International consensus document 

– Harmonized standard 

• Countries wishing to establish standards 

• Labs wishing to validate quality 

• Clinical lab focus 

– ISO 17025 

• Good for research and industrial laboratories 

• Does not address unique structure, operation 

and needs of a medical/clinical laboratory

Course Objectives 

• Be able to explain the difference between certification and 

accreditation. 

• Understand the fundamentals necessary to prepare for an ISO 

certification or for accreditation under an ISO standard (e.g. ISO 

15189). 

• Understand the difference between a quality operating procedure 

(QOP), a standard operating procedure (SOP) and a work desk 

instruction (WDI). 

• Understand the difference between a policy, a process and a procedure 

and the relationship to ISO terms QOP, SOP and WDI. 

• Become familiar with the fundamentals of a quality system under ISO. 

• Gain general familiarity with the content of ISO 15189.

Certification Versus Accreditation 

• Certification 

– Third party organization (or agency) attests that 

product, process or service conforms to specified 

requirements 

• ISO 9000 

• Accreditation 

– Third party organization (or agency) with authority 

formally recognizes competence to perform a 

task(s) 

• Third party 

– Totally independent and unbiased

Accreditation 

• Requirements 

– Is unique to the organization 

– May be based ISO 17025, ISO 15189 or 

CLIA (US) 

• Considered minimums 

• Accrediting organization may require a higher 

standard of performance

Preparation: 

Form A Steering Group 

• Include representatives from lab 

supervision and management 

– All departments, all shifts (work hours) 

• Aids acceptance 

• ISO is a collaborative/participative scheme 

• May use video tapes, teleconferencing as 

inclusion mechanisms

Steering Group: Purpose 

• Write the quality policy 

– Brief description: what lab is about, why it exists, 

overall objectives 

– General not prescriptive 

• “XYZ Hospital Laboratory is committed to producing 

reliable patient test results in a manner necessary to 

insure appropriate and timely patient care. The 

laboratory will strive to produce reliable patient test 

results by combining processes that promote efficiency 

with technology that is appropriate to the laboratory 

mission and operated by staff that is both trained and 

competent to perform the work.”


• Offer guidance, direction and support 

– Provide adequate resources to develop and maintain a 

quality system 

• Convene working groups to write quality procedures 

– Discourage “top down” development 

– Can be formed according to laboratory specialty 

• Coagulation 

• Immunohematology 

• Etc. 

– Include all lab staff 

• Use email, teleconferencing, videotapes to aid communication 

and exchange of ideas


• Oversee development of the quality manual 

– Identifies laboratory management by name, 

position 

– Defines the reporting structure (organizational 

chart) 

– Provides general description of the laboratory 

operation 

– States the quality policy 

– Contains a compendium of high level quality 

procedures

Quality Manger: 

Responsibilities 

• Insure the components of the quality system are current and 

relevant. 

• Insure the quality system is audited at regular intervals. 

• Keep laboratory management informed of all activities and 

findings of the quality system. 

• Insure that all staff are committed to and actively involved in the 

quality system, adhere to its policies, and document system 

failures or non-conformances (deviations from the accepted 

norm). 

• Facilitate introduction of new quality system procedures or 

modifications to existing procedures. 

• Act as liaison between the laboratory and other interfacing 

departments of the hospital and internally between various 

departments within the laboratory itself.


• Name a quality manager 

– Full time or part-time 

– Good communicator 

– Good negotiator

Types of Quality Procedures 

• QOP (Quality Operating Procedure) 

– Can be optional 

– Developed for each element of the quality 

system 

– Set laboratory policy 

– Can be more than one 

– Supports the Quality Policy


• SOP (Standard Operating Procedure) 

– Developed by the working groups 

– Provides general instructions 

– Assigns responsibility for each element 

– Are general, not prescriptive 

• Describes the overall process to complete a 

task 

– Supports the QOP


• WDI (Work Desk Instruction) 

– Commonly referred to as procedure 

– Is a step-by step instruction 

• Is prescriptive 

• Describes how to perform a single specific task or activity 

– Usually developed by staff familiar with the 

laboratory specialty or procedure in particular 

• Can be product inserts, instrument manuals, or original 

material

Guidance For Writing QOPs, 

SOPs, and WDIs 

• NCCLS GP 26 Application of a Quality 

System Model for Laboratory Services 

• QOP = policy 

– Statement of policy specifying intent and direction 

• SOP = process 

– Process used to transform the intent into action 

• WDI = procedure 

– Specific directions for a specific task

Example 1 

• (QOP) The laboratory shall implement and use an internal 

quality control program designed to detect those analytical 

errors, which can invalidate the reliability of patient test results. 

• (SOP) Laboratory testing personnel shall use Westgard rules 

and biological variation limits for all quantitative tests to monitor 

the analytical quality of the testing procedure (examination). 

• (WDI) The work desk instruction(s) supporting this SOP would 

give specific directions for monitoring analytical quality including 

but not limited to: 

– Setting Westgard rules. 

– Interpreting violations. 

– Setting biological variation limits.

Example 2 

• (QOP) The laboratory shall implement and use an internal 

quality control program designed to detect those analytical 

errors, which can invalidate the reliability of patient test results. 

• (SOP) Laboratory staff shall test quality control materials at an 

interval and in combinations suitable to detect analytical error. 

• (WDI)The work desk instructions would give specific directions 

about: 

– When to test quality control materials. 

– Which concentrations of the control material to test (normal, 

abnormal low and/or abnormal high).

QUALITY SYSTEM HIERARCHY 

Laboratory 

QUALITY 

POLICY 

ISO ELEMENT 

POLICY (QOP) 

ISO 15189 has 23 Elements 

PROCESS (SOP) 

PROCESS (SOP) 

PROCESS (SOP) 

PROCEDURE (WDI) PROCEDURE (WDI) PROCEDURE (WDI) 

PROCEDURE (WDI) 

PROCEDURE (WDI) 

PROCEDURE (WDI)

ISO 15189 Quality System 

Elements 

• 23 quality system elements 

– Each may have a QOP 

– Each must have at least one SOP and one 

or more WDIs.

ISO 15189: Element 4.1 

Organization and Management 

• Legally identifiable. 

• Free of any financial or political conflicts of interest. 

• Lab management is responsible: 

– For design, implementation and maintenance of the quality 

system. 

• Accomplished through policies and procedures. 

• Granting authority and responsibility. 

– To provide adequate resources. 

• Financial, educational and human. 

– To appoint a quality manager. 

• A core requirement


Quality Management System 

• Document all policies, programs and 

procedures 

• Communicate to all lab staff 

• Have a quality policy 

• Have and maintain a quality manual 



Document Control 

• Definition 

– “information (meaningful data) and its supporting 

medium” (ISO 9000-2000) 

– “An item of a factual or informative nature” 

(NCCLS NRSCL8)) 

– General rule: 

• Something not written upon except for an authorizing 

signature, stamp or official seal 

– Examples: 

• QOPs, SOPs, WDIs, product inserts, MSDS sheets, 

research papers, journal articles


Document Control 

• Approved and controlled 

• Reviewed at regular intervals for 

relevancy 

– Procedure for amendments or changes 

• Found on a Master List of documents 

– Obsolete documents 



Review of Contracts 

• Review contracts at regular intervals for 

services delivered by laboratory to 

clients 

– Sufficient resources:staff and knowledge 

base 

– Appropriate methods 

– Proper work environment to meet 

obligations 

• Can be formal or informal

Type of Laboratory 

Hospital-Based 

Remote or Clinic-Based 

Reference Laboratories 

Potential customers 

Emergency 

Infection control 

Intensive care units 

Medical school (if part of institution) 

Medical staff 

Nursing administration 

Outpatients 

Pharmacy 

Radiology 

Referring clinicians 

Research laboratories (if part of institution) 

Suppliers/Vendors 

Utilization review 

Community 

Main or parent laboratory 

Medical staff 

Referring clinicians 

Suppliers/Vendors (not always-depends on 

autonomy) 

Clinicians 

Governments (military possibly) 

Pharmaceutical companies 

Referring laboratories 

Suppliers/Vendors 

University-based research entities


Examination By Referral Laboratories 

• Outside services 

– Referral laboratories 

• Procedure for evaluating and selecting 

– Require quality system in place 

» Certification/accreditation 

• On-going monitor of referral laboratories 

– Blind specimens, performance on EQA


External Services and Supplies 

• Policies and procedures for: 

– Selecting outside vendors 

– Verifying purchased services meet lab 

requirements 

• Cheaper products/services may not be 

produced under a quality system 

– Questionable quality


Advisory Services 

• Meet regularly with medical staff 

– Services provided 

– Knowledge base required


Resolution of Complaints 

• Primary opportunity to identify 

weaknesses in the quality system 

– Opportunities for improvement 

• Maintain record of the complaint 

– Nature, date of occurrence, individuals 

involved, any investigations undertaken, 

resolution 



Identification and Control of Non-conformities 

• An occurrence that conflicts with a stated 

policy, process or procedure 

• Must be: 

– Recorded, investigated 

• Identify and document root cause and 

corrective action 

• Halt testing 

– Depends on nature of non-conformance and 

criticality 

– Results reported may need to be recalled 

• A core element


Identification and Control of 

Non-conformities 

• Examples of non-conformities: 

– Testing a plasma sample when a serum sample is 

required 

– Using expired reagents 

– Modifying the test procedure without appropriate 

approvals 

– Increasing incubation temperature to decrease 

incubation time 

– Improper preservation of samples 

– Using tap water instead of distilled or reagent 

grade water


Corrective Action 

• Document and record 

• Monitor and document effectiveness 

• Maintain records 

– Use to design process improvements 



Preventative Action 

• Actions taken to prevent non-conformances 

(occurrences) 

– Policy and procedure 

• Examples of possible preventative actions 

– Regular review of QC data 

• Trends, shifts , other anomalies 

– Participation in an external quality assessment 

scheme (EQA/EQAS) 

• Proficiency testing in the US


Continual Improvement 

• Review all operational procedures regularly 

– Minimum is annual 

• Review the quality system annually 

– Records of complaints or non-conformances 

– Redundant/obsolete policies/procedures 

• Implement quality indicators to monitor lab 

contribution to overall patient care 



Quality and Technical Records 

• Definition: 

– “a document (information and supporting medium) 

stating results achieved or providing evidence of 

activities performed” (ISO 9000-2000) 

– “a document that furnishes objective evidence of 

information obtained, activities performed or 

results achieved” (NCCLS NRSCL8) 

– General rule: 

• “something that is written upon”



• Can be paper or electronic 

• Must be kept and maintained by the 

laboratory 

– Specified period of time 

• Must be readily accessible 




• Some examples: 

–QC records 

– Instrument printouts 

– Patient test requisitions and reports 

– Records of specimen referrals 

– Non-conformances 

– Complaint records 

– Specimen acquisition records 

– Calibration and maintenance logs 

– Logs of contact with outside clients


Internal audits 

• Internal audits 

– Regular interval 

• Minimum is annual 

– Performed by trained laboratory staff 

• Avoid auditing own department 

– Document findings 

– Respond to findings 



Management Review 

• Review the quality system annually 

– More frequently for a new quality system 

– Assess level of commitment to the quality system 

– Review occurrences and activities since last review 

• Non-conformances, corrective actions, preventative measures, 

feedback and complaints from clients, results from internal and 

external QC programs 

– Make or recommend changes or adjustments as necessary 

• Document review 



Personnel 

• Job descriptions must include qualifications 

– Use certified or licensed personnel 

• Lab director must have knowledge and experience to 

direct lab 

• Management must provide staff adequate training 

• Staff must have access to continuing education 

• Must make effort to protect patient information 

• Comprehensive listing of director responsibilities


Accommodation and Environmental Conditions 

• Adequate space, safe environment, clean workspace 

– Lighting, ventilation, water, waste and refuse disposal, dust, 

electromagnetic interference, ambient temperature and 

humidity, electrical supply, sound and vibration levels 

• Maintain records of environmental conditions 

– Temperature and humidity 

• Prevent cross contamination 

– Mycobacteriology, nucleotide amplification 

• Accommodate patient disabilities and privacy


Laboratory Equipment 

• Instruments, reference materials, 

consumables, reagents, and analytical 

systems 

– Adequate to meet laboratory quality policy 

– Verify performance specifications 

• Accuracy and precision 

– Regularly monitor instrument calibration and 

preventative maintenance 

• Date, time, results, adjustments, acceptance criteria, due 

date for next calibration 

– Cofactors: insure current cofactors in use


Laboratory Equipment 

• Validate computer software before putting 

into use. 

• Protect privacy of patient information and test 

results 

– Control access to computer files 

• Prevent alteration or destruction 

– Annex B: Recommendations for protection of 

laboratory information systems (LIS) (informative) 

– Annex C: Ethics in laboratory medicine 

(informative)


Pre-examination Procedures (pre-analytical) 

• Requisition 

– Patient identification, name of ordering physician, 

clinician’s address, type of primary sample, 

anatomic site (where appropriate), the test 

requested, patient gender, date of birth, pertinent 

clinical information as may be required for test 

interpretation 

• Verbal requests 

– Have a procedure


Pre-examination Procedures (pre-analytical) 

• Procedures for proper patient preparation and 

specimen collection 

– Type of sample, initials of person collecting sample, 

anticoagulant required, acceptable sample volume 

– Date and time of specimen collection noted on test request 

– Date and time of receipt by the laboratory noted on test 

request 

• Monitor elapsed time for time critical tests 

• Specimen rejection criteria 

– No or inadequate patient identification 

– Insufficient sample 

– Improper sample (hemolysis) 

• Specimen storage requirements


Examination Procedures (analytical) 

• Validated written or electronic procedure for 

performing the test 

– Common language 

– May be product insert, textbook procedure, journal 

article. 

– In house methods must be fully validated before 

use. 

• Review reference intervals at regular intervals 



Assuring Quality of Examination (Analytical) 

Procedures 

• Lab shall have an internal quality control 

program to verify the quality of patient 

test results 

– Regular testing of quality control materials 

• Stability of method, frequency of testing, 

average number of samples tested 

– Regular review of QC records 

– Program should detect error when it occurs


Assuring Quality of Examination (Analytical) 

Procedures 

• Determine the uncertainty of measurement 

for each test and report as appropriate 

• Insure calibration materials are traceable to 

SI units 

• Participate in EQA programs 

– Small private non-commercial 

– Large non-commercial (College of American 

Pathologists, CWQAL, and Lab Quality) 

– Commercial (Bio-Rad, Randox)

Calibration Traceability Chain 

Modified from ISO 17511:2003 (E) In vitro diagnostic 

medical devices-Measurement of quantities in biological 

samples-Metrological traceability of values assigned to 

calibrators and control materials


Post-examination Procedures (post analytical) 

• Routinely review all results before 

reporting by authorized staff 

• Dispose of used samples in a safe and 

environmentally sensitive manner


Reporting of Results 

• Report on forms approved by Management and part 

of the quality system 

• Date and time of specimen collection, the test 

performed, reference or normal range, the 

interpretation where appropriate, name or initial of 

person who performed the test, authorized signature 

of person releasing results 

• Indicate if specimen was acceptable or unacceptable 

• Retain test reports for specified period of time

ISO/IEC 17025:1999 ISO 15189:2002 

1.0 Scope 1.0 Scope 

2.0 Normative References 2.0 Normative References 

3.0 Terms and Definitions 3.0 Terms and Definitions 

4.0 Management Requirements 4.0 Management Requirements 

4.1 Organization 4.1 Organization 

4.2 Quality System 4.2 Quality Management System 

4.3 Document Control 4.3 Document Control 

4.4 Review of requests, tenders and contracts 4.4 Review of contracts 

4.5 Subcontracting of tests and calibrations 4.5 Examination by referral laboratories 

4.6 Purchasing services and supplies 4.6 External services and supplies 

4.7 Service to the client 4.7 Advisory services 

4.8 Complaints 4.8 Complaints 

4.9 Control of nonconforming testing and/or calibration work 4.9 Identification and control of nonconformities 

4.10 Corrective action 4.10 Corrective action 

4.11 Preventative action 4.11 Preventative action 

4.12 Continual improvement 

4.12 Control of records 4.13 Quality and technical records 

4.13 Internal audits 4.14 Internal audits 

4.14 Management reviews 4.15 Management review 

5.0 Technical Requirements 5.0 Technical requirements 

5.1 General 

5.2 Personnel 5.1 Personnel 

5.3 Accommodation and environmental conditions 5.2 Accommodation and environmental conditions 

5.4 Test and method validation 5.5 Examination procedures 

5.5 Equipment 5.3 Laboratory equipment 

5.6 Measurement traceability 5.6 Assuring the quality of examination procedures 

5.7 Sampling 5.4 Pre-examination procedures 

5.8 Handling of test and calibration items 

5.9 Assuring the quality of test and calibration results 5.6 Assuring the quality of examination procedures 

5.10 Reporting the results 5.8 Reporting of results

Summation 

• ISO 15189 sets minimum standards 

– It is not static – constantly evolving 

• Available to laboratories who wish to 

certify to an international standard 

verifying laboratory commitment to 

quality 

• Available to laboratories who wish to 

accredit under this standard.

Laboratories wishing to obtain 

a copy of ISO 15189 

International Organization for Standardization 

Web www.iso.org 

Phone +41 22 749 01 11 

Fax +41 22 749 09 47 

E-mail sales@iso.org 

Post ISO, 1, rue de Varembé, CH-1211 Geneva 20, Switzerland 

NCCLS 

Web www.nccls.org 

Phone +1 610 688 0100 

Fax +1 610 688 0700 

Post 940 West Valley Road, Suite 1400, Wayne PA 19087 USA 

Laboratories interested in the GP 26 standard Application of a Quality System Model for Laboratory Services should 

contact NCCLS.

Laboratories wishing more information 

regarding certification or accreditation 

Asia Pacific Laboratory Accreditation Cooperation (APLAC) 

Web www.ianz.govt.nz/aplac (provides listing of member accrediting 

organizations by country) 

COLA (formerly Commission on Office Laboratory Accreditation) 

Web www.cola-international.org 

Phone +1 410 381 6581 

Fax +1 410 381 8611 

Post 9881 Broken Land Parkway, Suite 200, Columbia MD 21046 USA 

College of American Pathologists (CAP) 

Web www.cap.org 

Phone +1 847 832 7000 

Fax +1 847 832 8000 

Post 325 Waukegan Road Northfield, IL 60093-2750 USA 

International Laboratory Accreditation Organization (ILAC) 

Web www.ilac.org (provides listing of member accrediting 

organizations by country)

Preparing Your Laboratory to Certify or Accredit Under ISO 15189

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