QUALITY MANAGEMENT PROGRAM –

LABORATORY SERVICES (QMP–LS)

Ontario Laboratory Accreditation Division (OLA)

Guidance for Laboratory

Quality Manuals

 Quality Management Program – Laboratory Services (QMP–LS)

August 2006

Version 3

Prepared by J Coffey

Issued by L Crawford

Ontario Laboratory Accreditation Division

Suite 1510 • 250 Bloor Street

Phone 416.323.9540 • Fax 416.323.9324

OLA

Ontario Medical Association

OLA GUIDANCE FOR LABORATORY QUALITY MANUALS

AUGUST 2006

Version 3 Page 1 of 26

Table of Contents

SECTION PAGE

Introduction 2

Glossary of Terms 3

Quality Manual Basics 5

International Organization for Standardization (ISO) 6

ISO Definition of a Quality Manual 6

Structure and Contents of the Quality Manual 7

Table 1: ISO 15189:2003 Style Quality Manual Table of Contents 9

Table 2: ISO 9001:2000 Style Quality Manual Table of Contents 10

Table 3: CLSI Style Quality Manual Table of Contents 12

Table 4: OLA Style Quality Manual Table of Contents 13

The Introduction 14

The Quality Policy Statement 15

Document Control 16

Example Headers and Footers 17

Maintaining the Manual 18

Review of Laboratory Quality Manual 19

Table 5: Self- Assessment of Laboratory Quality Manual 20

The Peer Assessment Visit 22

Frequently Asked Questions 23

Sample Quality Manuals 25

Resources 25

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AUGUST 2006

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Introduction

An essential requirement of the Ontario Laboratory Accreditation (OLA) program is the design and

implementation of a quality management system. Central to an effective quality management system is the

creation of a laboratory quality manual, the top tier of a facility’s quality system documentation.

This guide will help laboratories write a quality manual that meets the criteria defined by the OLA

Program Requirements.

The guide:

§ Provides necessary information on the structure and content of the quality manual

§ Provides guidance on document control of the quality manual

§ Includes sample tables of contents to illustrate how a quality manual can be organized

§ Presents OLA criteria for participant self-assessment of their quality manual

§ Clarifies what assessors will evaluate during an assessment visit

§ Provides Internet links to examples of quality manuals

§ Suggests resources for those needing further information

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Glossary of Terms

Document

Any information that provides direction (e.g. instructions including policy statements, textbooks, reference

intervals and their origins, procedures, specifications, calibration tables, charts, posters, notices,

memoranda, plans, software, drawings, regulations and standards).

Document Control

A system to regulate the handling and management (including archiving, storing and destruction) of

documents containing information that communicates policies, processes, procedures as well as records.

Usually pertains to documents that are part of the quality management system.

ISO

International Organization for Standardization. A network of standards institutes from 140 countries

working in partnership with international organizations, governments, industry, business and consumer

representation. The source of more than 13,000 international standards for business, government and

society.

CLSI

Clinical and Laboratory Standards Institute. A global, voluntary organization that develops and

disseminates consensus standards, guidelines and best practices. Formerly known as the National

Committee for Clinical Laboratory Standards (NCCLS).

Non-Conforming Examinations

Non-fulfillment of any requirement in the performance of a laboratory examination or test. Identified

from many sources, including audits, quality control, staff comments and clinician complaints.

Policy

Statement describing what is done and why.

Process

Series of inter-related steps involved in an activity or examination that uses resources and is managed to

transform inputs into outputs.

Procedure

Written work instructions that specify a way to carry out an examination or step in a process.

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Quality Management System

A program developed to support efficient and effective, high quality and appropriate laboratory services

(e.g. accurate and precise results, appropriate test selection, timely reporting, correct interpretation of

results, clinical usefulness, appropriate recommendations for further tests).

Comprehensive and coordinated efforts (policies, processes and procedures) designed to meet quality

objectives, to direct and control an organization with regard to quality.

Encompasses quality (management) system, quality assurance and quality control.

Quality System

See “Quality Management System.”

Quality Manual

A document describing the quality management system.

Quality Manager

An individual with delegated responsibility and authority to ensure compliance with the quality

management system.

Record

Any information that produces evidence (e.g. requisitions, examination results and reports, instrument

printouts, laboratory workbooks and worksheets, accession records, calibration records, quality control

records, records of audits, complaints and action taken, external quality assessment records, instrument

maintenance records, incident/accident reports, staff training and competency records, personnel

records).

SOP

Standard Operating Procedure. See “Procedure”.

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Quality Manual Basics

The purpose of the quality manual is to:

§ Communicate information

§ Provide evidence of conformity to the OLA program requirements

§ Share knowledge

§ Provide evidence of management’s commitment to quality

The following points should be considered when creating a quality manual:

1. It is a document that describes a facility’s quality management system through a series of policies.

2. It is the primary documentation of a quality system and must provide a thorough description of the

system.

3. The expected length is from 30-70 pages although this could vary depending on the size and scope of

the facility, and the amount of information a facility chooses to include.

4. It will usually include management processes, but does not usually include any technical procedures.

Procedures are referenced where appropriate.

5. It is a road map to the rest of a laboratory’s documentation, and will refer to a myriad of supporting

documentation: procedures (work instructions), records, forms, charts, etc.

6. Some of the supporting documentation may be within the manual or included as appendices, but

usually it will be kept elsewhere. The quality manual should indicate where supporting documentation

can be found.

7. The medium can be either electronic or paper.

8. It must be easy for authorized personnel to update and easy for staff to access.

9. Typically, it is maintained and reviewed by a quality manager.

10. Everyone in the laboratory must be encouraged to provide input into the development of the quality

manual.

11. It is essential that the entire staff is familiar with, and understands the contents of the manual and its

related documentation

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International Organization for Standardization (ISO)

The International Organization for Standardization (ISO) was established in 1947 and since then as been

developing voluntary technical standards over sectors of business, industry and technology. The work is

conducted by a worldwide federation of national standards bodies from more than 140 countries.

With the exception of ISO 9000 and ISO 14000, the vast majority of ISO standards are highly specific

and technical in nature. The ISO 9000 series was first published in 1987, and was the first ISO document

to focus on management principles for a much wider business community. In 2000, the series was

rewritten. It consists of three basic documents:

• ISO 9000:2000. Quality management systems—Fundamentals and vocabulary

• ISO 9001:2000. Quality management systems—Requirements

• ISO 9004:2000. Quality management systems—Guidelines for performance improvements

The concept of a quality management system is based on principles described in ISO 9001:2000, Quality

management systemsRequirements. It describes eight quality management principles that can be

applied to any business or service. Five hundred thousand organizations are already registered to ISO

9001.

ISO 17025:2005 (General requirements for the competence of testing and calibration laboratories) and

ISO 15189:2003 (Medical laboratoriesParticular requirements for quality and competence) are more

technical documents written specifically for laboratories by international committees.

The OLA Program Requirements are based on both of the laboratory ISO standards: ISO 17025:2005

and ISO 15189:2003, which emphasize quality management system implementation. In addition,

requirements were added based on Ontario law. Also included were requirements that represent generally

accepted principles of good laboratory practice, usually consensus guidelines from professional societies

and institutes.

ISO Definition of a Quality Manual

“A document specifying the quality management system of an organization.” NOTE: Quality manuals

can vary in detail and format, in or to suit the size and complexity of an individual organization.

1

ISO 9001:2000 contains the following clause (4.2.2) regarding the quality manual:

The organization shall establish and maintain a quality manual that includes

a) The scope of the quality management system, including details of and justifications for any

exclusions;

b) The documented procedures or reference to them;

c) A description and interaction between the processes of the QMS.

2

1

CAN/CSA-ISO 9000-0 (ISO 9000:2000). Quality Management Systems—Fundamentals and Vocabulary. December 2000; 3.7.4:14.

2

CAN/CSA-ISO 9001-00 (ISO 9001::2000) Quality Management Systems—Requirements. December 2000; 4.2.:2: 3.

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Structure and Contents of the Quality Manual

The exact format, structure and contents of the quality manual are at the discretion of each facility. You

have the latitude to design your manual in keeping with your facility's size and complexity. Because of the

large variance in facility types in the province, QMP-LS is unable to provide a "one-size fits all" quality

manual template. Organize the manual as you wish, but be sure to divide it into manageable sections, and

at minimum include the following:

§ An introduction (overview of the manual),

§ A description of the organization

§ A quality policy statement

§ A table of contents

§ Cross references to other documents

§ Definitions and/or glossary of terms

§ Proper identification

In developing your quality manual contents, consider that your quality management system must

encompass all management activities and processes relating to quality assurance. The following list of

essential elements appears as part of OLA program requirement II.A.2:

The quality management system shall encompass all management activities and processes relating to quality

assurance

§ organization

§ personnel

§ equipment

§ purchasing and inventory

§ process control (includes validation of processes, internal quality control and external quality

assessment)

§ documents and records

§ information management

§ investigation of non-conformities

§ assessment (includes the use of quality indicators and internal audits)

§ process improvement

§ service and satisfaction

§ facilities and safety

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Structure and Contents of the Quality Manual: Suggestions

Option 1: Follow ISO 15189:2003 Guidance

Table 1 presents a quality manual table of contents developed from the list included as part of OLA

program requirement II.C.1. The list was developed in keeping with ISO 15189:2003, Medical

laboratories—Particular requirements for quality and competence. It is also harmonious with the ISO

9000 family of standards for quality management systems.

Option 2: Follow the Structure of ISO 9001:2000

Many quality manuals developed by facilities in industry will follow the structure of the ISO 9001:2000

requirements. Table 2 presents a table of contents developed in this fashion. This option would satisfy

both OLA requirements and ISO 9000 principles. In this model, the ISO standard is transformed from a

set of requirements, into the facilities commitment to those requirements in short and concise statements.

The facility quality manual is in sync with the ISO standard and in the example; the numbering structure is

the same as the ISO 9001:2000 standard.

Option 3: Follow CLSI Guidance

The essential activities and processes listed on page 7 are based on the CLSI document GP26-A3 titled

“Application of a Quality Management System Model for Laboratory Services Quality System Model for

Health Care” and HS1-A2 titled “A Quality Management System Model for Health Care”. The headings

of this list could easily be used as the basis for a quality manual; a sample table of contents organized with

this approach is presented in Table 3. An entire manual created with this format can be viewed at

http://www.clsi.org/Content/NavigationMenu/AboutCLSI/QualityManual/Quality-Manual-Second-

Edition-June2003-041102.pdf

Option 4: Follow the Structure of OLA Program Requirements

Table 4 is an example of a table of contents that is structured to follow the OLA Program Requirements.

In this model (as for Option 2), the OLA Program Requirements are transformed from a set of

requirements into your laboratory’s commitment to those requirements. The facility quality manual is in

sync with the OLA Program Requirements and in the example; the numbering structure is the same as the

OLA Program Requirements. Using this structure will make it easier for both the user and OLA assessors

to read the manual, and will help you to ensure that you don’t overlook anything.

Option 5: Create Your Own Structure

You may choose to create your own structure. Keep in mind that the quality manual should address all of

the key elements of the OLA Program Requirements, and that QMP–LS will use your quality manual to

pre-assess your quality management system prior to the OLA peer assessment visit.

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Table 1: ISO 15189:2003 Style Quality Manual Table of Contents

SECTION PAGE

1. Introduction.............................................................................................................................................................................

3

2. Description of Laboratory...........................................................................................................................................

4

a. Legal Identity..............................................................................................................................................................................

4

b. Resources....................................................................................................................................................................................

4

c. Main Duties................................................................................................................................................................................

4

3. Quality Policy.........................................................................................................................................................................

5

4. Staff Education and Training..................................................................................................................................

6

5. Quality Assurance .............................................................................................................................................................

8

6. Document Control.............................................................................................................................................................

11

7. Records Maintenance and Archiving................................................................................................................

14

8. Laboratory Physical Environment.......................................................................................................................

15

9. Instruments..............................................................................................................................................................................

18

10. Consumables Management........................................................................................................................................

20

11. Validation of Examination Procedures.............................................................................................................

22

12. Safety..............................................................................................................................................................................................

24

13. Research and Development.......................................................................................................................................

25

14. Examination Processes and Procedures List..............................................................................................

26

15. Pre- Examination................................................................................................................................................................

29

a. Request Protocols.....................................................................................................................................................................

29

b. Specimen Collection................................................................................................................................................................

29

c. Handling......................................................................................................................................................................................

30

16. Validation of Results.........................................................................................................................................................

31

17. Quality Control......................................................................................................................................................................

32

18. Reporting of Results.........................................................................................................................................................

35

19. Remedial Actions and Complaints.......................................................................................................................

38

20. Communications.................................................................................................................................................................

40

a. Patients.........................................................................................................................................................................................

40

b. Health Professionals................................................................................................................................................................

40

c. Suppliers......................................................................................................................................................................................

40

21. Audits.............................................................................................................................................................................................

41

22. Appendices...............................................................................................................................................................................

42

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Table 2: ISO 9001:2000 Style Quality Manual Table of Contents

SECTION PAGE

1. General

3

1.1 Purpose and Scope

................................

...............

3

1.2 Application

................................

.............................

3

2. Facility Information

................................

...............................

4

3. Terms and Definitions

................................

.........................

6

4. Quality Management System

................................

............

7

4.1 General Requirements

................................

.........

7

4.2 Documentation Requirements

................................

..........................

8

4.2.1 General.

................................

..............

8

4.2.2 Quality Manual.

................................

8

4.2.3 Control of Documents

................................

..................

9

4.2.4 Control of Records

................................

.........................

9

5. Managem

ent Responsibility

................................

..............

10

5.1 Management Commitment

................................

10

5.2 Customer Focus

................................

....................

10

5.3 Quality Policy

................................

.........................

11

5.4 Planning

................................

...

12

5.4.1 Quality Objectives

................................

...........................

12

5.4.2 Quality Management System Planning

................................

.....................

12

5.5 Responsibility, authority and communication

................................

...............................

1

3

5.5.1 Responsibility and authority

................................

.........

13

5.5.2 Management representative

................................

.........

13

5.5.3 Internal Communication

................................

...............

14

5.6 Management review

................................

.............

15

5.6.1 General

................................

...............

15

5.6.2 Review input

................................

.....

15

5.6.3 Review output

................................

..

15

6. Resource Management

................................

.......................

16

6.1

Provision of resources

................................

.........

16

6.2 Human resources

................................

..................

17

6.2.1 General

................................

...............

17

6.2.2 Competence, awareness and training

................................

.........................

18

6.2.3 Infrastructure

................................

....

19

6.2.4 Work environment

................................

.........................

19

7. Product Realization

................................

...............................

20

7.1 Planning of technical processes

................................

.........................

20

7.2

Customer

-

related processes

................................

20

7.2.1 Determination of customer requirements

................................

................

21

7.2.2 Review of customer requirements

................................

..............................

21

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7.2.3 Customer communication............................................................................................................ 22

7.3 Design and development of technical processes

................................

..........................

23

7.3.1 Design and development plan

ning

................................

............................

23

7.3.2 Design and development inputs

................................

.

23

7.3.3 Design and development outputs

................................

..............................

24

7.3.4 Review of processes

................................

.......................

24

7.3.5 Verification of examination processes and procedures

................................

........................

25

7.3.6 Validation of examination processes and procedures

................................

...........................

26

7.3.7 Management of process changes

................................

26

7.4 Purchasing

................................

...............................

27

7.4.1 Purchasing process

................................

.........................

27

7.4.2 Purchasing information

................................

.................

28

7.4.3 Verification of purchased product

................................

..............................

29

7.5 Provision of service

................................

..............

30

7.5.1 Quality control

................................

.

30

7.5.2 Valid

ation of results

................................

........................

31

7.5.3 Identification and traceabliity

................................

.......

32

7.5.4 Customer property

................................

.........................

33

7.5.4 Preservation of specimens

................................

............

33

7.6 Control and monitoring of equipment

................................

............

34

8. Measurement, analysis and improvement

................................

...................

35

8.1 General

................................

.....

35

8.2 Moni

toring and measurement

................................

...........................

36

8.2.1 Customer satisfaction

................................

.....................

36

8.2.3 Internal audits

................................

...

37

8.2.3 Monitoring and measurement of processes

................................

.............

38

8.2.4 Monitoring and measurement of product

................................

................

38

8.3 Management of non

-

conformities

................................

....................

39

8.4 Analysis of da

ta

................................

......................

40

8.5 Improvement

................................

.........................

41

8.5.1 Continual Improvement

................................

...............

41

8.5.2 Corrective Action

................................

............................

42

8.5.3 Preventive Action

................................

............................

42

9. Procedure Index

................................

......

43

10. Revision history and master verification

................................

.....................

47

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Table 3: CLSI Style Quality Manual Table of Contents

SECTION PAGE

Introduction

................................

.......................

3

Scope ................................................................................................................................................................

....................

3

Distribution................................................................................................................................................................

...............

3

Revisions

3

Glossary

4

General Information

................................

..............

8

History ................................................................................................................................................................

....................

8

Strategic planning................................................................................................................................

................................

9

Vision ................................................................................................................................................................

....................

11

Mission ................................................................................................................................................................

....................

11

Organizational Values................................................................................................................................

.............................

11

Quality Management System

................................

...............................

12

Intent ................................................................................................................................................................

....................

12

Quality Policy................................................................................................................................................................

............

12

Quality Principles................................................................................................................................

................................

12

Quality System Essentials.................................................................................................................................

.....................

13

Quality Plan................................................................................................................................................................

...............

13

Quality System Essentials

................................

14

Organization................................................................................................................................................................

.............

14

Personnel................................................................................................................................................................

...................

17

Equipment................................................................................................................................................................

.................

20

Purchasing and Inventory................................................................................................................................

.....................

23

Process Control.................................................................................................................................

................................

27

Documents and Records................................................................................................................................

.......................

30

Information Management................................................................................................................................

.....................

32

Investigation of Non-Conformities................................................................................................

................................

33

Assessment................................................................................................................................................................

................

35

Process Improvement.................................................................................................................................

...........................

37

Service and Satisfaction................................................................................................................................

..........................

39

Facilities and Safety................................................................................................................................

................................

41

Revision History

................................

....................

43

List of Appendices and Manuals

................................

..........................

45

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Table 4: OLA Style Quality Manual Table of Contents

Section Page

Introduction

1

I. Organizational Structure, Personnel Policies and Management

2

I.A. Organizational Structure

2

I.B. Personnel Policies

4

I.C. Laboratory Management

7

II. Quality Management System

9

II.A. Fundamentals

9

II.B. Quality Policy Statement

10

II.C. Quality Manual: Maintenance and review

12

II.D. Quality Improvement

13

II.E. Management Review

15

II.F. Document and Record Control

17

II.G. Referral Laboratories

19

III. Physical Facilities

21

IV. Equipment, Reagents and Supplies

24

V. Pre-Analytical Process

27

V.A Specimen Collection

27

V.B Transport of Samples

28

V. C. Receipt by the Laboratory

29

V.D Requisitions

30

VI. Analytical Process

31

VII. Quality Assurance of Laboratory Examinations

33

VIII. Reporting

35

IX. Laboratory Information System

37

X. Safety

39

XI. Point-of-Care Testing

42

Glossary of Terms

44

Record of Revisions

46

Appendices

48

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The Introduction

In the quality manual, there should be an introductory section containing a brief overview of the quality

manual and your facility. Consider including the following information:

§ The name of the individual who reviewed and approved the quality manual

§ The version status, and the date the current version was issued

§ The overall scope and use of the manual

§ Information about how revisions to the manual will occur

§ Distribution information: i.e. internal only, external

§ Information about your facility:

− Name, address, FAX numbers, e-mail contacts etc

− The scope of examinations offered

− History

− Vision, mission statement, values

§ Definitions and/or glossary of terms

§ A table of contents

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QMP-LS Quality Policy:

QMP–LS commits to provide high quality laboratory accreditation, assessment

and education services, that:

§ Meet all customers’ requirements; applicable regulatory, statutory and

contractual requirements; and relevant national/international standards;

§ Evaluate and continually improve the effectiveness of the service;

§ Ensure this policy is communicated to and understood by all employees;

§ Provide a process for establishment, review and modification of quality

objectives;

§ Review and modify this policy annually for continued suitability.

The Quality Policy Statement

The purpose of the quality policy statement is to define the intentions and direction of the quality

management system. It demonstrates the facility’s commitment to quality with clear leadership by top

management. This is essential since the leaders shape the culture of the laboratory: their commitment is

the key to success.

The following requirements appear in the OLA Program Requirements:

II.B Quality Policy Statement

II.B.1 Laboratory management shall define its quality management system in a quality

policy statement.

II.B.2 The quality policy statement shall include the laboratory’s commitment to good

professional practice, the quality of its examinations, compliance with and

continuous improvement of the quality management system.

II.B.3 The quality policy statement shall include the objectives of the quality

management system.

II.B.4 The quality policy statement shall include the scope of the service the laboratory

intends to provide.

II.B.5 The quality policy statement shall include a requirement that all personnel

familiarize themselves with the quality management system and implement it at

all times.

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Document Control

Your quality manual must be considered a controlled document. As such, it is subject to all of the

requirements for documents from Section II.F of the OLA Program Requirements:

II.F Document and Record Control

II.F.1 Laboratory management shall define, document and maintain a policy, process(es)

and procedures to control documents and records. Documents and records may be

maintained and stored on any appropriate medium.

II.F.2 Authorized documents shall be available at all locations where operations essential to

the effective functioning of the laboratory are performed.

II.F.3 All documents issued to laboratory personnel as part of the quality management

system shall be reviewed and approved for use by the laboratory director or

designate(s) prior to issue.

II.F.4 A list, also referred to as a document control log, that identifies the current valid

revisions and their distribution shall be maintained.

II.F.5 All documents relevant to the quality management system shall have a unique

identification.

II.F.6 Documents shall include the date of issue.

II.F.7 Documents shall include the edition and/or current revision date and/or revision

number.

II.F.8 Documents shall designate the number of pages within.

II.F.9 Documents shall contain authority for issue.

II.F.10 Documents shall contain an electronic identification, if applicable.

II.F.11 Document control processes shall be adopted to ensure that obsolete documents are

removed and only currently authorized versions of appropriate documents are

available for active use at relevant locations.

II.F.11.1 A retention period for superseded documents shall be defined.

II.F.11.2 Retained or archived superceded documents shall be appropriately identified

to prevent their inadvertent use.

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Example Headers and Footers

Figures 1-4 present a variety of headers/footers that meet the requirements for document identification

specified in OLA Program Requirements II.F.5-II.F.10. Any of these could be adapted for your quality

manual and for all of the related documentation in your quality management system. Note that pagination

can be either continuous or sectioned.

Figure 1: Example Header/Footer Combination

Header:

Best Test Laboratories

Quality

Manual

Section 0.0

TABLE OF CONTENTS

Page 1 of 1

Footer:

Prepared by William Jones Issue Number 2

Approved by Dr Mary Smith Issue Date Jan 21, 2002

Figure 2: Example Header

Section 0.0 Date Issued: 21/01/02

Element: Table of Contents Authorized by: William Jones

Revision 2 Approved by: Dr Mary Smith

Pg 1 of 1

Figure 3: Example Footer

01/11/10, 02/01/21 (rev) Quality manual.doc Pg 1 of 42

Authority for Issue: Dr Mary Smith

Figure 4: Example Header/Footer used internally at QMP-LS

Header:

Quality Manual Section 5.1 Page 1 of 2

Status: Approved Title: Document and Record Management Policy Version 1.0

Footer:

Prepared by: Jane Gun-Munro Approved by: Dr. Harold Richardson Effective Date: 2002 08 26

NOTE: This is a CONTROLLED document for internal use only. Any documents appearing in paper form

are not controlled and should be checked against the server file version prior to use.

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Maintaining the Manual

Ensure the quality manual:

§ Is up-to-date

§ Is required reading for all personnel

§ Is reviewed annually

These points are covered in the following OLA Program Requirements contained in Section II.C:

II.C Quality Manual

II.C.2 The quality manual shall be maintained current under the authority of an individual

appointed responsible by laboratory management (quality manager).

II.C.3 The quality manual should be reviewed, signed and dated regularly, and at minimum

annually by the quality manager or laboratory management.

It is advisable to include a “Record of Revisions” page within your quality manual. This could appear in

the front material or as an appendix. Alternatively, include a revision history for each individual policy as

part of a standard header or footer.

If your quality manual is primarily an electronic document wherein uncontrolled printed paper copies may

exist, you should consider adding a footer at the bottom of printed pages:

NOTE: This is a CONTROLLED Document as are all management system files on this server. Any

documents appearing in paper form are not controlled and should be checked against the server file

version prior to use.

Notice: This Document hardcopy must be used for reference purpose only.

The on-line copy must be used as the current documentation level.

This type of warning reminds personnel to ensure that they are using the most up to date issued copy of

any document.

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Review of Laboratory Quality Manual

Facilities will be requested to complete a self-assessment of their quality manual one month prior to each

accreditation peer assessment visit. With the initial notification of an upcoming accreditation peer

assessment, QMP–LS sends to each facility a form that outlines the criteria for the self- assessment. .

You will be required to submit the completed form to QMP– LS for review by the OLA Staff

Coordinator and copies will be provided to your peer assessment team. You are requested to have your

quality manual available for the team to review on-site.

The purpose of the self-assessment is to:

• Review the general characteristics of the quality manual

• Pre-assess the facility’s quality policies

• Expedite the on-site peer assessment of your quality management system

• Assist the assessment team in locating your quality policies

The list of policies included on the form (Table 5) are those for which QMPP– LS expects to see within the

quality manual. Facilities are encouraged to include the indicated information in their quality manual to

allow for an effective self-assessment and to expedite the accreditation assessment visit. However, non-

inclusion of a policy in the quality manual will not constitute a deficiency if the information is documented

elsewhere. For each of the criteria in Table 5, laboratories are instructed provide the page number in their

quality manual or specify where documentation of this information can be found by OLA assessors.

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Table 5: Criteria for Self-Assessment of Laboratory Quality Manual

Criteria

Requirement #

*

Yes/No and Page No. or

location **

General Criteria

1. Is the quality manual properly identified with the following?

a. Date of issue II.F.6

b. Current revision date or version number II.F.7

c. The page number and the number of pages therein II.F.8

d. Authority for issue II.F.9

e. Unique identifier or electronic file identification II.F.10

2. Was the quality manual approved by the laboratory director or designated responsible

person prior to implementation and distribution?

II.F.3

3. Do policies in the Quality Manual indicate that the Quality Management System

encompasses all management activities and processes (in all areas of the laboratory)?

II.A.2

4. Are there cross-references to related processes, procedures, and reports not included in

the quality manual?

II.C.1

5. Is the Quality Manual reviewed, signed and dated at minimum annually? II.C.3

Specific Policies/Processes or Statements

6. Is there an organizational chart? I.A.4

7. Is there a mission statement or statement of purpose? I.A.3

8. Are personnel policies defined (or a reference made to where they can be found)? I.B.2

9. Are there policies defined that address the confidentiality of patient information? I.C.9

10. Is there a quality policy statement? II.B.1

11. Does the laboratory have quality improvement programs in place? II.D.1

12. Have quality indicators been implemented? II.D.3

13. Is there a policy and process for non-conformities? II.D.5

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Criteria

Requirement #

*

Yes/No and Page No. or

location **

14. Is there a policy or process for the resolution of complaints? II.D.6

15. Does the laboratory have a defined policy and process to control documents and

records?

II.F.1

16. Is there a policy or process that describes the selection, use and monitoring of referral

laboratories and consultants?

II.G.1

17. Is there a policy for purchasing and inventory? IV.1

18. Are there policies/processes and/or procedures for calibration and verification

programs for instruments, reagents and analytical systems?

IV.8

19. Are computer policies, processes and procedures defined? IX.B.1

20. Is there a safety policy? X.A.1

21. Has the scope of POCT been defined by the Medical Advisory Committee or other

appropriate body?

XI.A.3

* Recommended best practice, not an essential requirement.

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The Peer Assessment Visit

OLA accreditation assessment visits will be conducted by a team of peers assembled from our pool of

over 300 volunteer assessors. An OLA staff coordinator will accompany each team to ensure consistency

and provide advice to the team as needed. Individual assessors will have specific expertise and will assess

the scope of a laboratory they are familiar with. They will utilize checklists that guide them in what to look

for in seeking objective evidence that the laboratory meets program requirements. They may ask to see

specific documentation, may directly observe the physical conditions of the laboratory and practices in

action, and may speak directly to all levels of staff to ensure that requirements are met.

The assessment team will ensure that policies, processes and procedures are implemented, that staff

follow them as written, and that appropriate “checks and balances” are in place to ensure quality and allow

for continual improvement. If a policy is documented and included in your quality manual, it must reflect

your actual practice. OLA will review the quality manual and make note of items to be validated by

observation of actual laboratory practice. The validation will be done at the time of the assessment visit.

Validation will be achieved through the following means:

• Interviews with laboratory director(s) and staff

• Observations of staff

• Review of laboratory records

• Review of additional documentation that the facility has not included as part of the quality manual

OLA assessors will conduct a process-based assessment, as opposed to a procedurally-based inspection.

In other words, OLA assessors will concentrate on laboratory policies and processes. Each laboratory

should provide evidence that its processes are effective in meeting the goals defined in its policies. OLA

will assess the efforts of laboratory management to define its own criteria for quality according to the

laboratory’s unique circumstances and patient population served. OLA assessors will ask to see evidence

that the laboratory’s defined processes are followed by staff and are effective. The assessment will be as

objective as possible, using checklists developed with emphasis on a process approach.

For example: One OLA program requirement (VIII.7) states that laboratory management, in consultation

with the requesters, shall establish clinically appropriate turnaround times (TAT) for each of its

examinations. A procedurally-based approach would likely lead assessors to look at the actual TAT of

each examination and make a judgment on whether or not the TAT is acceptable. OLA’s process-based

assessment will direct assessors not to look at individual TATs but to review the process by which the

laboratory has determined that its TATs are clinically appropriate. Thus, the specific “What to Look for”

instructions for this requirement are:

A) Did the laboratory determine clinically relevant TATs for each examination in consultation with their

clients?

B) Does the laboratory monitor the established TATs to ensure that they remain clinically relevant?

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Frequently Asked Questions

1. What is the difference between a policy, a process and a procedure?

A policy is a brief statement describing your intent, they describe what is done and why. Policies form

the basis of the quality manual. Policies define your goals.

A process describes the inter-related steps involved in an activity and may involve a number of people.

Processes are usually displayed as flowcharts and illustrate the path of workflow and who is

responsible. Most processes will be linked to one another because the output of one process is often

the input to the next. Rarely is there a process that is not linked to another.

A procedure is the written work instructions that specify a way to carry out an activity, examination or

step in a process. Procedures describe in detail exactly how one individual should perform an activity.

These should be written so that any individual who has a role in a process has detailed instructions to

follow.

2. Where in the typical document hierarchy does the quality manual fit in?

The Quality manual is the top tier of the document hierarchy:

Quality Manual (Policies)

Processes

Procedures

Records

3. Where do we put our process flow charts?

Once you have created a process flow chart, it is a controlled document. Some may be included within

the quality manual, such as your process for the investigation of non-conformities. Others will be more

technical in nature and may be included as part of a procedure manual. For instance, a flow chart on

the process for specimen reception and accessioning could be included in the procedure manual

located in your specimen reception area.

4. Is it better to use continuous pagination, or to number the pages within individual sections?

OLA does not dictate how you must set up the pagination of your quality manual, but it may be easier

to update individual polices and add/remove pages if the pagination is by section rather than

continuous.

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5. Do we include procedures in the quality manual?

No, you may want to include some process flow charts, but step-by-step work instruction should

generally not be included. However, you should indicate within the quality manual, a list of the

procedures related to each policy and where they can be found.

6. Do we write our quality manual according to what we actually do, or according to what we would like

to do, or plan to do in the future?

It is essential that the quality manual reflects what you actually do. Each laboratory should be able to

provide evidence that its processes are effective in meeting the goals defined in their policies. It is up to

the laboratory to define what records and documentation are necessary to provide this evidence.i OLA

assessors will ensure that policies, processes and procedures are implemented, that staff follow them

as written, and that appropriate “checks and balances” are in place to ensure quality and allow for

continual improvement.

7. Should there be only one Quality Manual per license/facility? If we have laboratory sections not

under Laboratory Medicine/Pathology (e.g. Genetics, molecular, MSS laboratories) should these

departments have a separate quality manual?

Our intent is that there is ONE quality manual to represent the general administrative policies of all

laboratory divisions. Differences between the types of programs listed and the rest of your laboratory

should be limited to operational or technical details that need not be included within the quality manual.

8. I have seen a quality manual from another organization that included reports of the outcomes of

management review such as the results of internal audits, results of quality indicators, process

improvement plans. Does OLA require this sort of information in the quality manual?

Management review reports such as these are not required to be included in the quality manual.

However, we will ask to see these kinds of reports as part of our assessment visit and that is the

rationale why some may choose to include them in the quality manual itself.

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Sample Quality Manuals

CLSI Quality Manual (US)

http://www.clsi.org/Content/NavigationMenu/AboutCLSI/QualityManual/Quality-Manual-Second-

Edition-June2003-041102.pdf

Delta Environmental Consulting (Australia):

http://www.deltaenvironmental.com.au/management/index.htm

National Institute of Standards and Technology (US):

http://ts.nist.gov/ts/htdocs/230/235/quality/d5802.htm

NASA Quality Manual (US):

http://nodis3.gsfc.nasa.gov/library/hq_list.cfm

Quality Network (UK):

http://www.quality.co.uk/example/manual.htm

Resources

Canadian Standards Association. Plus 15189. The ISO 15189:2003 essentials—A practical handbook for

implementing the ISO 15189:2003 Standard for medical laboratories. July 2004.

CAN/CSA-ISO 9000-0 (ISO 9000:2000). Quality Management Systems—Fundamentals and Vocabulary.

December 2000.

CAN/CSA-ISO 9001-00 (ISO 9001:2000) Quality Management Systems—Requirements. December

2000.

CAN/CSA-ISO 9004-00 (ISO 9004:2000). Quality Management Systems—Guidelines for Performance

Improvements. December 2000.

Canadian Standards Association. The ISO 9000:2000 Essentials, 3

rd

Edition. 2001.

CLSI. Laboratory Documents: Development and Control; Approved Guideline—Fifth Edition. CLSI

document GP2-A5, 2006.

CLSI. Continuous Quality Improvement: Integrating Five Key Quality System Components; Approved

Guideline—Second Edition. CLSI document GP22-A2, 2004.

CLSI. Application of a Quality Management System Model for Laboratory Services; Approved

Guideline—Third Edition. CLSI document GP26-A3, 2004.

CLSI. A Quality System Model for Health Care; Approved Guideline—Second Edition. CLSI document

HS1-A2, 2004.

OLA GUIDANCE FOR LABORATORY QUALITY MANUALS

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ISO/TC 176/SC 2/N 525R. ISO 9000 Introduction and Support Package: Guidance on the

Documentation Requirements of ISO 9001:2000.

ISO/TC 176/SC 2/N 544R. ISO 9000 Introduction and Support Package: Guidance on the Process

Approach to quality management systems. May 2001.

International Organization for Standardization ISO 15189 Medical Laboratories-Particular Requirements

for Quality and Competence. February 2003

Ontario Laboratory Accreditation Requirements and Guidance Information, Version 3, September

2005.

Richardson H. Medical Laboratories—Requirements for Quality and Competence: An ISO Perspective.

Vox Sang 2002; 83:333-5.