Key Elements of a Laboratory Quality ManualProcess concept vital to understanding QMS Process-based model is visual. 6. ISO 17025 Quality Manual 2014 LaboratoriesMadeBetter.com 3

The Association of Public Health Laboratories (APHL) sponsors educational programs on critical issues in laboratory science.

For more information, visit www.aphl.org/courses

2014 Webinar Series

Key Elements of a Laboratory Quality Manual Thursday, June 12, 2014

Speaker Lucia M. Berte, MA, MT(ASCP)SBB,DLM; CQA(ASQ)CMQ/OE, President, Laboratories Made Better! P.C., Broomfield, CO

Ms. Berte teaches laboratories how to implement the various aspects of a quality management system for improving patient safety, efficiency and effectiveness, and meeting accreditation requirements. In addition to being ASCP certified, she is also certified as a quality manager and quality auditor by the American Society for Quality. She recently chaired the CLSI Subcommittee on Quality Management Systems and has been actively involved in the development of many CLSI guidelines over the past 20 years.

Objectives At the conclusion of this program, participants will be able to:

• Describe ISO/IEC 17025 as a process-based model• Diagram and explain 4 different types of documents• Describe the contents of a quality manual• List several uses for the quality manual

Continuing Education Credit CE credit is not available for this program, but you will receive a Certificate of Attendance.

Evaluation/Certificate of Attendance Process Continuing education credit is not available for this program. Individuals who successfully complete the program and evaluation by December 31, 2018 will receive a Certificate of Attendance.

1. Go to http://www.surveymonkey.com/s/100-957-14za to complete the evaluation.2. After you complete the evaluation, you will automatically receive the Certificate of Attendance.3. Type or print your name on the certificate.

Archived Program The archived streaming video will be available within two days. Anyone from your site can register view the program for free using the complimentary discount code in the discount box during registration. URL: http://www.surveymonkey.com/s/590-957-14za

Comments, opinions, and evaluations expressed in this program do not constitute endorsement by APHL. The APHL does not authorize any program faculty to express personal opinion or evaluation as the position of APHL. The use of trade names and commercial sources is for identification only and does not imply endorsement by the program sponsors.

© This program is copyright protected by the speaker(s) and APHL. The material is to be used for this APHL program only. It is strictly forbidden to record the program or use any part of the material without permission from the author or APHL. Any unauthorized use of the written material or broadcasting, public performance, copying or re-recording constitutes an infringement of copyright laws.

Program deadline extended to 12/31/18

http://www.surveymonkey.com/s/100-957-14za

http://www.surveymonkey.com/s/590-957-14za

ISO 17025 Quality Manual

2014 LaboratoriesMadeBetter.com 1

How To Create a Quality Manualfor ISO 17025

Lucia Bertewww.LaboratoriesMadeBetter.com

Program Objectives

Describe ISO 17025 as a process-based model

Diagram and explain 4 different types of documents

Describe the contents of a quality manual List several uses for the quality manual

You will be able to:

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Program Structure – 2 Parts

This 90-minute introduction webinar◦ ISO 17025 as a graphic ◦ Document types and their uses ◦ Discussion of required quality manual

contents◦ Homework

One-day workshop on June 24, 2014◦ Alignment of clauses to graphic◦ Quality manual contents and development

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Denise.Korzeniowski

Typewritten Text

@ Luci Berte and APHL: Use of this material other than for this APHL program is an infringement of copyright.

Denise.Korzeniowski

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Denise.Korzeniowski

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The ISO 17025 Standard

Describes elements of a “management system for quality, administrative, and technical operations”◦ Elements derive from ISO 9001

Minimum requirements for laboratory competence

Used for◦ preparation for accreditation◦ accreditation of (nonmedical) laboratories

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ISO 17025:2005 Status in 2014

Required 5 year review in 2010◦ Decision to “retain unmodified”

Revision likely to begin in 2015, as ILAC is in favor

Revision planned to take 2 years (2017) ILAC has 2 year implementation of

new/revised requirements (2019) Use 2005 version – but stay tuned!

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In the beginning…ISO 9001 Generic quality management system◦ Applicable to any industry

No industry-specific technical requirements included

Changed to a “process-based” model in 2000◦ Process concept vital to understanding QMS◦ Process-based model is visual

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ISO 9001:2008 Process-Based Quality Management System

Customers

Requirements

Managementresponsibility

Resourcemanagement

Measurement, analysis, andimprovement

Customers

Satisfaction

Product Realization

Input Product Output

Continual improvement of thequality management system

Graphic presented in ISO 9000:2008 Fundamentals and Vocabulary 7

Benefits of Process-Based Thinking

All work is a sequence of processes◦ Management and technical

Processes should be documented, understood, and followed◦ Quality is lack of variation

Processes should be measured, monitored, and improved◦ Basis of “continual improvement” philosophy

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ISO 17025 Process-Based Quality Management System??

Customers

Requirements

Managementresponsibility

ResourceManagement(financial, facility,human, materials)

Measurement, analysis, andimprovement

Customers

Satisfaction

Product Realization


Continual improvement of thequality management system




Food and Feed Laboratories’ “Product Realization”

Customers

Requirements

Customers

Satisfaction

Product Realization



Preanalytic Analytic Postanalytic

Test Ordering Sample Collection Sample Transport Sample Receipt/Processing

TestingResults Review and Follow-UpInterpretation

Result Reporting and Archiving Sample Management

© CLSI. QMS01:2011. Used with permission11

Laboratory “Product Realization”

ISO 17025 Required Documentation*

Quality policy Quality manual Quality objectives Outline of the structure of

documentation Technical manuals Records – quality and technical

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QMS Documentation Terminology

Procedures Processes

Work Instructions Procedures

Quality and Technical Records Forms Records

Policies

Suggested Outline for Document Structure

Policies“What we do”

Processes“How it happens”

Procedures and Job Aids“How to do it”

Forms Records“What happened”

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Policy Documents

Describes “what we do and why”

The “why” is based on ◦ Regulations◦ Accreditation requirements, and◦ Your organization’s requirements

Policy states intent;◦ ie, laboratory’s intent to meet requirements◦ Not how intent is turned into action!

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Example of a Policy DocumentQMS Personnel Policy Effective: 04/12/2014Quality Manual Version1.3

QMS Personnel Policy

Policy

Facility Name, City State Page 1 of yFilename and path

Our laboratory hires qualified persons, trains them in respective job processes and procedures, periodically assesses their job competence and provides for continuingeducation through collaboration with our organization’sHuman Resource function.

Purpose This policy provides direction for the processes andprocedures needed to effectively manage our laboratory’s human resources.

Responsi-bility

The Human Resources function is responsible for……The Laboratory Director is responsible for…..The Section Managers are responsible for……….Staff is responsible for…….

Continued on next page

Qualifi-cationsand Job descrip-tions

Our laboratory has set qualifications that specify the education, training, and skills needed for each job title. The qualifications meet regulatory and accreditationrequirements and are documented in laboratory jobdescriptions that are kept current.

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Process Documents

Intent Action Sequence of activities across a span

of time “Who (function/section, job title) does

what and when” Description of “how it happens here”

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Example of a Process DocumentSample Receiving Process Effective: 03/04/2014All Testing Sections version1.4

Sample Receiving Process

Anytown Hospital, Anytown, CO, USA Page 1 of 1

G:\Lab\Testing\Reporting 18



Procedure Documents Instructions for how to perform a task

A specified way to perform a single activityin a process

By one person with defined start and stop

Written in the active tense“[You will] action verb (Write, Call, Incubate, Pipette, etc….”

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Example of a Procedure Document

Step Action

1 Prepare specimen on glass slide…

2 Flood the slide with crystal violet…

3 Decant crystal violet and rinse…

4 Flood the slide with Gram’s iodine…

5 Rinse gently with flowing water…

Gram Stain Procedure

Gram Stain Procedure Effective: 04/12/2013Bacteriology Version1.1

Anytown Hospital, Anytown, CO, USA Page 1 of 2G:\Lab\Microbiology\Bacteriology

Purpose This procedure provides instructions for how tostain smears made from culture plates.

Procedure:Inpatients

Follow the instructions below to perform a Gram stain.

Continued on next page

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Process vs. Procedure

How it happens

here

How do I do that?

Step Action

1 Label the tube with the patient’s initials.

2 Add 2 drops of patient plasma to the tube.

3 Add 3 drops of Reagent A to the tube.

4 Mix gently by swirling.

5 Incubate for 15 minutes at 37 °C.

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Job Aid Documents

“Information excerpted from an approved procedure that is presented in a more viewable format”◦ NOTE:

Job aids are subject to document control.

Example:Graphical depiction of bench set-up, tube placement in a rack, computer screen, etc.

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Sample Job Aid

CLSI QMS02-A6:2013, with permission

Tube Fill Job Aid

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Form Documents “A paper or electronic document on

which the results from the performance of a procedure, or other information are captured”◦ NOTE:

A completed form becomes a record.

Examples ◦ Refrigerator Temperature Chart◦ Laboratory test worksheet

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Sample Form

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ManagementProcesses

LaboratoryTechnicalProcesses

ISO 17025 Documentation

ManagementForms Records

Laboratory TechnicalForms Records

Quality andManagement

PoliciesLab Quality Manual

Laboratory Technical Manuals

ManagementProcedures and Job Aids

Laboratory TechnicalProcedures and Job Aids

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A Paradigm for Laboratory Documents

Flowchart the process, which…

Describes who does what and when, and…

Identifies activities in sequential order, therefore…

Providing the whole picture for◦ Communication◦ Training◦ Competence assessment

Start

Action

Action

Decision

Action

Action

Action

NextProcess

No

Yes

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ISO 17025 Required Documents

Quality policy Quality manual◦ Management policies◦ Management processes◦ Management procedures and forms

Technical manuals◦ Technical processes◦ Technical procedures and forms

Records – management and technical

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Why a Quality Manual?

It’s a requirement for a QMS◦ ISO 9001◦ ISO17025◦ ISO 15189◦ FDA cGMP Part 820

Place for administrative information◦ aka “laboratory administrative manual”

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Required Contents of a Laboratory Quality Manual (from section 4.2)

Quality policy statement

Overall objectives

Include or make reference to: ◦ supporting procedures

◦ technical procedures

Outline of the structure of the documentation used

Defined roles and responsibilities of the◦ Quality manager

◦ Technical management

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The Quality Manual is…

…management’s procedure manual !!!

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Use the Quality Manual To…

Fulfill ISO 17025 requirement

Organize and communicate your laboratory’s policies, processes, and procedures for management and technical activities

Train new managers and supervisors in their respective administrative duties

Describe your laboratory’s management system to◦ Staff◦ Others

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Your Homework 1.

Read ISO 17025 Sort the clause numbers (x.x.x) to the

process-based model◦ Customer requirements ◦ Management responsibility◦ Resource management◦ Product realization◦ Measurement, analysis, and improvement◦ Customer satisfaction

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Your Homework 2.

Use a table for the sorting

Model Section Clause Numbers

Customer requirements

Management responsibility

Resource management

Product realization

Measurement, analyis, and improvement

Customer satisfaction

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Your Homework 3.

Copy of ISO 17025 with clauses marked Copy of the sorting table Copy of your laboratory’s◦ Quality policy◦ Quality manual

Questions for discussion

Bring to the workshop

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