How To Create a Quality Manual for ISO 17025 Lucia Berte www.LaboratoriesMadeBetter.com
Program Objectives You will be able to: 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
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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 3
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 4
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 6
ISO 9001:2008 Process-Based Quality Management System Continual improvement of the quality management system Management responsibility
Customers
Resource management
Measurement, analysis, and improvement
Product Realization
Requirements Input
Customers
Product
Graphic presented in ISO 9000:2008 Fundamentals and Vocabulary
Satisfaction
Output
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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?? Continual improvement of the quality management system Management responsibility
Customers
Resource Management (financial, facility, human, materials)
Measurement, analysis, and improvement
Product Realization
Requirements Input
Customers
Product
Graphic presented in ISO 9000:2008 Fundamentals and Vocabulary
Satisfaction
Output
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Food and Feed Laboratories’ “Product Realization”
Customers
Customers
Satisfaction
Product Realization
Requirements Input
Product
Graphic presented in ISO 9000:2008 Fundamentals and Vocabulary
Output
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Laboratory “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 permission 11
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 Policies Procedures
Processes
Work Instructions Procedures Quality and Technical Records
Forms Records
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” 14
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! 15
Example of a Policy Document QMS Personnel Policy Quality Manual
Effective: 04/12/2014 Version1.3
QMS Personnel Policy Policy
Our laboratory hires qualified persons, trains them in respective job processes and procedures, periodically assesses their job competence and provides for continuing education through collaboration with our organization’s Human Resource function.
Purpose
This policy provides direction for the processes and procedures needed to effectively manage our laboratory’s human resources.
Responsi- The Human Resources function is responsible for…… The Laboratory Director is responsible for….. bility The Section Managers are responsible for………. Staff is responsible for…….
Qualifications and Job descriptions
Our laboratory has set qualifications that specify the education, training, and skills needed for each job title. The qualifications meet regulatory and accreditation requirements and are documented in laboratory job descriptions that are kept current. Continued on next page
Facility Name, City State Filename and path
Page 1 of y 16
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 Document Sample Receiving Process All Testing Sections
Effective: 03/04/2014 version1.4
Sample Receiving Process
Anytown Hospital, Anytown, CO, USA G:\Lab\Testing\Reportin g
Page 1 of 1 18
Procedure Documents
Instructions for how to perform a task
A specified way to perform a single activity in a process
By one person with defined start and stop
Written in the active tense “[You will] action verb (Write, Call, Incubate, Pipette, etc….” 19
Example of a Procedure Document Gram Stain Procedure Bacteriology
Effective: 04/12/2013 Version1.1
Gram Stain Procedure Purpose
This procedure provides instructions for how to stain smears made from culture plates.
Procedure: Inpatients
Follow the instructions below to perform a Gram stain. 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… Continued on next page
Anytown Hospital, Anytown, CO, USA G:\Lab\Microbiology\Bacteriology
Page 1 of 2 20
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. 22
Sample Job Aid Tube Fill Job Aid
CLSI QMS02-A6:2013, with permission 23
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 24
Sample Form Equipment Type (eg, Refrigerator)____________________ Temp Range: 2ºC to 6 ºC *
Days 7.0 6.5 6.0 5.5 5.0 Temp ºC
4.5 4.0 3.5 3.0 2.5 2.0 1.5 1.0 0.5
ID# ______
Month_________________
Year ______
1
2
3
4
5
…
• • • • • • • • • • • • • •
• • • • • • • • • • • • • •
• • • • • • • • • • • • • •
• • • • • • • • • • • • • •
• • • • • • • • • • • • • •
• • • • • • • • • • • • • •
Initials *Describe response to outliers on back side of this form Reviewed by: ___________________ Date Reviewed: ____________ 25
ISO 17025 Documentation
Lab Quality Manual
Quality and Management Policies Management Processes
Laboratory Technical Processes
Management Procedures and Job Aids
Laboratory Technical Procedures and Job Aids
Management Forms Records
Laboratory Technical Forms Records
Laboratory Technical Manuals
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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…
Start
Action
Action
Decision No
Providing the whole picture for ◦ Communication ◦ Training ◦ Competence assessment
Yes
Action Action
Action
Next Process
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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 28
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 !!! 31
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 32
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 33
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. Bring to the workshop Copy of ISO 17025 with clauses marked Copy of the sorting table Copy of your laboratory’s
◦ Quality policy ◦ Quality manual
Questions for discussion
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