Quality Management
Systems (QMS)
for Laboratories
Preparation and Implementation
Requirements of ISO/IEC 17025 and
ISO 9000
Elizabeth M. Dax
National Serology Reference
Laboratory, Australia
www.nrl.gov.au
From the
National Serology Reference Laboratory,
Australia
41 Victoria Parade, Fitzroy, Vic Australia 3065
WHO Collaborating Centre on HIV/AIDS since 1985
Roderick Chappel, Sandy Walker and
Elizabeth M. Dax
www.nrl.gov.au
Aims of the QMS Section

To clarify the requirements of a Quality
Management System (QMS)
Objectives of the QMS Section (1)

Define aims, costs and benefits of a QMS

Share NRL’s experience in preparing for
and implementing a QMS

Define requirements of ISO/IEC 17025 and
the overlap with ISO 9001
Objectives of the QMS Section (2)

To train in the more ‘difficult’ elements of
ISO/IEC 17025 and ISO 9001, including
 Requirements
of a documented quality
system
 Document
 Internal
control
audits
 Corrective
action
 Equipment
 Management
review
Aims in Achieving Quality

To ensure that outputs and outcomes are
 consistent
 reproducible
 traceable
 efficacious

To ensure no harm
The Value of Standards

Help us do things better

Necessary compliance

Learning from others' experiences

Encourage continuous improvement
Effect of Quality Management on
Costs

Initial costs
 internal
 e.g.
testing errors, reworking
 external
 e.g.
costs of failure
costs of failure
complaints, losing customers
Effect of Quality Management on
Costs

Implementation costs

Ongoing costs
 prevention
 appraisal
 failure
costs (reduced)
Effect of Quality Management on Costs
Implementation Costs
Internal costs
Prevention
Ongoing Costs
External Costs
Appraisal
Internal costs
External Costs
The Benefits
 Independent endorsement of
competence
 Improved service to stakeholders
 Increased awareness of quality
 Organisational stability
Accreditation and Certification

Laboratory Accreditation
 NATA/RCPA
Medical Testing
 NATA - ISO/IEC Guide 25:1990
 NATA - ISO 17025:2000
Accreditation and Certification

Quality Certification
 ISO
9001, ISO 9002:1994
 ISO
9001:2000
Requirements Simplified
Technical
Management
NATA/RCPA
yes
no
Guide 25
yes
yes
ISO 17025
yes
yes
ISO 9000
no
yes
Quality Assurance Systems
Why Both NATA & ISO 9000?
ISO 9000
Management
NATA
Technical
 Design a system
 Implement the system
 Verify the system meets the
guidelines (audits, review)
 Finalise implementation
QUALITY SYSTEM
Implementing the Guidelines
Developing a Quality System
In a Quality System, work activities are described in written procedures and carried out in a
planned way. The structure of a Quality System conforms to the relevant standards.
Mission Statement
Quality Policy
How policy implemented.
Quality Strategy
Quality Manual
QP + QS + description of quality
system, how standards are
applied.
Procedures
Describe how processes which
affect quality are carried out.
Work Instructions
Additional detail on how
specific jobs are carried out.
Implementing a QMS
1. Management

Management and staff commitment

“Management & leadership is for
everyone”

Appoint Quality Manager to establish,
implement and maintain the quality
system
Implementing a QMS
2. Quality System Planning

Training of appropriate personnel

Visit other organisations
Implementing a QMS
3. Quality System Design

Identify core processes

Create an organisation process map

Structure documentation around the processes

“Allow standard to fit organisation”
Implementing a QMS
4. Format of Documents

Determine format of quality system
documents

Document this in a procedure
Implementing a QMS cont.
5. Successful implementation requires:
 planning,
 belief
management,
in system
 understanding
the “spirit” of the standard
 understanding
organisation’s aims
 having
 look
staff involved at all levels
for real process improvements
 setting
realistic time frames
Implementing a QMS
5. Implementation

Set out the program for Implementation in
stages: Gantt chart format is most appropriate
Implementation at NRL
1996
1997
MarMay Jul SepNovJan MarMay Jul SepNov
ID Task Name
1 NRL CERTIFICATION
2
Quality system planning
3
Training - P & WI preparation
4
Produce Ps & WIs
5
Implementation
6
Prepare Quality Manual
7
Schedule audits
8
NATA assessment
9
Produce Ps & WIs
10
Implementation
11
Update Quality Manual
12
Schedule audits
13
ISO assessment
ISO Guide 25/ISO Guide 17025
ISO Guide 25 now ISO Guide
17025

ISO/IEC 17025 draws on ISO 9000:1994

Accreditation and certification
 different
 on

histories
convergent paths
With ISO/IEC Guide 25, close to ISO
9001
Management versus Laboratory
Standards

A large overlap between
 ISO
9000
and
 ISO Guide 25 - ISO/IEC 17025

Much of what follows applies directly
to ISO 9000
Management versus Laboratory
Standards

ISO/IEC 17025 includes:
 almost
all of ISO 9000 management
requirements
 technical
requirements
ISO/IEC 17025 & ISO/IEC Guide 25

Basically similar - structural change

More prescriptive in parts

More emphasis on:
 Method
validation
Using Structure of ISO/IEC
17025

Limited differences

Newer

Better structure

Guide 25 versus NATA requirements
ISO/IEC 17025
4.
Management requirements
5.
Technical requirements
ISO/IEC 17025 - Technical
5.1 General
5.2 Personnel
5.3 Accommodation and environment
5.4 Selecting & validating test methods
5.5 Equipment