1. Quality Management Systems (QMS) for Laboratories Preparation and Implementation Requirements of ISO/IEC and ISO Elizabeth M. Dax National Serology Reference Laboratory, Australia

2. Roderick Chappel, Sandy Walker and Elizabeth M. Dax 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

3. Aims of the QMS Section
To clarify the requirements of a Quality Management System (QMS)

4. 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 and the overlap with ISO 9001

5. Objectives of the QMS Section (2)
To train in the more ‘difficult’ elements of ISO/IEC and ISO 9001, including
Requirements of a documented quality system
Document control
Internal audits
Corrective action
Equipment
Management review

6. Aims in Achieving Quality
To ensure that outputs and outcomes are
consistent
reproducible
traceable
efficacious
To ensure no harm
Aims
Achieving Quality results is our goal
Efficient Process:
Turn around time for testing
Happy customers
Happy staff (no stress)
Traceable:
Records
Standard:
Maintenance of equipment
QC programme
Consistent/Reproducible
Standard operating procedures (SOPs)
Training

7. The Value of Standards Help us do things better Necessary compliance
Learning from others' experiences
Encourage continuous improvement
The Value of Standards
Quality management based on standards is of value because it improves the performance of the organisation, and provides a basis for ongoing continuous improvement.
It is important to focus on the intrinsic value of the standards. If compliance for its own sake is the primary focus, much of the value of quality management may be lost.

8. Effect of Quality Management on Costs
Initial costs
internal costs of failure
e.g. testing errors, reworking
external costs of failure
e.g. complaints, losing customers

9. Effect of Quality Management on Costs
Implementation costs
Ongoing costs
prevention
appraisal
failure costs (reduced)

10. Effect of Quality Management on Costs
External Costs
Internal costs
Implementation Costs
Ongoing Costs
Appraisal
Prevention
Cost $
Time
Effect of Quality Management on Costs
Initially it costs money to implement a quality management system.
Once implemented, the system can be expected to save money.
There will be ongoing costs of prevention and appraisal (e.g. document control costs, costs of internal and external audits). However, the internal and external costs of poor management can be expected to fall sharply, and more than compensate for the ongoing costs of prevention and appraisal.

11. The Benefits  Independent endorsement of competence
 Improved service to stakeholders
 Increased awareness of quality
 Organisational stability

12. Accreditation and Certification
Laboratory Accreditation
NATA/RCPA Medical Testing
NATA - ISO/IEC Guide 25:1990
NATA - ISO 17025:2000
Accreditation and Certification
Organisations can be recognised for their adherence to international standards by achieving accreditation or certification. This involves an external body auditing the systems for compliance against standards.
Laboratory accreditation
Can be achieved by meeting the requirements of ISO Guide 25 or ISO which review the laboratory’s technical competence. The auditing process is a ‘peer review’ which involves the use of a technical auditor with technical experience in the area to be audited. .
NATA = National Association of Testing Authorities
This is the prime accreditor of Laboratories in Australia

13. Accreditation and Certification
Quality Certification
ISO 9001, ISO 9002:1994
ISO 9001:2000
Accreditation and Certification
Certification
Is the recognition of an effective quality management system meeting the requirements of the ISO 9000 series. This standard has some elements such as maintaining equipment which affect the laboratory, but it does not review the laboratory’s technical competence on the whole.
Auditors are systems auditors and do not need any technical or laboratory experience.

14. Requirements Simplified
Each of the systems of requirements addresses slightly different issues – some technical, some managerial

15. Quality Assurance Systems Why Both NATA & ISO 9000?
Management
Quality Assurance Systems - Why both ISO (NATA) and ISO 9000 ?
The ISO standards alone could provide us with an effective quality management system to manage and control most of our processes.
NATA requirements (ISO 17025) would assure the validity of our laboratory technical processes, such as our reference testing.
Both these models would provide an effective quality system, ie a system which describes the organisational structure, responsibilities, processes, procedures and resources for implementing quality management.
NATA
Technical

16. Implementing the Guidelines
 Design a system
 Implement the system
 Verify the system meets the guidelines (audits, review)
 Finalise implementation
QUALITY SYSTEM

17. 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
QP + QS + description of quality system, how standards are applied.
Quality Manual
Describe how processes which affect quality are carried out.
Procedures
Additional detail on how specific jobs are carried out.
Work Instructions

18. 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 Quality Management System (QMS)
Management
Management is not just about organising and controlling, but leads to challenge processes, show the way and encourage the ‘spirit’ of the organisation.

19. Implementing a QMS 2. Quality System Planning
Training of appropriate personnel
Visit other organisations
Implementing a QMS
Quality System Planning
The QMS needs to be tailored to the needs of the organisation. However, there is benefit in learning from the experience of other comparable organisations.

20. 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
Quality System Design
The standard should be interpreted in a way that best meets the needs of the organisation.
The organisation should not be mindlessly reshaped around the standard.

21. Implementing a QMS 4. Format of Documents
Determine format of quality system documents
Document this in a procedure

22. Implementing a QMS cont.
5. Successful implementation requires:
planning, management,
belief in system
understanding the “spirit” of the standard
understanding organisation’s aims
having staff involved at all levels
look for real process improvements
setting realistic time frames
Implementing a QMS
Major consideration, ~50% of effort is spent documenting the system and 50% implementing the system

23. Implementing a QMS 5. Implementation
Set out the program for Implementation in stages: Gantt chart format is most appropriate

24. Implementation at NRL 1996 1997 ID Task Name Mar May Jul Sep Nov Jan
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

25. ISO Guide 25/ISO Guide 17025

26. ISO Guide 25 now ISO Guide 17025 ISO/IEC 17025 draws on ISO 9000:1994
Accreditation and certification
different histories
on convergent paths
With ISO/IEC Guide 25, close to ISO 9001
ISO Guide 25 now ISO Guide 17025
Certification of the management of organisations (according to the ISO 9000 standards) has arisen independently of accreditation of laboratories (according to ISO Guide 25, and ISO/IEC 17025).
However, the two approaches to quality management have converged over the years. In particular, ISO/IEC contains management requirements very similar to those of ISO 9000.
Accreditation dealt originally with technical matters, but ISO 9000 also has provisions (e.g. relating to equipment) with technical implications.

27. 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

28. Management versus Laboratory Standards
ISO/IEC includes:
almost all of ISO 9000 management requirements
technical requirements

29. ISO/IEC 17025 & ISO/IEC Guide 25
Basically similar - structural change
More prescriptive in parts
More emphasis on:
Method validation

30. Using Structure of ISO/IEC 17025
Limited differences
Newer
Better structure
Guide 25 versus NATA requirements
This presentation uses the numbering system of ISO/IEC rather than that of its predecessor, ISO Guide 25.

31. ISO/IEC 17025
4. Management requirements
5. Technical requirements

32. ISO/IEC 17025 - Technical 5.1 General 5.2 Personnel
5.3 Accommodation and environment
5.4 Selecting & validating test methods
5.5 Equipment