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

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 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 control Internal 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 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

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.

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

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

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.

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 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 17025 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

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.

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

Quality Assurance Systems Why Both NATA & ISO 9000? Management Quality Assurance Systems - Why both ISO 17025 (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

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

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

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.

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.

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.

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, 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

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

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

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 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 17025 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.

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 This presentation uses the numbering system of ISO/IEC 17025 rather than that of its predecessor, ISO Guide 25.

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