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Quality Management Systems (QMS) for Laboratories Preparation and Implementation Requirements of ISO/IEC 17025 and 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 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 l To clarify the requirements of a Quality Management Aims of the QMS Section l To clarify the requirements of a Quality Management System (QMS)

Objectives of the QMS Section (1) l Define aims, costs and benefits of a Objectives of the QMS Section (1) l Define aims, costs and benefits of a QMS l Share NRL’s experience in preparing for and implementing a QMS l Define requirements of ISO/IEC 17025 and the overlap with ISO 9001

Objectives of the QMS Section (2) l To train in the more ‘difficult’ elements Objectives of the QMS Section (2) l To train in the more ‘difficult’ elements of ISO/IEC 17025 and ISO 9001, including Ø Requirements of a documented quality system Ø Document Ø Internal control audits Ø Corrective action Ø Equipment Ø Management review

Aims in Achieving Quality l To ensure that outputs and outcomes are Ø consistent Aims in Achieving Quality l To ensure that outputs and outcomes are Ø consistent Ø reproducible Ø traceable Ø efficacious l To ensure no harm

The Value of Standards l Help us do things better l Necessary compliance l The Value of Standards l Help us do things better l Necessary compliance l Learning from others' experiences l Encourage continuous improvement

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

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

Effect of Quality Management on Costs Cost $ Implementation Costs Internal costs Prevention Ongoing Effect of Quality Management on Costs Cost $ Implementation Costs Internal costs Prevention Ongoing Costs External Costs Appraisal Internal costs External Costs Time

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

Accreditation and Certification l Laboratory Accreditation Ø NATA/RCPA Medical Testing Ø NATA - ISO/IEC Accreditation and Certification l Laboratory Accreditation Ø NATA/RCPA Medical Testing Ø NATA - ISO/IEC Guide 25: 1990 Ø NATA - ISO 17025: 2000

Accreditation and Certification l Quality Certification Ø ISO 9001, ISO 9002: 1994 Ø ISO Accreditation and Certification l Quality Certification Ø ISO 9001, ISO 9002: 1994 Ø ISO 9001: 2000

Requirements Simplified Requirements Simplified

Quality Assurance Systems Why Both NATA & ISO 9000? ISO 9000 Management NATA Technical 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, 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 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. Quality Policy Mission Statement 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 l Management and staff commitment l “Management & leadership Implementing a QMS 1. Management l Management and staff commitment l “Management & leadership is for everyone” l Appoint Quality Manager to establish, implement and maintain the quality system

Implementing a QMS 2. Quality System Planning l Training of appropriate personnel l Visit Implementing a QMS 2. Quality System Planning l Training of appropriate personnel l Visit other organisations

Implementing a QMS 3. Quality System Design l Identify core processes l Create an Implementing a QMS 3. Quality System Design l Identify core processes l Create an organisation process map l Structure documentation around the processes l “Allow standard to fit organisation”

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

Implementing a QMS cont. 5. Successful implementation requires: Ø planning, Ø belief management, in Implementing a QMS cont. 5. Successful implementation requires: Ø planning, Ø belief management, in system Ø understanding the “spirit” of the standard Ø understanding organisation’s aims Ø having Ø look staff involved at all levels for real process improvements Ø setting realistic time frames

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

Implementation at NRL 1996 1997 Mar. May Jul Sep. Nov. Jan Mar. May Jul Implementation at NRL 1996 1997 Mar. May Jul Sep. Nov. Jan Mar. May Jul Sep. Nov 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/ISO Guide 17025

ISO Guide 25 now ISO Guide 17025 l ISO/IEC 17025 draws on ISO 9000: ISO Guide 25 now ISO Guide 17025 l ISO/IEC 17025 draws on ISO 9000: 1994 l Accreditation and certification Ø different Ø on l histories convergent paths With ISO/IEC Guide 25, close to ISO 9001

Management versus Laboratory Standards l A large overlap between Ø ISO 9000 ðand Ø Management versus Laboratory Standards l A large overlap between Ø ISO 9000 ðand Ø ISO Guide 25 - ISO/IEC 17025 l Much of what follows applies directly to ISO 9000

Management versus Laboratory Standards l ISO/IEC 17025 includes: Ø almost all of ISO 9000 Management versus Laboratory Standards l ISO/IEC 17025 includes: Ø almost all of ISO 9000 management requirements Ø technical requirements

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

Using Structure of ISO/IEC 17025 l Limited differences l Newer l Better structure l Using Structure of ISO/IEC 17025 l Limited differences l Newer l Better structure l Guide 25 versus NATA requirements

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

ISO/IEC 17025 - Technical 5. 1 General 5. 2 Personnel 5. 3 Accommodation and ISO/IEC 17025 - Technical 5. 1 General 5. 2 Personnel 5. 3 Accommodation and environment 5. 4 Selecting & validating test methods 5. 5 Equipment