An introduction to Quality Management Systems ISO 9000 update

1
An introduction to Quality Management SystemsISO
9000 update

• Justin McCarthy
• Head of Clinical Engineering
• University Hospital of Wales
• Cardiff and Vale NHS Trust

2
What is Quality?

• Has some attributes of EXCELLENCE
• The right thing for the job, FITNESS FOR
  PURPOSE
• Realistic but demanding STANDARDS
• High level of PERFORMANCE
• Getting things RIGHT FIRST TIME.

3
More about Quality

• Influences the relationship with CUSTOMERS
• Influences how COMPLAINTS are dealt with
• finally,
• Something to do with how things LOOK and FEEL.

4
Quality Management

• Two approaches
• Intuitive, cultural, people centred
• Formal systematic, procedural.
• QM is about removing the reasons for problems,
  not about solving or accommodating the same
  problem over and over again
• Ref Rooney 1989

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Quality System Attributes

• The Quality System in use must-
• Be customer focused
• Be practical and workable
• Allow for change, adaptation and development
• Cope with unexpected situations
• Belong to the staff who are going to implement
  it.

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Principal Concepts

• A Quality Management System will-
• Meet stated or implied CUSTOMERS NEEDS
• Give CUSTOMERS CONFIDENCE that intended quality
  will be achieved
• Give MANAGEMENT CERTAINTIY that quality is being
  maintained and improved.

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Why have a QMS?

• To measure, monitor, document and control defined
  levels of quality
• To give max. confidence that defined levels of
  service quality are being delivered with optimal
  expenditure
• If standard of quality has not been defined, it
  cannot be controlled or improved.
• Ref Rooney 1989

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Setting and Monitoring Standards
EQUIPMENT MANAGEMENT SYSTEM FEEDBACK LOOP
EQUIPMENT, TREATMENTS, TECHNIQUES, STATUTORY
REQUIREMENTS, ETC., IDENTIFIED
SET STANDARDS OF QUALITY AND PERFORMANCE
DEFINE PROCEDURES
TAKE ACTION
TAKE ACTION
FOLLOW PROCEDURES
IDENTIFY PROBLEMS/COMPLAINTS
NO PROBLEMS
PROFESSIONALS AND PATIENTS IDENTIFY PROBLEMS AND
RISKS NOT FORMALLY DEFINED PREVIOUSLY
MONITOR OUTCOMES
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Reference

• This diagram is adapted from one published by
  Rooney and used in
• Quality in Health Care Application of the
  ISO9000 Standard McCarthy J, Hicks B, Int J
  Health Care QA 441991

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Reference

• Quality is about eliminating problems rather
  than accommodating or finding ways round the same
  problem time and time again.
• Rooney, M. 1989 A Quality Management System
  for the NHS and a Strategy for Training NHS
  Training Authority, ISBN 1 55446 011 0

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The ISO 9000 Standards

• ISO 9000 is a set of standards which provide a
  framework on which to build a formal documented
  Quality System
• The system can then be audited and registered by
  an external Quality Assurance body e.g. BSI,
  Lloyds Register

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• Pause,
• Question,
• Discuss!

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Old version to the new version
Old Version 1994 BS EN ISO 9001/2/3
1994 Quality systems Model for quality
assurance in design, development, production,
installation and servicing
New Version 2000 BS EN ISO 9001 2000 Quality
management systems Requirements
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Whats different?

• Change of Title Quality Management NOT Quality
  Assurance
• Change in philosophy
• Change in layout and numbering
• Transition to have been completed by 2003
• Consistent with ISO 14000 - Environmental
  Management
• Eventual aim one standard Management Systems
  to encompass Quality, HS, and Environmental

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Why new?

• This is to reflect that the QMS as a whole is
  aimed at enhancing customer satisfaction not just
  quality assurance of product.
• ISO 9000 series now consists of 3 parts
• ISO 9000 Fundamentals and Vocabulary
• ISO 9001 Requirements
• ISO 9004 Guidelines for performance
  improvements.

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Key changes in emphasis

• Customer focused
• Process approach
• Continual improvement based on objective
  measurement
• Plan, do, check, act cycle PDCA
• Leadership
• Aim to enhance customer satisfaction through
  effective application of the system.
• (cf previous emphasis on preventing non
  conformity)

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Process Approach
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Fundamental ground rules

• Clarity about management structures,
• Who reports to who who sets objectives
• Clarity about team objectives and performance,
• Is there top level statement of purpose and a set
  of measures
• Clarity about record keeping,
• What info. to be recorded?
• How long to be kept?

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Plan, Do, Check, Act
PLAN
IDENTIFICATION OF SEQUENCE, INTERACTION, CRITERIA
METHODS (clause 4.1 a,b,c)
IMPLEMENTATION OF THE PLANNING (clause 4.1 d)
DO
MONITORING, MEASUREMENT ANALYSIS (clause 4.1 e)
IMPLEMENTATION OF IMPROVEMENT (clause 4.1 f)
ACT
CHECK
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Terminology

• The Standard uses the terms
• Subcontractor gtgt Supplier gtgt Customer
• Product Result of a Process Service
• Process Set of interrelated activities which
  transform inputs into outputs

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ISO 90012000 - The Five Paragraphs

• The framework is structured around 5 main
  headings with 23 sub headings
• Para 4 Quality Management System
• Para 5 Management Responsibility
• Para 6 Resource Management
• Para 7 Product Realisation
• Para 8 Measurement, analysis improvement.

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4 Quality Management System

• Outsourcing if done, we need to exercise
  control
• Documentation Requirements (4.2) introduces the
  idea of competence,
• Competence ltgt Documentation
• Less prescriptive on Documentation
• Quality Manual must include Policy and
  Objectives any exclusion to scope of QMS.

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Documented Procedures

• Only 6 documented procedures are mandatory
• Document data control
• Control of quality records
• Internal audit
• Control of non-conforming product
• Corrective action
• Preventive action

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5 Management Responsibility

• Top management responsible for QMS
• Customer focus
• Quality objectives related to continual
  improvement.

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6 Resource Management

• Personnel competent on basis of education,
  training, skills experience
• Need to evaluate effectiveness
• Need to look at work environment.

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7 Product Realisation

• Planning must include measurable objectives and
  criteria for success
• Customer related processes check that customer
  requirements are met including implied
  requirements,
• Implied requirements might include statutory or
  HS issues that we know about but customer does
  not.

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Customer focused performance measures

• Different measures for different situations
• Home Response times
• normal hours
• out of hours
• Dialysis unit equipment availability
• of equipment in available at 16.00 hrs

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8 Measurement, Analysis Improvement

• Customer satisfaction must be monitored
• Includes measurement/monitoring of processes as
  well as product
• Analysis of data new section, includes customer
  satisfaction suppliers
• Continual improvement
• Internal audit switch from nonconformity to
  opportunities for improvement (OFI).

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Conclusions

• ISO 9000 has too big an overhead for a small,
  stand alone technical department
• The fundamentals of a QMS can be established
  relatively easily including internal audit
• The 2000 version of the Standard complements
  management changes arising out of clinical
  governance, controls assurance, performance
  management review and PBR

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Further Reading

• McCarthy Hicks, Quality in Health Care
  Application of the ISO9000 Standard, I. J.
  Healthcare Quality Assurance 441991 pp 21-26
• Standards quality management - An integrated
  approach BSI PD 35421998
• Useful web sites
• www.iso.ch
• www.bsi.org.uk/iso-tc176-sc2
• www.bsi-global.com

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Assignment

• Describe how a quality management system
  approach is relevant to a chosen area associated
  with the provision of health care.
• This may be, for example, delivery of scientific,
  technical or support services, delivery of
  clinical services, health and safety issues etc.
  
• The assignment should be 1500 /- 300 words and
  should show evidence of further work having been
  done over and above that based on the handouts
  provided.
• The usual rules apply i.e. to be handed/sent by
  post to Craig Davis 3 weeks before the next
  weekend but it would be a great help if you were
  able to e-mail me a copy at the same time.
• justin.mccarthy_at_cardiffandvale.wales.nhs.uk