Quality Management in Medical Laboratories
ISO 9000:2000
Wemmie Elsenga
Wemmie Elsenga is member of the Dutch Association
for Medical Scientists (NVML) and founder member of the EPBS. Currently
she works for Oxoid BV in the Netherlands as marketing, sales and
quality manager. Wemmie is a member of the NVML quality committee
and member of the ISO/CEN TC 140 Validation of Susceptibilitytesting.
Quality Management in Medical Laboratories: Contents
- Why?
- Certification versus accreditation
- Importance of accreditation
- ISO 9000 series
- Related ISO standards
- Process approach
- Main ISO clauses
- Continual improvement
1 Why accreditation
There are a number of reasons why medical laboratory seek recognition
as being compliant with particular standards:
- Voluntary / mandatory
- Competition
- Insurance company
- Precondition for contract
- Practise in accordance with accepted norms
- Laboratory management wishing to practise in accordance with
accepted norms
In some countries accreditation is voluntary eg Netherlands.
Laboratories in the public sector acting as reference laboratory
(external laboratories to which a sample is submitted for a supplementary
or confirmatory examination procedure and report) benefit from being
accredited
2 Certification versus Accreditation
In common English, the two words have the same meaning.
In ISO, the two words have specific technical meanings
Certification
Certification is based only on standards that have requirements
for quality systems.
Accreditation
Accreditation is based on standards that have beside “requirements
for quality systems” (ISO 9001:2000) and
also requirements for quality management and technical competence
Accreditation systems are based on standards that , in addition
to the requirements for quality systems have requirements for both
quality management and technical competence. Competence to carry
specific task
It is about putting standards into practise and using them to manage
quality and continual improvement in medical laboratories.
3 Importance of accreditation
- Recognising of competence
- Facilitating exchange of service
- Providing valuable management tools
- Ensuring the needs and requirements of all the users (clinicians,
patients) are met
4 ISO 9000 series
ISO 9000:2000
Quality management system -
Fundamentals and vocabulary
ISO 9001:2000
Quality management system-
Requirements
ISO 9004:2000
Quality management systems-
Guidelines for performance improvements
The new ISO 9000 series became active in December 2000 and is now
the new standard for certification or accreditation. The ISO standards
are applicable to any activity. ISO 9000:2000 are the fundamentals
and vocabulary and replaces the old norm ISO 8402:1995
ISO 9001:2000 describes the requirements
This norm replaces the old ISO 9001:9002 and 9003 from 1994
This norm does not provide specifications for reporting lab results,
service and specifications for technical competence of the lab,
the pre-examination, examination and post-examination to produce
a laboratory result.
ISO 9004:2000 are the guidelines for performance improvements replacing
the old ISO 9004:2000.
The general lifetime of a norm is approximately 5 years!!
5 Related ISO standards
Related ISO standards I
ISO 15189:2002
Medical laboratories - Particular requirements for quality and competence
ISO 17025:1999
General requirements for the competence of testing and calibration
laboratories
Related ISO standards II
ISO 15189:2002
Requirements for the quality and competence of medical laboratories
- covers examinations, provides guidance for laboratory procedures
to ensure quality in medical laboratories
Related ISO standards III
ISO 17025:1999
ISO 17025 contains two important statements:
- testing and calibration laboratories that comply with ISO 17025:1999
also operate in accordance with ISO 9001:2000
- but: certification against ISO 9001:2000 does not demonstrate
the competence to the lab to produce technically validated data
and results.
Quality management system: Continual improvement
Click for slide of Quality
management system
ISO 9001:2000 is a framework for process-based qualitymanagement
of medical laboratories
ISO 9001:2000 strongly promotes a process approach, when you are
implementing and improving your quality management system.
Deming Circle of PDCA
ISO 9001:2000 are standards that will have an increasing important
role in defining quality management and continual improvement.
Plan, Do, Check and Act the so called Demming circle….
6 Process approach
In a medical Laboratory many processes take place, they all are
interrelated or interacting process approach
Enhance customer satisfaction by meeting customer requirements
It is important to know the customers requirements and
expectations
7 Main clauses of ISO 9001:2000
"Laboratory Standard"
- Scope
- Source reference
- Terms and definitions
- Quality management system (see below)
- Management responsibility (see below)
- Resource management (see below)
- Examination processes/laboratory tests (see below)
- Evaluation and continual improvements (see below)
4 Quality Management System
- General requirements
- management responsibilities
- management commitment
- quality policy, objectives and plans
- responsibilities and communications
- quality manager
- management review
- Quality manual
- Control of documents
- Control of records
- Control of (clinical) samples
5 Organization and Management Responsibilities
- Management commitment
- Needs and requirements
- Quality policy
- Quality objectives and plans
- Responsibilities, communications
- Quality manager
- Management review
6 Recourse management
Personnel
- recruitment and retention - advertisements, interviews (how
take part in the interviews)
- job descriptions - responsibilities, terms and conditions of
employment, person specifications, job descriptions
- introduction an orientation - who is responsible, hospital /
laboratory introduction programme, record build up
- records - Staff record, relationship to human resources department
- annual review
- competence, awareness and training - responsibility, competence
testing and training records, training programmes, registration
of continuous professional development, study leave
- meetings and communications - department meetings, how talks
or informs somebody else in the organisation
- disciplinary procedures
Some labs add health and safety aspects, accommodation and environmental
conditions, equipment
7 Examination processes
- Sub-contracting of tests and calibrations
- Pre - and post - examination processes
- Method validation
- Traceability
- Reporting results
- Hazards and precautions
Product realisation
Pre-examination processes
sampling, handling test and calibration procedures
Examination processes
test and calibration methods and method validation
measurement traceability
control of non-conforming testing and/or calibration work
Post-examination
control of non-conforming testing and or calibration work
service to the client
reporting results.
8 Evaluation and continual improvement
- Complaints external / internal
- Control of non-conforming testresults / calibrations
- Corrective actions
- Preventive actions
- Internal audits
- Evaluation and continual improvement are synonymous with quality
assurance.
User complaint form, nature of the complaint, results of investigation
of the complaint, corrective and preventive action.
Continual improvement, corrective and preventive action are the
main contributors too continual improvement.
Continual improvement
One of the main objectives of the new ISO 9000:2000 norm is continual
improvement.
Elements that play an important role in achieving improvement
are:
- assessment of users satisfaction and complaints
- internal audit; audits can give a lot off information and point
of improvement
- the same with external audits, strange eyes seen more
- equipment and diagnostic tests
- health and safety
- personnel
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