1. Keven F Aglae
Director – Occupational Safety and Health
Ministry of Employment And Human
Resources.
Seychelles
2. Quality Management System -
Unit Objectives
Targeted Group: Medical Radiologist
Duration: three Weeks
Number of Participant: 8 - 10
Methods :
lecture/Group discussions
Assessment.
Research.
Attendance certificate
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3. Quality Management System Unit
Objectives
The objectives of this unit is to outline the
principles of quality management system.
To stress the importance of effective quality
management.
Should understand the basic concepts of
quality management, and how to apply them
in the workplace.(Radiological Unit)
Main components of the quality Management.
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4. What is Quality
• The quality can be defined
as ‘the totality of features of
a product or service that
bears its ability to satisfy
given needs’
• quality relates to
– Fitness for use
– Fitness for purpose
• Quality refers to certain
standards and the ways and
means by which those
standards are achieved,
maintained and improved
upon.
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5. What is Quality Management
Quality Management is a set of rules, which an
organization uses internally
• to assure that the products and services, which it
delivers to it’s customers satisfy customers needs
and also
• his expectation and
• are produced correctly
• at acceptable costs.
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6. Main components of the Quality
Management
Two main components of the quality
management (ISO9000:2000)
quality assurance (QA) and
quality control (QC)
QA is an interdisciplinary management tool that
provides a means for ensuring that all work is
adequately planned, correctly performed and
assessed;
QC is a means of applying controls to the
process to ensure that the product or service
consistently meets specifications.
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7. Difference Certification - Accreditation
• Certification only states that an organisation is
operating according to a set of rules complying to
relevant (international) standards.
• A certificate does not guarantee that the
products are of top quality.
• Accreditation not only confirms that a QM-
system according to relevant standards is in
operation, but also that the organisation is
competent in performing measurements, tests,
inspections or calibrations.
• It guarantees (to the extend of human error) that
the results are correct.
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8. International Standards for Quality
Management
•The ISO9000 standards series:
Present a concept ISO9000
Present requirements ISO9001
Present guidelines ISO9004
ISO17025 General requirements for the competence
of testing and calibration laboratories
ISO10012 Quality assurance requirements for
measuring systems
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9. QMS Implementation Basics
identify the processes needed for the QMS;
determine the sequence and interaction of
these processes;
determine criteria and methods required to
ensure the effective operation and control of
these processes;
ensure the availability of information necessary
to support the operation and monitoring of
these processes and
measure, monitor and analyze these processes,
and implement action necessary to achieve
planned results and continual improvement.
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10. QMS Implementation Process
1. Decision taking
2. Management
commitment
3. Implementation team
4. Plan the
implementation
5. Identify existing
processes
6. Define document
structure
7. Write
8. procedures
9. Initial Training of
personnel
10. Implementation
7. Internal Audit
8. Management Review
7. Improve system
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11. Documentation
• Documentation in quality management is the sum
of
documents = instructions that lead to
an action and
records = annotation of the results of an
action
• Documents are changeable and have to be shown
the development history (revisions), the period of
validity and the extend of distribution.
• Records primarily should not be altered and have
to be kept legible, identifiable and retrievable.
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12. ISO17025
• This standard contains
all the requirements to
demonstrate that
companies operate a
quality management
system and are
technically competent
and able to generate
technically valid results.
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13. ISO17025 Management
requirements
1. Organization
2. Quality system
3. Document control
4. Review of requests,
tenders and contracts
5. Subcontracting
6. Purchasing
7. Service to the client
8. Complaints
9. Control of
nonconforming
testing/calibrations
10. Corrective action
11. Preventive action
12. Control of records
13. Internal audits
14. Management reviews
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