quality management system - objectives
TRANSCRIPT
Keven F AglaeDirector – Occupational Safety and HealthMinistry of Employment And Human Resources.Seychelles
Quality Management System - Unit Objectives
Targeted Group: Medical RadiologistDuration: three WeeksNumber of Participant: 8 - 10Methods :lecture/Group discussionsAssessment.Research. Attendance certificate
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Quality Management System UnitObjectives
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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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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What is Quality ManagementQuality 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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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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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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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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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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QMS Implementation Process
1. Decision taking2. Management
commitment3. Implementation team4. Plan the
implementation5. Identify existing
processes6. Define document
structure
7. Write8. procedures9. Initial Training of
personnel10. Implementation
11. Internal Audit12. Management Review
13. Improve system
PLAN DO
ACT
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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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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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ISO17025 Management requirements
1. Organization2. Quality system3. Document control4. Review of requests,
tenders and contracts5. Subcontracting6. Purchasing7. Service to the client
8. Complaints9. Control of
nonconforming testing/calibrations
10. Corrective action11. Preventive action12. Control of records13. Internal audits14. Management reviews
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Seychelles 1414
Thank you very much and Welcome To the Seychelles Islands