Quality-management
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Quality Management Applied to the testing laboratory in PPSS
Definition of Quality
To know customer‘s expectations and to fulfil them to their satisfaction
Customers for PPSS testing laboratory for occupational radiation protection Safeguard Inspector External Expert
Department of Safeguards Department of Technical Co-operation
MEMBER STATES
Quality Management Coordinated activities to direct and control an organization with regard to quality. Is based on international standards like ISO9000 series
for general application or
ISO/IEC17025
for testing laboratories
Benefit
Benefit of quality management ¾ Organized and well documented workflow ¾ Processes well known and documented ¾ Necessary records described ¾ Documentation is help for training ¾ Instruments and methods are validated ¾ Results are traceable to primary standards ¾ Enhance and secure corporate knowledge
Do it correct the first time
Implementation history at PPSS 1999 Start of project (in December) 2000 Creation of the QM system with the help of an external expert during first half of the year 2001 First revision of the documents by another external expert 2002 Temporary recruitment of a quality manager in second half of the year to finalize implementation including first internal audit and management review
Implementation history 2004
Recruitment of Quality Manager as staff member
2004
Second revision of documents reflecting the change in organizational structure and addition of staff into the testing laboratory 2004 June Second internal audit and management review 2005 May
Accreditation application
Quality documentation hierarchy
Level 1
Quality Manual
Level 2
Procedures
Level 3
Work Instructions
Level 4
Checklists, Forms, Registries, Records, Reports,...
Quality documentation created
1
QUALITY MANUAL 26 Procedures
105 Working Instructions
Assessing improvement First internal audit
October 2002
„All audits showed that the testing laboratory is on the correct way to the defined quality objective of gaining accreditation by an independent authority and has done much more than an initial step .“
Assessing improvement Second internal audit June 2004 “Personnel was found to be very knowledgeable and competent for their working area” “The QMS was found in a state of ongoing and active development, despite some recent organizational restructuring and a regulatory framework under revision.”
Accreditation definition Formal recognition by an authorized or recognized body that a testing laboratory is competent to carry out specific tests or specific types of tests.
ACCREDITATION world wide network
ACCREDITATION schedule PPSS Target date
First quarter of 2006
Benefit Proficiency is approved by an independent “third party” authority Model for similar laboratories in MEMBER STATES
Training course The experience gained during installation of a Quality Management System in the PPSS testing laboratory has been transformed into a training course on “Quality Management Systems for Technical Services in Radiation Protection”
Training course objectives To provide guidance to technical services in radiation safety on developing and implementing a quality management system consistent with the requirements provided in applicable ISO-standards:
ISO9001, ISO9004 and ISO17025
Training course scope Participants from ¾ laboratory providing monitoring services including individual -, workplace- and environmental monitoring; ¾ laboratory dealing with calibration and verification services for monitoring devices and radiation sources
¾ radiation protection consultancy; ¾ shielding calculations; ¾ modeling for dose assessment, containment and ventilation; ¾ maintenance services covering both in-house operations and services contracted with an outside organization.
Training course organisation This course lasts five days. There will be 8 hours of course a day (including three breaks) with a mixture of lectures and exercises.
Training course content Establishment of a QMS
1. 2. 3. 4. 5. 6. 7. 8. 9.
Decision taking Management commitment Appointing an implementation team Planning the implementation Identifying existing processes Defining document structure Writing procedures Initial training Implementation, first internal audit and Management Review
Definition of Quality
To know customer‘s expectations and to fulfil them to their satisfaction
Customers for PPSS testing laboratory for occupational radiation protection Safeguard Inspector External Expert
Department of Safeguards Department of Technical Co-operation
MEMBER STATES
Quality Management Coordinated activities to direct and control an organization with regard to quality. Is based on international standards like ISO9000 series
for general application or
ISO/IEC17025
for testing laboratories
Benefit
Benefit of quality management ¾ Organized and well documented workflow ¾ Processes well known and documented ¾ Necessary records described ¾ Documentation is help for training ¾ Instruments and methods are validated ¾ Results are traceable to primary standards ¾ Enhance and secure corporate knowledge
Do it correct the first time
Implementation history at PPSS 1999 Start of project (in December) 2000 Creation of the QM system with the help of an external expert during first half of the year 2001 First revision of the documents by another external expert 2002 Temporary recruitment of a quality manager in second half of the year to finalize implementation including first internal audit and management review
Implementation history 2004
Recruitment of Quality Manager as staff member
2004
Second revision of documents reflecting the change in organizational structure and addition of staff into the testing laboratory 2004 June Second internal audit and management review 2005 May
Accreditation application
Quality documentation hierarchy
Level 1
Quality Manual
Level 2
Procedures
Level 3
Work Instructions
Level 4
Checklists, Forms, Registries, Records, Reports,...
Quality documentation created
1
QUALITY MANUAL 26 Procedures
105 Working Instructions
Assessing improvement First internal audit
October 2002
„All audits showed that the testing laboratory is on the correct way to the defined quality objective of gaining accreditation by an independent authority and has done much more than an initial step .“
Assessing improvement Second internal audit June 2004 “Personnel was found to be very knowledgeable and competent for their working area” “The QMS was found in a state of ongoing and active development, despite some recent organizational restructuring and a regulatory framework under revision.”
Accreditation definition Formal recognition by an authorized or recognized body that a testing laboratory is competent to carry out specific tests or specific types of tests.
ACCREDITATION world wide network
ACCREDITATION schedule PPSS Target date
First quarter of 2006
Benefit Proficiency is approved by an independent “third party” authority Model for similar laboratories in MEMBER STATES
Training course The experience gained during installation of a Quality Management System in the PPSS testing laboratory has been transformed into a training course on “Quality Management Systems for Technical Services in Radiation Protection”
Training course objectives To provide guidance to technical services in radiation safety on developing and implementing a quality management system consistent with the requirements provided in applicable ISO-standards:
ISO9001, ISO9004 and ISO17025
Training course scope Participants from ¾ laboratory providing monitoring services including individual -, workplace- and environmental monitoring; ¾ laboratory dealing with calibration and verification services for monitoring devices and radiation sources
¾ radiation protection consultancy; ¾ shielding calculations; ¾ modeling for dose assessment, containment and ventilation; ¾ maintenance services covering both in-house operations and services contracted with an outside organization.
Training course organisation This course lasts five days. There will be 8 hours of course a day (including three breaks) with a mixture of lectures and exercises.
Training course content Establishment of a QMS
1. 2. 3. 4. 5. 6. 7. 8. 9.
Decision taking Management commitment Appointing an implementation team Planning the implementation Identifying existing processes Defining document structure Writing procedures Initial training Implementation, first internal audit and Management Review
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