1
Horia Hulubei National Institute for Physics
and Nuclear Engineering - IFIN HH

• Implementation of the QM/QC requirementsin the
  laboratory activity
• Dipl.-Eng. Sibila Brancovici
• Dr. Emanuela Cincu
• Dr. Maria Sahagia
• As.I - Luminita Mischie

2
Implementation of the QM/QC requirementsin the
laboratory activity

• IFIN-HH has carried out nuclear activities under
  a Quality Management System since 1985. As the
  institute became a supplier of products and
  services for Cernavoda Nuclear Power Plant in
  1985 a QA System was created and implemented in
  accordance with Romanian nuclear legislation and
  national quality norms.
• As a result CNCAN (National Commission for
  Nuclear Activity Control), Romanian Nuclear
  Regulatory Body authorized the Institute to
  supply products and services to the Cernavoda
  plant. These authorized activities were performed
  under oversight of the Nuclear Power Plants
  contractors Canadas AECL and Italys Ansaldo.
• At present IFIN-HH carries out many of its
  activities under CNCANs licence for Quality
  Management System

3
Implementation of the QM/QC requirementsin the
laboratory activity

• Horia Hulubei
• National Institute for Physics and Nuclear
  Engineering- IFIN HH
• Organisational chart

4
Implementation of the QM/QC requirementsin the
laboratory activity

• IFIN-HH operates a QMS according to Quality
  Management Norms (CNCAN), ISO 90012000 , ISO/IEC
  170252000 andGMP.
• The modular system of IFIn-HH QMS documents
• manufacturing QM according to QMN-07
• manufacturing QM according to ISO 9001 - only
  for one department (IRASM)
• manufacturing QM according to GMP, only for one
  department (CPR)
• QM for Training Center according to ISO 9001
• decommissioning QM (stage 1) for Nuclear
  research Reactor (according QMN-11)
• QM for laboratories according to ISO/IEC 17025.

5
Implementation of the QM/QC requirementsin the
laboratory activity

• At present IFIN-HH labs using nuclear analytical
  techniques are
• Accredited
• Lab. ACTIVA-N which performs elemental analysis
  of metallic by INAA
• Analysis lab
• Photodosimetry and whole body counter labs
• On the way of accreditation
• Lab. for Control of the Environment
• Metrology and Testing Laboratory for Ionising
  Radiation
• Lab. for Radionuclide Metrology.
• There are also 4 labs which will start soon to
  implement ISO/ IEC 17025.

6
Implementation of the QM/QC requirementsin the
laboratory activity

• The laboratory managers understood
• the QMS implementation is indispensable for the
  survival of an analytical laboratory
• the advantages of having an official certificate
  about proper performance in compliance with
  international standards
• an accreditation helps to persuade customers and
  to credit analytical methods
• the implementation of QMS / Quality Control
  System can be decisive for the perspective of
  analytical labs, for competition of nuclear
  methods.

7
Implementation of the QM/QC requirementsin the
laboratory activity

• Managements goal is to establish a comprehensive
  QMS according to ISO/IEC 17025 and to assist labs
  to approach the national nuclear Regulatory Body
  and the national accreditation Body.
• Policy Statement
• Our General Director have written a quality
  policy statement stipulating the commitment of
  the management in implementing and continually
  improving the Quality management System, for all
  specific activities carried out in the institute
  in compliance with law 111 of 1996 on the safe
  performance of Nuclear Activities, republished in
  1998, and revised and supplemented by law 193 of
  2003 and

8
Implementation of the QM/QC requirementsin the
laboratory activity

• Quality management Norms (CNCAN)
• ISO 90012000
• ISO / IEC 170252000
• GMP.
• The management is committed to ensure the
  personnel and financing that are necessary for
  implementing and maintaining a Quality Management
  System.
• At each laboratory the managers have also written
  a Policy Statement stipulating the commitment of
  the management in implementing and continually
  improving the Quality Management System.

9
Implementation of the QM/QC requirementsin the
laboratory activity

• The action plan for implementation of ISO/IEC
  17025 in every lab includes the following steps
• training of staff for specific tasks, but also
  in QM/QC principle and practice.
• Very important it is necessary to train staff
  members to function as internal auditors, becouse
  they became aware of QMS. Labs keep the records
  for training.
• Elaboration of QMS documents for lab according
  to the reference documents.
• QMS for a lab is a component part of general QMS
  of IFIN-HH.
• IFIN-HH QM describes the general organisation of
  IFIN-HH and gives principles for the QMS within
  the institute.

10
Implementation of the QM/QC requirementsin the
laboratory activity

• Some general procedures of IFIN-HH are applicable
  to lab such as internal audit, management
  review, purchasing.

QM - Quality Manual SP - System procedures SOP -
Standard Operational Procedures
QM
SP
SOP
QM and SP - describe the labs organization and
QMS it self.
11
Implementation of the QM/QC requirementsin the
laboratory activity

• In QM it is specified that labs QMS is a
  component part of the general QMS of IFIN-HH.
• QMs content is in compliance with ISO/IEC 17025.
• QM and SP ensure the conformity with each
  chapter of ISO/IEC 17025.
• It as recommended to draw up a list of
  cross-reference to clauses in ISO/IEC 17025 .
• SOP - give detailed information about the way to
  do the work and check it.

12
Implementation of the QM/QC requirementsin the
laboratory activity

• Another documents relating to quality management
  are
• documents containing data that are essential for
  operating the QMS and for carring out the
  laboratory work, such as
• inventory of system documents and forms
• lists of instruments and equipments, technical
  reports on the validation of new methods
• reports from tests
• quality records of findings and recommendations
  from management review, non-conformance reports,
  corrective action reports established as a result
  of internal/external audits, reports on audits
  performed on suppliers or subcontractors
• quality plans.

13
Implementation of the QM/QC requirementsin the
laboratory activity

• Implementation of QMS
• QMS has to be put in place and / or have be to
  developed.
• Documents are already available and usable
• labs quality manager guides the process of
  implementation and supervices it
• during the process of implementation it is
  verified the compliance with the requirements of
  ISO/IEC 17025 and deficiences are corrected
• the necessity of modifications in QMS documents
  or elaboration of new documents (procedures,
  instructions)

14
Implementation of the QM/QC requirementsin the
laboratory activity

• the necessity of more training of staff
• non-conformances in QM of instruments (related
  to the current status and performance of
  equipment)
• the necessity of developing of methods and
  equipment that are more sensitive and efficient,
  etc.
• the necessity of improving of environmental
  conditions, of archiving conditions, procurement,
  etc.
• CONCLUSION Implementation of QMS is a continuous
  process.
• Management internal improvement
• it is achieved by internal audit and management
  review.

15
Implementation of the QM/QC requirementsin the
laboratory activity

• Internal audit
• According to the IFIN-HH procedure Internal
  Audit audit are planned and executed in
  accordance with an annual internal programme.
• IFIN-HH has an audit team including trained
  auditors in an IAEA Programme in the ISO/IEC
  17025 implementation in IFIN-HH, some of them
  are also certified as internal auditors in the
  ISO 9001 implementation by TUV - THURINGEN.
• Audits are usually scheduled by the QM department
  for one year cycle to include every
  department/lab, if need be, activities at
  subcontractors.

16
Implementation of the QM/QC requirementsin the
laboratory activity

• Management Review
• According to the procedure at the level of
  IFIN-HH, Management Review, cod AC-PS-08-00.
  Periodically IFIN-HH management reviews
  institutes suitability and effectivness of QMS.
• The input of the review
• quality policy and the objectives of the QMS
• the results of the external and internal audits
• clients feedback
• the results of the corrective or preventive
  actions
• reports from managerial personnel
• changes in the organizational structure or
  changes regarding to the type of the work

17
Implementation of the QM/QC requirementsin the
laboratory activity

• Different activities resources, training of the
  personnel, quality control activities, market
  studies.
• The output of the review
• An Improvement Programme of QMS (strategy goals,
  objectives and deadlines for coming period).
  Findings from management review are recorded in
  Management Review Report and QMS Improvement
  Programme.
• CONCLUSIONS
• By embarking on the IAEA RER 2/004 Regional
  Project, IFIN-HH has started to bring its QMS
  into the line with the requirements of ISO/IEC
  17025 in 2001
• At present IFIN-HH has a good experience in
  implementing ISO/IEC 17025

18
Implementation of the QM/QC requirementsin the
laboratory activity

• IFIN-HH has implemented this standard in 4 labs
  which are accredited by CNCAN or RENAR
• There are still 4 labs which started this
  process
• QM/QC is a concept of gradual improvement of
  performance for the benefit of analytical
  laboratories.

19
Implementation of the QM/QC requirementsin the
laboratory activity

• Weak points
• Internal audit in 2005
• Equipment is not up-to-date
• Lack of market studies
• Strong points
• Inereasing of number of our labs involved in
  INFRAS - NATIONAL PROJECT regarding to ISO/IEC
  17025
• A low no of complaints from our clients
• Participation of our labs in international
  intecomparisons.