Microsoft powerpoint - accreditation open scope total.ppt
“ISO17025:2005 and accreditation under “open
scope” NT-18 and NT-19. Required changes in
Imma Alsina Quality Assurance ManagerLaboratori Agroalimentari – DARP
Generalitat de Catalunya Departament d’Agricultura, Ramaderia i Pesca
Testing and calibration laboratories: Accreditation by
test category “Open scope” NT-18 Rev. 1 June 2004
The experience of the Laboratori Agroalimentari:
Generalitat de Catalunya Departament d’Agricultura, Ramaderia i Pesca
“Its concrete objective is to establish the rules so that the
laboratory can assume the responsibility of the management from
its scope of accreditation and to use concrete, validated and
suitable test methods, with no need for a previous evaluation on
the part of Accreditation body of this method." NT-18 Rev.1
Advantages of Open scope? Management of accreditation scope by the Laboratory. It’s possible to give accredited results within a test category
without an assessment of a accreditation body.
Generalitat de Catalunya Departament d’Agricultura, Ramaderia i Pesca
What requirements for technical note NT-18? The Laboratory will have to develop and to validate test
procedures when the client asks for a test by category not
included in the opened list of tests.
The Laboratory will have to implement a management
system that guarantees that all the requirements of the
Generalitat de Catalunya Departament d’Agricultura, Ramaderia i Pesca
TEST CATEGORY: set of tests made by a common technique or
test to determine a parameter or family of parameters in a
1 Parameter n Products 1 Parameter n Parameter 1 Product n Product 1 Technique 1 Technique n Parameters 1 Product
Generalitat de Catalunya Departament d’Agricultura, Ramaderia i Pesca
When the laboratory solicits an accreditation by a category of
test is declaring its technical competence to develop
procedures and to do all the specific tests included in the
Generalitat de Catalunya Departament d’Agricultura, Ramaderia i Pesca PROCEDIMENTO FAMILIA DE FAMILIA DE DE ENSAYO PRODUCTOS/ PARÁMETROS/ ANALITO/S
Generalitat de Catalunya Departament d’Agricultura, Ramaderia i Pesca
where the tests are included for which the Laboratory is
accredited within a category (LEBA or LPE). Within a category, only the tests included in the open list are accredited.
Generalitat de Catalunya Departament d’Agricultura, Ramaderia i Pesca
Title Number of revision and date of approval. Reference to the code and revision of the Attached
Family(s) of products Family(s) of parameters Test Procedure applicable to the category Intervals of measurement or limits of quantification
Responsible Responsible for revision for approval
Generalitat de Catalunya Departament d’Agricultura, Ramaderia i Pesca
2. Management of requests and contracts:
1. Analysis Request Reception2. Decision about method development / validation / term and price3. Inform customer about “incidence form”:
Head of Department / Head of Laboratory
Generalitat de Catalunya Departament d’Agricultura, Ramaderia i Pesca
2. DEVELOPMENT / VALIDATION OF METHODS
Head of Department / QUA Manger
2. SOP elaboration or modification3. Validation of analytical procedure4. Validation Final Report:
Head of Department / QUA Manger Head of Department / Head of Department / QUA Manger / Head of Laboratory Head of Laboratory
Generalitat de Catalunya Departament d’Agricultura, Ramaderia i Pesca
3. MODIFICATION, REVISION and APPROVAL OF THE OPEN
1. Validation Final Report Accepted2. New revision of LEBA3. Inform about new LEBA4. Accredited analytical result issued
QUA Manger Head of Department / Head of Laboratory
Generalitat de Catalunya Departament d’Agricultura, Ramaderia i Pesca
4. NON-CONFORMING WORKS and CORRECTIVE
1. Validation Final Report rejected2. Non Conforming Work3. Corrective Action
QAU Manager / Head of Laboratory QUA Manger
Generalitat de Catalunya Departament d’Agricultura, Ramaderia i Pesca
4. NON-CONFORMING WORKS and CORRECTIVE ACTIONS: A
Register of Non-Conforming Work produced by a "Report of
unfavorable validation of a test by category not included in the
opened list of test under accreditation." Corrective Actions will
To inform the client To modify the procedures or methods To redefine, if it applies, the category of test, and
consequently to modify the opened list of tests by category
Generalitat de Catalunya Departament d’Agricultura, Ramaderia i Pesca
1. New quality policy 2. Creation of the opened Lists of tests. Format, management,
3. Certification of qualifications. New responsibilities in key
4. Management of requests 5. Development of methods 6. Validation of methods 7. Non-Conforming Works and Corrective actions 8. Management reviews
Generalitat de Catalunya Departament d’Agricultura, Ramaderia i Pesca
The role of the bronchial provocation challenge tests in the diagnosis of exercise-induced bronchoconstriction in elite swimmers A Castricum, K Holzer, P Brukner, et al. 2010 44: 736-740 originally published online October 23, Br J Sports Med 2008doi: 10.1136/bjsm.2008.051169Updated information and services can be found at: http://bjsm.bmj.com/content/44/10/736.full.html References
PATIENT INFORMATION Patient Name Patient ID Diagnosis Referring Physician Exam Date Accession Number Primary Medication Secondary Medication As-Needed Medication As-Needed Medication NEUROTYPE GROUP Efficacy Type Resilience Type Focus Type Acceptance Type RECOMMENDED PAIN CONTROL COGNITIVE STRATEGIES NEUROTYPE GROUP