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
ƒ Testing and calibration laboratories: Accreditation by test category “Open scope” NT-18 Rev. 1 June 2004 ƒ The experience of the Laboratori Agroalimentari: Generalitat de Catalunya
Departament d’Agricultura,
Ramaderia i Pesca
ƒ “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 ƒ Advantages of Open scope?ƒ Management of accreditation scope by the Laboratory.
ƒ 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
ƒ What requirements for technical note NT-18? ƒ 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.
ƒ 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
ƒ 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
ƒ 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
ƒ Title ƒ Number of revision and date of approval. ƒ Reference to the code and revision of the Attached ƒ Family(s) of products ƒ Family(s) of parameters ƒ Test Procedure applicable to the category ƒ Intervals of measurement or limits of quantification Responsible
Responsible
for revision
for approval
Generalitat de Catalunya
Departament d’Agricultura,
Ramaderia i Pesca
ƒ 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
ƒ 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
ƒ 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
ƒ 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
ƒ 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 ƒ To inform the client ƒ To modify the procedures or methods ƒ 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

Source: http://www.furs.si/delavnice/TWL_spanija/2-Accreditation%20Open%20Scope.pdf