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Quality system documentation of:

National Metrology Network - CHILE. Quality system documentation of ... In Chile IDIC is a widely recognized laboratory that performs several quality ...

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Quality system documentation of:

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    1. Quality system documentation of: National Force Laboratory of Chile at IDIC (IDIC-LCPN-F) National Temperature Laboratory at CESMEC (CESMEC-LCPN-T) National Mass Laboratory at CESMEC (CESMEC-LCPN-M)

    Presented by Francisco García Deputy Head CESMEC-LCPN-M fgarcia@cesmec.cl

    2. Document of reference: Guidance for Presentation of Quality System Documentation for SIM NMIs

    3. National Metrology Network of Chile

    INN Director Unit of Coordination and Supervision of the National Metrology Network at the National Institute of Standards (INN) Technical Metrology Committee National Metrology Laboratories LCPNs Industry TODAY: 7 Physical Metrology Laboratories Vacant position Current contact: Manuel Lladser manuel.lladser@inn.cl Please send copy of the e-mails to the laboratory

    4. National Metrology Network of Chile

    The Future: More National Physical Metrology Laboratories plus National Chemical Metrology Laboratories for FOOD, ENVIRONMENT and MINERALS

    5. Web page of the National Metrology Network of Chile

    www.metrologia.cl

    6. Quality system documentation of the National Force Laboratory of Chile at IDIC (IDIC-LCPN-F)

    IDIC-LCPN-Fuerza Avenida Pedro Montt Nş 2050 837-0923 SANTIAGO Chile Phone: (56 2) 520 77 62 Fax: (56 2) 520 78 85 http://www.metrologia.cl/laboratorios/fuerza.act Christian Villarroel IDIC-LCPN-F Head idic@idic.cl villarroelchrist@hotmail.com

    7. Some information about IDIC

    IDIC is the spanish acronim for Institute of Research and Control IDIC belongs to the chilean Army.

    8. Some information about IDIC

    In Chile IDIC is a widely recognized laboratory that performs several quality testing and certification activities for the army and chilean companies. It holds accreditations issued by the National Accreditation System at INN and regulatory bodies for most of its activities.

    9. Some information about IDIC

    Main fields of testing: paints, fibers and shoes leather,chemistry, petroleum derivates, fire protection, metallurgy and materials, electronics, explosives and metrology.

    10. Section 1: Quality System Structure of IDIC-LCPN-F

    1.1 Quality Policy (Reference: 4.2 and ANNEX Nş 6, LCPNF-PG02) 4.2 LCPNF-PG02 Granting force proving equipment and instrument calibration services, in order to satisfy our client’s needs and expectations. Create a quality system based on NCh-ISO 17025-2001 and guide DKD-6, in order to achieve continuous process improvement, and to prevent problems, and not only to detect them only. Provide all staff necessary training and support, so that they are able to provide all clients with a quality service. Communicate all staff our mission and quality objectives, and specify individual responsibilities to accomplish our goal. Create and maintain a work environment that supports production and high quality service. Establish a relationship with the clients, so to improve quality in all aspects of services, materials, products and equipment usage.

    11. Section 1: Quality System Structure of IDIC-LCPN-F

    1.1 Quality Policy (Reference: 4.2 and ANNEX Nş 6 of LCPNF-PG02) 4.2 ANNEX Nş 6 : DECLARATION OF BINDING CHARACTER OF THE Quality Manual This Quality Manual (QM) describes the Calibration Laboratory's structure and process organisation as regards quality assurance in the technical services rendered by it. Adherence to it guarantees that organisational and technical activities are planned, supervised and controlled, and that provisions of the contract concluded with the accreditation body for calibration laboratories of the Deutscher Kalibrierdienst (DKD), i.e. the Physikalisch-Technische Bundesanstalt (PTB), are complied with. The quality assurance system is based on the requirements of DIN EN 45 001 "General criteria for the operation of testing laboratories". The staff members of the Calibration Laboratory and all organisational units of our Institute which are directly or indirectly involved are herewith bound to carry out their tasks in accordance with the quality policy laid down in the QM. The QA system of the Calibration Laboratory is integrated in the QA system of IDIC. The head of the Quality Assurance Department is the person in charge of the quality assurance management. He and the head of the Calibration Laboratory co-ordinate the planning, the execution and the review of QA measures in the Calibration Laboratory. The Quality Manual is herewith declared binding for LCPN-F and IDIC.

    12. Section 1: Quality System Structure of IDIC-LCPN-F

    1.2 Organization Chart of the NMI as it pertains to the delivery of the CMC services (Reference: 6.2.3 to 6.2.4, 5 an annex 4 of document LCPNF-PG02) DIRECTOR OF IDIC Lt. Col. Carlos Harding GENERAL ASSISTANT DIRECTOR OF IDIC Lt. Col. Carlos Matus Mechanical Department Col. Lt. Sergio Espinoza Head LCPN-F Eng. Christian Villarroel Head Tech. Jorge Villalobos Deputy Head IDIC’S QUALITY REPRESENTATIVE Mr. Jaime Muńoz Department of Finance Commercial Department Supplies Sales and quotations Operations management Costs Human Resources Department Other departments

    13. Section 1: Quality System Structure of IDIC-LCPN-F

    1.3 Quality Management Policies and Procedures including identification of Quality Manager-roles and responsibilities. (Reference: 6.2.4 of document LCPNF-PG02) IDIC’s Director representative for quality assurance in all the Institute, is responsible for: The administration, inspection and updating of IDIC’s quality manual and related general procedures. Supervising IDIC’s quality system proficiency, carrying out periodic audits. Ensuring that Instituto Nacional de Normalización – INN (National Standardization Institute) dispositions are carried out, where the laboratory’s accreditation is concerned.

    14. Section 2: Quality Manual Components - IDIC-LCPN-F

    2.1 Table of contents (Reference: Índice )

    15. Section 2: Quality Manual Components - IDIC-LCPN-F

    2.2 Cross-Walk between the Quality Manual sections and the ISO/IES 17025 sections (Reference: Annex 4 of document LCPNF-PG02 updated)

    16. Section 2: Quality Manual Components - IDIC-LCPN-F

    2.3 List of CMCs (Reference: page 8 of http://kcdb.bipm.org/appendixC/M/CL/M_CL.pdf or M_CL) Current CMCs are declared at Appendix C of CIPM MRA Summary: Calibration of force transducers against comparator machines with reference transducers according to ISO 376 requirements. For details, please review documents above.

    17. Section 2: Quality Manual Components - IDIC-LCPN-F

    2.4 List of procedures (Reference: Annexes 2 and 4 of document LCPNF-PG02)

    18. Section 3: Quality System Implementation - IDIC-LCPN-F

    3.1 Statistics on customer complaints, nonconforming work, and corrective actions. Quality Management philosophy and process of handling the items above. Complaints ----------------------------------- IDIC-PG17 and Chapter 1 of IDIC’s QM Non-conforming work-----------------------IDIC-PG12 Corrective actions -------------------------- Procedure IDIC-PG15 Chapters 13, 14 and 17 of IDIC’s QM

    19. Section 3: Quality System Implementation - IDIC-LCPN-F

    3.2 Internal Audits. Include bios of the assessor team. Quality Management related Procedures Internal audits ---------------------------------- Procedure IDIC-PG15 Chapters 13, 14 and 17 of IDIC’s QM Corrective actions -----------------------------Procedure IDIC-PG15 Chapters 13, 14 and 17 of IDIC’s QM Assessor team Assessors of the IDIC-LCPN-F QS are ISO 9000 and ISO/IEC 17025 trained personnel. Assessors know metrology concepts and regularly performs assessments of other IDIC´s laboratories.

    20. Section 3: Quality System Implementation - IDIC-LCPN-F

    3.3 Management reviews Management review ---------------------------------- Chapter 1 of IDIC’s QM IDIC-PG02

    21. Section 3: Quality System Implementation - IDIC-LCPN-F

    3.4 External reviews (Reference: 6.3 LCPNF-PG02) External reviews or assesments are performed by two accreditation bodies: SNA (National Accreditation System of Chile at the INN) and DKD (German Calibration Service). SNA performs a review of the QS once a year. DKD perfors a review of QS each 1,5 years. During each DKD review a comparison with PTB is planned or executed in order to assure confidence. For all results: En<1

    22. Section 4: Assesment process - IDIC-LCPN-F

    4.1 Accredited NMIs need to show the following: CMC uncertainties are not smaller than the uncertainties listed in the scope (References for Appendix C MRA: page 8 of http://kcdb.bipm.org/appendixC/M/CL/M_CL.pdf or M_CL; for DKD-K-33001 accreditation scope: http://www.dkd.info/english/deutsch/pdf/33001.pdf or 33001 for SNA-INN-LC028 accreditation scope: CertificadoINN2) The DKD and SNA accreditation scopes are the same. The CMCs declared in appendix C of CIPM MRA are the same as the accreditation scopes of DKD and SNA

    23. Section 4: Assesment process - IDIC-LCPN-F

    4.2 Accredited NMIs need to show the following: Accreditation body is a signatory to the ILAC MRA (Reference: http://www.ilac.org/downloads/Members_List.doc or Member_List) The IDIC-LCPN-F is accreditated by two bodies that hold memberships at ILAC: DKD and SNA-INN SNA-INN is Associate Member of ILAC, not ILAC MRA signatory. DKD is Full Member of ILAC and ILAC MRA signatory.

    24. Section 4: Assesment process - IDIC-LCPN-F

    4.3 Accredited NMIs need to show the following: Name of the Accreditation body and the names of the technical assessors Accreditation bodies: DKD (German Calibration Service, www.dkd.info) and SNA-INN (www.inn.cl) Tecnical assessors of DKD: Armitlav Swla, Friedrich Pietsch and Günther Hawcke Technical assesors of SNA-INN: Domingo Denegri and Pedro Pizarro

    25. Section 4: Assesment process - IDIC-LCPN-F

    4.4 Accredited NMIs need to show the following: Copy of the Accreditation Certificate Page 1 of accreditation certificate issued by DKD Page 2 of accreditation certificate issued by DKD (accreditation scope also may be downloaded from: http://www.dkd.info/english/deutsch/pdf/33001.pdf ) Page 1 of accreditation certificate issued by SNA-INN Page 2 of accreditation certificate issued by DKD (accreditation scope)

    CESMEC-LCPN-Temperature CESMEC Ltda. Marathon 2595 781-0552, Macul Chile Phone: (56 2) 350 21 85 Fax: (56 2) 350 21 83 http://www.metrologia.cl/laboratorios/temperatura.act http://www.cesmec.cl/esp/servicios/metrologia/LaboratoriosCustodios/LCPNT.act Quality system documentation of the National Mass Laboratory of Chile at CESMEC (CESMEC-LCPN-T) Mauricio Araya CESMEC-LCPN-T Head maraya@cesmec.cl Quality system documentation of the National Temperature Laboratory of Chile at CESMEC (CESMEC-LCPN-T) Rosamel Pizarro CESMEC-LCPN-T Deputy Head rpizarro@cesmec.cl

    28. Some information about CESMEC

    CESMEC is the spanish acronim for Center of Studies, Measurement and Certification CESMEC is a private company and was a founder member of SIM while belonged to the chilean government.

    29. Some information about CESMEC

    In Chile CESMEC is a widely recognized company that performs several quality testing and certification activities chilean and foreign companies. It holds accreditations issued by the National Accreditation System at INN and by national and foreign regulatory bodies for most of its activities.

    30. Some information about CESMEC

    Main fields of work: industrial inspection, minerals and metals chemical analysis, food testing, civil engineering testing services, product certification, maritime services, environment services, certification of quality systems and metrology.

    31. Section 1: Quality System Structure of CESMEC-LCPN-T

    Quality Policy (Reference: 2.2.2 and 2.1.1 of Quality Manual of CESMEC-LCPN-T) Quality policy (2.2.2) The LCPNT has as goal to be a technical organization of excellence in the industrial temperature metrology field through the traceability maintenance of the national measurements to the International Temperature Scale and it with an active participation in National Metrology Network managed by the INN. To reach this goal, the LCPNT counts on personnel committed, qualified and of high ethical values, in addition to equipment and facilities of the highest quality. With his personal work, each staff member contributes to the LCPNT rendering the services offered by in compliance of quality requirements. The LCPNT will maintain a policy that assure the reliability of its services, through a permanent evaluation of its competition level, capacity and experience, committing its participation only when such requirements could be satisfied.The services that lend the LCPNT have to satisfy the requirements of its clients and users, even if those expressed or implicit in the respective contract or agreement. To attain the objectives states above, the LCPNT will develop, implement and maintain in operation a Management System of Quality substantially according to the requirements of the estandard ISO/IEC 17025 in the version valid at the time in question, as well as all additional requirements for DKD-calibration laboratories, as established by PTB in DKD 1 / 6 and in the signed contract. The cooperation with the National Metrology Net is performed according to the document INN 70-05.

    32. Section 1: Quality System Structure of CESMEC-LCPN-T

    Quality Policy (Reference: 2.2.2 and 2.1.1 of Quality Manual of CESMEC-LCPN-T) Binding Character of the QM (2.1.1) This Quality Manual describes the laboratory’s structure and process organization regarding the quality assurance in the technical services rendered by the laboratory. Adherence to it guarantees that the organizational and technical activities are planned, supervised and controlled, and that the contract conditions (see section 2.12) agreed with the accreditation body for calibration laboratorties for the Deutscher Kalibrierdienst (DKD), by the Physikalisch-Technische Bundesanstalt (PTB) and the Instituto Nacional de Acreditación (INN), are met. The quality assurance system is based on the requirements of ISO/IEC 17025 “General requirements for the competence of testing and calibration laboratories”, as well as all additional requirements for DKD-calibration laboratories, as established by PTB in DKD 1 to 6 and the signed contract. The staff members of LCPNT and all organizational units of our firm which are directly or indirectly involved are herewith bound to carry out their tasks in accordance with the quality policy laid down in the QM, being the Head of the LCPNT responsible for the coordination, planning, execution and supervision of the quality regulations that are adopted. We confirm that the application of the present QM is mandatory for CESMEC LTDA.

    33. Section 1: Quality System Structure of CESMEC-LCPN-T

    1.2 Organization Chart of the NMI as it pertains to the delivery of the CMC services (Reference: 2.1.3 Quality Manual of CESMEC-LCPN-T)

    34. Section 1: Quality System Structure of CESMEC-LCPN-T

    1.3 Quality Management Policies and Procedures including identification of Quality Manager-roles and responsibilities. (Reference: 3.2, 4.3.1, 4.3.2, 4.3.3, 6.6.3 Quality Manual of CESMEC-LCPN-M and procedures of CESMEC) Quality Management related Procedures QM Recalibration of standards and measuring equipment ---------------------------------------------------------------- 2.1.4.2 Monitoring system for the Non-conforming work ----------------------------------------------------------------- 2.9 Internal audits -------------------------------------------------------------------------- 2.13.1 External audits ------------------------------------------------------------------------- 2.13.2 Preventive actions and management review ----------------------------------- 2.14 PCG 131/017-101, “Procedure for document control” PCG 131/017-102, “Corrective actions procedures” PCG 131/017-105, “Claims procedure”

    35. Section 1: Quality System Structure of CESMEC-LCPN-T

    1.3 Quality Management Policies and Procedures including identification of Quality Manager-roles and responsibilities. (Reference: 2.1.4.2 Quality Manual of CESMEC-LCPN-T) 2.1.4.2 CESMEC’s Quality Assurance Manager is responsible for: In order to satisfy our clients’s quality requirements, the quality Assurance Manager has the authority and responsability for the planification, development, organization and management all the QS resources and activities of the company and the LCPNT. Within the framework of the QS of the LCPNT, his responsibilities are: the execution of periodical internal audits. the handling of complaints in coordination with the Head of the LCPNT. execution of the surveillance system for standards and measuring equipment in coordination with the LCPNT Head.

    36. Section 2: Quality Manual Components - CESMEC-LCPN-T

    2.1 Table of contents (Reference: Index of contents of Quality Manual of CESMEC-LCPN-M)

    37. Section 2: Quality Manual Components - CESMEC-LCPN-T

    2.2 Cross-Walk between the Quality Manual sections and the ISO/IEC 17025 sections (Reference: Index of contents of Quality Manual of CESMEC-LCPN-M) Cross reference to ISO/IEC 17025 is easily materialized by subtracting 2 to each chapter of the Quality Manual of CESMEC-LCPN-M For example ISO/IEC 17025 QM CESMEC-LCPN-T Chapter 4.3 can be found at Chapter 2.3 Chapter 5.4.6 can be found at Chapter 3.4.6 ISO/IEC 17025 QM CESMEC-LCPN-T -2 +2

    38. Section 2: Quality Manual Components - CESMEC-LCPN-T

    2.3 List of CMCs (Reference: here) Current CMCs are declared at Appendix C of CIPM MRA, but… Summary: Calibration of Standard Platinum Resistance Thermometers and Digital Thermometric Devices against Standard Platinum Resistance Thermometers and Ice point and Triple point of water. For details, please review document above.

    39. Section 2: Quality Manual Components - CESMEC-LCPN-T

    2.4 List of procedures (Reference: Quality Manual of CESMEC-LCPN-T plus procedures listed in 4.2)

    40. Section 3: Quality System Implementation - CESMEC-LCPN-T

    3.1 Statistics on customer complaints, nonconforming work, and corrective actions. Quality Management philosophy and process of handling the items above. Customer complaints: 0, CESMEC-LCPN-T issues about 5 calibration certificates per year only. Preventive actions and management review ----------------------------------- 2.14 Non-conforming work ----------------------------------------------------------------- 2.9 PCG 131/017-102, “Corrective actions procedures” PCG 131/017-105, “Claims procedure” Philosophy: “Confidence is the essential prerequisite to any commercial activity. Corrective actions, claims handling and non conformity work detection activities should be perform in order to mantain and improve the confidence of our customers on our services”. QM

    41. Section 3: Quality System Implementation - CESMEC-LCPN-T

    3.2 Internal Audits. Include bios of the assessor team. (Reference: 2.13 of Quality Manual of CESMEC-LCPN-T and procedures of CESMEC) Quality Management related Procedures QM Internal and external audits ______________________________ 2.13 PCG 131/017-102, “Corrective actions procedures” Assessor team Chapter 4 of ISO/IEC 17025 is assesed by the Quality Manager or any representaive of him, they are certified assessors for ISO 9000 + experienced on quality systems. Chapter 5 of ISO/IEC 17025 is assessed by the Head or Deputy Head of the CESMEC-LCPN-Mass lab or supervisors of the Metrology División of CESMEC.

    42. Section 3: Quality System Implementation - CESMEC-LCPN-T

    3.3 Management reviews (Reference: 2.14 of Quality Manual of CESMEC-LCPN-T and procedures of CESMEC)

    43. Section 3: Quality System Implementation - CESMEC-LCPN-T

    3.4 External reviews (Reference: 2.13 of Quality Manual of CESMEC-LCPN-T) External reviews or assesments are performed by two accreditation bodies: SNA (National Accreditation System of Chile at the INN) and DKD (German Calibration Service). SNA performs a review of the QS once a year. DKD perfors a review of QS each 1,5 years. During each DKD review a comparison with PTB is planned or executed in order to assure confidence. For all results: En<1

    44. Section 4: Assesment process - CESMEC-LCPN-T

    4.1 Accredited NMIs need to show the following: CMC uncertainties are not smaller than the uncertainties listed in the scope (References for Appendix C MRA: http://kcdb.bipm.org/appendixC/T/CL/T_CL.pdf or T_CL; for DKD-K-28402 accreditation scope: http://www.dkd.info/english/deutsch/pdf/28402.pdf or 28402 for SNA-INN-LC026 accreditation scope: Scope INN LC026 CESMEC-LCPN-T The DKD and SNA accreditation scopes are the same. The CMCs declared in appendix C of CIPM MRA is not the same as the accreditation scopes of DKD and SNA-INN All documents can be downloaded from http://www.metrologia.cl/laboratorios/temperature.act

    45. Section 4: Assesment process - CESMEC-LCPN-T

    4.1 Accredited NMIs need to show the following: CMC uncertainties are not smaller than the uncertainties listed in the scope It is requested at this meeting to make a correction. Right information according to CIPM format is here and is in agreement to accreditations scopes. What happened? I dont’ know.

    46. Section 4: Assesment process - CESMEC-LCPN-T

    4.2 Accredited NMIs need to show the following: Accreditation body is a signatory to the ILAC MRA (Reference: http://www.ilac.org/downloads/Members_List.doc or Members List) The CESMEC-LCPN-T is accredited by two bodies that hold memberships at ILAC: DKD and SNA-INN SNA-INN is Associate Member of ILAC, not ILAC MRA signatory. DKD is Full Member of ILAC and ILAC MRA signatory.

    47. Section 4: Assesment process - CESMEC-LCPN-T

    4.2 Accredited NMIs need to show the following: Accreditation body is a signatory to the ILAC MRA (Reference: http://www.ilac.org/downloads/Members_List.doc or Members List) The CESMEC-LCPN-T is accreditated by two bodies that hold memberships at ILAC: DKD and SNA-INN SNA-INN is Associate Member of ILAC, not ILAC MRA signatory. DKD is Full Member of ILAC and ILAC MRA signatory.

    48. Section 4: Assesment process - CESMEC-LCPN-T

    4.3 Accredited NMIs need to show the following: Name of the Accreditation body and the names of the technical assessors Accreditation bodies: DKD (German Calibration Service, www.dkd.info) and SNA-INN (www.inn.cl) Tecnical assessors of DKD: Hans Bachmair and Friedrich Pietsch Technical assesors of SNA-INN: Domingo Denegri, Pedro Pizarro and Eduardo Ceballos.

    49. Section 4: Assesment process - CESMEC-LCPN-T

    4.4 Accredited NMIs need to show the following: Copy of the Accreditation Certificate Page 1 of accreditation certificate issued by DKD Page 2 of accreditation certificate issued by DKD (accreditation scope, also may be downloaded from: http://www.dkd.info/english/deutsch/pdf/28402.pdf ) Page 1 of accreditation certificate issued by SNA-INN Page 2 of accreditation certificate issued by SNA-INN (accreditation scope) All this documents can be downloaded from http://www.metrologia.cl/laboratorios/temperatura.act

    CESMEC-LCPN-Mass CESMEC Ltda. Marathon 2595 781-0552, Macul Chile Phone: (56 2) 350 21 85 Fax: (56 2) 350 21 83 http://www.metrologia.cl/laboratorios/masa.act http://www.cesmec.cl/esp/servicios/metrologia/LaboratoriosCustodios/LCPNM.act Quality system documentation of the National Mass Laboratory of Chile at CESMEC (CESMEC-LCPN-M) Quality system documentation of the National Mass Laboratory of Chile at CESMEC (CESMEC-LCPN-M) Fernando Leyton CESMEC-LCPN-M Head fleyton@cesmec.cl Francisco García CESMEC-LCPN-M Deputy Head fgarcia@cesmec.cl Raúl Hernández CESMEC-LCPN-M Technician Manuel Gálvez CESMEC-LCPN-M Technician

    52. Section 1: Quality System Structure of CESMEC-LCPN-M

    Quality Policy (Reference: 3.1 and 0 of Quality Manual of LCPN-M) Quality policy The LCPNM purpose is to offer calibration services with traceability to the international prototype of the kilogram. To reach this goal, the laboratory stands on personal committed, qualified and of high ethical values, in addition to equipment and facilities of the highest quality. With his personal work, each staff member contributes to the LCPNM rendering the services offered by in compliance of quality requirements. The LCPNM will maintain a policy that assure the reliability of its services, through a permanent evaluation of its competition level, capacity and experience, committing its participation only when such requirements could be satisfied. The services offered by the LCPNM have to satisfy the laboratory quality objective: to accomplish with the DKD and SNA accreditation scopes. To obtain the objectives stated above, the LCPNM will develop, implement and maintain in operation a Management System of Quality substantially according to the requirements of the standard ISO/IEC 17025:1999(E) in the version valid at the time in question. The cooperation with the National Metrology Neworkt is performed according to the document INN 70-05

    53. Section 1: Quality System Structure of CESMEC-LCPN-M

    Quality Policy (Reference: 3.1 and 0 of Quality Manual of CESMEC-LCPN-M) Binding Character of the QM This Quality Manual describes the laboratory's structure and process organization as regards quality assurance in the technical services rendered by it. Adherence to it guarantees that organizational and technical activities are planned, supervised and controlled, and that provisions of the contract (cf. Annex 11.2) concluded with the accreditation body for calibration laboratories of the Deutscher Kalibrierdienst (DKD), i.e. the Physikalisch-Technische Bundesanstalt (PTB) and the Instituto Nacional de Acreditación (INN) , are complied with. The quality assurance system is based on the requirements of ISO/IEC 17025:1999(E) "General requirements for the competence of testing and calibration laboratories" in the version valid at the time in question. The staff members of the Calibration Laboratory and all organizational units of our firm which are directly or indirectly involved are herewith bound to carry out their tasks in accordance with the quality policy laid down in the QM, being the Chief of the Laboratory responsible for the coordination of the planning, execution and supervision of the regulations of quality that are adopted. We confirm that the application of the present manual of quality is mandatory for CESMEC Ltda.

    54. Section 1: Quality System Structure of CESMEC-LCPN-M

    1.2 Organization Chart of the NMI as it pertains to the delivery of the CMC services (Reference: 3.2 Quality Manual of CESMEC-LCPN-M)

    55. Section 1: Quality System Structure of CESMEC-LCPN-M

    1.3 Quality Management Policies and Procedures including identification of Quality Manager-roles and responsibilities. (Reference: 3.2, 4.3.1, 4.3.2, 4.3.3, 6.6.3 Quality Manual of CESMEC-LCPN-M and procedures of CESMEC) Quality Management related Procedures QM Internal audits -------------------------------------------------------------------------- 4.3.1 External audits ------------------------------------------------------------------------- 4.3.2 Preventive actions and management review ----------------------------------- 4.3.3 Monitoring system for the Recalibration of standards and measuring equipment ---------------------------------------------------------------- 6.6.3 Non-conforming work ----------------------------------------------------------------- 9 PCG 131/017-101, “Procedure for document control” PCG 131/017-102, “Corrective actions procedures” PCG 131/017-105, “Claims procedure”

    56. Section 1: Quality System Structure of CESMEC-LCPN-M

    1.3 Quality Management Policies and Procedures including identification of Quality Manager-roles and responsibilities. (Reference: 3.2 Quality Manual of CESMEC-LCPN-M) 3.2 of QM Quality Manager-roles and responsibilities In order to satisfy our clients’ quality requirements, the Quality Assurance Manager has the authority and responsability for the planing, development, organization and management of all quality system resources and activities of the company and the Laboratory. Within the framework of the LCPNM quality system, his responsabilities are: the execution of periodical internal audits. the handling of complaints in coordination with the Laboratory Head. the execution of the surveillance system for standards and measuring equipment in coordination with the Laboratory Head (see 6.6.4)

    57. Section 2: Quality Manual Components - CESMEC-LCPN-M

    2.1 Table of contents (Reference: Index of contents of Quality Manual of CESMEC-LCPN-M)

    58. Section 2: Quality Manual Components - CESMEC-LCPN-M

    2.2 Cross-Walk between the Quality Manual sections and the ISO/IES 17025 sections (Reference: CROSS REFERENCES TABLE BETWEEN THE QM AND ISO/IEC 17025:1999 of Quality Manual of CESMEC-LCPN-M)

    59. Section 2: Quality Manual Components - CESMEC-LCPN-M

    2.3 List of CMCs (Reference: page 8 of http://kcdb.bipm.org/appendixC/M/CL/M_CL.pdf or M_CL) Current CMCs are declared at Appendix C of CIPM MRA Summary: Calibration of mass standards in conventional mass against comparator balances with reference standards according to OIML 111 requirements. For details, please review document above.

    60. Section 2: Quality Manual Components - CESMEC-LCPN-M

    2.4 List of procedures (Reference: Quality Manual of CESMEC-LCPN-M plus procures of CESMEC listed in 11.2) The whole Quality System of CESMEC-LCPN-M is contained in the Quality Manual of CESMEC-LCPN-M except of some procedures adopted from CESMEC that are listed in 11.2 of QM of CESMEC-LCPN-M PCG 131/017-101, “Procedure for document control” PCG 131/017-102, “Corrective actions procedures” PCG 131/017-105, “Claims procedure” PCE 131/700-002, “Reception, storage and dispatch of items for calibration”. PCE 131/700-006, “Training necessities detection” PCG 131/011 201, “Procedure for opening orders” PCG 131/011 202, “Procedure for certificates and invoices dispachment” PCG 131/011 203, “Procedure for setting payment conditions”

    61. Section 3: Quality System Implementation - CESMEC-LCPN-M

    3.1 Statistics on customer complaints, nonconforming work, and corrective actions. Quality Management philosophy and process of handling the items above. Customer complaints: 0, CESMEC-LCPN-M issues about 8 calibration certificates per month only. Preventive actions and management review ----------------------------------- 4.3.3 Non-conforming work ----------------------------------------------------------------- 9 PCG 131/017-102, “Corrective actions procedures” PCG 131/017-105, “Claims procedure” Philosophy: “Confidence is the essential prerequisite to any commercial activity. Corrective actions, claims handling and non conformity work detection activities should be perform in order to mantain and improve the confidence of our customers on our services”.

    62. Section 3: Quality System Implementation - CESMEC-LCPN-M

    3.2 Internal Audits. Include bios of the assessor team. (Reference: 4.3.1, 4.3.2 of Quality Manual of CESMEC-LCPN-M and procedures of CESMEC) Quality Management related Procedures QM Internal audits -------------------------------------------------------------------------- 4.3.1 External audits ------------------------------------------------------------------------- 4.3.2 PCG 131/017-102, “Corrective actions procedures” Assessor team Chapter 4 of ISO/IEC 17025 is assesed by the Quality Manager or any representaive of him, they are certified assessors for ISO 9000 + experienced on quality systems. Chapter 5 of ISO/IEC 17025 is assessed by the Head or Deputy Head of the CESMEC-LCPN-Temperature lab or supervisors of the Metrology División of CESMEC.

    63. Section 3: Quality System Implementation - CESMEC-LCPN-M

    3.3 Management reviews (Reference: 4.3.3 of Quality Manual of CESMEC-LCPN-M and procedures of CESMEC)

    64. Section 3: Quality System Implementation - CESMEC-LCPN-M

    3.4 External reviews (Reference: 4.3.2 of Quality Manual of CESMEC-LCPN-M and procedures of CESMEC) External reviews or assesments are performed by two accreditation bodies: SNA (National Accreditation System of Chile at the INN) and DKD (German Calibration Service). SNA performs a review of the QS once a year. DKD perfors a review of QS each 1,5 years. During each DKD review a comparison with PTB is planned or executed in order to assure confidence. For all results: En<1

    65. Section 4: Assesment process - CESMEC-LCPN-M

    4.1 Accredited NMIs need to show the following: CMC uncertainties are not smaller than the uncertainties listed in the scope (References for Appendix C MRA: page 8 of http://kcdb.bipm.org/appendixC/M/CL/M_CL.pdf or M_CL; for DKD-K-28402 accreditation scope: http://www.dkd.info/english/deutsch/pdf/28401.pdf or 28401 for SNA-INN-LC026 accreditation scope: Scope INN LC020 CESMEC-LCPN-M 1 and Scope INN LC020 CESMEC-LCPN-M 2) The DKD and SNA accreditation scopes are the same. The CMCs declared in appendix C of CIPM MRA are the same as the accreditation scopes of DKD and SNA-INN All documents can be downloaded from http://www.metrologia.cl/laboratorios/masa.act

    66. Section 4: Assesment process - CESMEC-LCPN-M

    4.2 Accredited NMIs need to show the following: Accreditation body is a signatory to the ILAC MRA (Reference: http://www.ilac.org/downloads/Members_List.doc or Members List) The CESMEC-LCPN-M is accredited by two bodies that hold memberships at ILAC: DKD and SNA-INN SNA-INN is Associate Member of ILAC, not ILAC MRA signatory. DKD is Full Member of ILAC and ILAC MRA signatory.

    67. Section 4: Assesment process - CESMEC-LCPN-M

    4.3 Accredited NMIs need to show the following: Name of the Accreditation body and the names of the technical assessors Accreditation bodies: DKD (German Calibration Service, www.dkd.info) and SNA-INN (www.inn.cl) Tecnical assessors of DKD: Dieter Knolle and Friedrich Pietsch Technical assesors of SNA-INN: Domingo Denegri, Pedro Pizarro, Eduardo Ceballos and Jorge Nuńez.

    68. Section 4: Assesment process - CESMEC-LCPN-M

    4.4 Accredited NMIs need to show the following: Copy of the Accreditation Certificate Page 1 of accreditation certificate issued by DKD Page 2 of accreditation certificate issued by DKD (accreditation scope, also may be downloaded from: http://www.dkd.info/english/deutsch/pdf/28401.pdf ) Page 1 of accreditation certificate issued by SNA-INN Page 2 of accreditation certificate issued by SNA-INN (accreditation scope) Page 3 of accreditation certificate issued by SNA-INN (accreditation scope) All this documents can be downloaded from http://www.metrologia.cl/laboratorios/masa.act

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