Quality system documentation of: National Force Laboratory of Chile at IDIC IDICLCPNF National Tempe

1
Quality system documentation of National Force
Laboratory of Chile at IDIC (IDIC-LCPN-F)Nationa
l 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_at_cesmec.cl

2
Document of referenceGuidance for Presentation
of Quality System Documentation for SIM NMIs
3
National Metrology Network of Chile
INN Director
TODAY 7 Physical Metrology Laboratories
Unit of Coordination and Supervision of the
National Metrology Network at the National
Institute of Standards (INN)
Vacant position Current contact Manuel Lladser
manuel.lladser_at_inn.cl Please send copy of the
e-mails to the laboratory
Technical Metrology Committee
National Metrology Laboratories LCPNs
Industry
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 Nº
2050 837-0923 SANTIAGO Chile Phone [phone]
62 Fax [phone] http//www.metrologia.cl
/laboratorios/fuerza.act
Christian Villarroel IDIC-LCPN-F Head idic_at_idic.c
l villarroelchrist_at_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 Nº
  6, LCPNF-PG02)
• 4.2 LCPNF-PG02
• Granting force proving equipment and instrument
  calibration services, in order to satisfy our
  clients 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 Nº
  6 of LCPNF-PG02)
• 4.2 ANNEX Nº 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
IDICS QUALITY REPRESENTATIVE Mr. Jaime Muñoz
GENERAL ASSISTANT DIRECTOR OF IDIC Lt. Col.
Carlos Matus
Mechanical Department Col. Lt. Sergio
Espinoza Head
Department of Finance
Commercial Department
Human Resources Department
Other departments
Sales and quotations
LCPN-F Eng. Christian Villarroel Head Tech. Jorge
Villalobos Deputy Head
Operations management
Supplies
Costs
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)

• IDICs Director representative for quality
  assurance in all the Institute,
• is responsible for
• The administration, inspection and updating of
  IDICs quality manual and related general
  procedures.
• Supervising IDICs quality system proficiency,
  carrying out periodic audits.
• Ensuring that Instituto Nacional de Normalización
  INN (National Standardization Institute)
• dispositions are carried out, where the
  laboratorys 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 IDICs
QM Non-conforming work-----------------------IDIC-
PG12 Corrective actions -------------------------
- Procedure IDIC-PG15 Chapters
13, 14 and 17 of IDICs QM
19
Section 3 Quality System Implementation -
IDIC-LCPN-F
3.2 Internal Audits. Include bios of the assessor
team.
Quality Management related Procedures Inte
rnal audits ---------------------------------- Pro
cedure IDIC-PG15 Chapters 13, 14 and 17 of
IDICs QM Corrective actions ---------------------
--------Procedure IDIC-PG15 Chapters 13, 14
and 17 of IDICs 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 IDICs laboratories.

20
Section 3 Quality System Implementation -
IDIC-LCPN-F
3.3 Management reviews
Management review --------------------------------
-- Chapter 1 of IDICs 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 Enlt1

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.or
g/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/3300
  1.pdf )
• Page 1 of accreditation certificate issued by
  SNA-INN
• Page 2 of accreditation certificate issued by DKD
  (accreditation scope)

26
Quality system documentation of the National Mass
Laboratory of Chile at CESMEC (CESMEC-LCPN-T)
CESMEC-LCPN-Temperature CESMEC Ltda. Marathon
2595 781-0552, Macul Chile Phone [phone]
85 Fax [phone] http//www.metrolo
gia.cl/laboratorios/temperatura.act http//www.ces
mec.cl/esp/servicios/metrologia/LaboratoriosCustod
ios/LCPNT.act
27
Quality system documentation of the National
Temperature Laboratory of Chile at CESMEC
(CESMEC-LCPN-T)
Mauricio Araya CESMEC-LCPN-T Head maraya_at_cesmec.cl
Rosamel Pizarro CESMEC-LCPN-T Deputy
Head rpizarro_at_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 laboratorys
  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 Re
calibration 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
• CESMECs Quality Assurance Manager is responsible
  for
• In order to satisfy our clientss 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
-2
QM CESMEC-LCPN-T
ISO/IEC 17025
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.
QM
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.
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 In
ternal 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 Enlt1

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/appendix
C/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/2840
  2.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
50
Quality system documentation of the National Mass
Laboratory of Chile at CESMEC (CESMEC-LCPN-M)
CESMEC-LCPN-Mass CESMEC Ltda. Marathon
2595 781-0552, Macul Chile Phone [phone]
85 Fax [phone] http//www.metrol
ogia.cl/laboratorios/masa.act http//www.cesmec.cl
/esp/servicios/metrologia/LaboratoriosCustodios/LC
PNM.act
51
Quality system documentation of the National Mass
Laboratory of Chile at CESMEC (CESMEC-LCPN-M)
Fernando Leyton CESMEC-LCPN-M Head fleyton_at_cesmec.
cl
Francisco García CESMEC-LCPN-M Deputy
Head fgarcia_at_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 170251999(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 170251999(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 In
ternal 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 170251999 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 In
ternal 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 Enlt1

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.or
g/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 Nuñez.

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/2840
  1.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