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Calibration Laboratory
Advanced Metrology
Calibration Laboratory
Quality Manual
QM 01/1
Reference Standard ISO/IEC 17025:2005 & ISO 9001:2008
Issue Number 1.0
Issue Date 24Jun2015
Advanced Metrology
Calibration Laboratory
Address
Khalid Ibn Alwaleed St,
Alrakah Alshamaliah, Al Khobar
Kingdom of Saudi Arabia
Name
Designation
Prepared By
Approved By
Haitham Abumarar
Mohammad Hourani
Quality Manager
Executive Manager
Signature
1.1
Chapter
No.
Page 1 of 32
Table of Contents
Subject
Advanced Metrology
Calibration Laboratory
Section
1
2
3
ANX-I
ANX-II
ANX-III
Description
Table of contents and amendment record sheet
Authorization statement and ADV-MET profile
Control and distribution
Management Requirements
Organization
Quality system
Document control
Review requests, tenders and contracts
Subcontracting Of calibration
Purchasing services and supplies
Service to the customer
Complaints
Control of nonconforming calibration work
Improvements
Corrective action
Preventive action
Control of records
Internal audits
Management review
Technical Requirements
General
Personnel
Accommodation and environmental conditions
Calibration methods and method validation
Equipment
Measurement traceability
Sampling
Handling of calibration items
Assuring The Quality Of calibration Results
Reporting the results
List of quality procedures
Glossary of terms
Nominal cross-references to ISO 9001:2008
1.2
Amd.
No.
Page 2 of 32
Page
No.
Current
Issue no.
Advanced Metrology
Calibration Laboratory
2.1
Authorization Statement
Executive Manager
2.2
2.2.1
Company Profile
Company Profile
ADV-MET is operated by well experienced technical persons, ADV-MET is having
adequate facilities for calibration of the identified equipments and have fully fledged
calibration laboratory.
2.2.2
Page 3 of 32
Instrument Name
Pressure Gauge
Vacuum Gauge
Height Gauge
Dial Indicator
Advanced Metrology
Calibration Laboratory
Thermal Field
2.2.3
1.
2.
Thermocouple
Thermometer
1.
2.
3.
Electrotechnical Field
Temperature Controller / Indicator
5. AC Ampere
AC Voltage
6. DC Ampere
DC Voltage
7. Resistance
3. Temperature gauge
Scope Of Accreditation
Scopes of accreditation for the calibration facilities provided by the ADV-MET are as under;
Mechanical Discipline
Sr.
No.
Instrument Name
01
External Micrometer
02
Calipers (Vernier
Dial / Electronic)
03
Internal Micrometer
Stick type
04
05
Pressure Gauges
06
Vacuum Gauge
07
08
Range
Least Count
Remarks
0 150 mm
0.01mm
0 150 mm
0.001 mm
Up to 300 mm
0.02 mm
0.01 mm
Up to 100 mm (For
major and effective dia
only)
-----
5 70 kg/cm2
0.02 kg/cm2
25 mm ( Head)
300 mm (Extension
Rod)
60 750 kg/cm
0.2 kg/cm
700 mm of Hg to 0
mm of Hg
2 mmHg
Height gauge
0 600 mm
0.02 mm
Dial Indicator
0 25 mm
0.005 mm
Range
Least Count
Thermal Discipline
Sr.
No.
Instrument Name
Remarks
09
Thermocouple
Ambient to 400 C
---
10
Thermometer
Ambient to 400 C
0.2 C
11
Temperature gauge
Ambient to 400 C
1 C
Page 4 of 32
Advanced Metrology
Calibration Laboratory
ElectroTechnical Discipline
Sr.
No.
12
13
Instrument
Name /
Parameters
Temperature
Controll
er
/
Indicator
AC Voltage
Range
200 to 850 C
(18.53 to 390.38 )
200 to 1370 C
(5.891 to 54.807 mV)
200 to 1200 C
(7.890 to 69.539 mV)
0 to 1750 C
(0.000 to 20.876 mV)
200 to 400 C
(5.603 to 20.869 mV)
0 to 1750 C
(0.000 to 18.504 mV)
450 to 1750 C
(1.002 to 13.006 mV)
200 to 1000 C
(8.824 to 76.356 mV)
Least Count
Remarks
0.1 C / 0.01
0.1 C / 0.001 mV
0.1 C / 0.001 mV
0.1 C / 0.001 mV
0.1 C / 0.001 mV
0.1 C / 0.001 mV
0.1 C / 0.001 mV
0.1 C / 0.001 mV
0 230 Volt
0.1 Volt
0 200 mV
0.1 mV
1 300 V
0.1 Volt
Using 5 Digital
Multimeter
Using Universal Calibrator
and 5 Digital
Multimeter
14
DC Voltage
15
AC Ampere
0 5 Ampere
0.001 Ampere
Using 5 Digital
Multimeter
16
DC Ampere
0 5 Ampere
0.001 Ampere
Using 5 Digital
Multimeter
17
Rsistance
0 100 M
Page 5 of 32
0.1 M
Advanced Metrology
Calibration Laboratory
3.0
3.1
3.2
Responsibility
Top Management approves the Quality Manual. The control and maintenance of this manual
is the responsibility of the Quality Manager, who is maintaining the master list of documents
for the quality manual.
3.3
Reference
ISO 9001:2008
ISO/IEC
17025:2005
Quality Procedure
3.4
Distribution
Quality Manuals are distributed to the various departments on a controlled" basis.
Controlled copies are the one, which are subject to incorporation of "revisions".
"Controlled" copies of the quality manual are stamped Controlled Copy on the first page
and given a unique copy number for maintenance purpose.
Quality Manager maintains the distribution list for issue of quality manual and accordingly
copies are distributed with copy number to Copy Holders.
Quality Manager, through a change note issues amendments of quality manual to holders
of controlled copies of the manual. Upon receipt of such revisions, the recipient will replace
the old manual with the new one.
"Uncontrolled" copies may be issued by the Quality Manager to the prospective customers
and others on the request of the Top Management and all employees but the recipient shall
not be issued the amendments / revisions.
Quality Manager is responsible to fill up amendment sheet in line with any amendment and
put Controlled Copy Stamp on the amendment sheet as well as table of contents. All the
information regarding revisions is distributed to Copy Holders.
3.5
(1.) The number for quality manual is given as QM 01/*, where * indicates issue number of quality
manual for ex. QM 01/1 indicates issue no. 1.0 of quality manual.
(2.) Revised Quality Manual is subject to the same approvals and controls as per the original one.
3.6
(1.)
(2.)
(3.)
Page 6 of 32
Chapter 1.
Advanced Metrology
Calibration Laboratory
(4.)
4.0
Management Requirements
4.1
Organization
4.1.1
4.1.2
ADV-MET is carrying out calibration activities for Dimensional, Thermal, Physical and
Electrical types of instruments calibration. All calibration performed by ADV-MET are based
on national or international references. Along with our calibration certificate, the customer
may choose to review our national / international traceability as per ISO/IEC 17025:2005
and ISO 9001:2008.
4.1.3
ADV-MET management system covers the work carried out in the laboratorys permanent
facilities as per the address given in cover page. No calibration activities are carried out at
sites away from its permanent facilities or in associated temporary or mobile facilities.
4.1.4
4.1.5
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Advanced Metrology
Calibration Laboratory
4.1.6
4.2
Management and personnel are free from any undue internal and external commercial,
financial and other pressures and influences that may adversely affect the quality of their
work, during routine calibration
Procedure is established for protection of customers confidential information. All
instruments received from customers are made confidential and such details are never
disclosed to other customers. All employees of ADV-MET have signed confidentiality
agreement and proprietary rights. Also procedure is prepared for storage and
transmission of electronic results and documented in procedure QP/01. Only Calibration
Report issued to the customers are maintained in computer. Also periodic back up is
taken for avoiding any problem in the event of computer failure etc. The backs up of all
Calibration Report prepared are taken at least on monthly basis in the appropriate
storage media. Currently, we are not transmitting electronic results to our customers.
Our customers are given only hard copy of Calibration Report.
Policies and procedures to avoid involvement in any activities that would diminish
confidence in the competence, impartiality, judgment or operational integrity and the
same is documented and is communicated and acknowledged by all employees.
Well-planned organization structure is developed considering managerial and technical
operation. Also the responsibility in terms of Management system implementation,
Technical Operation in terms of handling and performing of routine calibration job and
support services like purchasing etc. are defined in the respective procedure and job
description for all the designation mentioned in the organization chart are prepared and
communicated to the personnel.
Detail job description with reference of responsibility and authorities in terms of
managing, performing and verifying / review of calibration activities are prepared and
documented in the (F/QMS/09). Also interrelationship with other functions is also clearly
defined in such job descriptions, which are communicated to the employee and got
acknowledged.
Technical Manager does the routine supervision of all calibration activities performed by
engineers in consultation with Calibration In charge. Also procedure for Quality Control
QP/18 is established and is followed on routine practices for required assessment of
calibration work.
Technical Manager is overall responsible for all technical operations of the laboratory.
Technical Manager ensures that adequate resources are available for performing
calibration with precision. If at all any resource requirement is identified then the
Technical Manager prepares the details of resource requirement with the Executive
Manager, who provides resources to maintain quality of calibration work.
Executive Manager of the laboratory has appointed Quality Manager and Technical
Manager. Quality Manager is given full authority for ensuring effective implementation of
management system related to quality in the organization irrespective of his routine
duties; Quality Manager has direct access with Executive Manager. Furthermore,
detailed job description with responsibility and authority is prepared for the Quality
Manager.
Technical Manager is appointed as deputy of Quality Manager for all Management
system related functions and Quality Manager is appointed as deputy of Technical
Manager.
All employees are aware of the relevance and importance of their activities and their
contribution to the achievement of the objectives of the management system. Defined
objectives are made and are communicated to all employees. Periodic monitoring of
such objectives is done in F/SYS/05.
Executive Manager has established appropriate communication processes within the
laboratory. Method of communication is effectively implemented related to management
system within the Laboratory through management review and routine work.
Management system
Page 8 of 32
Advanced Metrology
Calibration Laboratory
4.2.1
4.2.2
Quality Policy
We at ADV-MET are committed to achieve total customer satisfaction and thereby
achieve leading name in the field of calibration.
We shall achieve this by:
Developing good professional practices and providing calibration facility that have
desired quality in accordance with customer requirements / reference standards to
create environment of trust with our customer,
Executive Manager
and
4.2.3
Executive Manager has provided evidence of commitment for the development and
implementation of the management system and continually improving effectiveness of
management system.
4.2.4
Executive Manager has documented the customer requirements and statutory and
regulatory requirements and the same is communicated to all employees within the
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Advanced Metrology
Calibration Laboratory
organization for ensuring importance of meeting customer requirements, statutory and
regulatory requirements related to services provided by us.
4.2.5
4.2.6
The roles and responsibility of Technical Manager and Quality Manager, including their
responsibility for ensuring compliance with ISO/IEC 17025:2005 and ISO 9001:2008 are
defined in Job description and specifications (F/QMS/09).
4.2.7
Executive Manager has established integrity with the management system to ensure
planning and implementation of changes in the management system as soon as they are
identified through management review.
4.3
Document Control
4.3.1
General
ADV-MET has established and maintained procedures to control all documents that has
formed part of management system, such as regulations, standards, other normative
documents, calibration methods, specifications, instructions, manuals and others as used as
references are covered in the document control system.
4.3.2
4.3.2.1
All documents issued to personnel in the laboratory as part of the management system are
reviewed and approved for use by authorized personnel prior to issue as per the details
given in QP/01. A master distribution list of document (F/QMS/01) is maintained for all tiers
of documents showing current issue status and distribution of documents. Also made readily
available to preclude the use of invalid and/or obsolete documents. Master distribution list is
accessible to all personnel of laboratory for review.
4.3.2.2
4.3.2.3
Management system documents prepared by the ADV-MET are uniquely identified as per
numbering system given in QP/01. The details like Issue no., date of issue, page numbering,
the total number of pages to signified the end of the document, and the issuing authority are
identified in documents itself. All documents are issued by Quality Manager and he
maintains master list and distribution list of documents.
4.3.3
Document Changes
4.3.3.1
Changes to documents are reviewed and approved by the same function that performed the
original review unless specifically designated otherwise. The designated personnel have
access to pertinent background information upon which to base their review and approval.
Also the details of approval of various documents are given in QP/01.
4.3.3.2
When any changes / amendments are done in any documents, such latest changes are
identified by putting esteric (*) or suitable marking on right or left hand of particular text
affected. Such marking indicates the latest changes and all personnel of laboratory are
acquainted for the same. Also changes are supported by change note (F/QMS/02), which
are maintained by Quality Manager.
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Advanced Metrology
Calibration Laboratory
4.3.3.3
In ADV-MET we are not allowing any hand written amendments in any documents. It is
amended as per the defined procedure for document control as defined above. Procedures
and authorities for amendments are defined. Amendments are clearly marked, initialed and
dated as per 4.3.3.2.
4.3.3.4
4.4.1
ADV-MET has established and maintained procedures for the review of request, tenders
and contracts for the calibration work in QP/02. The policies and procedures for these
reviews leading to a contract for calibration have ensured that;
Any differences between the request or tender and the contract are resolved before any
work commences. Each calibration contract is signed by ADV-MET representative and
customer representative as an agreement of acceptance of calibration work with al
technical details.
4.4.2
Records of acceptance of each contract are maintained, records of reviews, including any
significant changes, are maintained, records are also maintained of pertinent discussions
with a customer relating to the customers requirements or the results of the work during
the period of execution of the contract, if any.
4.4.3
In case, it is observed that the deviation is required in the calibration work, then the
customer is informed for the same. After receipt of approval from the customer the
calibration work is started. All such deviations and amendments are further processed as per
the details given in 4.4.4.
4.4.4
If a contract needs to be amended after work has commenced, the same contract review
process will be repeated as described above.
Subcontracting of Tests
At Presently ADV-MET is not subcontracting any calibration activities on customers UUTs.
Hence it is not applicable to us. At present we are having necessary manpower and
equipment for the required calibration. Also as a policy decision. We have decided not to do
any sub contracting work for the calibration done by us.
However in case of temporary in capacity / as required by our customer, we may get it done
through other SASO SAC accredited Lab. In such cases following steps will be followed;
4.5.1
Selection and approval of SASO SAC Accredited Lab. The criteria for approval are his capability
base on review of SASO SAC accreditation certificate.
4.5.2
In such case such arrangement is informed customer in writing. All such details and
communications are kept as a record purpose. Also customer acceptance for such
arrangement is taken in writing.
4.5.3
ADV-MET is responsible to the customer for the said work being sub contracted. In the event of
selection of subcontractor by customer, ADV-MET is responsible to extend all services to
Page 11 of 32
Advanced Metrology
Calibration Laboratory
the customer as per regular procedure till providing results of sample submitted by
customer.
4.5.4
4.6
4.6.1
ADV-MET has defined policy and procedure for purchasing of materials, services and
consumables used in the calibration, which can affect the quality of calibration. The
procedure number QP/03 is prepared and implemented, which gives guidelines for selection
and purchasing of materials, services and consumables. The procedure also includes the
details of receipt and storage of such products used in relevant calibration.
ADV-MET has ensured that purchased supplies and consumable materials that affect the
quality of calibrations are not used until they have been inspected or otherwise verified as
complying with standard specifications or requirements defined in the methods for the
calibrations. These services and supplies used have complied with specified requirements.
Records of actions taken to check compliance are maintained in the indent (F/PUR/02).
Purchasing documents (mainly purchase order as per format number F/PUR/01) for items
affecting the quality of laboratory output contains data describing the services and supplies
ordered with necessary purchasing data and specifications. These purchasing documents
are reviewed and approved for technical content prior to release by Executive Manger. The
details system is given in QP/03.
ADV-MET has developed method for evaluation of suppliers of critical consumables,
supplies and services that affect the quality of calibration, and maintain records of these
evaluations and list of approved supplier (F/PUR/03). Also approved supplier list is
maintained and is used for all routine purchasing activities. The purchase activity also
includes calibration of our equipments done through outside laboratory. No purchase is done
through the vendor not listed in Approved Supplier List (F/PUR/03).
4.6.2
4.6.3
4.6.4
4.7.1
ADV-MET affords customers or their representative cooperation to clarify the customers request
and to monitor the laboratorys performance in relation to the work performed, and it
provides confidentiality to other customers.
4.7.2
At every two year customer feedback (Both positive and negative) is taken by sending customer
feedback form (F/QMS/28) to the customers dealt in last two years for further improvement.
After receipt of feedback analysis is done and action plan is made for further improvement, if
any. Also following services are provided to the customers;
4.8
Access to calibration area including witnessing of calibration performed for them. The
customer representative can witness the calibration on request and approval of our
Director against contract review terms.
Verification to the preparation and dispatch activities for calibration item and reports are
also allowed.
Necessary communications are made to the customers throughout the calibration work.
Complaints
Procedure number QP/04 is documented and implemented for handling of complaints.
Procedure indicates both the complaints received from customer as well as other parties
related to our scope of work. Any complaint received is first logged in to complaint report
(F/QMS/17) by Technical Manager / Quality Manager and is forwarded to Technical Manager
/ Executive Manager for necessary analysis. Based on analysis actions are taken to resolve
the complaints. Upon satisfactory results the complaint is closed by Executive Manager /
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Advanced Metrology
Calibration Laboratory
Technical Manager and records are maintained in same report. Necessary corrective actions
are initiated to prevent recurrence of similar type of complaint in future.
(Reference Quality Procedure No. QP/04)
4.9
4.9.1
ADV-MET has defined a policy and procedures for control on nonconforming work (QP/05)
that is implemented when any aspect of calibration work, or the result of this work, do not
conform to own procedures or the agreed requirements of the customer. The non
conformities are identified based on follow up of quality control method, analysis of
customer complaints, calibration of equipments, supervision of staff work, internal audits,
review of Calibration Report, management reviews etc. The procedure ensure that;
4.9.2
The responsibilities and authorities for the management of nonconforming work are
designated and actions (including halting of work and withholding of Calibration Report,
as necessary) are defined and taken when nonconforming work is identified. Also
details of types of nonconforming work, actions to be taken and person responsible etc.
are prepared and are supported to the procedure for nonconforming work. Records of
nonconforming work are maintained in nonconforming work register (F/NCP/01).
Evaluation of the significance of the nonconforming work is done when it is identified
and necessary actions are initiated.
Corrective action is taken after analysis of nonconforming calibration work. Also in
some cases immediate corrective actions are initiated considering seriousness of non
conforming calibration work and implemented with immediate effect.
If required, the calibration work is repeated after necessary correction. Also if required
the customer is informed for such nonconforming work. If the seriousness on non
conforming calibration work found later on and customer UUts are already issued to
customer, in such cases all such UUts are collected back by informing customers and
recalibrated.
The responsibility for authorizing the resumption of work is defined considering types of
nonconforming calibration activities and the details of type of nonconforming, its
resumption and person authorized etc. are given in QP/05.
Where the evaluation indicates that the nonconforming work could recur or there is doubt
about the compliance of the operations with own policies and procedures then corrective
action as per 4.11 is promptly taken and followed.
General
ADV-MET has established a policy and documented procedure (QP/06) and designated
appropriate authorities for implementing corrective action when nonconforming work or
departures from the policies and procedures in the management system or technical
operations have been identified.
4.11.2
Cause Analysis
The procedure for corrective action (QP/06) starts with an analysis and investigation of
problems (includes nonconforming calibration work and/or departures from the procedures)
and to determine the root causes of the problem / nonconforming calibration work
departure from the procedures.
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Advanced Metrology
Calibration Laboratory
Upon identification of nonconformity or deviation, analysis for the same is done to identify
root cause of problem. Once the root cause is identified, it is further reviewed for probable
corrective action to prevent the recurrence of nonconformity.
4.11.3
4.11.4
4.11.5
Additional Audits
During identification of nonconformities or departure from routine work casts any doubt
for compliance with the documented system or the compliance with respect to ISO/IEC
17025:2005 and ISO 9001:2008 , we have decided to put additional audit in accordance with
the requirements of clause no. 4.14 as soon as possible. In such cases internal audit is
organized to ensure compliance of all requirements of the standard. Also additional audits
are also carried out as a basis of implementation of corrective actions to confirm
effectiveness of corrective action. Also additional audit may be conducted if any serious
issue arises or business risk is identified.
Page 14 of 32
After analysis of all such potential nonconformities / data, root causes is identified and
investigated;
Advanced Metrology
Calibration Laboratory
Necessary preventive actions are initiated corresponding the potentiality with action plan
for implementation
Selection of appropriate preventive action and implementation
Review of preventive action for effectiveness (at specified time period)
Identifying opportunities for further improvement and need for further preventive action
4.12.2 Procedures for preventive actions (QP/06) as mentioned above include the initiation of such
actions and application of controls to ensure that they are effective. The preventive action
taken will be pro active as a part of improvement opportunity rather than reaction to
problems or complaints. The preventive action also involves analysis of data, trends, risk
analysis and proficiency testing results.
(Reference Quality Procedure No. QP/06)
4.13
Control of Records
4.13.1
General
4.13.1.1
ADV-MET has established and maintained procedure for control of records (QP/07)
considering identification, collection, indexing, access, filing, storage, maintenance and
disposal of quality and technical records. Quality records also include reports from internal
audits and management reviews as well as records of corrective and preventive actions.
4.13.1.2
All records are legible and stored and retained in such a way that they are readily retrievable
in facilities, which provides suitable environment to prevent damage or deterioration and to
prevent loss. Retention times of records are established and recorded in the Master List of
Records (F/QMS/04). No records are maintained in the electronic media except temperature
monitoring records (stored by temperature data logger) and nonaccredited certificates
issued to the customers.
4.13.1.3
All records are kept secure and in confidence. Also all employees are trained to maintain
security and confidentiality of records.
4.13.1.4
Procedure is prepared to protect and back-up records stored electronically and to prevent
unauthorized access to or amendment of these records. All records maintained in computer
are safe guarded from virus, having password protection and back up of all such data /
records are taken on monthly basis.
4.13.2
Technical Records
4.13.2.1
ADV-MET retains records of original observations, derived data and sufficient information to
establish an audit trail, calibration records, staff records and a copy of each Calibration
Report issued, for a defined period as recorded in the master list of records (F/QMS/04). The
records for each calibration shall contain sufficient information to facilitate, if possible,
identification of factor affecting the uncertainty and to enable the calibration to be repeated
under conditions as close as possible to the original. The records shall include the identity of
personnel responsible for the sampling, performance of each calibration and checking of
results.
4.13.2.2
Observations, data and calculations are recorded at the time they are made and are
identified with respect to the specific tasks. All such records are maintained in different raw
data sheet.
4.13.2.3
When mistakes occur in records, each mistake is crossed out, not erased, made illegible or
deleted, and the correct value entered alongside. All such alterations to records are signed
or initialed by the person making the correction. In the case of records stored electronically,
possible care is taken to prevent loss or change in the original data. Any alteration made in
computer / electronic media re identified with amended copy. Also original one is maintained.
Internal Audits
4.14.1 ADV-MET has established and maintained procedure for internal audit (QP/08), which defines
frequency of audit as At least once in a twelve months, as per predetermined schedule,
and documented procedure internal audits of all activities are conducted to verify that all
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Advanced Metrology
Calibration Laboratory
operations continue to comply with the requirements of the management system and
ISO/IEC 17025:2005 and ISO 9001:2008. The internal audit programmed addresses all
elements of the management system, including the calibration activities. It is the
responsibility of the Quality Manager to plan and organize audits as required by the
schedule and requested by management. Such audits are carried out by trained and
qualified personnel who are, independent of the activity to be audited. Quality Manager
prepares Annual Internal Quality Audit Schedule (F/QMS/05) for Year. Before the scheduled
month comes, Quality Manager prepares audit plan (F/QMS/06) after referring last schedule.
Audit plan is then circulated to all auditor and audittees. Actual audit is done and audit
findings are recorded. From audit findings, audit nonconformity reports are prepared and
are agreed between auditor and audittee. Then the report is given to Quality Manager for
review.
4.14.2 When audit findings cast doubt on the effectiveness of the operations or on the correctness or
validity of the laboratorys results, the ADV-MET takes timely corrective action, and notifies
customer in writing, if investigations show that the laboratory results may have been
affected.
4.14.3 The area of activity audited the audit findings and corrective actions that arise from them are
recorded. Copy of internal audit nonconformity report (F/QMS/07) is given to audittee for
taking necessary action to close the nonconformity. Also evidence of audit of all elements
of ISO/IEC 17025:2005 and ISO 9001:2008 is maintained in clause wise document wise
audit review report (F/QMS/08). Auditor follows the Audit checklist (F/QMS/08/01) during
audit.
4.14.4 Followup audit activities are arranged to verify and record the implementation and
effectiveness of the corrective action taken. The audit activities are carried out as per
documented procedure to verify effectiveness of system in all departments for all the
requirements of standards. Upon satisfactory actions auditor close the nonconformity with
his findings and forward the copy to Quality Manger and audittee.
(Reference Quality Procedure No. QP/08)
4.15
Management Reviews
4.15.1
Management Review is carried out At least once in a twelve months as per the
documented procedure (QP/09). The ADV-METs Executive Manager conduct At least
once in a twelve month a review of the laboratorys management system and calibration
activities with all ADV-MET staff to ensure their continuing suitability and effectiveness, and
to introduce necessary changes or improvements. The review includes followings as
minimum;
4.15.2
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Advanced Metrology
Calibration Laboratory
(Reference Quality Procedure No. QP/09)
Related Quality Procedures
1.
QP/01
Document control
2.
QP/02
Contract review
3.
QP/03
Purchasing
4.
QP/04
Complaint handling
5.
QP/05
Control of nonconforming calibration work
6.
QP/06
Corrective and preventive actions
7.
QP/07
Control of records
8.
QP/08
Internal audit
9.
QP/09
Management review
Technical Manager
Calibration In charge
Mech. And Thermal
Calibration In charge
ElectroTechnical
Calibration Engineer/Technician
Calibration Engineer/Technician
Computer In
charge And
Accountant
Quality
Manager
Note
1. Quality Manager will work as deputy to Technical Manager and Technical Manager will work as
deputy to Quality Manager for smooth execution of routine activity in their absence.
2. Quality Manger can directly report to the Executive Manager for effective functioning on
requirements of ISO/IEC 17025:2005 and ISO 9001:2008.
5.0
5.1
General
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Technical Requirements
Advanced Metrology
Calibration Laboratory
5.1.1
Many factors determine the correctness and reliability of the calibration performed by ADVMET. These factors include contributions from;
5.1.2
The extent to which the factors contributed to the total uncertainty of measurement differs
considerably between (types of) calibrations. ADV-MET takes account of these factors in
developing calibration methods and procedures, in the training and qualification of
personnel, and in the selection and calibration of the equipment used. Necessary training
and qualification of personnel is ensured by way of maintaining records of all personnel.
5.2
Personnel
5.2.1
ADV-MET management has ensured the competence of all personnel of laboratory who
operate specific equipment, perform calibration, evaluate results, and sign calibration
certificates. The competent person having engineering / technical qualification (degree /
diploma) with minimum 1 year experience is used for calibration work. The list of authorized
personnel for review and approval of calibration certificates is maintained and followed.
When using staff, which are undergoing training, appropriate supervision is provided.
Personnel performing specific tasks are qualified on the basis of appropriate education,
training, experience and / or demonstrated skills, as required. Employees competence chart
is prepared for all employees considering competence requirements and competence
requirements fulfilled by ADV-MET staff. Records of employees competence are maintained
in training need record sheet (F/TRG/01) and Employees Competence Chart (F/QMS/12).
5.2.2
The management has formulated the goals with respect to the education, training and skills
of the personnel. ADV-MET has defined a policy and procedures for identifying training
needs and providing training of personnel (QP/10). The training programme relevant to the
present and anticipated tasks / work of the ADV-MET are arranged and training provided. All
employees are trained for quality system requirements and technical requirements
(Technical Training). The training needs of the employees are identified on the following
basis;
All such training identified is compiled and detailtraining calendar (F/TRG/03) is prepared.
Training is provided to the concern employees as identified and records of training are
maintained in training need cum record sheet (F/TRG/01). Also training effectiveness is
checked in (F/TRG/02) by following;
Routine implementation
By interviewing
By conducting exams
5.2.3
Whenever hiring or contracting any personnel for calibration work, the same should be
supervised by the technical manager and assured to work as per lab procedures.
5.2.4
ADV-MET has prepared current job descriptions (F/QMS/09) documents for managerial,
technical and key support personnel involved in calibration and same is communicated to
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Advanced Metrology
Calibration Laboratory
employees and are acknowledged by employees. The job description of each employee
includes followings;
Responsibility and authority considering type and nature of work done by the particular
position, including requirements of system
Reference of required education and experience etc.
5.2.5
5.2.6
Personnel records are maintained by the Quality Manager and contain personal data,
educational qualifications, professional experience, special skill, training records and results
of the competence assessment for all levels of employees.
5.3.1
ADV-MET facilities for calibration, including Energy Sources, Lighting, Noise Level, Vibration
Level and environmental conditions, have been identified considering nature of work and
provided to facilitate correct performance of the calibration. Procedure is established and
maintained for accommodation and environment condition (QP/11).
ADV-MET has ensured that the environmental conditions do not invalidate the results or
adversely affect the required quality of any measurement / calibration. The technical
requirements for accommodation and environmental conditions that can affect the results of
calibration have been documented.
5.3.2
5.3.3
There is effective separation between neighboring areas in which there are incompatible
activities, measures has taken to prevent crosscontamination. Neighboring area is
commercial and residential, hence no chances of industrial contamination.
5.3.4
Routine access to the Calibration area is restricted to all. Except laboratory concern staff are
having routine access. However if any customers, wants to witness the activities then he is
allowed only after approval of Executive Manager . Records of such entry in the working
area are maintained for further evaluation, if any
5.3.5
5.3.6
Also periodic checking is done as per the established procedure for Illumination Level and Noise
Level at ADV-METs Calibration area to ensure monitoring on environment conditions.
5.3.7
The limits are defined for all environmental affecting parameters as given below;
Limit
Sr.
Parameter
No.
Mechanical
Thermal
ElectroTechnical
1.
Page 19 of 32
Temperature
20 2 C
25 2 C
25 2 C
Advanced Metrology
Calibration Laboratory
2.
Humidity
40 to 60 % Rh
40 to 60 % Rh
40 to 60 % Rh
3.
Illumination
4.
Noise
60 dBA Max.
60 dBA Max.
60 dBA Max.
5.4.1
General
ADV-MET is using appropriate methods and procedures for all calibration within its scope.
These include handling, transport, storage and preparation of items to be calibrated, an
estimation of the measurement uncertainty as well as statistical techniques for analysis of
calibration data during routine operation.
ADV-MET has defined instructions on the use and operation of all relevant equipment, and
on the handling and preparation of items for Calibration. All instructions, standards, manuals
and reference data relevant to the work of ADV-MET are kept up to date and are made
readily available to personnel performing Calibration activities. Deviation from Calibration
methods has occurred only if the deviation has been documented, technically justified,
authorized, and accepted by the customer.
5.4.2
Selection of Methods
ADV-MET uses calibration methods given in relevant reference standards. Methods
published in international regional or national standard like SASO standard being used. The
ADV-MET has ensured that it uses the latest valid edition of a standard unless it is not
appropriate or possible to do so. Where required, the standard or relevant data of standard
are supplemented with additional details to ensure consistent application. All such
Calibration methods are informed to customers when requested.
As we are using methods based on national / international standard hence the further
selection of method is not applicable to us. All of our calibration methods identify the
followings;
Identification No.,
Scope of activity,
Description of item to be calibrated,
Parameters, ranges, least count etc.,
Equipment requirements, including technical performance requirements,
Reference of standards / materials on which basis the method is prepared,
Environment condition during Calibration including reference of soaking time
requirements,
Description of Calibration method, including
Preparation of item for Calibration,
Checks to be done before commencement of calibration
Method for recording observation / results in raw data sheet
Safety precautions to be taken before and during calibration
Criteria for Conformance / Compliance or Nonconformance / Noncompliance is
provided only at customers written request against the acceptance norms given in the
related Standards.
Calibration certificate preparation method
Reference of procedure for estimation of uncertainty in measurement, if any
Page 20 of 32
Advanced Metrology
Calibration Laboratory
As we are using methods based on national / international standards. Hence we do not need
to prepare laboratory developed method.
5.4.4
Nonstandard methods
We do not use any nonstandard method, hence it is not applicable to us, and this will not
be applicable to us.
5.4.5
Validation of methods
5.4.5.1
As we use only national / international published valid methods for calibration hence we do
not require to validate the methods. Validation of method is not applicable, as we are not
using nonstandard methods.
5.4.6
5.4.6.1
ADV-MET performing its own calibration has applied a procedure to estimate the uncertainty
of measurement (QP/13) for all calibration and types of calibration. Procedure is established
and is implemented for estimation of measurement uncertainty and uncertainties are
calculated as per defined procedure.
5.4.6.2
When estimation of the uncertainty of measurement, all uncertainty components that are of
importance in the given situation have been taken into account using appropriate method of
analysis. Also all such components are identified in the Calculation sheet for measurement
uncertainty (F/QMS/15/xx) and are followed.
5.4.6.3
Sources contributing to the uncertainty include the reference standards and reference
materials used, methods and equipment used, environmental conditions, properties and
condition of the item being calibrated, and the operator.
5.4.6.4
The predicted longterm behavior of the calibrated item is not normally taken into account
when estimating the measurement uncertainty.
5.4.6.5
The measurement uncertainty is calculated as per the established procedure and reference
standard of uncertainty in measurement uncertainty.
Control of Data
5.4.7.1
All calculations and data transfers generated and derived during routine activities are
checked by Technical Manager / Calibration In charge / Executive Manager at all stages of
operation systematically. For simplicity standard formats are prepared and used to reduce
error in report preparation.
5.4.7.2
Computer is used for entry of results and all required information during preparation of report
/ certificate. However for recording, storage and retrieval of such data following cares are
taken;
5.5
Equipment
5.5.1
ADV-MET has established and maintained procedure for equipment and reference materials
(QP/14) and furnished with all items of measurement and calibration equipment required for
the correct performance of calibration (including preparation of calibration items, processing
and analysis of calibration data). We are not using any equipment outside our permanent
control. Hence it is not applicable to us.
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Advanced Metrology
Calibration Laboratory
5.5.2
Equipment and its software used for Calibration are capable of achieving the accuracy
required and have complied with specifications relevant to the calibration during its
Calibration. Calibration schedule is established for all primary and secondary equipments,
where these properties have a significant effect on the results. Before being placed into
service, equipment are tested or checked to establish that it meets the specification
requirements of ADV-MET and complies with the relevant standard specifications. All such
Calibration details of equipments reviewed before use.
5.5.3
All equipments of laboratory are operated by authorized personnel. Also up to date work
instruction for routine used and preventive maintenance check points for maintenance of
such equipments are documented and are made readily available for use by the laboratory
personnel. Also manufacturers manual are also supported, where available to the users for
proper use of equipments.
5.5.4
Each item of the particular equipments and equipment itself are uniquely identified in the
laboratory including its Calibration status and validity.
5.5.5
Records are maintained for each item of equipment significant to the calibration performed
till date. The records includes at least the followings;
The identity of the item of equipment and its software including Name of the equipment /
reference materials,
The manufacturers name, type, identification, and serial number or other unique
identification
Date of receipt and placed in service where available,
Availability of copy of manufacturers manual,
Equipment history cards are maintained for any damage, malfunction, modification or
repair and Calibration.
The maintenance plan, where appropriate, and maintenance carriedout with date
Checks that equipment complies with the specification / accuracy / acceptance criteria
The current location, where appropriate
Dates, results and copies of reports and certificates of all calibration, adjustments,
acceptance criteria, and the due date of next Calibration
Any damage, malfunction, modification or repair to the equipment
5.5.6
Procedure is established for safe handling, transport storage use and planned maintenance
of measuring equipment to ensure proper functioning and in order to prevent contamination
or deterioration. It is strictly followed by all persons, during routine activities.
5.5.7
5.5.8
All primary and secondary equipments are identified by pasting sticker on equipment / box
for the status of Calibration, Calibration date, due for calibration.
5.5.9
We are not allowing our equipments to outside the direct control of our Lab. Hence this is not
applicable.
5.5.10
Defined intermediate check points are established and are followed as per the Standard
Operating Procedure to maintain confidence in the Calibration status of equipment and
calibration performed by the same equipment. Records of such intermediate checks are
maintained.
5.5.11
When calibration results give rise to a set of correction factors, copies maintained in hard
and soft both are updated correctly, considering rise in correction factor and the same is
applied during the routine test data.
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Advanced Metrology
Calibration Laboratory
5.5.12
All Calibration equipments, environment condition monitoring equipments are safe guarded
from the adjustment, which would invalidate the calibration results. Such things are
protected by pasting appropriate stickers so that damages to the stickers indicate mischief
with the equipments.
Measurement Traceability
5.6.1
General
All equipment used for calibration, including equipment for subsidiary measurements (e.g.
for environmental conditions) having a significant effect on the accuracy or validity of the
results of Calibration is calibrated before being put into service. ADV-MET has an
established programme and procedure for the Calibration of UUT. Procedure no. QP/15. The
procedure covers details like selection, use, Calibration, checking, controlling and
maintenance of measurement standards, reference standards for measuring equipment.
5.6.2
Specific Requirements
5.6.2.1
Calibration
5.6.2.1.1
The programme for Calibration of equipment is designed and operated so as to ensure that
calibration and measurements made by the ADV-MET are traceable to the international
system of units (SI) through a National / International Standards.
5.6.2.1.2
We have identified our primary master for Calibration through outside Calibration
laboratory providing unbroken chain of Calibration (either SASO SAC accredited
laboratory or equivalent).
Our secondary master equipments are Calibrated inhouse through outside Calibrated
primary masters.
Our reference masters are calibrated though accredited competent Calibration
laboratory. Only after checking best measurement capability of laboratory, which can
satisfy our requirements for Calibration.
All the Calibration Certificates received from the outside laboratory are first reviewed for
its competence, measurement capability and traceability. Also the measurement results,
measurement uncertainty and statement of compliance etc. and other details given in the
procedure (QP/15) are checked to ensure validity of Calibration and Calibration
Certificates issued by outside laboratory.
Also the certificate prepared for secondary master inhouse is also reviewed as per the
same checks given above.
It is ensured that accreditation logo must be available on all master equipments
certificates of ADV-MET.
In our laboratory no such equipments are there whose calibration currently cannot be
strictly made as above. Hence this paragraph of standard is not applicable to us.
5.6.3.1
Reference Standards
ADV-MET has defined programme and procedure for the Calibration of its reference
standards. Reference standards have been calibrated by a body that can provide traceability
as described in 5.6.2.1. Such reference standards of measurement held by the laboratory
are used for Calibration only and for no other purpose, unless it can be shown that their
performance as reference standards would not be invalidated. Reference standards are
tested before and after any adjustment.
5.6.3.2
Reference Materials
In operation of calibration activity no reference material is used by ADV-MET.
Page 23 of 32
Advanced Metrology
Calibration Laboratory
5.6.3.3
Intermediate Checks
Checks needed to maintain confidence in the Calibration / Accuracy status of reference;
Equipments used for calibration are defined and are conducted on each equipment
periodically. Records of intermediate checks conducted on all the equipments used in the
calibration are maintained along with the results of checks. Intermediate check schedule is
prepared and followed. During intermediate checks, if any equipment found having doubt in
the required accuracy and precision, then the same is treated as per the procedure for
control of nonconforming work.
5.6.3.4
5.6.3.5
Calibration Programme
All measuring and testing instruments having an effect on the accuracy or validity of
calibrations are calibrated before putting into service. The calibration schedule for the
masters is prepared and followed accordingly.
Where relevant reference standards and measuring and testing equipment are subjected
to in service checks between calibration and verifications.
5.7
Sampling
5.7.1
5.7.2
This Element is not applicable to us, the same is referred here to align clause numbering.
5.7.3
As we only do selection of calibration points hence further to these is not applicable to us.
5.8.1
ADV-MET has defined procedures for the transportation, receipt, handling, protection,
storage, retention and / or disposal of calibration items (QP/17), including all provisions
necessary to protect the integrity of the calibration items, and to protect the interests of the
ADV-MET and the customer.
Page 24 of 32
Advanced Metrology
Calibration Laboratory
5.8.2
As soon as UUT is received at ADV-MET, first of all details of all such sample are entered in
the inward outward register (F/INV/01). Also sticker is affixed on each UUT specifying
services request no. / sr. no. of UUT on the UUT / box, as appropriate. After that the
calibration service request UUT receipt form (F/QMS/31) is prepared.
5.8.3
Upon receipt of the UUT, the condition of UUT is checked as per the details given in the
Calibration method. The records of such checks conducted are maintained. When there is
doubt as to the suitability of an item for Calibration, or when an item does not confirm to the
description provided, or the Calibration parameter requirements are not specified in sufficient
detail, ADV-MET consults the customer for further instructions before proceeding.
5.8.4
ADV-MET has defined procedures and appropriate facilities for avoiding deterioration, loss
or damage to the calibration item during storage, handling and preparation. Handling
instruction provided with the items has to be followed. When items have to be stored or
conditioned under specified environmental condition, these conditions have been
maintained, monitored and recorded in calibration standard room. Where a calibration item
or a portion of an item is to be held secure, ADV-MET has arrangements for storage and
security that protect the condition and integrity of the secured items or portions concerned.
5.8.5
The process followed for UUTs collection, UUT handling and storage are well defined and
the UUT quantity required for each calibration is defined.
After UUT is received in our laboratory and after recording the details in Inward outward
register, the UUT is checked during receipt for ;
Physical condition,
Proper functioning, (abnormalities, malfunctioning etc.)
Parameters to be calibrated,
Availability of details specification etc.
5.9.1
ADV-MET has quality control procedures (QP/18) for monitoring the validity of calibration
undertaken on the customers UUTs. The resulting data are recorded in such a way that
trends are detectable and statistical techniques have been applied (as identified in
procedure) to the reviewing of the results. This monitoring is planned and reviewed and may
include but not limited to the followings;
5.9.2
Regular use of certified reference materials and / or internal quality control using
secondary reference materials;
Participation in inter laboratory comparison or proficiency calibration programs
Recalibration of retained items
Correlation of results for different characteristics of an item
Verification of reference materials, periodically.
All the above described quality control checks are followed by ADV-MET as defined in
procedure no. QP/18 and records are maintained.
Quality control data are analysed and, where they are found outside predefined criteria,
actions are planned and taken to correct the problem and to prevent incorrect results from
being reported.
5.10.1
General
The results of each calibration, or series of calibration carried out by the ADV-MET are
reported accurately, clearly, unambiguously and objectively, and in accordance with any
specific instructions as referred in the Calibration methods.
Page 25 of 32
Advanced Metrology
Calibration Laboratory
The results are reported, usually in a Calibration Certificate, and includes all the information
requested by the customer and necessary for the interpretation of the Calibration results
and all information required by the method used. This information as described in next
paragraph 5.10.2 and 5.10.4.
We are an independent laboratory and we are not having any internal customers, hence the
same is not applicable to us.
5.10.2
Calibration certificate
For different type of UUTs standard formats are made to report calibration results. Each
Calibration Certificate includes at least the following information, unless the ADV-MET has
valid reasons for not doing so;
5.10.3
Test Report
5.10.3.1
5.10.4
Calibration Certificate
5.10.4.1
In addition to the requirements listed 5.10.2 calibration certificate includes the following, for
the interpretation of calibration results
5.10.4.2
The conditions (e.g. environmental) under which the calibration were made that have an
influence on the measurement results
The calibration certificate relates only to quantities and the results of functional calibration. If
a statement of compliance with a specification is made, this identifies which clauses of the
specification are met or not met. The same is done only at customer requirements.
When a statement of compliance with a specification is made omitting the measurement
results and associated uncertainties, ADV-MET is recording those results and maintains
them for possible future reference.
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Advanced Metrology
Calibration Laboratory
When statements of compliance are made, the uncertainty of measurement is taken into
account in the calibration certificate.
5.10.4.3
When UUT for calibration has been adjusted or repaired, the calibration results before and
after adjustment or repair, are reported suitably to identify status of calibration.
5.10.4.4
A calibration certificate (or calibration label) does not contain any recommendation on the
calibration interval except where this has been agreed with the customer in our calibration
service request UUT receipt form. This requirement is superseded by legal regulations.
5.10.5
5.10.8
5.10.9
Such amended certificate also complies the requirements given in 5.10.2 and 5.10.4.
When it is necessary to issue a complete new Calibration certificate, this has been uniquely
identified and has contained a reference to the original that it replaces. In such cases, the
Calibration certificate is identified as Duplicate.
(Reference Quality Procedure No. QP/19)
Page 27 of 32
Advanced Metrology
Calibration Laboratory
Related Quality Procedures
10.
QP/10
11.
QP/11
12.
QP/12
Working procedure
13.
QP/13
Measurement uncertainty
14.
QP/14
15.
QP/15
16.
QP/16
17.
QP/17
18.
QP/18
19.
QP/19
Page 28 of 32
Advanced Metrology
Calibration Laboratory
ISO/IEC
1
7
0
2
5
C
l
a
u
s
e
Sr.
Quality
Proce
dure
Numb
er
N
u
m
b
e
r
1.
4.2
4.3
Document control
QP/01
2.
7.2
4.4
Contract review
QP/02
3.
7.4
4.6
Purchasing
QP/03
4.
7.2.3
4.8
Complaint handling
QP/04
5.
8.3
4.9
QP/05
6.
8.5.2
4.11 / 4.12
QP/06
7.
4.2.4
4.13
Control of records
QP/07
8.
8.2.2
4.14
Internal audit
QP/08
9.
4.6
4.15
Management review
QP/09
10.
6.2
5.2
QP/10
5.3
QP/11
12.
7.5
5.4
Working procedure
QP/12
13.
5.4.6
Measurement uncertainty
QP/13
14.
6.1
5.5 / 5.6.3
QP/14
15.
7.5
5.6
QP/15
16.
7.5
5.7
QP/16
17.
7.5
5.8
QP/17
18.
7.5
5.9
QP/18
Page 29 of 32
Advanced Metrology
Calibration Laboratory
7.5
19.
5.10
Preparation
and review of
certificates / reports
calibration
QP/19
Abbreviation
For
1.
ADV-MET
2.
Top Management
Executive Manager
3.
QM
Quality Manual
4.
QP
Quality Procedure
5.
CM
6.
TM
Technical Manager
7.
Exhibit
8.
NCR
9.
IQA NCR
10.
AVL
11.
CAR
12.
PAR
13.
Clause 1
Clause 1
14.
Clause 2
Clause 2
15.
Clause 3
Clause 3
16.
4.1
4.1, 4.1.1, 4.1.2, 4.1.3, 4.1.4, 4.1.5, 4.2, 4.2.1, 4.2.2, 4.2.3, 4.2.4
17.
4.2.1
18.
4.2.3
4.3
Sr.
No.
Page 30 of 32
Advanced Metrology
Calibration Laboratory
19.
4.2.4
4.3.1, 4.12
20.
5.1
4.2.2, 4.2.3
21.
5.1 a)
4.1.2, 4.1.6
22.
5.1 b)
4.2.2
23.
5.1 c)
4.2.2
24.
5.1 d)
4.15
25.
5.1 e)
4.1.5
26.
5.2
4.4.1
27.
5.3
4.2.2
28.
5.3 a)
4.2.2
29.
5.3 b)
4.2.3
30.
5.3 c)
4.2.2
31.
5.3 d)
4.2.2
32.
5.3 e)
4.2.2
33.
5.4.1
4.2.2 c)
34.
5.4.2
4.2.1
35.
5.4.2 a)
4.2.1
36.
5.4.2 b)
4.2.1
37.
5.5.1
38.
5.5.2
4.1.5 i)
39.
5.5.2 a)
4.1.5 i)
40.
5.5.2 b)
4.11.1
41.
5.5.2 c)
4.2.4
42.
5.5.3
4.1.6
43.
5.6.1
4.15
44.
5.6.2
4.15
45.
5.6.3
4.15
46.
6.1 a)
4.10
47.
6.1 b)
48.
6.2.1
5.2.1
49.
6.2.2 a)
5.2.2, 5.5.3
50.
6.2.2 b)
5.2.1, 5.2.2
51.
6.2.2 c)
5.2.2
52.
6.2.2 d)
4.1.5 k)
53.
6.2.2 e)
5.2.5
54.
6.3.1 a)
Page 31 of 32
Advanced Metrology
Calibration Laboratory
55.
6.3.1 b)
56.
6.3.1 c)
57.
6.4
58.
7.1
5.1
59.
7.1 a)
4.2.2
60.
7.1 b)
61.
7.1 c)
5.4, 5.9
62.
7.1 d)
63.
7.2.1
64.
7.2.2
65.
7.2.3
66.
7.3
5, 5.4, 5.9
67.
7.4.1
68.
7.4.2
4.6.3
69.
7.4.3
4.6.2
70.
7.5.1
71.
7.5.2
72.
7.5.3
5.8.2
73.
7.5.4
74.
7.5.5
75.
7.6
5.4, 5.5
76.
8.1
77.
8.2.1
4.10
78.
8.2.2
4.11.5, 4.14
79.
8.2.3
80.
8.2.4
81.
8.3
4.9
82.
8.4
4.10, 5.9
83.
8.5.1
4.10, 4.12
84.
8.5.2
4.11, 4.12
85.
8.5.3
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