Hellenic Accreditation System S.A.

GUIDANCE ON THE APPLICATION OF THE LABORATORY

ACCREDITATION CRITERIA

MEASUREMENT AND CALIBRATION SYSTEMS

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 Hellenic Accreditation System S.A.

ESYD GA 1

Issue: 01
Revision: 06
Issue Date: 14-03-1997
Revision Date: 20-06-2007
Prepared by: Quality Manager of ESYD
Approved by: Chairman of ESYD

Quality Manager of ESYD Chairman of ESYD

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MEASUREMENT AND CALIBRATION SYSTEMS

0 INTRODUCTION

0.1 ESYD GA1 contains the ESYD requirements for measurement traceability and
calibration. This Guideline has been prepared to ensure that laboratories
comply with both the measurement and traceability requirements of ELOT EN
ISO/IEC 17025 and the relevant requirements for calibration and testing
equipment set out in ISO 10012: 2003.

0.2 The requirements of this Guideline shall be met by all ESYD accredited
calibration laboratories and testing laboratories when providing an ESYD
accredited calibration or testing service for a Client, or performing in-house
calibrations in support of their accredited activities.

0.3 For the purposes of this Guideline, the terminology of ELOT EN ISO/IEC 17025
and the definitions of ISΟ 10012:2003 apply.

1 GENERAL

1.1 The Laboratory shall have a system for selecting, using, calibrating, checking,
controlling and maintaining measurement standards, reference materials used
as measurement standards and measuring/test equipment used in the
performance of accredited calibrations and tests. Measurements performed by
the Laboratory and by sub-contractors that it uses shall be covered by this
system.

1.2 This system shall be designed to ensure that the Laboratory has the necessary
procedures and resources to carry out calibrations, tests and supporting
measurements within the required time-scales and designated limits. The
Laboratory should set these limits and they shall be consistent with the
Laboratory’s schedule of accreditation, the relevant calibration or test
specifications and/or the requirements of the Client. The system shall also
ensure that any measuring and test equipment, and any reference material
used, performs as intended.

1.3 The system shall include arrangements to prevent errors that are outside
specified limits of permissible error, and to provide for rapid detection of
deficiencies and immediate corrective action as required by ELOT EN ISO/IEC
17025.

1.4 The policies and the procedures for this system shall be documented in the
Laboratory’s quality manual and associated quality documentation. They shall
clearly define the responsibilities and duties of each member of staff involved in
the activities listed in paragraph 1.1 of this Guideline.

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1.5 The Quality Manager shall ensure that the measurement and calibration system
used by the Laboratory is included in the program for quality system audits, and
that the results of such audits are evaluated at the Laboratory’s periodic review
of the quality system.

1.6 Laboratory staff shall have the qualifications, training, experience and skill to
perform the tasks referred to in this Guideline. Staff training shall be maintained
up-to-date .

1.7 As required by ELOT EN ISO/IEC 17025, the Laboratory shall maintain records
on training, competency and staff authorized to use equipment or/and reference
materials or perform calibrations or/and tests in-house or in the Client’s house.

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2 PLANNING AND SELECTION OF EQUIPMENT/REFERENCE

MATERIALS

2.1 The Laboratory shall review the requirements of the Client, and of any relevant
technical specification, before commencing calibration or testing. If the work is
within the capability of the Laboratory it shall, before commencing, establish a
program to ensure that measurement standards/reference materials,
measuring/test equipment and environmental conditions necessary for the
performance of the work are available to achieve the accuracy, stability, range
and resolution required. The Laboratory shall also ensure that it has the staff
resources needed.

2.2 The Laboratory shall ensure that all the items of measuring equipment needed
for the work, including reference measurement standards, meet the
requirements of ESYD GA 1.

2.3 The Laboratory shall also ensure that, where required by ESYD, it uses
reference materials as measurement standards to assist in the estimation of
uncertainties of measurement, to calibrate measuring and test equipment, to
monitor Laboratory performance and to validate methods. Where required,
reference materials shall also be used as transfer standards to compare
methods.

2.4 Wherever possible, the Laboratory should use both primary pure reference
materials and reference materials that have matrices matching those of the
calibration/test items to take account of matrix effects.

2.5 The Laboratory shall also, wherever possible, use reference materials that have
been certified as having been produced and characterized in a technically valid
manner. The use of organizations operating to the ISO 9000 series of standards
for the production of reference materials, which also perform their analysis or
testing activities in accordance with ELOT EN ISO/IEC 17025, would provide
assurance of the quality of reference materials. The certificate shall, wherever
possible, also provide evidence of traceability to national or international
standards of measurement, or to national or international standard reference
materials.

2.6 Where a certified reference material is not available, reference materials with
suitable properties and stability shall be used. The properties required of these
materials shall, wherever possible, be characterized by acceptable procedures
such as those as recommended in ISO Guide 35:2006, "Certification of
reference materials – General and statistical principles for certification". These

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procedures may include: analysis/testing by a definitive method; analysis/testing

by a number of methods based on different physical or chemical principles, or
analysis/testing by a number of laboratories using either the same or different
methods.

2.7 Where the Laboratory prepares standards from materials of known properties,
or purchases uncertified standards such as chemical standards, the Laboratory
shall verify that the standards are of acceptable quality and suitable for the
purpose. Standards should be purchased, where possible, from suppliers as
detailed in 2.5 of this Guideline.

3 UNCERTAINTY OF MEASUREMENT

3.1 The Laboratory is required to produce an estimate of the uncertainty of its

measurements, to include the estimation of uncertainty in its methods and
procedures for calibration and testing, and to report the uncertainty of
measurement in calibration certificates and in test certificates and test reports,
where relevant.

3.2 Estimates of uncertainty of measurement shall take into account all significant
identified uncertainties in the measurement and testing processes, including
those attributable to measuring equipment, reference measurement standards
(including material used as a reference standard), staff using or operating
equipment, measurement procedures, sampling and environmental conditions.

3.3 In estimating uncertainties of measurement, the Laboratory shall take into

account the data obtained from internal quality control schemes and other
relevant sources, (see ELOT EN ISO/IEC 17025). The Laboratory shall also
ensure that any requirements for the estimation of uncertainty and for the
determination of compliance with specified requirements shall be stated as in
the relevant EA publications.

3.4 In setting the acceptance limits for the calibration of measuring and testing
equipment, the Laboratory shall ensure that the limits chosen allow for the
conditions under which the equipment or reference material is to be used. Such
limits may be significantly different to those applicable during the calibration
process.

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4 CALIBRATION PROCEDURES- CALIBRATION CERTIFICATES

4.1 The Laboratory shall use methods and procedures for the calibration of
measuring equipment, reference measurement standards (including reference
materials) and test equipment used in calibration and testing laboratories that
comply with the requirements of ELOT EN ISO/IEC 17025. The methods and
procedures shall include, but not be limited to:

(a) identification of the instrument, gauge or test equipment, or group of

such items to which the procedure is applicable

(b) identification of all measurement standards/reference materials and

associated equipment used to perform the calibration

(c) the procedures to be adopted for handling, transporting, storing and

using measuring equipment and reference materials used for
calibration, including details of lifetime and measures to prevent
contamination or loss of determinant

(d) the procedures to be adopted for handling, transporting, storing and

preparing items for calibration

(e) the environmental conditions that must be used, the limits applicable,
the procedure for any corrections that may have to be made as a result
of the environmental conditions and, where relevant, the minimum
period of stabilization before calibration

(f) the method or procedure for calibration in the form of written

instructions and diagrams where appropriate

(g) details of the measurement or calibration data to be recorded and the

method for presentation and analysis of this data

(h) the limits of acceptance for the calibration data for the item or type of
item being calibrated

(i) the estimation of the uncertainty of measurement of the calibration

process (see paragraph 4.2 of this Guideline)

(j) the procedures to be adopted for selecting calibration intervals when

the equipment/reference material is being used by the Laboratory to
perform calibration or tests

(k) the procedures for checking equipment and reference materials

between calibrations

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(l) an identification number, number of pages, date of issue and name and
person authorizing issue and use of the procedure.

4.2 In its procedures for estimating the uncertainty of the calibration process, the
Laboratory shall take into account the cumulative effect of the uncertainties of
measurement of each successive stage in the chain of calibrations for each
measurement standard and item of equipment calibrated. The Laboratory shall
take action when the total uncertainty of measurement is such that it
significantly compromises its ability to make measurements within the limits of
permissible error.

4.3 Where the Laboratory uses the services of an external organization to calibrate
measuring and test equipment, the requirements of ELOT EN ISO/IEC 17025
shall be met. If the services of a ESYD accredited calibration laboratory are not
available, the Laboratory shall ensure that the calibration certificate provided
contains the information described in the following paragraph.

4.4 The Calibration certificate shall include at least the following information:

(a) the title “Certificate of Calibration”

(b) the name and the address of the laboratory and the place where the
measurements were took place, if it is different than that of the
laboratory premises
(c) a unique identification of the calibration certificate (e.g. the issue
number) and into each page an identification element, in order to
ensure that the page is recognized as part of the calibration certificate,
and also a clear identification of the end of the certificate.
(d) the name and the address of the client
(e) the identification of the method and the instrumentation used (type of
instrument and serial number)
(f) the description, the status and the identity of the calibrated item
(g) the receipt date of the item when it is critical for the validity and the
application of the results and the date of calibration
(h) information about the plan and sampling procedures used by the
laboratory or other organizations
(i) the calibration results and where are necessary the units
(j) the name, the position and the signature of the person(s) who are in
charge to grant the calibration certificate
(k) where it is relevant, a statement that the results are related only with the
calibrated items
(l) the conditions (eg environmental) under which the calibration was
carried out
(m) the uncertainty of measurement (*) or/and a a statement of compliance
with any relevant metrological specification
(n) a statement indicating how traceability to national standards has been
achieved

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(o) for calibration certificates which are within the Scope of Accreditation of
the laboratory, the accreditation certificate issue number and the logo of
the Accreditation Body
(p) a statement that the certificate shall not be reproduced other than in full
and after the written approval of the Lab
(q) the seal of the Lab

(*) the confidence levels should accompany the uncertainty of the measurement

An example of a Calibration Certificate is the following:

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ΠΙΣΤΟΠΟΙΗΤΙΚΟ ∆ΙΑΚΡΙΒΩΣΗΣ
∆ιακριβώσεις *
Αρ. Πιστ. ΧΧΧ

(* εφόσον το Πιστοποιητικό περιέχει διαπιστευµένες µετρήσεις)

Certificate of Calibration
Αριθµός πιστοποιητικού / Certificate number :D9-06-XXX
Αριθµός σειράς οργάνου / Instrument serial No: XXXX

Θέση Λογότυπου Εργαστηρίου

Εκδόθηκε από / Issued by :
Τίτλος Εργαστηρίου
Laboratory Name
Εργαστήριο Θερµοκρασίας
Laboratory of Temperature ∆ιεύθυνση Εργαστηρίου,
.........................................
Laboratory Address
................................
Tηλ./Tel. +030 .............., Fax +030 ..................
e-mail: ....................

Πελάτης / Customer:

Κωδικός αντικειµένου / Item Code: 18/03-06/6

Περιγραφή: Θερµόµετρο Υδραργύρου, εύρος κλίµακας: 50 έως 100 oC,
διαγράµµιση κλίµακας: 0,5oC, µερικής βύθισης: 3 inch

Description: Mercury in glass thermometer, scale range: 50 to 100 oC

scale division: 0,5 oC, partial immersion: 3 inch

Κατασκευαστής / Manufacturer: BAIRD & TATLOCK British make N/F

Τύπος / Type: ZECOL

Αριθµός Σειράς / Serial Number: XXXXX

Ηµεροµηνία Παραλαβής / Date of receipt: 29/03/06

∆εν επιτρέπεται η αναπαραγωγή του πιστοποιητικού αυτού παρά µόνο καθ' ολοκληρία, εκτός αν δοθεί γραπτή έγκριση από "Τίτλος
Εταιρείας" και "Τίτλος Εργαστηρίου" που το εκδίδει. Πιστοποιητικά ∆ιακρίβωσης µη φέροντα σφραγίδα και υπογραφή δεν έχουν
ισχύ. Αντίγραφο του παρόντος πιστοποιητικού θα διατηρηθεί στο εργαστήριο που το εκδίδει για µία περίοδο τουλάχιστο δέκα ετών.
Τα αποτελέσµατα αφορούν µόνο τα αντικείµενα που έχουν διακριβωθεί.
This certificate may not be reproduced other than in full, except with the prior written approval of both the Laboratory Name and
the issuing laboratory. Calibration Certificates without seal and signature are not valid. A copy of this certificate will be kept at
the issuing laboratory for a period of at least ten years. The results concern only the calibrated items

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ΠΙΣΤΟΠΟΙΗΤΙΚΟ ∆ΙΑΚΡΙΒΩΣΗΣ
∆ιακριβώσεις *
Αρ. Πιστ. ΧΧΧ

(* εφόσον το Πιστοποιητικό περιέχει διαπιστευµένες µετρήσεις)

Certificate of Calibration
Αριθµός πιστοποιητικού / Certificate number :D9-06-XXX
Αριθµός σειράς οργάνου / Instrument serial No: XXXX
Ηµεροµηνία ∆ιακρίβωσης: 14/04/06
Date of Calibration:
Σφραγίδα / Seal : Ηµεροµηνία έκδοσης / Υπογραφή / Signature:
Date of issue: 02/05/06

Υπεύθυνος Εργαστηρίου / Person in charge of the Laboratory

∆ιακρίβωση θερµοµέτρου Υδραργύρου µε τη µέθοδο της σύγκρισης /

Comparison calibration of Mercury in glass thermometer

1. Κατάσταση αντικειµένου προς διακρίβωση / Condition of object to be calibrated

Το θερµόµετρο κατά την παραλαβή ήταν σε καλή κατάσταση / the thermometer is in good condition

2. Συνθήκες εργαστηρίου διακρίβωσης / Laboratory ambient conditions

Θερµοκρασία / Temperature: 23 ± 2oC
Σχετική Υγρασία / Relative Humidity: 45 ± 10 % R.H.

3. ∆ιαδικασία ∆ιακρίβωσης / Calibration Procedure

Το θερµόµετρο διακριβώθηκε µέσω σύγκρισης των ενδείξεών του µε τις θερµοκρασιακές ενδείξεις από
δύο θερµόµετρα αναφοράς. Η σύγκριση έγινε µέσα σε συνεχώς αναδευόµενο λουτρό νερού. Το
θερµόµετρο διακριβώθηκε σε συνθήκες µερικής βύθισης της στήλης του υδραργύρου στο υγρό του
λουτρού βαθµονόµησης (3 inches,σύµφωνα µε τις προδιαγραφές του). Ως θερµόµετρα αναφοράς
χρησιµοποιήθηκαν δύο θερµόµετρα αντιστάσεως Λευκόχρυσου, ονοµαστικής αντιστάσεως 100Ω,
στους 0,01oC.
∆εν επιτρέπεται η αναπαραγωγή του πιστοποιητικού αυτού παρά µόνο καθ' ολοκληρία, εκτός αν δοθεί γραπτή έγκριση από "Τίτλος Εταιρείας"
και "Τίτλος Εργαστηρίου" που το εκδίδει. Πιστοποιητικά ∆ιακρίβωσης µη φέροντα σφραγίδα και υπογραφή δεν έχουν ισχύ. Αντίγραφο του
παρόντος πιστοποιητικού θα διατηρηθεί στο εργαστήριο που το εκδίδει για µία περίοδο τουλάχιστο δέκα ετών.
Τα αποτελέσµατα αφορούν µόνο τα αντικείµενα που έχουν διακριβωθεί.
This certificate may not be reproduced other than in full, except with the prior written approval of both the Laboratory Name and the issuing
laboratory. Calibration Certificates without seal and signature are not valid. A copy of this certificate will be kept at the issuing laboratory for
a period of at least ten years. The results concern only the calibrated items

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ΠΙΣΤΟΠΟΙΗΤΙΚΟ ∆ΙΑΚΡΙΒΩΣΗΣ
∆ιακριβώσεις *
Αρ. Πιστ. ΧΧΧ

(* εφόσον το Πιστοποιητικό περιέχει διαπιστευµένες µετρήσεις)

Certificate of Calibration
Αριθµός πιστοποιητικού / Certificate number :D9-06-XXX
Αριθµός σειράς οργάνου / Instrument serial No: XXXX
The thermometer was calibrated by comparison using two standard Platinum resistance thermometers
as a reference. The comparison was performed in a continuously stirred water bath. The thermometer
was calibrated under conditions of partial immersion in the liquid bath (3inches, according to its
specifications). The reference thermometers used have a nominal resistance value of 100 Ohms at 0,01
o
C.

4. Ιχνηλασιµότητα / Traceability
Τα πρότυπα θερµόµετρα αντιστάσεως Λευκόχρυσου που χρησιµοποιήθηκαν σαν αναφορά (Αρ. Σειράς:
24000/1 & 24000/2), έχουν πιστοποιητικά διακρίβωσης µε ιχνηλασιµότητα στα Εθνικά πρότυπα της
Ελλάδας.
The reference standard Platinum resistance thermometers used (Serial No: 24000/1 & 24000/2) bear
calibration certificates traceable to the national standards of Greece.

5. Αβεβαιότητα / Uncertainty
Η διευρυµένη αβεβαιότητα που αναφέρεται είναι το γινόµενο της τυπικής αβεβαιότητας (u) µε τον
συντελεστή κάλυψης k = 2 και παρέχει επίπεδο εµπιστοσύνης 95%. Προσδιορίζεται σύµφωνα µε το
έντυπο «Guide to the expression of uncertainty in measurement» (ISO, Geneva, 1995).
Περιλαµβάνει την αβεβαιότητα της θερµοκρασίας αναφοράς και την αβεβαιότητα του οργάνου υπό
διακρίβωση.
Αφορά τις µετρήσεις κατά την διάρκεια της διακρίβωσης και δεν περιέχει ενδεχόµενες
µακροπρόθεσµες µεταβολές του οργάνου. Είναι ευθύνη του χρήστη να προσδιορίσει τις µεταβολές
αυτές καθώς και την αβεβαιότητα µέτρησης του οργάνου στις εκάστοτε συνθήκες χρήσης του.
The reported expanded uncertainty is based on a standard uncertainty (u) multiplied by a coverage
factor k = 2, providing a confidence level of 95%. It has been evaluated in accordance to the «Guide
to the expression of uncertainty in measurement» (ISO, Geneva, 1995).
It includes the reference temperature uncertainty and the instrument under test uncertainty.
It applies at the time of the calibration only. It is the user’s responsibility to determine the long term
drift and the uncertainty under the actual conditions of use.

6. Αποτελέσµατα ∆ιακρίβωσης/ Calibration Results

∆εν επιτρέπεται η αναπαραγωγή του πιστοποιητικού αυτού παρά µόνο καθ' ολοκληρία, εκτός αν δοθεί γραπτή έγκριση από "Τίτλος Εταιρείας"
και "Τίτλος Εργαστηρίου" που το εκδίδει. Πιστοποιητικά ∆ιακρίβωσης µη φέροντα σφραγίδα και υπογραφή δεν έχουν ισχύ. Αντίγραφο του
παρόντος πιστοποιητικού θα διατηρηθεί στο εργαστήριο που το εκδίδει για µία περίοδο τουλάχιστο δέκα ετών.
Τα αποτελέσµατα αφορούν µόνο τα αντικείµενα που έχουν διακριβωθεί.
This certificate may not be reproduced other than in full, except with the prior written approval of both the Laboratory Name and the issuing
laboratory. Calibration Certificates without seal and signature are not valid. A copy of this certificate will be kept at the issuing laboratory for
a period of at least ten years. The results concern only the calibrated items

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ΠΙΣΤΟΠΟΙΗΤΙΚΟ ∆ΙΑΚΡΙΒΩΣΗΣ
∆ιακριβώσεις *
Αρ. Πιστ. ΧΧΧ

(* εφόσον το Πιστοποιητικό περιέχει διαπιστευµένες µετρήσεις)

Certificate of Calibration
Αριθµός πιστοποιητικού / Certificate number :D9-06-XXX
Αριθµός σειράς οργάνου / Instrument serial No: XXXX

Ένδειξη του προς διακρίβωση ∆ιόρθωση Θερµοκρασία εξέχουσας Aβεβαιότητα

θερµοµέτρου(oC) ένδειξης (oC) στήλης υδραργύρου* (oC) µέτρησης (2u)

Temperature reading of the Indication Emergent liquid column Measurement

thermometer under calibration (oC) correction(oC) temperature *(oC) uncertainty (2u)
60,00 -0,15 42 ±0,10oC

99,00 -0,25 65 ±0,10oC

*Σε περίπτωση που το όργανο χρησιµοποιηθεί σε διαφορετική θερµοκρασία εξέχουσας στήλης,

από αυτή που αναφέρεται στο πιστοποιητικό διακρίβωσης, πρέπει να γίνει µία πρόσθετη διόρθωση
στην ένδειξη του θερµοµέτρου, µε βάση την εξίσωση

C = nk(Tcert-Tuser) όπου :

n = ο αριθµός των βαθµών της εξέχουσας στήλης

k = ο συντελεστής διαστολής του υδραργύρου σε γυαλί (=0,00016 0C-1)
Tcert = η τιµή (θερµοκρασία εξέχουσας στήλης) από το πιστοποιητικό διακρίβωσης
Tuser = η θερµοκρασία εξέχουσας στήλης κατά τη χρήση

Τέλος Πιστοποιητικού ∆ιακρίβωσης / End of Calibration Certificate

∆εν επιτρέπεται η αναπαραγωγή του πιστοποιητικού αυτού παρά µόνο καθ' ολοκληρία, εκτός αν δοθεί γραπτή έγκριση από "Τίτλος Εταιρείας"
και "Τίτλος Εργαστηρίου" που το εκδίδει. Πιστοποιητικά ∆ιακρίβωσης µη φέροντα σφραγίδα και υπογραφή δεν έχουν ισχύ. Αντίγραφο του
παρόντος πιστοποιητικού θα διατηρηθεί στο εργαστήριο που το εκδίδει για µία περίοδο τουλάχιστο δέκα ετών.
Τα αποτελέσµατα αφορούν µόνο τα αντικείµενα που έχουν διακριβωθεί.
This certificate may not be reproduced other than in full, except with the prior written approval of both the Laboratory Name and the issuing
laboratory. Calibration Certificates without seal and signature are not valid. A copy of this certificate will be kept at the issuing laboratory for
a period of at least ten years. The results concern only the calibrated items

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5 RECORDS

5.1 The Laboratory shall maintain records for each item of measuring equipment,
including reference measurement standards and reference material standards
and test equipment, used in the performance of calibration or tests. The records
shall show, either through in-house documentation or calibration certificates
from external organizations, that each calibration in the chain of traceability has
been carried out.

5.2 The Laboratory shall ensure that the records contain detailed information of the
equipment/reference material used for calibrations (see ELOT EN ISO/IEC
17025), and that there is also a full and up-to-date history of the calibration of
this equipment/reference material (see ELOT EN ISO/IEC 17025).

5.3 The records shall provide sufficient information to demonstrate the

measurement capability and traceability of each item of measuring equipment
and the range of use of each reference material, its lifetime and required
storage conditions.

5.4 Each record shall include or refer to:

(a) the date on which each calibration was performed

(b) the calibration results obtained after and, where relevant, before any
adjustment and repair

(c) the specified calibration interval

(d) reference to the calibration method or procedure used and any relevant
standard or specification

(e) the specified limits of permissible error

(f) calibration certificates, bearing the ESYD logo, from ESYD accredited
calibration laboratories of appropriate measurement capability or from
the Laboratory holding the national standard for the measurement
standards used, or from a laboratory meeting the requirements for
traceability specified in ESYD GA2, Traceability of Measurement

(g) certificates or other documentation, for all reference materials used for
calibration, providing evidence of characterization of the material, and
evidence of traceability to national or international standards of
measurement, or to national or international standard reference
materials

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(h) the environmental conditions at the time of calibration and the

corrections made, where necessary, for such conditions

(i) a statement of the uncertainties of measurement involved in the

calibration and of their cumulative effect

(j) any design or performance specifications met

(k) name of persons performing the calibration and checking the results

(l) any limitations in use resulting from the calibration data obtained

(m) details of any maintenance carried out in accordance with the

requirements of ELOT EN ISOIEC 17025 and of any servicing,
adjustment, repair or modification, particularly at the time of calibration.

5.5 Similar records, as appropriate, shall be maintained for any checks carried out
on equipment or reference materials between calibrations.

6 CALIBRATION INTERVALS

6.1 The Laboratory shall have documented criteria for the selection of calibration
intervals for all measuring and test equipment used.

6.2 Reference measurement standards shall be calibrated at intervals approved by

ESYD. Reference materials shall be checked for deterioration and, if necessary,
replaced.

6.3 All other measuring and test equipment shall be calibrated at intervals approved
by ESYD and determined by the following factors:

(a) the requirements of any relevant standard specifications for the

measurements/tests involved

(b) the recommendation of the equipment manufacturer

(c) the type and stability of the equipment

(d) the extent and severity of use

(e) the influence of the environmental conditions (eg temperature, humidity,

vibration and dust)

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(f) the accuracy of measurement needed for the calibration or test

concerned

(g) trends determined by examination of records of previous calibrations

(h) evidence obtained from service and maintenance records

(i) any known or observed tendency for the equipment to exhibit wear or to
drift in performance

(j) the frequency of, and information from, in-house checks, using known
standards.

6.4 When selecting intervals for the maintenance and calibration of measuring and
test equipment, the Laboratory shall take into account all of the relevant factors
in 6.3 of this Guideline. It shall do so in such a way as to minimize the risk that
the results of any calibrations/tests performed between calibrations may be
affected because some of the measuring or test equipment used has failed to
perform to specified requirements. For certain types of measurement, such as
chemical analysis using chromatographs or spectrometers, calibration is
necessary as part of normal operations using appropriate chemicals or certified
reference materials.

6.5 When selecting intervals for the maintenance and calibration of new measuring
and test equipment, the Laboratory shall ensure that, where only limited
information is available, the interval initially selected is shorter than the expected
eventual interval. The interval may then be adjusted at a later date as a result of
information obtained from further calibrations and checks.

6.6 The Laboratory shall have procedures for the periodic review of maintenance
and calibration intervals to take into account the variation in the type, frequency
and conditions of use of any measuring or test equipment. When the
performance of measuring and test equipment deviates from the specified
requirements, the requirements of ELOT EN ISO/IEC 17025 shall be met and
the maintenance and calibration intervals shall be reviewed immediately and
modified where necessary. The ISO 10012: 2003 provides guidance on
methods for the determination and review of maintenance and calibration
intervals. Such equipment shall not be returned to service until the reason for
the deviation has been eliminated and the equipment has been re-calibrated.

6.7 The Laboratory shall shorten the intervals between calibrations (and
maintenance where appropriate) when the results of preceding calibrations or
intermediate checks indicate that the measuring and test equipment is no longer
performing in accordance with the specified requirements.

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6.8 The Laboratory shall increase the interval between calibrations only when the
results of preceding calibrations, and any intermediate checks or quality control
data, indicate that the performance of the measuring and test equipment is
likely to remain within the specified requirements throughout the new period
between calibrations.
6.9 Due to the fact that there is not a general rule relevant to the calibration intervals
each type of equipment shall be handled separately.
The Laboratory determines the calibration intervals taking into consideration the
following:
• the standard equipment shall have at least 3 times better accuracy than the item
under calibration, which means that the contribution from the standard
equipment error’s shall be lower than the 1/3, taking into consideration that
during the uncertainty calculation a confidence level of 95% (k=2) shall be
assured
• the history of the equipment. Generally the following principle exists: when the
calibration results, under the predetermined calibration interval, for three
consequent calibration intervals are within the predetermined limits of error, then
the calibration interval may be increased, e.g. 50%. On the opposite, if they are
out of the limits, then the calibration interval shall be reduced, e.g. to the half.
• methods of statistical analysis
• the way of handling and restoration of the equipment during it’s usual operation
• the recommendation of the equipment manufacturer
• the consequences of the equipment measurement of its clients, when uses
standard equipment which is out of the acceptable limits
• international Standards or bibliography

It is mentioned that in the cases where the primary and secondary equipment
are used as working standards, the calibration intervals shall be determined
as the same of working standards.

• The Calibration Laboratories may establish the calibration intervals up to

the double of the time intervals set in Table A of Annex A which follows,
only when the history of the equipment and it’s use allow it
• For measurement equipment used in testing laboratories and in the
industry the calibration intervals set in Table B of Annex A are proposed.
• In Part C of Annex A the minimum parameters which shall be
checked/calibrated for equipment used in chemical, microbiological and
clinical laboratories are included in order to be a guide for the ESYD
assessors and the testing labs.
The proposed calibration and performance checking intervals are
indicative for providing a tool for the assessors and the labs.

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7 SEALING OF CALIBRATED EQUIPMENT

7.1 The Laboratory shall have procedures to prevent adjustable devices on

measuring and test equipment (other than those intended for the user), whose
setting affects the performance, being altered by unauthorized staff. Where
seals (labels, solder, wire, paint etc) are used, they shall be designed to indicate
clearly when unauthorized adjustment has been made. The procedures shall
ensure that, where a seal has been damaged or broken, the requirements of
ELOT EN ISO/IEC 17025 are met.

8 LABELING OF CALIBRATED EQUIPMENT AND REFERENCE

MATERIALS

8.1 The requirements for labeling, codifying, or otherwise identifying the status of
calibration of measuring and test equipment used by the Laboratory are given in
ELOT EN ISO/IEC 17025.

8.2 When equipment has been calibrated, or reference materials certified by an

external organization, the Laboratory shall ensure that the equipment/reference
material is fit for use, is labeled and that it has a certificate (or notification, where
a certificate might be delayed) to indicate the results of the calibration.

8.3 Labels, or other methods of codifying or identifying the equipment/reference

material, shall, as well as indicating calibration status, clearly indicate to the staff
using the equipment/reference material, any limitations of the calibration and/or
any restrictions on the use of the equipment/reference material.

8.4 Any item of measuring or test equipment, or any reference material, that is
not calibrated, shall not be used for accredited calibration/testing. If there is
any possibility that staff might at any time use such equipment or material for
accredited calibration/testing before it has been calibrated, it shall be
appropriately labeled and, if possible, segregated.

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9 GUIDANCE FOR THE INTERNAL CALIBRATIONS ASSESSMENT

9.1 The Labs that perform internal calibrations or checking of their test equipment must fulfill
the requirements of EN ISO/IEC 17025:2005 Standard.

9.2 The Lab’s that carry out tests in various fields perform, usually, internal calibrations or
checking of their testing equipment in the following categories:

• Volumetric equipment: Calibration according to proper ISO Standard.

• Ovens, furnaces, incubators: Temperature profile checking using calibrated standard
thermometer.
• Autoclaves: Temperature checking and profile using calibrated standard thermometer with
proved traceability and chronometer checking.
• Thermometers: Calibration using a calibrated standard thermometer with proved traceability.
• Balances: Calibration using calibrated standard weights of proper class, with proved
traceability
(i.e : Class E1 for balances of 0.1mg resolution)
• Spectrophotometers: Calibration using CRM’s for specific wavelengths.
• Instrumental analysis equipment, such as GC, HPLC, AAS, FT-IR etc.: Operation
qualification, performance verification and gradation using proper CRM’s.
• Instrumental analysis equipment, such as calorimeters: Calibration using CRM’s.
• Micrometers, dimension measurement equipment etc: Calibration using Gauge Blocks.
• Manometers: Calibration using standard pressure.
• Other.

9.3 Where in the above list an internal calibration is performed, then this calibration must
fulfill the requirements of this Guidance as well as the requirements of Guidance ESYD-
GA2. More specifically:

a. The Laboratory must have and apply standardized calibration methods.

b. The Laboratory must have and apply proper uncertainty of measurements procedures
including the uncertainty budget, for each measurement.
c. The personnel that perform the internal calibrations must have the proper training to
indicate the technical competence for these calibrations.

9.4 The assessment of the Laboratory’s competence at internal calibrations is included in

the plan of assessment, according to ESYD-PA.

9.5 The Laboratory must have informed ESYD with its Application Form, Part 7, that it
performs internal calibrations in specific quantities.

9.6 The Laboratory that performs internal calibrations must submit the relevant Procedures
(including the uncertainty budget calculation), accompanying the Quality Manual and the
rest of its Procedures.

9.7 In the special case that the Laboratory performs internal calibrations, which have not
been previously stated and therefore the Assessment Team is not technically competent
to assess them, the Lead Assessor informs ESYD to modify the Assessment Team by
adding an appropriate Assessor, who performs a complementary assessment.

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9.8 The assessment of the internal calibrations is mandatory in the Laboratory initial
assessment and re-assessment.

9.9 The present chapter applies also to Internal Calibrations performed by Accredited
Laboratories or Laboratories that are employed by Certification or Inspection Bodies and
Inspection Bodies for Motor Vehicles.

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ANNEX A

Table A. Proposed calibration intervals for standard equipment of the Calibration Laboratories
(according to the proposals of OIML and NIST)

See the Greek version

Table B. Proposed calibration intervals of measurement equipment of testing laboratories and industry
(according to the Hellas Lab technical document)

See the Greek version

Part C. Calibration intervals, calibrations and performance checks of testing laboratory’s equipment

See the Greek version

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