R 79-04

REQUIREMENTS FOR THE ISSUE OF SANAS

CALIBRATION CERTIFICATES

Approved By: Acting Chief Executive Officer: Tumelo Baleni

Executive Committee
Proposed By: Accreditation Manager: Neville Tayler
Reviewed By: Accreditation Manager: Neville Tayler
Date of Approval: 2021-07-29
Date of Implementation: 2021-07-29

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CONTENTS:

1. Purpose and Scope ...........................................................................................................3

2. References ........................................................................................................................3
3. Definitions ..........................................................................................................................3
4. Abbreviations .....................................................................................................................4
5. General Requirements .......................................................................................................4
6. Additional Requirements ....................................................................................................7
7. Authorship .........................................................................................................................8

ADDENDUM 1: Amendment Record......................................................................................10

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1. Purpose and Scope

This document is applicable to accredited bodies in calibration as defined in the Accreditation Act, Act
No. 19 of 2006 [6]. The purpose of this document is to ensure that certificates issued by SANAS
accredited bodies meet all of the ISO/IEC 17025:2017 requirements and accreditation body
requirements, whilst at the same time providing the customer with calibration data presented in a clear,
unambiguous and objective manner [1].

SANAS is required as a member of the AFRAC and ILAC MRA to specify the minimum requirements
regarding the format and content of certificates and reports issued by accredited facilities and covered
by the scope of accreditation. [3]

A certificate that complies with the requirements of this document, issued by an accredited laboratory
will enjoy legal status as envisaged by Section 25 of Act 19 of 2006. [6]

For practical purposes, there are certain requirements originating in SANAS R04 and PM01 that have
been included in this document. Should there be any difference in the requirements, the requirements as
specified in R04 and PM01 will take precedence.

2. References

[1] ISO/IEC 17025:2017 General Requirements for the Competence of Testing and
Calibration Laboratories.

[2] ISO/IEC 17021-1:2015 Conformity Assessment—Requirements for Bodies

Providing Audit and Certification of Management Systems.
Part 1: Requirements

[3] ILAC-P8 Supplementary Requirements and Guidelines for the Use

of Accreditation Symbols and for Claims of Accreditation
Status by Accredited Laboratories.

[4] SANAS R 04 Conditions for the use of accreditation symbols, reference to

accreditation and combined marks.

[5] Act 18, 2006 Measurement Units and Measurement Standards Act, 2006.

[6] Act 19, 2006 Accreditation for Conformity Assessment, Calibration and Good
Laboratory Practice Act, 2006.

[7] Act 25, 2002 Electronic Communication and Transactions Act, 2002

[8] The SI of units The International System of Units, BIPM, 8th Ed 2006
ISBN 92-822-2213-6.

[9] ILAC-P14 ILAC Policy for Uncertainty in Calibration

[10] SANAS PM01 SANAS Policy Manual

3. Definitions

Accreditation Symbol:
Means a symbol issued by an accreditation body to be used by an accredited body to indicate its
accredited status. [6]

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Advanced Electronic Signature

Means an electronic signature which results from process which has been accredited by an authority
provided for in Section 37 of the Act, 25 of 2002 [7].

Calibration and Measurement Capability

Means a calibration and measurement capability available to customers under normal conditions:
a) as described in the laboratory’s scope of accreditation granted by a signatory to the AFRAC and
ILAC arrangements; or
b) as published in the BIPM key comparison database (KCDB) of the CIPM MRA.

Decision rule
Rule that describes how measurement uncertainty is accounted for when stating conformity with a
specified requirement. [1]

Electronic Signature:
Means data attached to, incorporated in or logically associated with other data and which is intended by
the user to serve as a signature. [7]

Uncertainty of Measurement:
Means a parameter, associated with the result of a measurement that characterises the dispersion of the
values that could reasonably be attributed to the measurement. [5]

4. Abbreviations

CGPM General Conference of Weights and Measures

CMC Calibration and Measurement Capability
AFRAC African Accreditation Cooperation
ILAC International Laboratory Accreditation Cooperation
MRA Mutual Recognition Arrangement
SANAS South African National Accreditation System
UoM Uncertainty of Measurement

5. General Requirements

The Calibration Certificate shall:

5.1 Have a title, for example “Calibration Report” or “Calibration Certificate”; [1 § 7.8.2.1 a)]

5.2 State the full name and address of the laboratory performing the calibration. [1 § 7.8.2.1 b)] The
accreditation symbol may only be used when the name specified on the calibration certificate is
the same as that with which the laboratory holds accreditation; [3]

5.3 Specify the name and contact information of the customer; [1 § 7.8.2.1 e)]

5.4 Specify the location where the calibration was conducted if different to that of the laboratory.
The actual physical location needs to be specified; a postal address (PO Box or Private Bag) is
not acceptable. The location shall be specified with sufficient detail, including any associated
temporary or mobile facility and where appropriate shall include room numbers, particularly
where relocation of the instrument may influence the calibration status, for example weighing
instruments; [1 § 7.8.2.1 c)]

5.5 Have unique identification (a certificate number) on each and every page of the certificate or
report, any components such as annexures or graphs forming part of the certificate or report
must include the unique reference number; [1 § 7.8.2.1 d)]

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5.6 Have each page numbered, preferably in the form Page X of Y, or similar; [1 § 7.8.2.1 d)]

5.7 Provide a clear indication of the end of the certificate or report; [1 § 7.8.2.1 d)]

5.8 Identify the method used to perform the calibration. Where a laboratory developed method or
procedure is specified it is desirable to include a short description of the method followed; [1 §
7.8.2.1 f)]

5.9 Provide an unambiguous identification of the item calibrated. Typically this would include a
description of the item, Manufacturer, Model and Serial numbers where available; [1 § 7.8.2.1
g)]

5.10 State the date of receipt of the calibration item if critical to the validity and application of the
measurement results; [1 § 7.8.2.1 h)]

5.11 Specify the date(s) on which the calibration was performed, and the date of issue; [1 § 7.8.2.1 i
& j)]

5.12 Provide a reference to the sampling plan, where critical to the validity and application of the
results; [1 § 7.8.2.1 k)]

5.13 List the calibration results and the units of measurement. [1 § 7.8.2.1 m)]

5.13.1 The results shall:

• be stated accurately, clearly, unambiguously and objectively; [1 § 7.8.1.2)]
• be presented in a manner that they can be easily interpreted; [1 § 7.8.1.2)]
• be presented in either SI units or SI coherent derived units;
• use prefixes in accordance the prefixes adopted by the CGPM.

5.13.2 Certain non SI units are also considered acceptable, such as (time) minute, hour, day
(plane angle) degree, minute, second (area) hectare (volume) litre (mass) tonne and
(pressure) bar, mmHg. Examples of SI coherent derived units are cubic metre (volume),
metre per second (velocity), candela per square metre (luminance), hertz (frequency),
newton (force), ohm (electric resistance), etc.; [8]

5.13.3 Instruments that measure in other non-SI units are still in common usage, and in such
cases, when they are calibrated, the originally observed value together with the
acceptable SI value, and the applicable conversion factor applied, shall be stated on the
certificate;

5.13.4 When the instrument is repaired or adjusted, the measurement results before and after
the repair/adjustment shall be reported. Where an instrument is damaged to the extent
that pre-repair measurement results are not possible, a note or remark to this effect shall
be included on the certificate; [1 § 7.8.4.1 d)]

5.13.5 When the measurement results are omitted from the report or certificate in lieu of a
statement of compliance, the measurement results shall be available for possible future
reference;

5.13.6 Where any data included on the certificate or report has been provided by the customer
this shall be clearly identified.

5.14 Include the name(s), function(s) and signature(s) of the person authorizing the calibration
certificate.

5.14.1 The name of the person(s) authorizing the certificate shall be designated as ‘technical
signatory’.

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5.14.2 ISO/IEC 17025:2017 § 7.8.2.1 o) requires only the identification of the person or
persons responsible for the authorization of the report or certificate, however, Section
25 of the Accreditation Act, Act 19 of 2006, requires that a document purporting to be a
certificate, and issued by an accredited body, be signed by a person deemed by SANAS
as competent. Without the aforementioned signature the certificate would not be
considered as evidence in legal proceedings or process. [1]

5.14.3 The Accreditation Act, Act 19 of 2006 does not specify the type of signature to be used
when a authorizing person of an accredited body signs a certificate, an electronic
signature is therefore permitted, provided it is of the advanced electronic type, as
specified in section 13(1) of the electronic communications and transactions act, Act 25
of 2002.

5.14.4 In instances where the calibration was performed by a person other than the person
authorizing the certificate, the certificate shall include the identityof the person who
performed the calibration.

5.14.5 The calibration certificate or report may not be signed p.p. (per procurator) on behalf of
the technical signatory, or the person who performed the calibration. Signing the
certificate on behalf of laboratory management may be permitted, depending on the
rules of the accredited facility. [4]

5.14.6 Scanned signatures do not satisfy the requirements for advanced electronic signatures
and are therefore not permitted.

5.14.7 Where a facility outside of South Africa is accredited by SANAS and these facilities wish to
make use of Electronic signatures, they are required to demonstrate that the advanced
electronic signature complies with their national legislation. In the absence of such
legislation, electronic signatures will not be permitted. [10]

5.15 Include a statement that the measurement results relate only to the items calibrated. Exclusions
may include for example the calibration of thermocouple extension or compensating lead, where
samples may be drawn from a roll of cable. In such instances the requirements of 5.12 are
applicable.

5.16 Include a statement of the environmental conditions, specifically where the environmental
conditions may influence the measurement results. The environmental conditions may be
stated as a range, except where the exact actual environmental condition and its associated
uncertainty need to be known in order for the user to apply appropriate corrections. [1 § 7.8.4.1
b)]

5.17 Specify the uncertainty of measurement

5.17.1 The uncertainty of measurement shall:

• normally be stated at approximately the 95% level of confidence;

• not be reported to more than 2 significant digits, unless this can be technically
justified;
• be rounded up, unless the rounding reduces the uncertainty by less than 5%;
• not be smaller than the CMC as specified on the laboratory’s scope of
accreditation; and
• be presented in the same unit as the measurand or in a term relative to the
measurand (e.g. percent). [1 § 7.8.4.1 a)]

5.17.2 Any statement of conformity shall clearly identify:

• the results to which the conformity applies;

• which specification, standards or parts therof are met or not met; and
• the decision rule applied, unless inherent to the specification or standard.
[1 § 7.8.6.2 a) to c)]

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5.17.3 The following (or a similar) statement shall be included on the certificate:

‘The reported expanded uncertainty is based on a standard uncertainty multiplied by a

coverage factor k = 2 providing a level of confidence of approximately 95%, the
uncertainty of measurement has been estimated in accordance with the principles
defined in the GUM, Guide to Uncertainty of Measurement, ISO, Geneva.

Note : When uncertainty is quoted at higher levels of confidence, for example the
customer requests k=3 for a level of confidence of approximately 99,7%, the statement
above needs to be modified accordingly.

5.17.4 The coverage factor and the coverage probability shall be stated on the certificate. [9]

5.18 Include a statement statement identifying how the measurement results are metrologically
traceable. In addition it is also recommended that a list of the measurement standards, and their
calibration status, used to perform the calibration be listed in the calibration certificate. [1 §
7.8.4.1 c)]

5.19 Do not include any recommendation on the calibration interval, including an expiry date unless
this has been agreed in writing by the customer. [1 § 7.8.4.3]

5.20 The laboratory shall include a statement taking the following form:

The measurement results recorded in this certificate were correct at the time of calibration. The
subsequent accuracy will depend on factors such as care, handling and frequency of use. It is
recommended that recalibration be undertaken at an interval that will ensure that the instrument
remains within the desired limits.

5.21 Include a statement specifying that the calibration certificate or report may not be reproduced
except in full, without the written approval of the laboratory. The purpose of this requirement is to
prevent selective extraction and reporting of results, and is not intended to prevent the customer
from making legitimate copies of the certificate for record keeping purposes.

6. Additional Requirements

6.1 Laboratories are encouraged to issue calibration certificates or reports bearing the accreditation
symbol for calibrations covered by their scope of accreditation. [3].

Any certificate or report not displaying the relevant SANAS accreditation symbol or referring to
accreditation shall not be considered as endorsed by SANAS. When a calibration certificate
is issued without the accreditation symbol there shall be nothing in the certificate, or any
attachments that lead the user to believe that the work is covered by accreditation when it is not.
[3]

6.2 The accreditation number shall shall appear beneath and aligned to the right of the SANAS
Symbol. The accreditation number shall be font type Arial. [4]

6.3 The accreditation symbol may not be more prominent than the logo of the accredited
laboratory. [4]

6.4 The symbol and the accreditation number shall be considered as a single unit entity for
purposes of enlargement or reduction. [4]

6.5 The accreditation symbol shall be printed in the colours as specified in R 04. [4]

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6.6 Misuse of the accreditation symbol is an offence in terms of section 24 (2) of the Accreditation
Act, Act 19 of 2006, and upon conviction may result in a fine and/or imprisonment for a period
not exceeding 24 months. [6]

6.7 The use of the ILAC MRA Mark is limited to laboratories that have signed the sublicense
agreement (F 112) with SANAS, and have received written approval permitting its use on
calibration certificates and reports subject to the requirements of the agreement.

6.8 Accredited laboratories wishing to make reference to the ILAC MRA may include the following
statement on their calibration certificates or reports:

“The South African National Accreditation System (SANAS) is a member of the International
Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA). This
arrangement allows for the mutual recognition of technical test and calibration data by member
accreditation bodies worldwide. For more information on the arrangement please consult
www.ilac.org

6.9 When the management system of an accredited laboratory has been certified or registered to
ISO 9000, the certification body symbol or logo may not be included on any calibration
certificate or report issued by the laboratory. [3] [2]

6.10 Laboratories may issue Calibration Certificates or reports for measurements not covered by
their scope of accreditation, provided:
• the non-accredited results are less than or equal to half (<50%) of the results reported
• they are clearly identified;
• are accompanied by a disclaimer in a font no smaller than that used to report the
results;
• are carried out to a similar standard as the accredited measurement results;
• meet all of the recognized criteria e.g. documented procedure, competent personnel,
traceability, and uncertainty of measurement.

6.11 Should it be necessary to include opinions and interpretations, they should be indicated as such
and a statement should be included indicating that they are not part of the accredited scope of
the laboratory. [3]
Note: Statements of compliance with a metrological specification or standard by a calibration
laboratory are not considered to be opinions or interpretations.

6.12 When it is necessary to change, amend or reissue a calibration certificate or report:

• any change of information must be clearly identified, and where appropriate the reason
for the change included in the report;
• amendments shall be made in the form of a further document, and must include the
statement ‘Amendment to Report, Serial Number….’, or equivalent wording;
• any reissued certificate or report, shall be uniquely identified, and contain a reference to
the original that it replaces. [1]

6.13 Where the laboratory deems it appropriate a statement limiting the liability of the laboratory may
be included on the certificate.

6.14 Any person who knowingly issues a certificate or report that contains an untrue statement of
fact, or omits to state a material fact, may be guilty of an offence, and upon conviction be liable
to a fine or imprisonment or both. [6]

7. Authorship

The original SANAS Requirement document has been prepared by a working group committee
consisting of the following members:
• Neville Tayler SANAS

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• Steve Sidney NLA

• Ms Hanlie Badenhorst NLA
• Benjamin van der Merwe NMISA
• Dr Jaco Mostert NECSA
• Ms Diane de Jager NMISA
• Eddie Tarnow NMISA
• Van Zyl Kruger SABS Regulatory
• Ms Germa Maré SABS Commercial
• Meyer van der Merwe Telkom SA
• Guy Snelling Intercal
• Mark Mathieson Unique Metrology
• Ms Yvette Volschenk Technology Solutions
• Bart van Oostrom Private

SANAS is indebted to the contribution made in the preparation of this document.

This document has also been amemded with contributions for assessors and representatitive of various
calibration laboratories.

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ADDENDUM 1: Amendment Record

Proposed Section Change

By:
AM 1, Par 1 1st sentence added
“Bodies” replaced “laboratories”
Changed the version of ISO/IEC 17025 to 2017
AM 1, Par 2 Added reference to AFRAC
AM 2 Amended versions of ISO/IEC 17025 and ISO/IEC 17021
Deleted reference to SANAS Reports 45 and 50, and SANAS R50
AM 3 Calibration and Neasurement Capability – added reference to AFRAC
Added definition of “Decision Rule”
AM 4 Added reference to AFRAC
Deleted reference to UUT – unit under test
AM 5 Added clause references to the clauses
AM 5.3 “Contact information” replaced “address”
AM 5.4 Added “including any associated temporary or mobile facility”
AM 5.5 Added “any components such as annexures or graphs forming part of the certificate
or report must include the unique reference number”
AM 5.10 Added “and application”
AM 5.11 Deleted “issue if not the same as the date of calibration”
AM 5.12 Added “where critical to the validity and application of the results”
Deleted “where applicable”
AM 5.13.3 SI replaced “standard”
AM 5.13.6 Clause added
AM 5.14.2 Clause added
AM 5.14.3 Clause added
AM 5.14.4 Deleted “designation and signature”
Deleted “ [The National Prosecuting Authority (NPA) has requested that the
information concerning the metrologist who performed the calibration be available
on the certificate in order to limit the potential for Calibration Certificates and
Reports being questioned during prosecutions in terms of the Road Traffic Act.]”
AM Deleted previous clause 5.14.3 “The use of an electronic signature is only permitted
where this signature is in the form of an advanced electronic signature. [10] [13]”
AM 5.15 Deleted “where relevant”
AM 5.17 Deleted “and/or a statement of compliance with a metrological specification.”
AM 5.17.1 4th bullet: Changed Schedule to “scope”
Added 5th bullet point
AM 5/17.2 Changed from:
Any statement of compliance shall:
• take cognisance of the measurement uncertainty;
• specify the clause(s) of the specification that have been met or not met.

AM 5.18 Replaced “of traceability” with “statement identifying how the measurement results
are metrologically traceable”
AM 5.19 “this has been agreed in writing by the customer; [1 § 7.8.4.3] “ replaced bullets:
• this has been agreed in writing by the customer during the contract review
process;
• it is a legal requirement, and the regulation or act has been specified.

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