PROCEDURE PG.EL.7.

INFORMING OF RESULTS

REVISION N°: 02

DATE OF ISSUE: 2019-08-06

Prepared by Revised by Revised by Approved by

Name: Vicente Name: Yesenia Name: Sabino Name: Jaime Pineda

Ordóñez Aguilar Pineda
Position: ASC Position: GC Position: GT Position: GG

Signature: Signature: Signature: Signature:

Date: 2019-08-04 Date: 2019-08-05 Date: 2019-08-05 Date: 2019-08-06

IMPORTANT NOTE:
This document is owned by ELICROM and may not be reproduced, in whole or in part,
or provided to third parties without the written consent of its owner.

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CHANGE CONTROL

AFFECTED
REVISION DATE CAUSE
PAGES
01 2019-03-11 All pages Document Development
Inclusion of Reference Documents.
Inclusion of Definitions.
Clarification of criteria for presenting the
results.
Clarification for the Statement of
02 2019-08-06 5-13, 18, 20-27 Metrological Traceability in Calibration
Certificates.
Update of Information on statements of
conformity: Clarification of the use of the
decision rule and content of the declarations
of conformity with examples.

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probability of falsely rejecting a conforming item (laboratory's risk). The length parameter
associated with a guarded rejection guard band is

EXAMPLE:

The anabolic steroid nandrolone belongs to a group of substances banned as growth promoters in food-
producing animals. The substance occurs naturally in some live animals and consequently a threshold
(tolerance) limit T equal to 2,00 μg/L has been established.

In a screening test for nandrolone, a measured concentration exceeding the threshold value with a
probability of 95 % or greater is considered suspect and should be followed up by a confirmation
procedure.

In performing a screening test, a laboratory wishes to set a decision (acceptance) limit A given by

where | | is a guard band (see figure 4), such that for a measured concentration value , the
probability that is at least 95 %.

The laboratory validates its measurement procedure by spiking ten blank samples at a concentration
level close to the threshold. The samples are measured under within-laboratory reproducibility
conditions, yielding an observed reproducibility standard deviation of 0,20 μg /L.

From the spiking experiment, the laboratory concludes that its measurements are free from significant
systematic errors. The measurement uncertainty is dominated by reproducibility effects and the
Probability Density Function for nandrolone concentration is thus taken to be a scaled and shifted t-
distribution with degrees of freedom.

From a table or appropriate software for the t-distribution (one-sided, ν = 9 degrees of freedom, 95 %
probability), the guard band is calculated as

⁄ ⁄

A sample with measured value of nandrolone concentration greater than or equal to

( ) ⁄ ⁄

is thus considered suspect.

7.6.2. Statement of conformity

The laboratory shall report on the statement of conformity, such that the statement clearly
identifies:

a) to which results the statement of conformity applies;

b) which specifications, standards or parts thereof are met or not met;

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c) the decision rule applied (unless it is inherent in the requested specification or standard).

NOTE: For further information, see ISO/IEC Guide 98-4.

The specific editing criteria for the statement of conformity shall be written in the test or
calibration procedures, considering that the requirements of the reference documents shall
be complied if applicable and that both the specifications and the decision rule to be
included in the results report, shall be those agreed upon during the review of requests,
tenders and contracts.

Taking this into account, examples for the statements of conformity are presented below:

7.6.2.1. Example for Statement of Conformity in Calibration Certificates

In this example, the calibration of a class A 50 ml narrow-necked volumetric flask is
considered. In the section of the calibration results the value of 0.060 ml has been included
as the maximum permitted error and a measurement error and uncertainty of 0.020 ml and
0.010 ml (k = 2) respectively have been obtained. In this case, both the decision rule and
the maximum permitted errors established in the international standard ISO 1042 were
provided by the customer during the review of requests, tenders and contracts, since a
statement of conformity has been requested to be included in the report of results. So:

STATEMENT OF CONFORMITY:

Decision rule (Customer Requirement): The measurement error ± the expanded

uncertainty shall be less than or equal to the maximum permitted error stated in Section 7 -
Table 1 of ISO 1042: 1998.

“The measurement error of the calibration item meets the maximum permitted error
requirement (specifications).”

7.6.2.2. Example for Statement of Conformity in Testing Reports

In this example an occupational noise measurement test is considered in a full 8-hour work
day. In the section of the testing results the maximum limit of sound pressure is included as
85 decibels scale A of the sound level meter, measured in the place where the worker
usually maintains the head, for the case of continuous noise with 8 hours of work. In this
test, a result of 77.1 dBA and a measurement uncertainty of +2.3 dBA (k = 2) have been
obtained.

The maximum limit of sound pressure is established in article 55 of the Regulation of

safety and health of workers and Improvement of the work environment (Executive Decree
2393 - Ecuadorian Institute of Social Security). In this case, the laboratory has decided to

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include a statement of conformity in the results report, at its own risk. The selected decision
rule has been communicated and agreed with the client during the review of requests,
tenders and contracts. So:

STATEMENT OF CONFORMITY:

Decision rule: The result of the measurement + the uncertainty of measurement shall be
less than or equal to the maximum limit indicated in subsection 6 of Article 55 of the
Regulation of safety and health of workers and Improvement of the work environment
(Executive Decree 2393 - Ecuadorian Institute of Social Security).

“The result of the measurement allows to state conformity with the requirement of the
maximum limit (specifications).”

7.7. Reporting opinions and interpretations

7.7.1. Authorization
When opinions and interpretations are expressed, the laboratory shall ensure that only
personnel authorized for the expression of opinions and interpretations release the
respective statement. The laboratory shall document the basis upon which the opinions and
interpretations have been made.

NOTE: It is important to distinguish opinions and interpretations from statements of inspections and
product certifications as intended in ISO/IEC 17020 and ISO/IEC 17065, and from statements of
conformity as referred to in 7.6.

The authorization for staff issuing opinions and interpretations shall be recorded in the
personnel qualification records (see General Procedure PG.EL.6.2).

DA-acr-06D (Ref. [6]): When the Laboratory is asked for opinions, interpretations,
suggestions or recommendations based on the results of the test, sampling or calibration,
these shall be done in a document that is not part of the report test or calibration certificate.

7.7.2. Expression and Identification

The opinions and interpretations expressed in reports shall be based on the results obtained
from the tested or calibrated item and shall be clearly identified as such.

7.7.3. Communication
When opinions and interpretations are directly communicated by dialogue with the
customer, a record of the dialogue shall be retained (e.g. by means of printed versions of
the emails that will be attached in the records of the review of Requests, Tenders and
Contracts).

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