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Front Door to Back Door
This section is also applicable to tests or calibrations performed
on site at the customer location.
 Change brought forth with ISO/IEC 17025:2017
When the customer requires the item to be tested or calibrated
acknowledging a deviation from specified conditions, the
laboratory shall include a disclaimer in the report indicating which
results may be affected by the deviation (7.4.3)

Overall this Section is intact from the 2005 Standard (5.8)

7.4.1 The laboratory shall have a procedure for the transportation,
receipt, handling, protection, storage, retention, and disposal or return of
test or calibration items, including all provisions necessary to protect the
integrity of the test or calibration item, and to protect the interests of the
laboratory and the customer. Precautions shall be taken to avoid
deterioration, contamination, loss or damage to the item during handling,
transporting, storing/waiting, and preparation for testing or calibration.
Handling instructions provided with the item shall be followed.

Procedure is required “How is this accomplished”

The laboratory shall have a procedure for the transportation,
receipt, handling
The laboratory shall have a procedure for the protection, storage,
retention, and disposal or return of test or calibration items
including all provisions necessary to protect the integrity of the
test or calibration item, and to protect the interests of the
laboratory and the customer;
7.4.2 The laboratory shall have a system for the unambiguous
identification of test or calibration items. The identification shall
be retained while the item is under the responsibility of the
laboratory. The system shall ensure that items will not be confused
physically or when referred to in records or other documents. The
system shall, if appropriate, accommodate a sub-division of an
item or groups of items and the transfer of items.
a system for identifying test and/or calibration items.
a system for identifying test and/or calibration items
If identified directly on test sample ensure that the ID tag or other
ID method is not likely to come off resulting in a mis-
identification or confusion with other samples ;
7.4.3 Upon receipt of the test or calibration item, deviations
from specified conditions shall be recorded. When there is
doubt about the suitability of an item for test or calibration, or
when an item does not conform to the description provided, the
laboratory shall consult the customer for further instructions
before proceeding and shall record the results of this consultation.
When the customer requires the item to be tested or calibrated
acknowledging a deviation from specified conditions, the
laboratory shall include a disclaimer in the report indicating
which results may be affected by the deviation.
 Key Points
• Deviations from specified conditions shall be recorded, asking
the customer for further instructions and record the results of
the consultation, and inclusion of a disclaimer
- If the customer wants the items tested or calibrated anyway, the
lab needs to include a statement with the results
deviations from specified conditions shall be recorded.
For example within the internal procedure
Environmental conditions required:
Temperature to be within the range of 68 ºF +/- 2 ºF.
Relative Humidity to be less than 50 % RH
The UUT must remain in the laboratory for a minimum of 12 hours prior
to calibration to permit thermal stabilization.
Note: Calibrations are not to be performed if the environmental
conditions are outside the allowable limits stated above
 Untestable/deviating samples are items which have been received
by a laboratory, but which are not in an appropriate condition to
truly reflect the original sample. This could be due to the samples
not being handled correctly during transport or in the way
prescribed in the relevant standard or that lack essential
information for a quality analysis to be undertaken. Consequently,
the validity of the reported results may be jeopardized.
Such a sample might:
- not been preserved adequately (e.g. not cooled, not acidified),
- have exceeded its maximum preservation time,
- in the case of microbiological analyses, lack the date and time of
sampling,
- be denatured through heat, light or humidity,
- have rotted or suffered microbiologically, or
- have become cross contaminated.
 Recommendations EUROLAB “Cook Book” – Doc No. 3
When a sample is taken by the customer or on the customer’s behalf
by an external provider and transferred to the laboratory, the
laboratory cannot be responsible for verifying if the sample was taken
in accordance with the relevant requirements. Nevertheless, a
competent laboratory must not ignore any obvious observations
concerning any adverse condition of the sampling process which
might jeopardies the validity of the results. Just a statement that the
results relate to the item tested/analyzed as received, which is used by
many laboratories is certainly not enough. In such a case, the
laboratory shall contact the customer, inform them of the problem and
ask for further instructions. Clause 7.1.4 has to be considered in this
context (Review of Request Tenders and Contracts)
7.1.4 Any differences between the request or tender and the
contract shall be resolved before laboratory activities commence.
Each contract shall be acceptable both to the laboratory and the
customer. Deviations requested by the customer shall not impact
the integrity of the laboratory or the validity of the results;
When the customer requires the sample to be tested as the laboratory
received it, it is the responsibility of the laboratory to perform the test.
However, in such cases, the report shall include a disclaimer which
clearly notices that deviations from the relevant standard were observed
and that the validity of the results can be affected by these deviations.
This general finding could be further specified e.g. by stating that the
sample was supplied in packing which was inappropriate for the relevant
analysis or that the sampling date was unknown or that the sample
condition had deteriorated.

See 7.8.2.2 reporting the results

7.4.4 When items need to be stored or conditioned under specified
environmental conditions, these conditions shall be maintained,
monitored and recorded.
What ISO/IEC 17025:2017 brought forth
The entire chapter has been rewritten and adapted to handle
electronic information.
The laboratory might have an information management system
applicable to electronic and conventional information. The system
has to be validated and protected
7.11.1 The laboratory shall have access to the data and
information needed to perform laboratory activities

The requirements for information management systems are not

restricted only to computerized systems (LIMS) but to any kind of
system handling information
7.11.2 The laboratory information management system(s) used for the
collection, processing, recording, reporting, storage or retrieval of data
shall be validated for functionality, including the proper functioning of
interfaces within the laboratory information management system(s) by
the laboratory before introduction. Whenever there are any changes,
including laboratory software configuration or modifications to
commercial off-the-shelf software, they shall be authorized,
documented and validated before implementation
NOTE 1: In this document “laboratory information management
system(s)” includes the management of data and information
contained in both computerized and non-computerized systems. Some
of the requirements can be more applicable to computerized systems
than to non-computerized systems.

Still recognizes paper systems of data collection and management;

NOTE 2: Commercial off-the-shelf software in general use within its

designed application range can be considered to be sufficiently
validated
7.11.3 The laboratory information management system(s) shall:
a) be protected from unauthorized access;
b) be safeguarded against tampering and loss;
c) be operated in an environment that complies with supplier or
laboratory specifications or, in the case of non-computerized systems,
provides conditions which safeguard the accuracy of manual recording
and transcription;
d) be maintained in a manner that ensures the integrity of the data and
information;
e) include recording system failures and the appropriate immediate and
corrective actions.
-e would address system crashes)
7.11.4 When a laboratory information management system is
managed and maintained off-site or through an external provider,
the laboratory shall ensure that the provider or operator of the
system complies with all applicable requirements of this
document
7.11.5 The laboratory shall ensure that instructions, manuals and
reference data relevant to the laboratory information management
system(s) are made readily available to personnel

The staff shall have access to instructions to the LIMS

7.11.6 Calculations and data transfers shall be checked in an
appropriate and systematic manner;
This time is allocated for answering questions. You should have a
space provided for submitting questions.
Please keep questions related to the topic covered in this webinar;
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Use of Accreditation Symbols and References to Accreditation