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7.1 Review of requests, tenders
and contracts
7.1.1
The laboratory shall have a procedure
for the review
of requests, tenders
and contracts. The procedure shall ensure that:
a)
the requirements are adequately defined,
documented and understood;
b)
the laboratory has the capability
and resources to meet the requirements;
c)
where external providers are used, the requirements of 6.6 are applied and the laboratory advises the customer
of the specific laboratory activities to be performed by the external provider
and gains the customer's approval;
NOTE 1 It is recognized
that externally provided
laboratory activities can occur when:
—
the laboratory has the resources
and competence to perform the activities, however,
for unforeseen reasons is
unable to undertake these in part or full;
—
the laboratory does not have the resources
or competence to perform the activities.
d)
the appropriate methods
or procedures are selected and are capable
of meeting the customers' requirements.
NOTE 2
For internal or routine customers, reviews of requests,
tenders and contracts
can be performed in a simplified way.
The
laboratory examines applications, bids, and contracts for requirements in a
practical and efficient manner, taking into account the impact of financial,
legal, and scheduling factors on this process (see Appendix 15: Procurement
File).
The laboratory
maintains records of applications, bids, and contract reviews, including any
significant changes, using the GP18 general procedure (Appendix 18: General
Procedures and Forms Manual). The laboratory keeps a file of documentation for
this procedure in the Records Room (Quality Assurance Room) (see Appendix 15:
Procurement File) (see Appendix 10: Protocol File - Protocol for Reviewing
Applications, Bids, and Contracts).
The
laboratory has the necessary physical resources, information sources, and staff
with the required skills and experience to perform the relevant tests (see
Appendix 9: Training File). The laboratory participates in interlaboratory
comparisons or proficiency testing and/or conducts pilot testing using samples
or materials of known value to determine measurement uncertainties, limits of
detection, and confidence limits (see Appendix 10: Protocol File - Measurement
Uncertainty Assessment Protocol).
Services
(calibration services, sampling services, testing services, facility and
instrument maintenance services, proficiency testing services, and evaluation
and auditing services) and products (measuring standards and instruments,
auxiliary equipment, consumables, materials, and reference materials) provided
by suitable external suppliers support the operation of the laboratory (see
Appendix 14: Maintenance and Calibration File) and (see Appendix 10: Protocol
File: External Protocol - Products and Services Provided).
7.1.2
The laboratory shall inform the customer
when the method
requested by the customer is considered to be inappropriate or out of date.
7.1.3
When the customer requests
a statement of conformity to a specification or standard for the
test or calibration (e.g. pass/fail, in-tolerance/out-of-tolerance),
the specification or standard and thedecision rule shall be clearly defined.
Unless inherent in the requested specification or standard, the
decision rule selected
shall be communicated to, and agreed
with, the customer.
NOTE For further guidance on statements of conformity, see ISO/IEC Guide 98-4.
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.
7.1.5 The customer
shall be informed
of any deviation from the contract.
7.1.6 If a contract is amended after work has commenced, the contract review shall be repeated and any amendments shall be communicated to all affected
personnel.
7.1.7 The
laboratory shall cooperate with customers or their representatives in
clarifying the customer's request and in monitoring the laboratory’s
performance in relation to the work performed.
NOTE Such cooperation can include:
a)
providing reasonable access to relevant areas of the
laboratory to witness customer-specific laboratory activities;
b)
preparation, packaging, and dispatch of items needed by the customer for verification purposes.
7.1.8 Records
of reviews, including any significant changes, shall be retained. Records shall
also be retained of pertinent
discussions with a customer relating
to the customer's requirements or the results of the laboratory activities.
When a client requests a specific method, the laboratory
informs the client if the method is unsuitable or outdated.
The laboratory clearly defines the characteristics or
specifications and the decision basis when a client requests a statement of
conformity for the characteristics or specifications of a test or calibration.
It also communicates and agrees upon the decision basis with the client if it
is not inherent in the requested specifications or standard.
The laboratory addresses any discrepancies between the
order, tender, and contract with its clients, and these discrepancies are
resolved before laboratory activities commence. Laboratory activities begin
only when the contract is acceptable to both the laboratory and the client. The
laboratory ensures that any deviations (special requirements) requested by the
client do not compromise laboratory safety or the validity of the results.
The laboratory informs the client of any deviation from
the contract and does not begin testing until the client is fully satisfied.
If the contract is amended after work has commenced, the
contract is reviewed again, and all affected staff are notified of any
amendments.
The laboratory collaborates with clients or their
representatives to clarify the client's requirements and monitors the
laboratory's performance in relation to the work performed. The laboratory
allows the client access to the testing areas to observe the process firsthand.
The laboratory also prepares, packages, and ships the materials the client
requires for verification purposes.
The laboratory maintains records of all revisions,
including any significant changes. It also keeps a record of all relevant
discussions with the client regarding client requirements or the results of
laboratory activities.
7.2 Selection, verification and validation of methods
7.2.1 Selection and verification of methods
7.2.1.1 The
laboratory shall use appropriate methods and procedures for all laboratory
activities and, where appropriate, for evaluation of the measurement
uncertainty as well as statistical techniques for analysis of data.
NOTE “Method” as
used in this document can be considered synonymous with the term “measurement
procedure” as defined in ISO/IEC Guide 99.
7.2.1.2 All
methods, procedures and supporting documentation, such as instructions,
standards, manuals and reference data relevant to the laboratory activities,
shall be kept up to date and shall be made readily available to personnel (see 8.3).
7.2.1.3 The
laboratory shall ensure that it uses the latest valid version of a method
unless it is not appropriate or possible to do so. When necessary, the
application of the method shall be supplemented with additional details to
ensure consistent application.
NOTE International,
regional or national standards or other recognized specifications that contain
sufficient and concise information on how to perform laboratory activities do
not need to be supplemented or rewritten as internal procedures if these standards are written in a way that they can be used by the operating
personnel in a laboratory. It can be necessary to provide additional
documentation for optional steps in the method or additional details.
7.2.1.4 When the
customer does not specify the method to be used, the laboratory shall select an
appropriate method and inform the customer of the method chosen. Methods
published either in international, regional or national standards, or by reputable technical organizations, or in relevantscientific
texts or journals, or as specified by the manufacturer of the equipment, are
recommended. Laboratory-developed or modified methods can also be used.
7.2.1.5 The
laboratory shall verify that it can properly perform methods before introducing
them by ensuring that it can achieve
the required performance. Records of the verification shall
be retained. If the
method is revised by the issuing body, verification shall be repeated to the
extent necessary.
7.2.1.6 When
method development is required, this shall be a planned activity and shall be
assigned to competent personnel
equipped with adequate resources. As method development proceeds, periodic
review shall be carried out to confirm that the needs of the customer are still
being fulfilled. Any modifications to the development plan shall be approved
and authorized.
7.2.1.7 Deviations
from methods for all laboratory activities shall occur only if the deviation
has been documented, technically justified, authorized, and accepted by the
customer.
NOTE
Customer acceptance of deviations can be agreed in advance in the contract.
The
laboratory gives preference to internationally, nationally, or regionally
published reference methods (standard methods) (ASTM methods, methods published
in national and international journals, and other journals approved by the
Technical Director) for use in conducting laboratory tests, including
uncertainty assessment and statistical techniques for data analysis, to meet
client needs.
The
laboratory ensures the use of the latest version of the standard (standard
method) when necessary, unless otherwise appropriate or feasible, and the
standard method is supplemented with additional details to ensure consistent application.
The laboratory's ability to achieve satisfactory performance against documented
performance characteristics is verified before sample analysis (calibration and
standardization) (see Appendix 10: Protocol File - Results Validation
Protocol).
The
laboratory also validates laboratory-developed methods or methods used in the
laboratory. It also informs the client of the method chosen for their tests.
The laboratory also ensures that it can operate the standard methods correctly
before commencing testing. If the standard method changes, the laboratory
reiterates the correct use of these methods.
The
laboratory maintains a verification log in the verification log file (see
Appendix 11: Log File - Verification Log).
7.2.2 Validation of methods
7.2.2.1 The
laboratory shall validate non-standard methods, laboratory-developed methods
and standard methods used outside their intended scope or otherwise modified.
The validation shall be as extensive as is necessary to meet the needs of the
given application or field of application.
NOTE 1 Validation can include procedures for sampling, handling
and transportation of test or calibration items.
NOTE 2 The techniques used for method validation can be one of, or a
combination of, the following:
a)
calibration or evaluation
of bias and precision using reference standards
or reference materials;
b)
systematic assessment of the factors influencing the result;
c)
testing method robustness through variation of controlled parameters, such as incubator
temperature, volume dispensed;
d)
comparison of results
achieved with other validated methods;
e)
interlaboratory comparisons;
f)
evaluation of measurement uncertainty of the results based on an understanding of the theoretical principles
of the method and practical
experience of the performance of the sampling
or test method.
7.2.2.2 When
changes are made to a validated method, the influence of such changes shall be
determined and where they are found to affect the original validation, a new
method validation shall be performed.
7.2.2.3 The performance characteristics of validated
methods, as assessed
for the intended use, shall
be relevant to the customers' needs and consistent with specified requirements.
NOTE
Performance characteristics can include, but are not limited to,
measurement range, accuracy, measurement uncertainty of the results, limit of
detection, limit of quantification, selectivity of the method, linearity,
repeatability or reproducibility, robustness against external influences or
cross-sensitivity against interference from the matrix of the sample or test
object, and bias.
7.2.2.4 The laboratory shall retain the following records
of validation:
a)
the validation procedure
used;
b)
specification of the requirements;
c)
determination of the performance characteristics of the method;
d)
results obtained;
e)
a statement on the validity
of the method, detailing its fitness for the intended
use.
When a
client does not specify the method they wish to use for their tests, the
laboratory uses methods published by reputable international or national
technical organizations or bodies, in relevant scientific books or journals, or
by the manufacturer.
Prior to
analyzing samples, the laboratory verifies its ability to achieve satisfactory
performance against documented performance characteristics (Appendix 10:
Protocol Equipment).
The
laboratory maintains verification records as outlined in section 7.5. These
records include the validation procedure. The procedure used for verification
is likely to vary depending on the method. Therefore, the procedures recorded
in laboratory records are not as detailed as a typical protocol.
7.3 Sampling
7.3.1 The laboratory shall have a sampling plan and method when it carries out sampling of substances,
materials or products for subsequent testing or calibration. The sampling
method shall address the factors to be controlled to ensure the validity of
subsequent testing or calibration results. The sampling plan and method shall
be available at the site where sampling is undertaken. Sampling plans shall,
whenever reasonable, be based on appropriate statistical methods.
7.3.2 The sampling
method shall describe:
a)
the selection of samples or sites;
b)
the sampling plan;
c)
the preparation and treatment of sample(s) from a substance, material or product
to yield the required item for subsequent
testing or calibration.
NOTE When received into the laboratory, further handling can be required
as specified in 7.4.
7.3.3 The laboratory
shall retain records of sampling data that forms part of the testing or calibration that is undertaken. These records shall include, where relevant:
a)
reference to the sampling method used;
b)
date and time of sampling;
c)
data to identify
and describe the sample (e.g. number, amount,
name);
d)
identification of the personnel performing sampling;
e)
identification of the equipment
used;
f)
environmental or transport
conditions;
g)
diagrams or other equivalent means to identify
the sampling location,
when appropriate;
h)
deviations, additions to or exclusions
from the sampling method and sampling plan.
When a
laboratory samples materials, equipment, or products for testing or
calibration, this is done according to a pre-defined method. This method
describes the plan and procedures for sampling, including the selection or
location of samples; the plan for preparing and processing the sample(s) of a
material, equipment, or product to obtain the part required for testing or calibration;
and the sampling plan, which describes how a sample(s) of a material,
equipment, or product are identified, drawn, and prepared to obtain the
required information. Samples are collected and placed in sealed containers.
Sampling plans are based on appropriate statistical methods. Upon receipt of
the sample at the laboratory, it is handled as specified in 7.4.
The
laboratory maintains records of sampling data, which form part of the test or
calibration being performed. These records include the sampling method used;
the date and time of sampling; data identifying and describing the sample (such
as number, quantity, and name); identification of the personnel taking the
samples; identification of the equipment used; and environmental or transport conditions.
Schemes or other equivalent means of determining the sampling location, where
appropriate; and deviations, additions, or deletions from the sampling method
and sampling plan.
7.4 Handling of test or calibration items
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.
The
laboratory employs a procedure for transporting samples, reagents, and
calibration materials to ensure their safety by preventing deterioration,
contamination, and loss of identity. Full details of this procedure are
provided in the Receiving, Handling, and Storage (see Appendix 10: Protocol
File - Sample Receiving and Handling Protocol and Sample Receiving and Handling
Protocol (CBCD) protocol). The laboratory also maintains controls to protect
the integrity of testing and calibration materials, serving the interests of
both the laboratory and the client.
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.
The
laboratory uses a unique classification, categorization, or labeling system to
ensure that testing or calibration materials are not confused, or when
referenced in records or other documents (see No. 10: Protocol File - Coding
Protocol). The laboratory receives, handles, and monitors samples step by step
using the Sample Protocol (see Appendix No. 10: Protocol File - Sample Receipt
and Handling Protocol and Sample Receipt and Handling Protocol (CBCD)) and the
Receipt, Handling, and Storage Form (Procedures Manual and Forms).
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.
Upon
receiving test materials from the client, and finding any distortions or
deviations from normal or specified conditions, as described in the relevant
test, the laboratory consults with the client for further instructions before
proceeding. In this case, the laboratory retains a record of the discussion
between it and the client in order to absolve itself of responsibility for any
deviation from specified conditions (Appendix 12: Procedures Manual and Order
Forms FT.33.0, FT.34.0 and FT.35.0).
7.4.4
When items need to be stored or conditioned under specified environmental conditions, these conditions shall be maintained, monitored and recorded.
The sample
receipt, processing, and storage model and protocol (Appendix 10: Protocol File
and Appendix 12 - Procedures and Forms Manual) define the instructions to be
followed when storing materials or placing them under specific environmental
conditions, particularly temperature, to prevent sample deterioration, loss, or
damage during storage, handling, preparation, and testing. The laboratory
maintains, monitors, and records the environmental conditions for sample
preservation. The laboratory also informs the client of these requirements and
conditions before proceeding with the process. When the laboratory holds a test
material securely (for example, for reasons of recording, safety, value, or
confidentiality), it has arrangements in place for the safe storage of the test
materials.
7.5.1
The laboratory shall ensure that
technical records for each laboratory activity contain the results, report and sufficient information to facilitate, if possible, identification of factors affecting the measurement result and its
associated measurement uncertainty and enable the repetition of the laboratory
activity under conditions as close as possible to the original. The technical
records shall include the date and the identity of personnel responsible for
each laboratory activity and for checking data
and results. Original
observations, data and calculations shall be recorded
at the time they are made
and shall be identifiable with the specific task.
The
laboratory ensures that the quality manual for the technical records of each
laboratory activity includes the protocols, procedures, forms or templates,
appendices, and attachments for that activity, and any other requirements,
where applicable. It also ensures the identification of factors affecting
measurement results and associated measurement uncertainty, and the possibility
of replicating the laboratory activity under conditions as close as possible to
the original conditions. The technical records for each laboratory activity
include the date and identity of the personnel responsible for each activity
and how the data and results were verified. Original observations, data, and
calculations are recorded at the time they are performed, and the laboratory
identifies them with each specific activity or task (see No. 11: The
laboratory's technical records include a list of records).
7.5.2
The laboratory shall ensure that
amendments to technical records can be tracked to previous versions or to
original observations. Both the original and amended data and files shall be
retained, including the date of alteration, an indication of the altered
aspects and the personnel responsible for the alterations.
The
laboratory ensures that modifications to technical records can be traced back
to previous versions or original notes. The laboratory maintains original and
modified data and files in the procedures manual (see No. 11: Procedures and
Forms Manual: Document Review History and Amendment Procedures) (Appendix No.
10: Technical Record Protocol).
7.6 Evaluation of measurement uncertainty
7.6.1
Laboratories shall identify the
contributions to measurement uncertainty. When evaluating measurement
uncertainty, all contributions that are of significance, including those
arising from sampling, shall be taken into account using appropriate methods of
analysis.
The laboratory estimates all sources contributing to the
uncertainty components, including reference standards, reference materials
used, methods and equipment used, environmental conditions, material under
test, and operator.
7.6.2
A laboratory performing
calibrations, including of its own equipment, shall evaluate the measurement
uncertainty for all calibrations.
The laboratory calibrates its equipment (see Appendix 10:
Protocol File - Equipment Protocol). Multiple iteration and calibration data
are a component of uncertainty measurement (see Appendix 10: Protocol File -
Equipment Protocol). The laboratory identifies the components of uncertainty
measurement as a first step toward estimating them for that agent or material.
The analysis report or calibration certificate from the subcontractor contains
the uncertainty values for the measurement.
7.6.3 A laboratory performing testing shall
evaluate measurement uncertainty. Where the test method
precludes rigorous evaluation of measurement uncertainty, an estimation shall
be made based on an understanding of the theoretical principles or practical
experience of the performance of the method.
NOTE 1 In those cases where a
well-recognized test method specifies limits to the values of the major sources of measurement uncertainty and specifies
the form of presentation of the calculated results, the laboratory is
considered to have satisfied 7.6.3 by following the
test method and reporting instructions.
NOTE 2 For a particular method where the
measurement uncertainty of the results has been established and verified, there
is no need to evaluate measurement uncertainty for each result if the
laboratory can demonstrate that the identified critical influencing factors are
under control.
NOTE 3 For
further information, see ISO/IEC Guide 98-3, ISO
21748 and the ISO 5725 series.
The
laboratory uses uncertainty measurements and validation of results (see
Appendix 10: Protocol File - Measurement Uncertainty Assessment Protocol) to
estimate uncertainties in test measurements, except where testing methods
prevent such precise calculations.
7.7 Ensuring the validity of results
7.7.1
The laboratory shall have a
procedure for monitoring the validity of results. The resulting data shall be
recorded in such a way that trends are detectable and, where practicable,
statistical techniques shall be applied to review the results. This monitoring
shall be planned and reviewed and shall include, where appropriate, but not be
limited to:
a)
use of reference
materials or quality control materials;
b)
use of alternative instrumentation that has been calibrated
to provide traceable results;
c)
functional check(s) of measuring and testing equipment;
d)
use of check or working standards with control charts, where applicable;
e)
intermediate checks on measuring equipment;
f)
replicate tests or calibrations using the same or different
methods;
g)
retesting or recalibration of retained items;
h)
correlation of results for different
characteristics of an item;
i)
review of reported
results;
j)
intralaboratory comparisons;
k)
testing of blind sample(s).
The laboratory subjects its calculations and data to
appropriate audits. The technical director verifies the validity of the test
data (see Appendix 2: Technical Director Responsibilities) by: (1) determining
the accuracy of calculations and data transmission; and (2) checking for
transcription errors, omissions, and mistakes; and determining consistency with
normal or expected values. The procedure and calculations are performed in
accordance with the instructions set out in the Results Validation Protocol.
7.7.2 The
laboratory shall monitor its performance by comparison with results of other
laboratories, where available and appropriate. This monitoring shall be planned
and reviewed and shall include, but not be limited to, either or both of the
following:
a)
participation in proficiency testing;
NOTE ISO/IEC 17043 contains additional
information on proficiency tests and proficiency testing providers. Proficiency
testing providers that meet the requirements of ISO/IEC 17043 are considered to
be competent.
b)
participation in interlaboratory comparisons other than proficiency testing.
The laboratory monitors its performance by comparing it
with the results of other laboratories, and by participating in proficiency testing
and interlaboratory comparisons (see Appendix 10: Protocols File - Results
Validation Protocol).
7.7.3 Data from
monitoring activities shall be analysed, used to control and, if applicable,
improve the laboratory's activities. If the results of the analysis of data
from monitoring activities are found to be outside pre-defined criteria,
appropriate action shall be taken to prevent incorrect results from being reported.
The
laboratory analyzes data from monitoring activities and uses the results of the
analysis to control and improve laboratory activities.
7.8 Reporting of results
7.8.1 General
7.8.1.1 The results
shall be reviewed
and authorized prior
to release.
The
technical director reviews and approves the results before the test results are
released (see Appendix 10: Protocols File - Test Results Reporting Protocol).
7.8.1.2 The results
shall be provided
accurately, clearly, unambiguously and objectively, usually
in a report (e.g. a test report or a calibration certificate or report
of sampling), and shall include all the information agreed with the customer
and necessary for the interpretation of the results and all information
required by the method used. All issued reports shall be retained as technical
records.
NOTE 1 For the
purposes of this document, test reports and calibration certificates are
sometimes referred to as test
certificates and calibration reports, respectively.
NOTE 2 Reports can be issued as hard copies or by electronic means, provided that the requirements of this document are met.
The
laboratory typically reports the results in a test report. The results include
all information requested by the client and necessary for interpreting the test
results, as well as all information required by the method used. The laboratory
issues test reports either in hard copy and/or electronically (upon request)
(see Appendix 11: Records File: Test Reports).
7.8.1.3 When agreed
with the customer,
the results may be reported
in a simplified way. Any information listed
in 7.8.2 to 7.8.7 that is not reported
to the customer shall be readily available.
In the case
of tests conducted for internal clients, and where a written agreement exists
with the client, the results can be reported in a simplified manner. However,
the information contained in sub-clauses 7.8.2 to 7.8.7 that has not been
communicated to the client is readily available to them by the laboratory.
7.8.2 Common requirements for reports (test,
calibration or sampling)
7.8.2.1
Each report shall include at least
the following information, unless the laboratory has valid reasons for not
doing so, thereby minimizing any possibility of misunderstanding or misuse:
a)
a title (e.g. “Test Report”, “Calibration Certificate” or “Report
of Sampling”);
b)
the name and address of the laboratory;
c)
the location of performance of the laboratory activities,
including when performed at a customer facility or at sites away from the
laboratory’s permanent facilities, or in associated temporary or mobile
facilities;
d)
unique identification that all its components are
recognized as a portion of a complete report and a clear identification of the
end;
e)
the name and contact information of the customer;
f)
identification of the method used;
g)
a description, unambiguous identification, and, when necessary, the condition of the item;
h)
the date of receipt of the test or calibration item(s), and the date of sampling, where this is critical
to the validity
and application of the results;
i)
the date(s) of performance of the laboratory activity;
j)
the date of issue of the report;
k)
reference to the sampling plan and sampling method used by
the laboratory or other bodies where these are relevant to the validity or
application of the results;
l)
a statement to the effect that the results relate only to the items tested, calibrated or sampled;
m)
the results with, where appropriate, the units of measurement;
n)
additions to, deviations, or exclusions from the method;
o)
identification of the person(s) authorizing the report;
p)
clear identification when results are from external providers.
NOTE Including a statement specifying that the report shall not be reproduced except in full without
approval of the laboratory can provide assurance that parts of a report are not
taken out of context.
7.8.2.1 The
test report includes all the data required by the client and the laboratory
management (see Appendix 11: Records File - Test Reports).
7.8.2.2 The laboratory shall be responsible for all the information provided
in the report, except when information is provided by the
customer. Data provided by a customer shall be clearly identified. In addition,
a disclaimer shall be put on the report when the information is supplied by the
customer and can affect the validity of results. Where the laboratory has not
been responsible for the sampling stage (e.g. the sample has been provided by
the customer), it shall state in the report that the results apply to the
sample as received.
The laboratory is responsible for all information
contained in the report, except for information provided by the client as
specified in 7.8.2.1. The client provides the sample, and the laboratory
applies the report's findings to the sample as received.
7.8.3 Specific requirements for test reports
7.8.3.1 In addition
to the requirements listed in 7.8.2, test reports
shall, where necessary for the interpretation of the test results, include
the following:
a)
information on specific
test conditions, such as environmental conditions;
b)
where relevant, a statement of conformity with requirements or specifications (see 7.8.6);
c)
where applicable, the measurement uncertainty presented in the same unit as that of the measurand
or in a term relative to the measurand
(e.g. percent) when:
—
it is relevant to the validity
or application of the test results;
—
a customer's instruction so requires, or
—
the measurement uncertainty affects conformity to a specification limit;
d)
where appropriate, opinions
and interpretations (see 7.8.7);
e)
additional information that may be required by specific methods, authorities, customers
or groups of customers.
The laboratory's test report includes, in addition to the
requirements listed in 7.8.2: information about environmental conditions, where
appropriate and where possible; and additional information that may be required
by specific methods, authorities, clients, or groups of clients.
7.8.3.2 Where the laboratory is responsible for the sampling
activity, test reports
shall meet the requirements listed in 7.8.5 where necessary for the interpretation of test results.
The test report meets the requirements listed
in 7.8.5 for maintaining the sampling process or activity.
7.8.4 Specific requirements for calibration certificates
7.8.4.1 In addition
to the requirements listed in 7.8.2, calibration certificates shall include the following:
a)
the measurement uncertainty of the measurement result
presented in the same unit as that of the measurand or in a term relative to
the measurand (e.g. percent);
NOTE According
to ISO/IEC Guide 99, a measurement result is generally expressed as a single
measured quantity value including unit of measurement and a measurement
uncertainty.
b)
the conditions (e.g. environmental) under which the
calibrations were made that have an influence on the measurement results;
c)
a statement identifying how the measurements are metrologically traceable
(see Annex A);
d)
the results before and after any adjustment
or repair, if available;
e)
where relevant, a statement of conformity with requirements or specifications (see 7.8.6);
f)
where appropriate, opinions
and interpretations (see 7.8.7).
The laboratory does not issue calibration certificates and
often obtains calibration services from subcontractors (see Appendix 16:
Calibration Contract). The calibration certificate includes, in addition to the
requirements mentioned in 7.8.2, the conditions under which the calibrations
are to be carried out, including environmental conditions.
7.8.4.2 Where the laboratory is responsible for the sampling
activity, calibration certificates shall meet the
requirements listed in 7.8.5 where necessary
for the interpretation of calibration results.
The
conditions under which calibration is performed include environmental
conditions.
7.8.4.3 A calibration certificate or calibration label shall not contain any recommendation on the calibration interval, except where this has been agreed
with the customer.
The
calibration certificate does not contain any recommendation regarding the
calibration interval. However, if the client requests a recommendation
regarding the calibration interval, the laboratory will agree after discussion.
7.8.5
Reporting sampling – specific
requirements
Where the laboratory is responsible for the sampling
activity, in addition
to the requirements listed in
7.8.2, reports shall include the following, where necessary for the interpretation of results:
a)
the date of sampling;
b)
unique identification of the item or material sampled (including
the name of the manufacturer, the model or type of designation and serial
numbers, as appropriate);
c)
the location of sampling, including
any diagrams, sketches
or photographs;
d)
a reference to the sampling
plan and sampling method;
e)
details of any environmental conditions during sampling that affect the interpretation of the results;
f)
information required to evaluate measurement uncertainty for subsequent testing or calibration.
The laboratory records data and processes related to sampling that
form part of the test or calibration being performed. The record includes the
sampling procedure used, the identification of the sampling device,
environmental conditions and sampling location as needed; the statistics upon
which the sampling procedure is based; and the information required to assess
the measurement uncertainty for the test or calibration.
7.8.6
Reporting statements of conformity
7.8.6.1 When a statement of conformity to a specification or standard is provided, the laboratory shall document the decision rule employed, taking into account
the level of risk (such as false
accept and false reject and statistical assumptions) associated with the decision rule employed, and apply the decision rule.
NOTE Where the decision rule
is prescribed by the customer, regulations or normative documents, a further
consideration of the level of risk is not necessary.
7.8.6.2 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;
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
laboratory does not issue a statement of conformity; however, if the client
requests one, the laboratory will provide a calibration report to confirm that
the instrument readings are within the required specifications (see Appendix
10: Equipment Protocol).
The
calibration report issued by the laboratory determines the suitability of the
instruments used.
7.8.7
Reporting opinions and interpretations
7.8.7.1 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 7.8.6.
7.8.7.2 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.
7.8.7.3 When opinions
and interpretations are directly communicated by dialogue with the customer,
a record of the dialogue
shall be retained.
When opinions and interpretations are included in a test report,
the basis upon which they are founded is documented. These opinions and
interpretations are clearly identified in the test report and are only provided
to the client by authorized personnel (the technical manager).
The opinions and interpretations included in the test report may
include, but are not limited to, the following: an opinion on whether the
results conform to requirements; and on whether contractual requirements are
met.
In many cases, it is appropriate to communicate opinions and
interpretations through direct dialogue with the client. In such cases, a
record of this dialogue should be maintained.
7.8.8 Amendments to reports
7.8.8.1 When an
issued report needs to be changed, amended or re-issued, any change of
information shall be clearly identified and, where appropriate, the reason for
the change included in the report.
7.8.8.2 Amendments
to a report after issue shall be made only in the form of a further document,
or data transfer, which includes the statement “Amendment to Report, serial
number... [or as otherwise identified]”, or an equivalent form of wording.
Such amendments shall meet all the requirements of this document.
7.8.8.3 When it is
necessary to issue a complete new report, this shall be uniquely identified and shall contain a reference to the original
that it replaces.
When the laboratory needs to change, amend, or
reissue a report, any change in information is clearly identified, and the
reason for the change is included in the report (see Appendix 10: Protocols
File - Document and Amendment Protocol).
The laboratory makes amendments to a report
after issuance only in the form of a supplementary document or data transfer,
which includes the data and amendments that meet all the requirements of that
document (see Appendix 10: Protocols File - Document and Amendment Protocol).
When the laboratory finds it necessary to issue
a completely new report, the new report is clearly and distinctly identified,
and the reference to the original report it replaces is indicated (see Appendix
10: Protocols File - Document Revision Date and Amendment Protocol).
7.9 Complaints
7.9.1
The laboratory shall have a documented process to receive,
evaluate and make decisions on complaints.
The
laboratory's Quality Control Manager is responsible for documenting and
responding to customer feedback, including complaints. The laboratory uses
forms FT.44.0 and FT.45.0 to receive, evaluate, and resolve customer complaints
(Appendix 12: Procedures and Forms Manual).
7.9.2
A description of the handling
process for complaints shall be available to any interested party on request. Upon receipt of a complaint, the laboratory shall confirm whether
the complaint relates to laboratory activities that it
is responsible for and, if so, shall deal with it. The laboratory shall be
responsible for all decisions at all levels of the handling process for
complaints.
7.9.3 The process
for handling complaints shall include at least the following elements
and methods:
a)
description of the process for receiving, validating, investigating the complaint, and deciding what actions are to be taken in response to it;
b)
tracking and recording
complaints, including actions undertaken to resolve them;
c)
ensuring that any appropriate action is taken.
7.9.4 The
laboratory receiving the complaint shall be responsible for gathering and
verifying all necessary information to validate the complaint.
7.9.5 Whenever possible,
the laboratory shall acknowledge receipt of the complaint, and provide the complainant with progress reports
and the outcome.
7.9.6 The
outcomes to be communicated to the complainant shall be made by, or reviewed and
approved by, individual(s) not involved in the original laboratory activities
in question.
NOTE This can be performed
by external personnel.
7.9.7 Whenever possible,
the laboratory shall give formal notice of the end of the complaint handling
to the complainant.
The process
for receiving, reporting, or uploading complaints to the laboratory website:
https://..................................................
The process
includes: (1) describing the complaint receipt, verification, and investigation
process, and identifying the actions to be taken in response; (2) recording and
tracking complaints (see Appendix 17: Complaints File), including the actions
taken to resolve them; and (3) the action taken. The laboratory maintains
records of all complaints and their follow-up. These records include details of
the complaint, the investigation, corrective actions, and the investigation
follow-up.
The Quality
Control Manager is responsible for collecting and verifying all necessary
information to confirm the validity of the complaint.
The
laboratory acknowledges receipt of the complaint and provides the complainant
with progress reports and the outcome of the investigation.
The
response sent to the complainant is reviewed and approved by an individual(s)
not involved in the original laboratory activities related to the subject of
the complaint.
The
laboratory provides the complainant with an official opinion on the subject of
the complaint
7.10.1 The laboratory shall have a procedure that shall be implemented when any aspect of its laboratory activities or results of this work do not conform to its own procedures or the agreed
requirements of the customer (e.g. equipment or
environmental conditions are out of specified limits, results of monitoring
fail to meet specified criteria). The procedure shall ensure that:
a)
the responsibilities and authorities for the management of nonconforming work are defined;
b)
actions (including halting or repeating of work and
withholding of reports, as necessary) are based upon the risk levels
established by the laboratory;
c)
an evaluation is made of the significance of the
nonconforming work, including an impact analysis on previous results;
d)
a decision is taken on the acceptability of the nonconforming work;
e)
where necessary, the customer is notified and work is recalled;
f)
the responsibility for authorizing the resumption of work is defined.
7.10.2 The
laboratory shall retain records of nonconforming work and actions as specified
in 7.10.1, bullets b) to f).
7.10.3 Where the
evaluation indicates that the nonconforming work could recur, or that there is
doubt about the conformity of the laboratory's operations with its own
management system, the laboratory shall implement corrective action.
The Quality Control Manager is responsible for assessing
non-conforming work using the GP19 General Procedure for Controlling
Non-Conforming Testing and Calibration Work (see Appendix 18: General
Procedures and Forms Manual). The corrective action taken is communicated to
the laboratory technician for implementation. The action may involve suspending
or repeating the work and withholding reports, as necessary and depending on
the identified risk levels. The client is notified, and the work is reworked.
The decision regarding the non-conforming work includes the person responsible
(the Quality Manager) authorizing the resumption of work.
The laboratory maintains records of non-conforming work
and actions as specified in (7.10.1, B-F): the action taken, the assessment
made, the decision made, the client notified, and the assignment of
responsibility (see Appendix 11: Record File - Non-Conformity Record), which
includes records of the non-conforming tests.
The laboratory implements corrective actions where the
assessment indicates that the non-conforming work could be repeated or that
there is doubt about the consistency of the laboratory's processes with its
management system.
7.11 Control of data and information management
7.11.1
The laboratory shall have access to the data and information needed to perform
laboratory activities.
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.
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 provider
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.
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.
7.11.6
Calculations and data transfers
shall be checked
in an appropriate and systematic manner.
Authorized laboratory staff have access to the data and
information necessary for performing their laboratory activities (see Appendix
16: List of Authorized Staff and Their Responsibilities).
The laboratory information management systems used to collect,
process, record, report, store, and retrieve computerized and non-computerized
data (record control) are validated for effectiveness. Data generated using
computer software directly linked to the hardware includes all dilutions and
calculations, thus eliminating the need for manual data reduction. The
laboratory permits software configurations and modifications of commercially
available software, which are documented and validated before implementation.
The Quality Control Manager is responsible for protecting the
laboratory information management systems from unauthorized access. The systems
are tamper-proof and loss-proof, stored securely in the Quality Control
Manager's office, and operated in an environment that complies with the
supplier's or laboratory's specifications. The computers and equipment housing
these systems are maintained to ensure smooth operation and are operated under
the necessary environmental conditions to preserve the integrity of test and
calibration data. The management system includes recording system failures and implementing
immediate and appropriate corrective actions.
The laboratory ensures that instructions, manuals, and relevant
reference data for the laboratory information management system(s) are readily
available to staff.
The laboratory also ensures that technicians and technical
managers perform calculations and verify transmitted data in a proper and
systematic manner.
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