International standard iso/iec 17025:2017

General requirements for the competence of testing and calibrating

laboratories:

Introduction

1. Scope
2. Normative references
3. Terms and definitions
4. General requirements
4.1 Impartiality
4.2 Confidentiality
5. Structural requirements
6. Resource requirements
6.1 General
6.2 Personnel
6.3 Facilities and environmental conditions
6.4 Equipment
6.5 Metrological traceability
6.6 Externally provided products and services
7. Process requirements
7.1 Review of requests, tenders and contracts
7.2 Selection, verification and validation of methods
7.2.1 Selection and verification of methods
7.2.2 Validation of methods
7.3 Sampling
7.4 Handling of test or calibration items
7.5 Technical records
7.6 Evaluation of measurement uncertainty
7.7 Ensuring the validity of results
7.8 Reporting of results
7.8.1 General
 7.8.2 Common requirements for reports ( test, calibration or
sampling)
7.8.3 Specific requirements for test reports
7.8.4 Specific requirements for calibration certificates
7.8.5 Reporting sampling – Specific requirements
7.8.6 Reporting statements of conformity
7.8.7 Reporting opinions and interpretations
7.8.8 Amendments to reports
7.9 Complaints
7.10 Nonconforming work
7.11 Control of data and information management
8. Management system requirements
8.1 Options
8.1.1 General
8.1.2 Option A
8.1.3 Option B
8.2 Management system documentation (option A)
8.3 Control of management system documents (option A)
8.4 Control of records(Option A)
8.5 Actions to address risks and opportunities (optionA)
8.6 Improvement(option A)
8.7 Corrective actions(Option A)
8.8 Internal audits (option A)
8.9 Management reviews (OptionA)
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 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.

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.

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.

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 required 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.
7.4.4 When items need to be stored or conditioned under specified
environmental conditions, these conditions shall be maintained, monitored
and recorded.

7.5 Technical Records

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 data and the identity of the 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.

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.

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.

7.6.2 A laboratory performing calibrations, including of its own equipment,

shall evaluate the measurement uncertainty for all calibrations.

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; In those cases where a well-organised 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 by following the test method and reporting
instructions.

NOTE: 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.

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 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) Interlaboratory comparisons

k) Testing of blind sample

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;

b) Participation in interlaboratory comparisons other than proficiency testing

7.7.3 Data from monitoring activities shall be analyses, 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 actions shall be taken to prevent incorrect results from
being reported.

7.8 Reporting of results

7.8.1 General

7.8.1.1 The results shall be reviewed and authorized prior to release.

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 For the purposes of this document, test reports and calibration
certificates are sometimes referred to as test certificates and calibration
reports, respectively.

NOTE Reports can be issued as hard copies or by electronic means,

provided that the requirements of this document are met.

7.8.1.3 When agreed with the customer, the results may be reported in a
simplified way. Any information that is not reported to the customer shall be
readily available.

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 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 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

7.8.2.2 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.

7.8.3 Specific requirements for test reports

7.8.3.1 In addition to the requirements listed 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

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 instructions so required, or

-the measurement uncertainty affects conformity to a specification limit

d) Where appropriate, opinions and interpretations

e) Additional information that may be required by specific methods,

authorities, customers or groups of customers.
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.

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

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

d) The results before and after any adjustment or repair, if available

e) Where relevant, a statement of conformity with requirements or

specifications

f) Where appropriate, opinions and interpretations

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

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.

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

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)

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 expressions of
opinions and interpretations release the respective statement.
The laboratory shall document the basis upon which the opinions and
interpretations have been made.

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.

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.

7.9 Complaints

7.9.1 The laboratory shall have a documented process to receive,

evaluate and make decisions on complaints.

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 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 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.

7.10 Nonconforming work

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

7.10.3 Where the evaluation indicated 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

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 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 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 In this document “ laboratory information management system

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

Note2 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 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
transcriptions/

5 Structural requirements

5.1 The lab shall be a legal entity, or a defined part of a legal entity, that
is legally responsible for its lab activities

For the purposes of this document, a governmental lab is deemed to be

a legal entity on the basis of its governmental status

5.2 The lab shall identify management that has overall responsibility for
the lab

5.3 The lab shall define and document the range of lab activities for
which it conforms with this document. The lab shall only claim conformity
with this document for this range of lab activities which excludes
externally provided lab activities on an ongoing basis

5.4 Lab activities shall be carried out in such a way to meet the
requirements of this document, the lab’s customers, regulatory
authorities and organizations providing recognition

This shall include lab activities performed in all its permanent facilities at
sites away from its permanent facilities in associated temporary or
mobile facilities or at a customer;s facility

5.5 The lab shall

a) Define the organization and management structure of the lab, its

place in any parent organization and the relationships between
management technical operations and support services
b) Specify the responsibility authority and interrelationship of all
personnel who manage, perform or verify work affecting the results of
lab activities

c) Document its procedure to the extent necessary to ensure the

consistent application of its lab activities and the validity of the results

5.6 The lab shall have personnel who irrespective of other

responsibilities have the authority and resources needed to carry out
their duties including

a) Implementation, maintenance and improvement of the management

system

b) Identification of deviations from the management system or from the

procedures for performing lab activities

c) Initiation of actions to prevent or minimize such deviations

d) Reporting to lab management on the performance of the

management system and any need for improvement

e) Ensuring the effectiveness of lab activities

5.7 Lab management shall ensure that

a) Communication takes place regarding the effectiveness of the

management system and the importance of meeting customer and other
requirements

b) The integrity of the management system is maintained when changes

to the management system are planned and implemented

6 Resource requirements

6.1. General

The lab shall have available the personnel, facilities, equipment,

systems and support services necessary to manage and perform its lab
activities
 6.2 The lab shall document the competence requirements for each
function influencing the results of lab activities including requirements for
education qualification training technical knowledge skills and
experience

The lab shall ensure that the personnel have the competence to perform
lab activities for which they are responsible and to evaluate the
significance of deviations

The management of the lab shall communicate to personnel their duties

responsibilities and authorities

The lab shall have procedure and retain records for

Determining the competence requirements

Selection of personnel

Training of personnel

Supervision of personnel

Authorization of personnel

Monitoring competence of personnel

6.2.6 The lab shall authorize personnel to perform specific lab activities
including but not limites to the following

Development modification verification and validation of methods

Analysis of results including statements of conformity or opinions and

interpreatations

Report, review and authorization of results

6.3 Facilities and environmental conditions

6.3.1 The facilities and environmental conditions shall be suitable for the
lab activities and shall not adversely affect the validity of results
Influences that can adversely affect the validity of results can include, but
are not limited to microbial contamination, dust, or electromagnetic
disturbances radiation humidity electrical supply temperature sound and
vibration

The requirements for facilities and environmental conditions necessary for

the performance of the lab activities shall be documented

6.3.3 The lab shall monitor control and record environmental conditions in
accordance with relevant specifications, methods or procedures or where
they influence the validity of the results

6.3.4 Measures to control facilities shall be implemented monitored and

periodically reviewed and shall include

Access to and use of areas affecting lab activities

Prevention of contamination interferences or adverse influences on lab

activities

Effective separation between areas with incompatible lab activities

6.3.5 When the lab performs lab activities at sites or facilities outside its
permanent control, it shall ensure that the requirements related to facilities
and environmental conditions of this document are met

6.4 Equipment

6.4.1 The lab shall have access to equipment measuring instruments

software measurement standards reference materials reference data
reagents consumables or auxiliary apparatus that is required for the correct
performance of lab activities and that can influence the results

6.4.2 When the lab uses equipment outside its permanent control, it shall
ensure that the requirements for equipment of this document are met

6.4.3 The lab shall verify that equipment conforms to specified

requirements before being placed or returned into service
6.4.5 The equipment used for measurement shall be capable of achieving
the measurement uncertainty required to provide a valid result

6.4.6 Measuring equipment shall be calibrated when:

The measurement accuracy or measurement uncertainty affects the validity

of the reported results

Calibration of the equipment is required to establish the metrological

traceability of the reported results

Used for the direct measurement of the measurand weighing balance

Used to make corrections to the measured value

Used to obtain a measurement result calculated from multiple quantities

6.4.7 The lab shall establish a calibration programme which shall be

reviewed and adjusted as necessary in order to maintain confidence in the
status of calibration

6.4.8 Equipment that has been subjected to overloading or mishandling

gives questionable results or has been shown to be defective or outside
specified requirements shall be taken out of service IT shall be isolated to
prevent its use or clearly labeled or marked as being out of service until it
has been verified to perform correctly

The lab shall examine the effect of the defect or deviation from specified
requirements and shall initiate the management of nonconforming work
procedure

6.4.10 When intermediate checks are necessary to maintain confidence

in the performance of the equipment these checks shall be carried out
according to a procedure

6.4.11 When calibration and reference material data include reference

values or correction factors, the lab shall ensure the reference values
and correction factores are updated and implemented as appropriate to
meet specified requirements
The lab shall take practicable measures to prevent unintended
adjustments of equipment from invalidating results

Records shall be retained for equipment which can influence lab

activities the records shall include the following where applicable

The identity of e