Introduction

to
ISO 17025:2017
e-book

17025.store
17025.store Introduction to ISO 17025:2017

Index

1. Introduction

2. Terminology

3. General Requirements

4. Structural Requirements

5. Resource Requirements

6. Process Requirements

7. Management System Requirements

17025.store Introduction to ISO 17025:2017

Chapter:1 | Introduction to ISO 17025

ISO/IEC 17025:2017 is the standard that covers the

“General requirements for the competence of testing and calibration

laboratories”

The Standard ISO/IEC 17025 was first issued in 1999 by the International
Organization for Standardization (ISO) and the International Electrotechnical
Commission (IEC).

ISO/IEC 17025 is the single most important standard for calibration and testing
laboratories around the world.
Laboratories/Companies that are accredited to ISO 17025 international standard
have demonstrated that they are technically competent and able to produce
precise and accurate results.

As you know ISO 17025 is for any organization that performs testing, sampling or
calibration.

This Standard also enables laboratories to demonstrate that they operate

competently and generate valid results, thereby promoting confidence in their
work both nationally and around the world.
Chapter:2 | Terminology

Impartiality
It means the Presence of objectivity, In the context of testing or calibration
Laboratories, Lab results cannot be influenced, or have the appearance of being
influenced by any relationships the laboratory or the people involved in laboratory
activities may have with the client.

Laboratory activities also cannot be influenced by any undue pressure being put
on the people involved in conducting those laboratory activities

Complaint
Organizations can’t avoid dealing with complaints. Therefore, your laboratory
must have effective complaints management.
When there’s an established complaints procedure, your laboratory will be able to
determine areas for improvement, especially in products, services, and processes.

Interlaboratory comparison
Organization, performance and evaluation of measurements or tests on the same
or similar items by two or more laboratories under predetermined conditions.

Interlaboratory comparison
organization, performance and evaluation of measurements or tests on the same
or similar items within the same laboratory (3.6) by predetermined
conditions

Proficiency testing
Proficiency testing is the establishment of the calibration or testing performance
of a laboratory. It also refers to an inspection body’s testing performance against
pre-determined criteria using interlaboratory comparison.

Hence, proficiency testing is one of the most dominant ways of checking the
validity of the test and/or calibration results.

Laboratory
a body that performs one or more of the following activities:
— testing;
— calibration;
— sampling, associated with subsequent testing or calibration
Decision rule

a rule that describes how measurement uncertainty is accounted for when stating
conformity with a specified requirement or verification.

Validation

ISO/IEC 17025 defines validation as “the confirmation by examination and

the provision of objective evidence that the particular requirements for
specific intended use are fulfilled”.
Chapter:3 | General Requirements

The main requirements of the new ISO/IEC 17025:2017 standard can be found
throughout clauses 4 to 8.

Clause 4 explains the requirements involving impartiality and confidentiality.

Since risk-based thinking is evident throughout ISO/IEC 17025:2017, the new

standard expects laboratories to plan and implement actions to address risks
and opportunities.

The confidential requirement extends to laboratory personnel such as individuals

acting on the laboratory’s behalf, contractors, personnel of external bodies, and
committee members.

The confidential requirement extends to cases wherein data is recovered from

regulators or complainants.
Chapter:4 | Structural Requirements

Clause 5 Structural Requirements defines main requirements such as:

 A laboratory’s legal status;

 Identification of management;
 Organization and management structure;
 Range of laboratory activities;
 Availability of personnel responsible for the implementation;
 Availability of personnel in maintaining the integrity of the management system;
 Documentation of procedures;

ISO/IEC 17025:2017 requires a laboratory to only claim conformity with this document for this
range of laboratory activities.

This omits externally provided laboratory activities on an ongoing basis.

Therefore, a laboratory expected to be accredited should specify in the scope of accreditation
only testing/calibration/sampling activities.

However, the new standard states that a laboratory can be accredited only for those
laboratory activities, for which it is competent.

Thus, subcontracting is allowable for circumstances such as sickness of personnel, an overload

of work, maintenance of equipment, and the like.
Chapter:5 | Resource Requirements

Resource requirements include personnel, equipment, facilities, systems, and support services
essential to conduct and handle the laboratory activities.

It expects all internal and external personnel of the laboratory to be competent and act
impartially.

This standard doesn’t refer all personnel at this clause, but only to those who might influence
the results of laboratory activities.

Aside from personnel directly working in testing/calibration/sampling activities, the

requirement also covers personnel who are indirectly involved, such as technical personnel,

 personnel that perform maintenance of the equipment;

 management system personnel;
 personnel who evaluate suppliers;
 personnel who maintain the management system and internal auditing
activities.
Meanwhile, there are competency requirements that must be documented:

 education;
 qualification;
 technical knowledge;
 skills;
 experience;
 training

Moreover, procedures and records are expected for selection, supervision training,
authorization, and monitoring of a personnel’s competence.

ISO/IEC 17025:2017 outlines the cases where a laboratory is expected to authorize personnel
to carry out particular laboratory activities.
The requirements for facilities and environmental conditions appropriate for the laboratory
activities should be documented.

The documentation should also cover conditions associated with controlling, monitoring, and
recording environmental conditions.

ISO/IEC 17025:2017 establishes requirements to those environmental conditions that can

impact the results of laboratory activities.

Depending on the laboratory activities’ nature, a similar parameter can be or cannot be

significant for the testing results.

For instance, the relative humidity value that is critical to textile testing, which should then be
controlled, is typically not critical in the case of routine mechanical tests of plastics.
Measures to control facilities may cover:

 access to and use of areas impacting laboratory activities;

 deterrence of impurity and effective area separation, as well as facilities or sites outside
the permanent control of a laboratory.

Furthermore, ISO/IEC 17025:2017 requires a procedure for handling, transport, storage, use,
and planned maintenance of equipment.

There are equipment requirements that can obtain correct results during laboratory activities:

 software;
 hardware;
 reference data;
 reference materials;
 measurement standards;
 reagents;
 consumables;
 auxiliary apparatus
Chapter:6 | Process Requirements

Clause 7 Process Requirements has deployed process requirements as follows:

Review of requests, tenders, and contracts

ISO/IEC 17025:2017 requires the need to address issues like:
 level of understanding of requirements;
 laboratory’s competence and resources to meet the requirements;
 application of suitable control over external providers;
 selection of fitting methods to fulfil the requirements of customers.

A laboratory is expected to notify customers when the necessary testing/calibration/sampling

method is deemed outdated or unfitting.

When there’s a required statement of conformity to a standard or specification, the selected

decision rule must be communicated to, and agreed with, the customer.

Additionally, a laboratory must apply a contract review for any modifications in the contract,
tender, or request. Relative review records are also required.
Selection, verification, and validation of methods
ISO/IEC 17025:2017 describes the word ‘method’ as a way to classify the sampling procedure,
calibration method, and testing/measurement procedure.

Methods include methods published by:

– regional standards;– national standards;

– international standards;
– relevant scientific texts or journals;
– reputable technical organizations;
– manufacturer of the equipment;
– laboratory

Sampling

A sampling method and a sampling plan should be accessible and instigated when the
laboratory executes sampling of products, materials, or substances for subsequent testing or
calibration.
Lastly, sampling data records should be kept per standard requirements.

Handling of test or calibration items

A laboratory should draft a procedure for the transportation, receipt, handling, protection,
storage, preservation, and return or dumping of test or calibration items.

This should also include a system for the identification of test or calibration items.
Then, a laboratory should record deviations from specified conditions, Meanwhile, the
customer should be consulted for the next steps.
Technical records
ISO/IEC 17025:2017 expects a laboratory to comply with requirements in maintaining
technical records.

This is to guarantee the traceability of laboratory activities and to provide details for possible
decision making.
The technical records are expected to contain the results, reports, and adequate data.
The record should be able to assist in categorizing matters impacting the measurement result
and its measurement uncertainty.

Evaluation of Measurement Uncertainty

Testing laboratories are expected to evaluate measurement uncertainty. This should consider
all significant contributions, including those coming from sampling.
ISO/IEC 17025:2017 states that for a certain method, where the measurement uncertainty of
the results has been identified and confirmed, there is no need to evaluate measurement
uncertainty for each result.

Assuring the Validity of Results

ISO/IEC 17025:2017 requires a procedure and records to check the validity of results. Yet, a
laboratory should first plan and review when using some of the following activities:

 use of reference materials or QC materials;

 intermediate checks;
 use of alternative traceable instrumentation;
 replicate tests or calibrations;
 functional checks;
 use of standards with control charts;
 intra-laboratory comparisons;
 retesting or recalibration;
 correlation of results;
 review of reported results;
 testing of blind samples
 participation in PT’s (proficiency tests) and/or ILC’s (interlaboratory comparisons)
Reporting of Results
ISO/IEC 17025:2017 established requirements for results review and authorization as reserved
in the relative technical records.
Hence, laboratory activity results must be reported.

The following clauses have their designated coverage:

– Common data is mandatory to be incorporated in the test, calibration, or

sampling reports.
– Particular information for test reports.
– Calibration certificates.
– Reporting sampling.
– Reporting statements of conformity.
– Reporting interpretations and opinions.
– Amendments to reports.

Complaints
ISO/IEC 17025:2017 requires a laboratory to have a documented process for receiving,
evaluating, and making decisions on complaints.

This process should be accessible to any interested party upon request.

Nonconforming work

ISO/IEC 17025:2017 expects a laboratory to apply for a nonconforming work

procedure to ensure that:
 the authorities and responsibilities for the management of
 nonconforming work is established;
 subsequent actions are taken considering the risk levels;
 an evaluation is made of the significance of the nonconforming work;
  a decision is made on the satisfactoriness of the nonconforming work;
 work is recalled, if necessary;
 the responsibility for approving the recommencement of work is distinct;
 stopping or repeating work and withholding reports, if necessary.

Control of Data – Information Management

This clause covers requirements for the laboratory information management system(s) used
for the accumulation, handling, recording, reporting, storage, and recovery of data.
Chapter:7 | Management Requirements

There are two options a laboratory can choose from in implementing a management system.

1. Listing the minimum requirements for the implementation of a laboratory’s management

system. This option incorporates some ISO 9001 requirements. Those ISO 9001 requirements
are important to the scope of laboratory activities that are covered by the management
system.

2. Creating and maintaining a management system following the requirements of ISO 9001.
Laboratories that use this option will function under ISO 9001.

A laboratory’s conformity to the requirements of ISO 9001 does not, by itself, exhibit the
competence of the laboratory to release technically valid data and results.

This is obtained only through compliance with ISO/IEC 17025.

Clause 8 shows that the requirements for documentation have been substantially deducted.

 Management system policies and objectives (8.2.1)

 Analysis of customer feedback (8.6.2)
 Corrective actions, non-conformities related records (8.7.3)
 Internal audit and results records (8.8.2)
 Management review input and output record (8.9.2)
 Note that there are no requirements for documented procedures associated
 with management system activities mentioned in clause 8.
 Besides, there is no requirement for a Quality Manual.

Due to the introduction of risk-based thinking in ISO/IEC 17025:2017, some reduction in

prescriptive requirements and their replacement by performance-based requirements became
possible.

Furthermore, the recent version of the standard added Clause 8.5, which covers actions to
address risks and opportunities.

Clause 8.5 requires a laboratory to consider the risks and opportunities associated with the
laboratory activities.

These activities are described throughout the standard and include:

 risks related to impartiality (4.1.4);

 statements of conformity (7.8.6);
 nonconforming work (7.10.1);
 corrective actions (8.7.1)

Nevertheless, ISO/IEC 17025:2017 doesn’t require a particular or formal method for risk
management or a documented risk management process.

You can check on the Risk Management – Principles and Guidelines found in ISO 31000
17025.store

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