ATTACHMENT E - ISO-IEC-17025 - HEMODIALYSIS WATER TESTING.pdf

INTERNATIONAL

STANDARD

ISO/IEC

17025

Third edition

2017-11

General requirements for the competence of testing and calibration laboratories Exigences générales concernant la compétence des laboratoires d'étalonnages et d'essais

Reference number

ISO/IEC 17025:2017(E)

© ISO/IEC 2017

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Contents Page

Foreword ............................................................................................................................................................................................. v Introduction ................................................................................................................................................................... vi 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 (Option A)

8.6 Improvement (Option A)

8.7 Corrective actions (Option A)

8.8 Internal audits (Option A)

8.9 Management reviews (Option A)

Annex A (informative) Metrological traceability Annex B (informative) Management system options Bibliography v

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee.

International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. In the field of conformity assessment, ISO and the International Electrotechnical Commission (IEC) develop joint ISO/IEC documents under the management of the ISO Committee on Conformity assessment (ISO/CASCO).

The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see w w w.iso.org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see w w w.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: w w w.iso.org/iso/foreword.html.

This document was prepared by the ISO Committee on Conformity Assessment (CASCO) and circulated for voting to the national bodies of both ISO and IEC, and was approved by both organizations.

This third edition cancels and replaces the second edition (ISO/IEC 17025:2005), which has been technically revised.

The main changes compared to the previous edition are as follows:

— the risk-based thinking applied in this edition has enabled some reduction in prescriptive requirements and their replacement by performance-based requirements;

— there is greater flexibility than in the previous edition in the requirements for processes, procedures, documented information and organizational responsibilities;

— a definition of “laboratory” has been added (see 3.6).

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Introduction

This document has been developed with the objective of promoting confidence in the operation of laboratories. This document contains requirements for laboratories to enable them to demonstrate they operate competently, and are able to generate valid results. Laboratories that conform to this document will also operate generally in accordance with the principles of ISO 9001.

This document requires the laboratory to plan and implement actions to address risks and opportunities.

Addressing both risks and opportunities establishes a basis for increasing the effectiveness of the management system, achieving improved results and preventing negative effects. The laboratory is responsible for deciding which risks and opportunities need to be addressed.

The use of this document will facilitate cooperation between laboratories and other bodies, and assist in the exchange of information and experience, and in the harmonization of standards and procedures.

The acceptance of results between countries is facilitated if laboratories conform to this document.

In this document, the following verbal forms are used:

— “shall” indicates a requirement;

— “should” indicates a recommendation;

— “may” indicates a permission;

— “can” indicates a possibility or a capability.

Further details can be found in the ISO/IEC Directives, Part 2.

For the purposes of research, users are encouraged to share their views on this document and their priorities for changes to future editions. Click on the link below to take part in the online survey:

17025_ed3_usersurvey https://www.surveymonkey.com/r/6MQ95ZC

INTERNATIONAL STANDARD ISO/IEC 17025:2017(E)

General requirements for the competence of testing and calibration laboratories

1 Scope This document specifies the general requirements for the competence, impartiality and consistent operation of laboratories.

This document is applicable to all organizations performing laboratory activities, regardless of the number of personnel.

Laboratory customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others use this document in confirming or recognizing the competence of laboratories.

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

ISO/IEC Guide 99, International vocabulary of metrology — Basic and general concepts and associated terms (VIM)1)

ISO/IEC 17000, Conformity assessment — Vocabulary and general principles

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO/IEC Guide 99 and ISO/IEC 17000 and the following apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https://w w w.iso.org/obp

— IEC Electropedia: available at http://w w w.electropedia.org/

3.1 impartiality presence of objectivity

Note 1 to entry: Objectivity means that conflicts of interest do not exist, or are resolved so as not to adversely influence subsequent activities of the laboratory (3.6).

Note 2 to entry: Other terms that are useful in conveying the element of impartiality include “freedom from conflict of interests”, “freedom from bias”, “lack of prejudice”, “neutrality”, “fairness”, “open-mindedness”, “even-handedness”, “detachment”, “balance”.

[SOURCE: ISO/IEC 17021-1:2015, 3.2, modified — The words “the certification body” have been replaced by “the laboratory” in Note 1 to entry, and the word “independence” has been deleted from the list in Note 2 to entry.]

1) Also known as JCGM 200.

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3.2 complaint expression of dissatisfaction by any person or organization to a laboratory (3.6), relating to the activities or results of that laboratory, where a response is expected

[SOURCE: ISO/IEC 17000:2004, 6.5, modified — The words “other than appeal” have been deleted, and the words “a conformity assessment body or accreditation body, relating to the activities of that body” have been replaced by “a laboratory, relating to the activities or results of that laboratory”.]

3.3 interlaboratory comparison organization, performance and evaluation of measurements or tests on the same or similar items by two or more laboratories in accordance with predetermined conditions

[SOURCE: ISO/IEC 17043:2010, 3.4]

3.4 intralaboratory comparison organization, performance and evaluation of measurements or tests on the same or similar items within the same laboratory (3.6) in accordance with predetermined conditions

3.5 proficiency testing evaluation of participant performance against pre-established criteria by means of interlaboratory comparisons (3.3)

[SOURCE: ISO/IEC 17043:2010, 3.7, modified — Notes to entry have been deleted.]

3.6 laboratory body that performs one or more of the following activities:

— testing;

— calibration;

— sampling, associated with subsequent testing or calibration

Note 1 to entry: In the context of this document, “laboratory activities” refer to the three above-mentioned activities.

3.7 decision rule rule that describes how measurement uncertainty is accounted for when stating conformity with a specified requirement

3.8 verification provision of objective evidence that a given item fulfils specified requirements

EXAMPLE 1 Confirmation that a given reference material as claimed is homogeneous for the quantity value and measurement procedure concerned, down to a measurement portion having a mass of 10 mg.

EXAMPLE 2 Confirmation that performance properties or legal requirements of a measuring system are achieved.

EXAMPLE 3 Confirmation that a target measurement uncertainty can be met.

Note 1 to entry: When applicable, measurement uncertainty should be taken into consideration.

Note 2 to entry: The item may be, for example, a process, measurement procedure, material, compound, or measuring system.

Note 3 to entry: The specified requirements may be, for example, that a manufacturer's specifications are met.

Note 4 to entry: Verification in legal metrology, as defined in VIML, and in conformity assessment in general, pertains to the examination and marking and/or issuing of a verification certificate for a measuring system.

Note 5 to entry: Verification should not be confused with calibration. Not every verification is a validation (3.9).

Note 6 to entry: In chemistry, verification of the identity of the entity involved, or of activity, requires a description of the structure or properties of that entity or activity.

[SOURCE: ISO/IEC Guide 99:2007, 2.44]

3.9 validation verification (3.8), where the specified requirements are adequate for an intended use

EXAMPLE A measurement procedure, ordinarily used for the measurement of mass concentration of nitrogen in water, may be validated also for measurement of mass concentration of nitrogen in human serum.

[SOURCE: ISO/IEC Guide 99:2007, 2.45]

4 General requirements

4.1 Impartiality

4.1.1 Laboratory activities shall be undertaken impartially and structured and managed so as to safeguard impartiality.

4.1.2 The laboratory management shall be committed to impartiality.

4.1.3 The laboratory shall be responsible for the impartiality of its laboratory activities and shall not allow commercial, financial or other pressures to compromise impartiality.

4.1.4 The laboratory shall identify risks to its impartiality on an on-going basis. This shall include those risks that arise from its activities, or from its relationships, or from the relationships of its personnel.

However, such relationships do not necessarily present a laboratory with a risk to impartiality.

NOTE A relationship that threatens the impartiality of the laboratory can be based on ownership, governance, management, personnel, shared resources, finances, contracts, marketing (including branding), and payment of a sales commission or other inducement for the referral of new customers, etc.

4.1.5 If a risk to impartiality is identified, the laboratory shall be able to demonstrate how it eliminates or minimizes such risk.

4.2 Confidentiality

4.2.1 The laboratory shall be responsible, through legally enforceable commitments, for the management of all information obtained or created during the performance of laboratory activities.

The laboratory shall inform the customer in advance, of the information it intends to place in the public domain. Except for information that the customer makes publicly available, or when agreed between the laboratory and the customer (e.g. for the purpose of responding to complaints), all other information is considered proprietary information and shall be regarded as confidential.

4.2.2 When the laboratory is required by law or authorized by contractual arrangements to release confidential information, the customer or individual concerned shall, unless prohibited by law, be notified of the information provided.

4.2.3 Information about the customer obtained from sources other than the customer (e.g. complainant, regulators) shall be confidential between the customer and the laboratory. The provider (source) of this information shall be confidential to the laboratory and shall not be shared with the customer, unless agreed by the source.

4.2.4 Personnel, including any committee members, contractors, personnel of external bodies, or individuals acting on the laboratory's behalf, shall keep confidential all information obtained or created during the performance of laboratory activities, except as required by law.

5 Structural requirements

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

NOTE For the purposes of this document, a governmental laboratory is deemed to be a legal entity on the basis of its governmental status.

5.2 The laboratory shall identify management that has overall responsibility for the laboratory.

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

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

This shall include laboratory 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 laboratory shall:

a) define the organization and management structure of the laboratory, 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 laboratory activities;

c) document its procedures to the extent necessary to ensure the consistent application of its laboratory activities and the validity of the results.

5.6 The laboratory 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 laboratory activities;

c) initiation of actions to prevent or minimize such deviations;

d) reporting to laboratory management on the performance of the management system and any need for improvement;

e) ensuring the effectiveness of laboratory activities.

5.7 Laboratory management shall ensure that:

a) communication takes place regarding the effectiveness of the management system and the importance of meeting customers' 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 laboratory shall have available the personnel, facilities, equipment, systems and support services necessary to manage and perform its laboratory activities.

6.2 Personnel

6.2.1 All personnel of the laboratory, either internal or external, that could influence the laboratory activities shall act impartially, be competent and work in accordance with the laboratory's management system.

6.2.2 The laboratory shall document the competence requirements for each function influencing the results of laboratory activities, including requirements for education, qualification, training, technical knowledge, skills and experience.

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

6.2.4 The management of the laboratory shall communicate to personnel their duties, responsibilities and authorities.

6.2.5 The laboratory shall have procedure(s) and retain records for:

a) determining the competence requirements;

b) selection of personnel;

c) training of personnel;

d) supervision of personnel;

e) authorization of personnel;

f) monitoring competence of personnel.

6.2.6 The laboratory shall authorize personnel to perform specific laboratory activities, including but not limited to, the following:

a) development, modification, verification and validation of methods;

b) analysis of results, including statements of conformity or opinions and interpretations;

c) 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 laboratory activities and shall not adversely affect the validity of results.

NOTE Influences that can adversely affect the validity of results can include, but are not limited to, microbial contamination, dust, electromagnetic disturbances, radiation, humidity, electrical supply, temperature, sound and vibration.

6.3.2 The requirements for facilities and environmental conditions necessary for the performance of the laboratory activities shall be documented.

6.3.3 The laboratory 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, but not be limited to:

a) access to and use of areas affecting laboratory activities;

b) prevention of contamination, interference or adverse influences on laboratory activities;

c) effective separation between areas with incompatible laboratory activities.

6.3.5 When the laboratory performs laboratory 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 laboratory shall have access to equipment (including, but not limited to, measuring instruments, software, measurement standards, reference materials, reference data, reagents, consumables or auxiliary apparatus) that is required for the correct performance of laboratory activities and that can influence the results.

NOTE 1 A multitude of names exist for reference materials and certified reference materials, including reference standards, calibration standards, standard reference materials and quality control materials. ISO 17034 contains additional information on reference material producers (RMPs). RMPs that meet the requirements of ISO 17034 are considered to be competent. Reference materials from RMPs meeting the requirements of ISO 17034 are provided with a product information sheet/certificate that specifies, amongst other characteristics, homogeneity and stability for specified properties and, for certified reference materials, specified properties with certified values, their associated measurement uncertainty and metrological traceability.

NOTE 2 ISO Guide 33 provides guidance on the selection and use of reference materials. ISO Guide 80 provides guidance to produce in-house quality control materials.

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

6.4.3 The laboratory shall have a procedure for handling, transport, storage, use and planned maintenance of equipment in order to ensure proper functioning and to prevent contamination or deterioration.

6.4.4 The laboratory 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 accuracy and/or 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, and/or

— calibration of the equipment is required to establish the metrological traceability of the reported results.

NOTE Types of equipment having an effect on the validity of the reported results can include:

— those used for the direct measurement of the measurand, e.g. use of a balance to perform a mass measurement;

— those used to make corrections to the measured value, e.g. temperature measurements;

— those used to obtain a measurement result calculated from multiple quantities.

6.4.7 The laboratory 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 All equipment requiring calibration or which has a defined period of validity shall be labelled, coded or otherwise identified to allow the user of the equipment to readily identify the status of calibration or period of validity.

6.4.9 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 labelled or marked as being out of service until it has been verified to perform correctly. The laboratory shall examine the effect of the defect or deviation from specified requirements and shall initiate the management of nonconforming work procedure (see 7.10).

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 laboratory shall ensure the reference values and correction factors are updated and implemented, as appropriate, to meet specified requirements.

6.4.12 The laboratory shall take practicable measures to prevent unintended adjustments of equipment from invalidating results.

6.4.13 Records shall be retained for equipment which can influence laboratory activities. The records shall include the following, where applicable:

a) the identity of equipment, including software and firmware version;

b) the manufacturer's name, type identification, and serial number or other unique identification;

c) evidence of verification that equipment conforms with specified requirements;

d) the current location;

e) calibration dates, results of calibrations, adjustments, acceptance criteria, and the due date of the next calibration or the calibration interval;

f) documentation of reference materials, results, acceptance criteria, relevant dates and the period of validity;

g) the maintenance plan and maintenance carried out to date, where relevant to the performance of the equipment;

h) details of any damage, malfunction, modification to, or repair of, the equipment.

6.5 Metrological traceability

6.5.1 The laboratory shall establish and maintain metrological traceability of its measurement results by means of a documented unbroken chain of calibrations, each contributing to the measurement uncertainty, linking them to an appropriate reference.

NOTE 1 In ISO/IEC Guide 99, metrological traceability is defined as the “property of a measurement result whereby the result can be related to a reference through a documented unbroken chain of calibrations, each contributing to the measurement uncertainty”.

NOTE 2 See Annex A for additional information on metrological traceability.

6.5.2 The laboratory shall ensure that measurement results are traceable to the International System of Units (SI) through:

a) calibration provided by a competent laboratory; or

NOTE 1 Laboratories fulfilling the requirements of this document are considered to be competent.

b) certified values of certified reference materials provided by a competent producer with stated metrological traceability to the SI; or

NOTE 2 Reference material producers fulfilling the requirements of ISO 17034 are considered to be competent.

c) direct realization of the SI units ensured by comparison, directly or indirectly, with national or international standards.

NOTE 3 Details of practical realization of the definitions of some important units are given in the SI brochure.

6.5.3 When metrological traceability to the SI units is not technically possible, the laboratory shall demonstrate metrological traceability to an appropriate reference, e.g.:

a) certified values of certified reference materials provided by a competent producer;

b) results of reference measurement procedures, specified methods or consensus standards that are clearly described and accepted as providing measurement results fit for their intended use and ensured by suitable comparison.

6.6 Externally provided products and services

6.6.1 The laboratory shall ensure that only suitable externally provided products and services that affect laboratory activities are used, when such products and services:

a) are intended for incorporation into the laboratory’s own activities;

b) are provided, in part or in full, directly to the customer by the laboratory, as received from the external provider;

c) are used to support the operation of the laboratory.

NOTE Products can include, for example, measurement standards and equipment, auxiliary equipment, consumable materials and reference materials. Services can include, for example, calibration services, sampling services, testing services, facility and equipment maintenance services, proficiency testing services and assessment and auditing services.

6.6.2 The laboratory shall have a procedure and retain records for:

a) defining, reviewing and approving the laboratory’s requirements for externally provided products and services;

b) defining the criteria for evaluation, selection, monitoring of performance and re-evaluation of the external providers;

c) ensuring that externally provided products and services conform to the laboratory’s established requirements, or when applicable, to the relevant requirements of this document, before they are used or directly provided to the customer;

d) taking any actions arising from evaluations, monitoring of performance and re-evaluations of the external providers.

6.6.3 The laboratory shall communicate its requirements to external providers for:

a) the products and services to be provided;

b) the acceptance criteria;

c) competence, including any required qualification of personnel;

d) activities that the laboratory, or its customer, intends to perform at the external provider's premises.

7 Process requirements

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.

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 the decision 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.

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 relevant scientific 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.

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.

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.

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 requires the item to be tested or calibrated acknowledging a deviation from specified conditions, the laboratory shall include a disclaimer in the report indicating which results may be affected by the deviation.

7.4.4 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 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.

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 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.

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).

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.

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.

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 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.

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.

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.

7.8.2.2 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 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.

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 (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…