Scribd Logo
Upload

Welcome to Scribd!

  • 31 views

    Hoklas SC-01

    Uploaded by

    Carson Chow
    This document provides guidelines for laboratories on the acceptable use of chemical reference materials and commercial chemicals for calibrating equipment. It outlines requirements for using certified reference materials from accredited producers without verification as they meet traceability requirements. Non-certified materials must be verified by laboratories before use through comparisons to certified materials or other means. Laboratories must document the source and certification details of all reference materials used and ensure matrices match test samples. Commercial chemicals used to prepare calibration standards also require following good practice principles.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    Hoklas SC-01

    Uploaded by

    Carson Chow
    31 views5 pages
    This document provides guidelines for laboratories on the acceptable use of chemical reference materials and commercial chemicals for calibrating equipment. It outlines requirements for using certified reference materials from accredited producers without verification as they meet traceability requirements. Non-certified materials must be verified by laboratories before use through comparisons to certified materials or other means. Laboratories must document the source and certification details of all reference materials used and ensure matrices match test samples. Commercial chemicals used to prepare calibration standards also require following good practice principles.

    Original Title

    HOKLAS_SC-01

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    This document provides guidelines for laboratories on the acceptable use of chemical reference materials and commercial chemicals for calibrating equipment. It outlines requirements for using certified reference materials from accredited producers without verification as they meet traceability requirements. Non-certified materials must be verified by laboratories before use through comparisons to certified materials or other means. Laboratories must document the source and certification details of all reference materials used and ensure matrices match test samples. Commercial chemicals used to prepare calibration standards also require following good practice principles.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    31 views5 pages

    Hoklas SC-01

    Uploaded by

    Carson Chow
    This document provides guidelines for laboratories on the acceptable use of chemical reference materials and commercial chemicals for calibrating equipment. It outlines requirements for using certified reference materials from accredited producers without verification as they meet traceability requirements. Non-certified materials must be verified by laboratories before use through comparisons to certified materials or other means. Laboratories must document the source and certification details of all reference materials used and ensure matrices match test samples. Commercial chemicals used to prepare calibration standards also require following good practice principles.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    You are on page 1of 5

    HOKLAS SC-01

    Issue No. 9

    Issue Date: 25 July 2022

    Implementation Date: 25 July 2022

    Page 1 of 5

    HOKLAS Supplementary Criteria No. 1


    Acceptability of Chemical Reference Materials and Commercial Chemicals
    Used for the Calibration of Equipment

    1 INTRODUCTION

    1.1 This document is applicable to tests involving the use of chemical reference
    materials for the calibration of equipment. It covers all test categories except
    for medical testing.

    1.2 ISO/IEC Guide 99:2007 defines reference material (RM) as material,


    sufficiently homogeneous and stable with reference to specified properties,
    which has been established to be fit for its intended use in measurement or in
    examination of nominal properties. It further explains that examination of a
    nominal property provides a nominal property value and associated
    uncertainty. This uncertainty is not a measurement uncertainty. RM with or
    without assigned quantity values can be used for measurement precision
    control whereas only reference materials with assigned quantity values can
    be used for calibration or measurement trueness control. RMs comprise
    materials embodying quantities as well as nominal properties. A RM is
    sometimes incorporated into a specially fabricated device. Some RMs have
    assigned quantity values that are metrologically traceable to a measurement
    unit outside a system of units. Such materials include vaccines to which
    International Units (IU) have been assigned by the World Health
    Organisation. In a given measurement, a given RM can only be used for
    either calibration or quality control. The specifications of a RM should
    include its material traceability, indicating its origin and processing.

    1.3 ISO/IEC Guide 99:2007 defines certified reference material (CRM) as RM,
    accompanied by documentation issued by an authoritative body and
    providing one or more specified property values with associated uncertainties
    and traceabilities, using valid procedures. It explains that documentation is
    given in the form of a ‘certificate’. Requirements for the production and
    certification of CRMs are given in ISO 17034:2016. In this definition,
    ‘uncertainty’ covers both ‘measurement uncertainty’ and ‘uncertainty
    associated with the value of a nominal property’, such as for identity and
    sequence. ‘Traceability’ covers both ‘metrological traceability of a quantity
    value’ and ‘traceability of a nominal property value’. Specified quantity
    values of CRMs require metrological traceability with associated
    measurement uncertainty.
    HOKLAS SC-01

    Issue No. 9

    Issue Date: 25 July 2022

    Implementation Date: 25 July 2022

    Page 2 of 5

    1.4 In establishment of traceability of reported results, ISO/IEC 17025:2017


    requires that, measuring equipment be calibrated with traceability to the
    International System of Units (SI units), and if this is not technically possible,
    to, for example, certified values of CRMs provided by a competent producer,
    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, unless it
    has been established that the associated contribution from calibration
    contributes little to the total uncertainty of the test results. RMs provided by a
    competent producer shall be used to give a reliable physical or chemical
    characterization of a material. RMs shall, where possible, be traceable to SI
    units of measurement, or to CRMs. RMs produced in-house shall be checked
    as far as technically and economically practicable.

    2 HOKLAS REQUIREMENTS FOR THE USE OF REFERENCE


    MATERIALS FOR CALIBRATION OF EQUIPMENT

    2.1 Where test standards call for the use of certain RMs, laboratories shall use
    those specified materials.

    2.2 In cases where RMs to be used for calibration of equipment are not specified,
    suitable CRMs supplied by appropriate National Metrology Institutes or
    Designated Institutes with assigned values covered by the International
    Bureau of Weights and Measures (BIPM) Key Comparison Database, if
    available, may be used without further verification.

    2.3 CRMs produced by an accredited reference material producer (RMP) under


    its scope of accreditation to ISO 17034:2016 are considered to have met the
    metrological traceability requirement of ISO/IEC 17025:2017 and may be
    used for calibration without further verification.

    2.4 Non-certified RMs, and RMs supplied by producers other than those given in
    clauses 2.2 and 2.3, shall be verified before use. The purpose of verification
    is to demonstrate that the assigned values are reliable and that the materials
    are sufficiently homogenous and stable for use as RMs. The extent of
    verification depends on the information supplied by the producers as well as
    the nature and properties of the RMs. Laboratories shall have a defined
    procedure for the verification of these materials, according to the provisions
    as follow:

    2.4.1 Laboratories should verify non-certified RMs or RMs from


    non-accredited RM producers against those CRMs given in clause 2.2
    HOKLAS SC-01

    Issue No. 9

    Issue Date: 25 July 2022

    Implementation Date: 25 July 2022

    Page 3 of 5

    and 2.3, whenever possible.

    2.4.2 Otherwise, laboratories should verify two independently sourced RMs


    from different producers against each other to ascertain that the values
    agree with each other within specified limits that are suitable for the
    application.

    2.4.3 If another independent source is not available, a less preferred method


    is to compare RMs from the same supplier but a different batch.

    2.4.4 If neither clause 2.4.1, 2.4.2 nor 2.4.3 is possible, the laboratory should
    consider using appropriate methods based on physical or chemical
    properties of the RMs, such as melting point, boiling point, mass
    spectrum, infra-red spectrum, etc. to confirm their identity and purity.

    2.5 Laboratories shall also demonstrate that, for all CRMs and non-certified RMs
    used,

    (a) full records are kept of the identity and source of each material;

    (b) the documentation of certified values includes details of the mode of


    verification of the assigned values by the producers and/or laboratories,
    uncertainties of the assigned values, instructions for storage and use,
    and homogeneity and stability data, and expiration dates;

    (c) the matrices of the RMs used match those of the laboratory's test
    samples and the effect of any non-matching of matrices are determined
    and accounted for; and

    (d) uncertainties of the assigned values and of the verifications of RMs are
    appropriate for the test methods concerned, and that their contributions,
    where significant, are included in the evaluation of the total
    measurement uncertainties of the test results.

    2.6 Laboratories should particularly note that RMPs certified to ISO 9001 or
    other management system standards are not considered as ‘competent’
    suppliers of RMs. RMs produced by these producers shall be verified before
    use, following the provisions given herein. By the same token, RMs supplied
    by the manufacturer of equipment or proprietary test kits shall be verified
    before use unless the RMs meet the requirements given in clauses 2.2 or 2.3.

    2.7 RMs produced in-house shall also be subject to appropriate verifications and
    relevant provisions given herein apply.
    HOKLAS SC-01

    Issue No. 9

    Issue Date: 25 July 2022

    Implementation Date: 25 July 2022

    Page 4 of 5

    2.8 RMs shall be uniquely identified and bear an expiration date. Laboratories
    shall record the unique identity of the RMs used in worksheets.

    2.9 When using RMs for calibration, the principles described in ISO Guide
    33:2015 ‘Reference materials - Good practice in using reference materials’
    should be followed where appropriate.

    3 REQUIREMENTS FOR THE USE OF COMMERCIAL CHEMICALS

    3.1 Laboratories sometimes use commercial chemicals to prepare ‘standard’


    mixtures for calibration of analytical instruments. These ‘standard’ mixtures
    are prepared by, for example, mixing known amounts of chemicals or
    dissolving the chemicals in a solvent. Sometimes ‘standard solutions’
    available commercially are also used for calibration. These mixtures or
    solutions however are often not CRMs and thus measurement traceability is
    not provided by these solutions.

    3.2 Laboratories should determine the need to strictly follow the metrological
    traceability requirement of ISO/IEC 17025:2017 by evaluating the
    contribution of calibration uncertainty to the total uncertainty. If the
    contribution is significant, the standard mixtures or standard solutions used
    for calibration of equipment as mentioned in clause 3.1 are functioning as
    RMs. Laboratories should have a defined system and procedure for
    verification of these calibration mixtures or standard solutions, and relevant
    requirements given in ISO/IEC 17025:2017 and Section 2 of this document
    apply. Records of such verification shall be maintained. If such mixtures or
    solutions are to be stored for an extended period, their stability throughout
    the intended storage period shall also be verified and records shall be kept.
    HOKLAS SC-01

    Issue No. 9

    Issue Date: 25 July 2022

    Implementation Date: 25 July 2022

    Page 5 of 5

    Annex (Informative)

    The following is a list of references which contain useful information on RMs and CRMs.

    1. ISO Guide 30:2015 Reference materials - Selected terms and definitions

    2. ISO Guide 31:2015 Reference Materials – Contents of certificates, labels and


    accompanying documentation

    3. ISO Guide 33:2015 Reference materials - Good practice in using reference


    materials

    4. ISO 17034:2016 General requirements for the competence of reference material


    producers

    5. ISO Guide 35:2017 Reference materials – Guidance for characterization and


    assessment of homogeneity and stability

    6. ISO Guide 99:2007 International vocabulary of metrology - Basic and general


    concepts and associated terms (VIM)

    7. ILAC P10:07/2020 Policy on traceability of measurement results

    You might also like