ISO Guide 34:2000
(Main)General requirements for the competence of reference material producers
General requirements for the competence of reference material producers
Exigences générales pour la compétence des producteurs de matériaux de référence
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Standards Content (Sample)
GUIDE 34
General requirements for the
competence of reference
material producers
Second edition 2000
©
ISO 2000
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ISO GUIDE 34:2000(E)
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ISO GUIDE 34:2000(E)
Contents Page
Foreword.iv
Introduction.v
1 Scope .1
2 Normative references .1
3 Terms and definitions .2
4 Organization and management requirements .2
4.1 Quality system requirements .2
4.2 Organization and management .3
4.3 Document and information control.4
4.4 Request, tender and contract reviews.5
4.5 Use of collaborators .5
4.6 Procurement of services and supplies.6
4.7 Client feedback .6
4.8 Control of non-conforming (poor quality) reference materials.6
4.9 Corrective action.7
4.10 Preventative action.7
4.11 Records.8
4.12 Internal audits .9
4.13 Management reviews.9
5 Technical and production requirements .9
5.1 Management, staffing and training .9
5.2 Collaborators.10
5.3 Production planning.10
5.4 Production control.11
5.5 Environment.11
5.6 Material handling and storage.11
5.7 Post-distribution service.12
5.8 Material preparation .12
5.9 Assessment of homogeneity and stability.13
5.10 Measurement methods.14
5.11 Measuring equipment.14
5.12 Traceability and validation.15
5.13 Data evaluation .15
5.14 Characterization.15
5.15 Assignment of property values and their uncertainties .16
5.16 Certificates and information for users .17
Annex A (informative) Examples of traceability of the property values of reference materials .18
Bibliography.22
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ISO GUIDE 34:2000(E)
Foreword
ISO (the International Organization for Standardization) and IEC (the International Electrotechnical Commission)
form the specialized system for worldwide standardization. National bodies that are members of ISO or IEC
participate in the development of International Standards through technical committees established by the
respective organization to deal with particular fields of technical activity. ISO and IEC technical committees
collaborate in fields of mutual interest. Other international organizations, governmental and non-governmental, in
liaison with ISO and IEC, also take part in the work.
Guides are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
Draft Guides adopted by the responsible Committee or Group are circulated to national bodies for voting.
Publication as a Guide requires approval by at least 75 % of the national bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this Guide may be the subject of patent rights. ISO
and IEC shall not be held responsible for identifying any or all such patent rights.
ISO Guide 34 was prepared by the ISO Committee on Reference Materials (REMCO).
This second edition cancels and replaces the first edition (ISO Guide 34:1996), which has been technically revised.
Annex A of this Guide is for information only.
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ISO GUIDE 34:2000(E)
Introduction
The use of reference materials makes possible the transfer of the values of measured or assigned quantities
between testing, analytical and measurement laboratories. Such materials are widely used for the calibration of
measuring equipment and for the evaluation or validation of measurement procedures. In certain cases, they
enable properties to be expressed conveniently in arbitrary units.
There is an increasing number of reference material producers, and a demonstration of their scientific and technical
competence is now a basic requirement for ensuring the quality of reference materials. The demand for new
reference materials of higher quality is increasing as a consequence of both the increased precision of measuring
equipment and the requirement for more accurate and reliable data in the scientific and technological disciplines.
Some previously acceptable reference materials may not meet these more stringent requirements. It is, therefore,
not only necessary for reference material producers to supply information about their materials in the form of
reports, certificates and statements, but also to demonstrate their competence in producing reference materials of
appropriate quality.
The first edition of ISO Guide 34 set out specific guidelines on the interpretation of ISO/IEC Guide 25 and the
ISO 9000 family of standards in the context of reference materials production. The more general requirements of
these standards were omitted. Since the first edition of ISO Guide 34 was published in 1996, the assessment of the
competence of reference material producers has gained considerable impetus. The present revision of Guide 34
now sets out all the general requirements in accordance with which a reference material producer has to
demonstrate that it operates.
Pharmacopoeial standards and substances are established and distributed by pharmacopoeial authorities following
the general principles of this Guide. It should be noted, however, that a different approach is used by the
pharmacopoeial authorities to give the user the information provided by certificates of analysis and expiration
dates. Also, the uncertainty of their assigned values is not stated since it is negligible in relation to the defined limits
of the method-specific assays of the pharmacopoeias for which they are used.
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ISO GUIDE 34:2000(E)
General requirements for the competence of reference
material producers
1 Scope
1.1 This Guide sets out the general requirements in accordance with which a reference material producer has to
demonstrate that it operates, if it is to be recognized as competent to carry out the production of reference
materials.
1.2 This Guide is intended for the use of reference material producers in the development and implementation of
their quality system, and by accreditation bodies, certification bodies and others concerned with assessing the
competence of reference material producers.
1.3 This Guide sets out the quality system requirements in accordance with which reference materials shall be
produced. It is intended to be used as part of a reference material producer’s general quality assurance (QA)
procedures.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this Guide. For dated references, subsequent amendments to, or revisions of, any of these publications do not
apply. However, parties to agreements based on this Guide are encouraged to investigate the possibility of
applying the most recent editions of the normative documents indicated below. For undated references, the latest
edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid
International Standards.
ISO/IEC Guide 2:1996, Standardization and related activities — General vocabulary.
ISO/IEC Guide 25:1990, General requirements for the competence of calibration and testing laboratories.
ISO Guide 30:1992, Terms and definitions used in connection with reference materials.
ISO Guide 31:1981, Contents of certificates of reference materials.
ISO Guide 35:1989, Certification of reference materials — General and statistical principles.
ISO 8402:1994, Quality management and quality assurance — Vocabulary.
ISO 10012-1:1992, Quality assurance requirements for measuring equipment — Part 1: Metrological confirmation
system requirements for measuring equipment.
VIM:1993, International vocabulary of basic and general terms in metrology (issued by ISO, IEC, BIPM, IFCC,
IUPAC, IUPAP and OIML).
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ISO GUIDE 34:2000(E)
3 Terms and definitions
For the purposes of this Guide, the terms and definitions given in ISO/IEC Guide 2, ISO/IEC Guide 25,
ISO Guide 30, ISO 8402, VIM and the following apply.
3.1
reference material producer
technically competent body (organization or firm, public or private) that is fully responsible for assigning the certified
or other property values of the reference materials it produces and supplies which have been produced in
accordance with ISO Guides 31 and 35
3.2
collaborator
technically competent body (organization or firm, public or private) that undertakes aspects of the manufacture or
characterization of the (certified) reference material on behalf of the reference material producer, either on a
contractual (as a subcontractor) or voluntary basis
4 Organization and management requirements
4.1 Quality system requirements
4.1.1 General
The reference material producer shall establish, implement and maintain a quality system appropriate to the scope
of its activities, including the type, range and magnitude of the reference material production it undertakes.
It should be recognized that a reference material needs to be characterized mainly to the level of accuracy required
for its intended purpose (i.e. appropriate measurement uncertainty). The reference material producer shall describe
the procedure for establishing the quality of materials as a component of the quality system.
Reference material producers shall define their scope in terms of the application, the measurement methods used
in the homogeneity, stability and characterization studies, and any limitations due to the material matrix.
4.1.2 Quality policy
The reference material producer shall define and document its policy, objectives and commitment to ensuring and
maintaining the quality of all aspects of reference material production, including material quality (e.g. homogeneity
and stability), characterization (e.g. equipment calibration and measurement method validation), assignment of
property values (e.g. use of appropriate statistical procedures) and material handling, storage and transport
procedures.
The quality policy shall, when appropriate, include use of interlaboratory characterization studies employing
laboratories which are active and competent in the respective field of measurement. In this context, the policy shall
include a commitment to interact with the appropriate sectors of the measurement community, in order to prevent
working in isolation. The policy shall also include a commitment to produce reference materials which conform to
the definitions given in ISO Guide 30, characterized according to the requirements of ISO Guide 35 and whose
property values are assessed using accepted statistical techniques. The policy shall, where appropriate, include a
commitment to comply with ISO Guide 31 for the contents of reference material certificates and supply of
associated information for users. It is important that the policy also specify the intended use of the reference
materials, in order to ensure that the reference material producer fully advises the user for which types of
application the materials may be used.
4.1.3 Quality system
The reference material producer shall establish, implement and maintain a documented quality system appropriate
to the type, range and volume of reference material production it undertakes. The reference material producer shall
document all of its policies, systems, programmes, procedures, instructions, findings, etc., to the extent necessary
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ISO GUIDE 34:2000(E)
to enable the producer to assure the quality of the reference materials produced. Documentation used in this
quality system shall be communicated to, understood by, available to and implemented by all personnel concerned.
In particular, the producer shall have a quality system that covers the following:
a) arrangements for ensuring the suitable choice (e.g. particle size range, concentration range, etc.) of the
candidate reference materials;
b) preparation procedures;
c) achievement of the required degree of homogeneity of the reference material;
d) assessment of the stability of the reference material; including on-going assessment of stability where
necessary;
e) procedures for undertaking characterization;
f) practical realization of traceability to national or international standards of measurement;
g) assignment of property values, including preparation of certificates or statements in accordance with
ISO Guide 31 when appropriate;
h) arrangements for ensuring adequate storage facilities;
i) arrangements for suitable identification, labelling and packaging facilities, packing and delivery procedures and
customer service;
j) compliance with ISO Guides 30, 31, 34 and 35.
The documented quality system should specify which activities are undertaken by the reference material producer
and, where relevant, which activities are undertaken by collaborators. It shall include policies and procedures used
by the producer to ensure that all activities conducted by collaborators comply with the relevant clauses of this
Guide.
The documented quality system shall define the roles and responsibilities of the technical manager (however
named) and quality manager, including their responsibilities for ensuring compliance with this Guide.
4.2 Organization and management
4.2.1 The reference material producer, or the organization of which it is part, shall be legally identifiable.
4.2.2 The reference material producer shall be organized and shall operate in such a way that it meets all the
applicable requirements of this Guide, whether carrying out work in its permanent facilities or at sites (including
associated temporary or mobile facilities) away from its permanent facilities (including work undertaken by
collaborators).
4.2.3 The reference material producer shall:
a) have managerial personnel supported by technical personnel with the authority and resources needed to
discharge their duties and to identify the occurrence of departures from the quality system or the procedures
for the production of reference materials and to initiate actions to prevent or minimize such departures;
b) have arrangements to ensure that its management and personnel are free from any commercial, financial and
other internal and external pressures that may adversely affect the quality of their work;
c) have policies and procedures to ensure the protection of its client’s confidential information and proprietary
rights;
d) have policies and procedures to avoid involvement in any activities that might diminish confidence in its
competence, impartiality, judgement or operational integrity;
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ISO GUIDE 34:2000(E)
e) define, with the aid of organizational charts, the organization and management structure of the reference
material producer, its place in any parent organization, and the relations between management, technical
operations, support services, collaborators and the quality management system;
f) specify the responsibility, authority and interrelationships of all personnel who manage, perform or verify work
affecting the quality of production of reference materials;
g) have technical management, which has overall responsibility for the technical operations and the provision of
the resources needed to ensure the required quality of each operation which forms part of the reference
material production;
h) appoint a member of staff as quality manager (however named) who, irrespective of other duties and
responsibilities, shall have defined responsibility and authority for ensuring that the requirements of this Guide
are implemented and followed at all times. The quality manager shall have direct access to the highest level of
management at which decisions are taken on production policy or resources;
i) where appropriate, appoint deputies for key managerial personnel such as the technical and quality managers.
4.3 Document and information control
4.3.1 General
The reference material producer shall establish and maintain procedures to control all documents (both internally
generated and from external sources) and other information that form part of its quality documentation. These may
include documents of external origin, such as standards, guides, test and/or calibration methods, as well as
specifications, instructions and manuals related to the reference material under production.
NOTE In this context “document” means any information or instruction including policy statements, text books, procedures,
specifications, calibration tables, charts, software, etc. These may be on various media, whether hard or electronic, and they
may be digital, analog, photographic or written.
4.3.2 Document approval and issue
4.3.2.1 All documents (including documented procedures) issued to personnel as part of the quality system
shall be suitably controlled. This shall include review and approval for use by authorized personnel prior to issue. A
master list or equivalent, identifying the current revision status of documents in the quality system, shall be
established and be readily available to preclude the use of invalid and/or obsolete documents.
4.3.2.2 The procedures adopted shall also ensure that:
a) authorized editions of appropriate documents are available at all locations where operations essential to the
effective production of reference materials are performed;
b) documents are periodically reviewed and, where necessary, revised to ensure continuing suitability and
compliance with applicable requirements;
c) invalid or obsolete documents are promptly removed from all points of issue or use, or otherwise assured
against unintended use;
d) obsolete documents retained for either legal or information preservation purposes are suitably marked.
4.3.3 Document changes
4.3.3.1 Changes to documents (including documented procedures) shall be reviewed and approved by
designated personnel performing the same function as that conducted for the original review and approval unless
specifically decided otherwise. The designated personnel shall have access to pertinent background information
upon which to base their review and approval.
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ISO GUIDE 34:2000(E)
4.3.3.2 Where practicable, the nature of the change shall be identified in the document with appropriate
attachments.
4.3.3.3 If the reference material producer’s documentation control system allows for the amendment of
documents by hand, pending the re-issue of the documents, the procedures and authorities for such amendments
shall be defined and shall ensure that amendments are initialled and dated. Documents amended by hand shall be
marked, signed and dated and shall be formally re-issued as soon as practicable.
4.3.3.4 Procedures shall be established to describe how changes in documents maintained in computerized
systems are made.
4.4 Request, tender and contract reviews
4.4.1 When relevant, each request, tender or contract concerning the production of a reference material shall be
reviewed by the reference material producer to ensure that:
a) the requirements are adequately defined, documented and understood;
b) the reference material producer has the capability and resources to meet the requirements;
c) in the case of external contracts, any differences between the contract or order requirements and those in a
tender are resolved to the satisfaction of the reference material producer and the customer or client.
The request, tender or contract review should be conducted in a practical and efficient manner and the financial,
legal and time schedule aspects should be taken into account.
NOTE 1 Capability means that the reference material producer possesses the necessary equipment, intellectual and
information resources and that its personnel have the skills and expertise necessary for the production of those reference
materials in question. The review of the capability may include an assessment of previous reference material production and/or
the organization of interlaboratory characterization programmes using samples of similar composition to the reference materials
to be produced.
NOTE 2 A contract may be any written or verbal agreement to provide a customer or client with reference materials from
stock or custom-produced respectively.
4.4.2 Records of such reviews, including any changes, shall be maintained. Records shall also be maintained of
pertinent discussions with a customer relating to the customer’s requirements or the results of the work during the
period of execution of the contract or request.
4.4.3 The review shall include any work that has to be subcontracted by the reference material producer.
4.5 Use of collaborators
4.5.1 The reference material producer shall establish and maintain procedures to ensure that all tasks performed
by collaborators comply with specifications set by the reference material producer for such tasks. The reference
material producer shall also ensure that collaborators comply with any clauses of this Guide relevant to the tasks
performed by them for the reference material producer.
4.5.2 The reference material producer shall select collaborators on the basis of their ability to meet
subcontracted requirements in terms of both their technical competence and any specific quality assurance
requirements relevant to their tasks. The technical requirements to be satisfied by collaborators shall be equivalent
to the technical requirements specified in clause 5 of this Guide.
4.5.3 The reference material producer shall maintain a register of all collaborators used in the production
process, and include a record of any assessments made of their abilities to carry out subcontracted tasks according
to the requirements of this Guide.
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ISO GUIDE 34:2000(E)
The reference material producer is always responsible for ensuring that a collaborator is competent. The
collaborator should be able to demonstrate compliance with the requirements of this Guide for all subcontracted
work.
4.6 Procurement of services and supplies
4.6.1 The reference material producer shall have policies and procedures for the selection of services and
supplies that affect the quality of its reference materials.
4.6.2 The reference material producer shall use only those services and supplies that are of adequate
specification to ensure the quality of its reference materials.
4.6.3 When no formal approval of the quality of services and supplies is available, the reference material
producer shall have procedures to ensure that purchased materials and services comply with specified
requirements and records of actions taken shall be maintained.
4.6.4 The reference material producer shall ensure that purchased equipment and consumable materials are not
used until they have been inspected, calibrated or otherwise verified as complying with standard specifications or
requirements defined in specifications for production, characterization and certification of its reference materials.
4.6.5 The reference material producer shall maintain records of the main suppliers and collaborators from whom
it obtains supplies required for the production of reference materials. These records should include any quality
assurance approval the suppliers and/or collaborators hold.
4.7 Client feedback
The reference material producer shall have a policy and procedures for the resolution of complaints or other
feedback received from its customers or other parties. Records shall be maintained of all complaints and of the
investigations and corrective actions taken by the reference material producer.
4.8 Control of non-conforming (poor quality) reference materials
4.8.1 The reference material producer shall h
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