BS ISO 17034:2016 pdf free download
BS ISO 17034:2016 pdf free download.General requirements for the competence of reference material producers.
BS ISO 17034 specifies general requirements for the competence and consistent operation of reference material producers.
This International Standard sets out the requirements in accordance with which reference materials are produced. It is intended to be used as part of the general quality assurance procedures of the reference material producer.
This International Standard covers the production of all reference materials, including certified reference materials.
NOTE Reference material producers, regulatory authorities. organizations and schemes using peer assessment, accreditation bodies and others can also use this International Standard in confirming or recognizing the competence of reference material producers.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO/I EC 17025, General requirements for the competence of testing and calibration laboratories
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/IEC 17000, ISO Guide 30,
ISO/IEC Guide 99, ISO 9000 and the following apply.’)
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at http://www.iso.org/obp
— IEC Electropedia: available at http://www.eIectropedia.org/
4 General requirements
4.1 Contractual matters
4.1.1 Any request, tender or contract concerning the production of an RM shall be reviewed, following documented policies and procedures established by the RMP, to ensure that:
a) the requirements for RMs and their production are adequately defined, documented and understood;
b) the RMP has the capability and resources to meet the requirements.
NOTE 1 Capability means that the RMP has access to, for example, the necessary equipment, knowledge and information resources and that its personnel have the skills and expertise necessary for the production of those RMs in question. The review of capability can include an assessment of previous RM production and/or the organization of interlaboratory characterization programmes using samples of similar composition to the RMs to be produced.
NOTE 2 A contract can be any written or verbal agreement.
NOTE 3 A request to prepare a specific RM can originate from the RMP.
4.1.2 The review shall include any work that needs to be subcontracted by the RMP.
4.1.3 The RMP shall maintain records of these reviews, including any changes, records of pertinent discussions with the customer relating to the customer’s requirements, and subcontracted work
4.2 Impartiality
4.2.1 The RMP shall be structured and managed so as to safeguard impartiality.
NOTE Impartiality implies that decisions are based on objective criteria and not on the basis of bias, prejudice, or preferring the benefit of one person over another for improper reasons.
4.2.2 The RMP shall:
a) have arrangements to ensure that its management and personnel are free from any undue internal and external commercial, financial and other pressures and influences that may adversely affect the quality of their work;
b) identify risks to its impartiality on an on-going basis, which 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 an RMP with a risk to impartiality;
c) be able to demonstrate, if a risk to impartiality is identified, how it eliminates or minimizes such risk;
d) have top management commitment to impartiality.
NOTE A relationship that threatens the impartiality of the RMP can be based on ownership, governance, management, personnel, shared resources, finances or contracts for purposes other than the sale or production of RMs.
4.3 Confidentiality
4.3.1 The RMP shall be responsible for and shall treat in an appropriate manner all information obtained, including confidential information. Where information is received from another individual or body, such information shall be regarded as confidential unless the individual or body concerned places the information in the public domain or agrees to its disclosure to others.
4.3.2 When the RMP is required by law or authorized by contractual arrangements to release confidential information, the individual or the body concerned shall, unless prohibited by law, be notified of the information provided.
5 Structural requirements
5.1 The RMP shall be a legal entity or a defined part of a legal entity, that can be held responsible for all its activities related to the production of RMs.
5.2 The RMP shall be organized and shall operate in such a way that it meets all the applicable requirements of this International Standard, whether carrying out work at its permanent facilities or at other sites (including associated temporary or mobile facilities).
5.3 The RMP shall:
a) have a description of its legal status, define the organizational and management structure of the RMP, its place in any parent organization and the relations between management, technical operations, support services and subcontractors;
b) define the parts of the organization covered by the management system for the production of RMs;BS ISO 17034 pdf download.
