ISO 17034:2016, General requirements for the competence of reference material producers – Accreditation

General requirements for the competence of reference material producers have been developed in order to build confidence in reference materials produced by the Producer. As Certified Reference Material is an important aspect of establishing and maintaining traceability of Measurement. This standard is also refereed in the ISO/IEC 17025:2017 version for the reference materials traceability. Reference material is an important, but due to lack of awareness, the manufacturer or producer of reference materials is not use to the system. ISO 17034 is the system, which is having complete requirements for the reference materials producer to comply and can produce the RM. There are ILAC/APLAC MRA partner, who can provide the accreditation to RMP as per ISO 17034:2016. ISO 17034 Accreditation is a procedure by which an authoritative body gives formal recognition of technical competence for specific Reference Materials or Certified Reference Materials, based on third-party assessment as per ISO17034:2016 for certification.

The ISO17034 standard is developed based on the ISO Guide 34. ISO 17034 Accreditation is managed by International Laboratory Accreditation Co-operation Committee (ILAC) as well as Asia Pacific Laboratory Accreditation Co-operation Committee (APLAC) Mutual Recognition Arrangements (MRA). ILAC and APLAC are engaged in development and updating of guidelines connected with accreditation activities. Such international arrangements facilitate acceptance of RM as well as CRM and its certificate between countries to which MRA partners represent. On iso 17034 certificaiton of RM Producer by such recognized body, the Reference Materials and Certified Reference Materials gets global acceptance due to such mutual recognition. Reference Material Producers Accreditation gives formal recognition of competence to carry out the production of reference materials based on third party assessment and following international standards and we had leading name globally for iso 17034 consultancy and providing online auditor training as well as ready made documentation for iso 17034.

ISO 17034:2016 is intended for the use by reference material producers in the development and implementation of their management system for quality, administrative and technical operations. This Standard covers the production of certified and non-certified reference materials.

The standard is mainly applicable to all types of industries, where the activities of the industry have potential chances of pollution to the environment as well potential health hazards to the employees.

Reference material (RM)

Material, sufficiently homogeneous and stable with respect to one or more specified properties, which has been established to be fit for its intended use in a measurement process.

Certified reference material (CRM)

Reference material characterized by a metrological valid procedure for one or more specified properties, accompanied by a certificate that provides the value of the specified property, its associated uncertainty, and a statement of metrological traceability.

Steps for ISO 17034 Accreditation Consultancy by Global Manager Group – Global Manager Group, an ISO 17034 consultancy company is having vast experience in the implementation of ISO17034:2016 in all types of reference material producers in the field of Chemical Composition, Biological and Clinical Properties, Physical Properties, Engineering Properties as per the ILAC RM category and have made iso 17034 documentation package. Before finalization of products as RM or CRM, first need to refer ILAC RM Category and define the scope of accreditation. The category needs to be define based on the ILAC RM Category. As leading ISO 17034 Consultancy Company in India, develops the system for its customers in the following manners for iso 17034 accreditation:

  1. Micro–level survey for each and every department of the RM Producer and submission of detailed Gap Analysis report,
  2. Preparation of applicable documents required by ISO17034:2016 based on detail study of all activities of the RM Producer,
  3. ISO 17034:2016 training to all levels of employees of RM Producer,
  4. Helps in effective implementation of system by periodic visit till ISO 17034 accreditation,
  5. Conduct internal audit to check readiness for the ISO 17034 accreditation.
  6. Preparation of all RC 14001 related documents,
  7. Formats to establish the objective evidence of implementation and to ensure control over all the activities.
  8. RC 14001 training to all levels of employees within the organization;
  9. Help in effective implementation of system by periodic visit till certification;
  10. Conduct internal audit to check readiness for the certification.
  11. Conduct management review meeting in presence of Top Management to guide the RM Producer for effective implementation on all the issues related to RM Production (such as Assessment of homogeneity, Assessment and monitoring of stability etc.)
  12. Witnessing the whole process of reference materials production,
  13. Pre–assessment and final assessment by Accreditation body.

Benefits for RMP ISO 17034 Accreditation:

  1. Facilitate easy and timely availability of less expensive reference material in country.
  2. Accreditation is an effective marketing tool for RMPs
  3. Accreditation provides assurance that the accredited RMPs are competent to produce the RMs as listed in the scope of accreditation
  4. RMs offer the highest level of Quality assurance, accuracy and traceability.
  5. It gives complete confidence that results are reliable and reproducible.
  6. Offer market differentiation and leadership.
  7. These uses include the assessment of precision and trueness of measurement methods, quality control, assigning values to materials, calibration, and the establishment of conventional scales. This eliminates the needs of the users to evaluate the quality of the RMs themselves.
  8. Cost and time saving, because the RMs help optimize operations and avoid multiple testing.
  9. International recognition to RM Producers.

Also provides technical helps in implementation as well as selection etc.:

  1. Production planning and control of RM Production,
  2. Material handling, storage and processing,
  3. Measurement procedures and measuring equipment,
  4. Data integrity and evaluation
  5. Metrological traceability of certified values
  6. Assessment of homogeneity
  7. Assessment and monitoring of stability
  8. Characterization
  9. Assignment of property values and their uncertainties
  10. RM documents and labels
  11. Distribution service

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