ISO 17025

and 17034
Topics

– What is Certified Reference Material (CRM)

– Common Uses
– Advantages
– User Responsibility
– CRM in Microbiology
– Reference Material Producers
– Where to find CRM
What is Certified Reference Material?
• ISO Guide 34 defines Reference Material as “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. Properties can be quantitative or qualitative (e.g. identity of
substances or species).”
• Certified Reference Material, CRM, differs from reference material in that
certified reference material:
– Is metrologically traceable.
– Each property value has an uncertainty assigned to it
– The material comes with a certificate providing traceability and uncertainty.
• Metrological traceability means that there is a documented unbroken chain of
calibrations
What is Certified Reference Material
• Material that is storing a value.
• This value and uncertainty can be transported just like a
measurement instrument.
• Value gives traceability.
• Material has a certificate.
Common Uses of Certified Reference
Materials
• When you are trying to establish metrological traceability
(ISO 17025).
• When you are trying to assess trueness and precision of a
measurement.
• Method Validation
– Use CRMs to validate your test methods, cleaning methods and to
validate equipment used for measuring or detecting a substance.
• Calibration
The Use of CRM is Required for Accreditation
• ISO 17025:2005 Section 5.6.2.2.2
– “Where traceability of measurements to SI units is not possible and/or
not relevant, the same requirements for traceability to, for example,
certified reference materials, agreed methods and/or consensus
standards are required”
• ISO 17025:2005 Section 5.6.3.2 states that “reference materials
shall, where possible, be traceable to SI units of measurement
or to certified reference materials.”
• ISO 17025 accredited companies not using Certified Reference
Materials or not providing adequate justification will be cited for
this non-conformance.
Regulatory Requirements
• Food Safety Modernization Act, Sec 202 – Laboratory
Accreditation for Analysis of Foods.
• ISO 17025 is an existing testing standard that food testing
laboratories have become accredited.
• Food companies that are seeking accreditation for their
testing labs will need to estimate the uncertainties of their
methods and establish traceability.
Advantages of Using Certified
Reference Material
• CRM provides traceability
• CRM provides known uncertainty for the
property values ensuring reliable
measurements for users
• CRM is accompanied by documentation
– Traceability and uncertainty documented,
ensuring smooth regulatory audits
User Responsibility
• Make sure what you are buying is CRM.
• Select a CRM with the correct certified property value for your purpose.
• Use the material per its intended use. It is the responsibility of the user to
determine if the CRM is appropriate for the intended use.
• Understand the uncertainty of the property values. The uncertainty may be
greater than what is required by your testing. You may need a different CRM
with less uncertainty.
• The user must be familiar with the information provided on the certificate of
the CRM.
• Be aware of any validity or shelf-life dates.
• Be aware of proper storage requirements for the material.
• ISO Guide 33 – Uses of Certified Reference Material
Certified Reference Material in Microbiology
• Qualitative
– Identity of an organism
• Quantitative
– CFU count
• Currently there are limited options for microbiological certified reference
materials. When choosing a CRM producer of a microorganism, consider the
following:
– Stability and shelf life
– Handling and storage requirements
– Ease-of-use and preparation time
– Traceability to culture collections
– Distribution registration – provides traceability to end user. Full supply chain
traceability through your supplier.
Reference Material Producers, RMP
• CRM must be obtained from an accredited Reference Material
Producer
• ISO Guide 17034 accredited
– General requirements for the competence of reference material
producers
• This accreditation ensures that you are obtaining material from a
competent supplier
• Certificate should have accrediting body logo indicating that the
producer is accredited to ISO Guide 17034 and the material you
have purchased is Certified Reference Material.
ISO Guide 17034
• ISO Guide 17034 has many similarities to ISO 9001 and ISO 17025,
particularly in the area of Management Controls. However, ISO Guide
17034 has additional requirements for producing CRM:
– Production planning, process controls, environmental controls and material
handling throughout processing and storage
• Material selection
– Controls on data evaluation including software validation
– Assigning property values, uncertainty and traceability
– Assessment of homogeneity, stability and characterization
• Including post transport stability
– Certificates
– Distribution service
Obtaining CRM
• How to find CRM?
– AOAC Technical Division on Reference Materials (TDRM)
o TDRM Database
– COMAR International database for CRM
o www.comar.bam.de
– Virtual Institute for Reference Materials (VIRM)
o www.virm.net
– European Reference Materials
o http://www.erm-crm.org/
– International Atomic Energy Agency, IAEA
o http://nucleus.iaea.org/rpst/
– BIPM
o www.bipm.org
What to do if you can’t find CRM?
• Determine if another reference material is available that will
meet your testing needs
– Demonstrate that the alternative is fit for your purpose.
• In house produced reference materials
– Can be costly

CAUTION – Make sure you understand the limitations and risks of the
alternative selected.

Have well documented justification.

Useful References
• ISO Guide 33 – Use of Certified Reference Materials
• AOAC Technical Division on Reference Materials Website
– TDRM Guidelines – Applications and Resources for Use of
Reference Materials
• Ilac Guidelines for the Selection and Use of Reference
Materials.
Take Aways
Certified Reference Material is unique in that the material has
metrological traceability, known uncertainty for property values,
and supporting documentation.

If you are obtaining ISO 17025 accreditation you may need to use
CRM.

User is responsible for ensuring the CRM they are purchasing is

adequate for their use.
Thank You

Questions?

128th Annual Meeting & Exposition

September 7-10, 2014
Boca Raton, Florida