How Iso 17034 – Reference Materials Helps To Meet Regulatory Requirements For Laboratories?

By Author: ISO Consultant
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Laboratories are required to provide proof that the materials used for method validation and process controls are objective, uniform and stable. Certified Reference Materials (CRMs) are designed to meet these strict standards. As regulatory standards of ISO 17034 continue to increase, additional burden is placed on laboratories to ensure the quality and safety of finished products. Now more than ever, tracking is a major problem.
ISO 17034 defines reference equipment as “sufficient and stable” in relation to one or more specified areas, designed to be suitable for its intended use in the measurement process. Features can be quantitative or qualitative. Certified Reference Materials is different from reference information because it is more compliant with ISO 17034 certification, has more metrology, and each property value has a certain amount of uncertainty. When goods are assigned to CRM, prices are "stored" by CRM and transferred when the CRM itself is moved from one location to another.
To become a Certified Reference Materials manufacturer, the manufacturer's methods must ...
... meet the requirements of ISO 17034:2016 General Competitive Requirements for Manufacturers of Products. To obtain ISO 17034 Accreditation, the manufacturer must demonstrate that they are able to provide CRM.
Here are some advantages we consider:
As technology advances over time, the ability and need to measure more and more accurately increases.This drives the requirement for better identification tools that can be used in testing and evaluation.CRMs provide metrological tracking and known uncertainty of item prices.CRMs can ensure reliable user ratings. Tracking is provided by a certificate that records the prices of the goods, the uncertainty, and the authorized Certifying body.CRM users are responsible for determining whether CRM is suitable for its intended use.The user must follow all the label instructions given by the CRM manufacturer.
Following are the General Use of CRM:
Validation of Method: A laboratory may need to verify the methods or equipment used to measure or obtain an object. CRM can be used to verify the measurement method or the ability to find something.Method Verification: The laboratory may need to test the process at any time to ensure that the process continues to measure and detect as confirmed earlier. For example, CRM can be used to monitor the process and determine whether inconsistencies have occurred and problem solving is needed.Calibration: CRM is a pure object that can be used to measure equipment, intended to detect or measure that object, or CRM can be used as an independent measurement check.How to monitor or control the Method: CRMs can be used continuously to provide proof that processes are stable and continue to measure and detect as needed.Training: The laboratory can use CRMs to train and/or test operators using an object with a known proportion of ownership and assets.
There is ISO 17034 Documents are essential for RMPs to achieve ISO 17034 accreditation that demonstrates the competence of reference material producers by formal compliance with a set of internationally-recognized criteria. The ISO 17034 covers the production of all reference materials, including certified reference materials and is intended to be used as part of the general quality assurance procedures of the reference material producer.
Source: accreditationconsultancy.wordpress.com