What is Certified Reference Material? – Advantages & Uses

CRM is different from reference material because it is certified, it has metrology tracking, and each property value has an uncertain value given to it. The ISO 17034 defines reference equipment as “sufficient and stable” in relation to one or more specified areas, established for its intended use in the measurement process.

To become a CRM 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. For implementing 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, Contact Punyam.com – A leading ISO 17034 Consultancy Company in India which develops the system for customers in the following manners for ISO 17034 Accreditation:

• Micro–level survey for each and every department of the RM Producer and submission of detailed Gap Analysis report,
• Preparation of applicable documents required by ISO 17034:2016 based on detail study of all activities of the RM Producer,
• ISO 17034:2016 training to all levels of employees of RM Producer,
• Helps in effective implementation of system by periodic visit till ISO 17034 accreditation,
• Conduct internal audit to check readiness for the ISO 17034 accreditation.
• Preparation of all related documents,
• Formats to establish the objective evidence of implementation and to ensure control over all the activities.
• ISO 17034 training to all levels of employees within the organization;
• Help in effective implementation of system by periodic visit till certification;
• Conduct internal audit to check readiness for the certification.
• 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.
• Witnessing the whole process of reference materials production,
• Pre–assessment and final assessment by Accreditation body.

CRMs provide metrological tracking and known uncertainty of item prices. CRMs can ensure reliable user ratings. Traceability is provided by an ISO 17034 Certificate that records property values, uncertainty, and an authorized Certifying body. The Values for certified consumer goods from reference material manufacturers compliant with ISO 17034 provide metrology compliance.” 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.

General Uses of CRM:

• Verification of Method: A laboratory or industry 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.
• How to verify: The laboratory may need to monitor the process at any time to ensure that the process continues to be measured and detected as previously confirmed.
• Evaluation: 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 process: CRMs can be used continuously to provide evidence 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 something with a well-known property and product prices.

Source: accreditationconsultancy.wordpress.com

Preparation for ISO 15189 Documents for Accreditation in Medical Laboratories

The ISO 15189 Accreditation is the recognition of a competent medical laboratory, testing body or certification body to perform specific functions that are clearly defined and evaluated throughout the ISO 15189 accreditation study. This knowledge of skills is intended to assure clients of accredited bodies, that the delivery of these accredited organizations, under their accreditation, is reliable.

Emphasizes the implementation of a quality plan that incorporates key or minor approaches that can lead to compliance with international quality standards, such as ISO 15189. The ISO 15189 Document and its recommendations related to implementation strategy can be easily used as it stands, or after adaptation to meet ISO 15189 requirements. The Guidance should be read as development recommendations as well implementation of quality standards that can be done by all types of health and health laboratories.

The ISO 15189 - Quality manual should describe the quality management system and its document structure. The quality manual should include or refer to supporting ISO 15189 procedures; including technical processes. It should highlight the textual structure of the quality management system.

ISO 15189 Documentation Requirements

The 15189 Documentation should include:

• quality policy statement;
• quality manual;
• the procedures and records required for the relevant procedures;
• documents and records, determined by the laboratory to ensure good order, the operation and control of its processes; and
• copies of relevant local and international regulations, laws and standards ordinary texts.

The laboratory must regulate the documentation required by the quality management system and ensure that the unintentional use of any outdated ISO 15189 document is prohibited.

The laboratory must ensure that:

• All documents, including computer-generated, are issued as part of the quality management system is periodically updated and approved by authorized personnel prior to dismissal;
• only current, authorized types of active documents available locally for use;
• altering changes in the text;
• texts are readable;
• documents are periodically updated and updated periodically that they are always ready for the purpose; any changes to the document need to be permanent re-authorization;
• Be careful. The duration of the document review should be defined by the lab according to its requirements,
• The records are kept for a specified period in the laboratory
• storage policy and compliance with privacy requirements.
• obsolete documents dated and marked as obsolete;
• archiving and tracking records; and
• The authorization to obtain documents is clearly defined and in writing.

Source: accreditationconsultancy.wordpress.com 

How ISO 17034 – Reference Materials Helps to Meet Regulatory Requirements for Laboratories?

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