What Mandatory Procedures are Required for the ISO 17034 Accreditation Process?

accreditationconsultancy

What Mandatory Procedures are Required for the ISO 17034 Accreditation Process?

The general requirements for the proficiency and reliability of reference material producers are outlined in the ISO 17034 standard. Reference materials (RMs) are utilized for method validation, calibration, and quality control at every stage of the measurement process. They are also utilized in interlaboratory comparisons to evaluate laboratory competence and validate methods.

A fundamental criterion for guaranteeing the quality of reference materials (RMs) is for reference material producers (RMPs) to demonstrate their technical and scientific expertise. The requirement for RMs of greater quality is increasing as a result of both increased measurement equipment precision and the need for more precise and trustworthy data in the scientific and technological disciplines. RMPs must not only supply information on their materials in the form of RM documents but also show that they are capable of creating RMs of the appropriate quality.

The creation of CRMs is included, along with all other forms of RMs. There is a comment in the scope that makes it clear that regulatory agencies and accreditation organizations may also utilize ISO 17034:2016 to evaluate the proficiency of RMPs. The overall advantages of ISO 17034 accreditation include trade gains in the market, acknowledgement of expertise in the creation of reference materials, assistance in lowering organizational expenses, and these benefits. It has been demonstrated that accreditation boosts organizational effectiveness and the marketing of RMPs.

An important prerequisite for individuals who create certified reference materials (CRM) is ISO 17034 accreditation, which also serves as proof of both technical and scientific proficiency for RMPs. The need for new RMs of greater quality is growing as a result of enhanced measuring tool precision as well as the need for more accurate and trustworthy data in the scientific and technological disciplines. ISO17034 documentation that is well-written and arranged is required for RMP accreditation. Documentation required for ISO 17034 accreditation must comprise the ISO 17034 manual, ISO 17034 procedures, records, SOPs, formats for different activities, audit checklists, etc. The overall goal of the documents is to support reference material producers in ISO 17034 documents and give assurance to their customers, regulating authorities, accreditation bodies that are associated with them, as well as ISO 17034 consultants that the reference material producers satisfy all the documentation requirements as per the standard.

List of Mandatory Procedures for ISO 17034 Accreditation

Below is the list of mandatory documents of ISO 17034 accreditation procedures that are required to complete the accreditation procedure:

Procedure for establishing the quality of materials as a component of the management system
Procedure for data evaluation
Procedure for material handling, storage and transportation
Procedure for preparation of processing procedures
Procedure for undertaking characterization
Procedure for identification, labelling and packaging facilities, packing and delivery
Procedure for production of reference materials
Procedure for protection of customer's confidential information and proprietary rights
Procedure to avoid involvement in any activities that might diminish confidence in its competence, impartiality, judgment or operational integrity
Procedure for Document and Data Control
Procedure for review of request, tender and contracts
Procedure for subcontracting
Procedure for procurement of services and supplies
Procedure for Complaint Handling
Procedure for Control of non–non-conforming work and reference materials
Procedure for Corrective Action
Procedure for Control of Records
Procedure for Internal Audit
Procedure for Management Review
Procedure for Personnel and Training
Procedure for production planning and implementation
Procedure for production control
Procedure for accommodation and environment
Procedure for material processing
Procedure for measurement method
Procedure for measuring equipment
Procedure for protecting the integrity of data
Procedure for metrological traceability
Procedure for assessment of homogeneity
Procedure for assessment of stability
Procedure for assignment of property values and calculation of uncertainty of measurement

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The Backbone of Accreditation: ISO 17034 Document Requirements Unveiled

accreditationconsultancy 2023-10-03

The comprehensive collection of document specifications that form the basis of accreditation is at the core of ISO 17034. The Role of ISO 17034 DocumentationThe basis of ISO 17034 compliance is documentation. Let’s delve into the key ISO 17034 documents requirements of ISO 17034: Quality Manual: A company's quality management system is outlined in its quality manual, which is its foundational document. The ISO 17034 Document Requirement and its Importance The following key functions are served by the ISO 17034 document requirements:Quality Assurance: They make sure that every procedure is carefully recorded and under control, reducing the possibility of mistakes and deviations. In conclusion, ISO 17034 document requirements are the bedrock upon which accreditation to this standard is built.

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