Why Do We Need ISO 17034 for Reference Material Producers?

 

The general requirements for the competency of reference material producers (RMPs) are outlined in the international standard ISO 17034. For businesses, labs, and institutions that depend on precise and trustworthy reference materials (RMs) for quality assurance, calibration, and testing, it is essential. Credibility of results, consistency in production, and international acceptance of reference materials are all made possible by the standard.

What is the ISO 17034 Standard?

The requirements specified by ISO 17034:2016 are what RMPs must fulfil to prove their technical proficiency and capacity to generate RMs that satisfy their clients' demands. The production process, the quality management system, and the technological specifications that affect the RMs' integrity and quality are all covered by the standard. To create a unified structure that ensures measurement accuracy and comparability across the globe, ISO 17034 closely connects with other ISO standards, including ISO/IEC 17025 (testing and calibration laboratories) and ISO 15189 (medical laboratories).

In addition to imparting fundamental knowledge of the ISO 17034:2016 standard, the online ISO 17034 awareness training provides an extensive understanding of the criteria for reference material manufacturers. Participants who successfully finish this course will have a thorough understanding of the ISO 17034:2016 standard.

Difference Between ISO 17025 and ISO 17034

ISO 17025-2 vs. ISO 17034-0 With the specific purpose of offering a framework to reference material producers (RMPs), ISO 17034:2016 is in line with the necessary details of ISO/IEC 17025:2017, the standard for the competence of testing and calibration laboratories. Through the use of stability and homogeneity studies, statistical criteria, manufacturing and transport requirements, and other subjects, ISO 17034 builds upon the technical requirements of testing and applies them directly to the production of RMs. ISO 17034 includes traditional ISO 9001 requirements as well as the technical ISO/IEC 17025 requirements relevant to any testing conducted by an RMP.

The Importance of ISO 17034 Standard for RMPS

·         Ensures Results Are Accurate and Dependable: The validation of testing procedures, instrument calibration, and laboratory performance evaluation all depend on reference materials. Reliability and accuracy of tests and measurements are guaranteed by using RMs generated by ISO 17034. Since incorrect outcomes can have serious repercussions, this is especially crucial in industries like medicines, environmental testing, and food safety.

·         Improved the Competence for Reference Material Producers: ISO 17034 gives a framework for RMPs to establish procedures and maintain technical competence. It supports producers in displaying their capacity to regularly generate RMs of the highest quality. Establishing confidence with clients that depend on these products for their testing and calibration requirements is essential.

·         Promotes Mutual Recognition and International Trade: The requirement for harmonized standards grows as trade between countries rises. By offering internationally recognized standards for RM production, ISO 17034 contributes to the removal of technological barriers. Through mutual recognition, reference materials are more widely accepted worldwide, promoting trade and collaboration across a range of industries.

·         Encourages Compliance with Regulations: Certified reference materials (CRMs) are required to be used in many industries due to strict regulatory requirements. To ensure that the RMs generated are appropriate for their intended use and adhere to industry standards, ISO 17034 accreditation aids in RMP compliance with these requirements. This is particularly important in industries where standard compliance is required, such as healthcare, environmental protection, and manufacturing.

·         Encouraged to Continual Improvements: RMPs are encouraged by ISO 17034 to have a quality management system that consists of ongoing monitoring, reviews, and continuous improvement. RMPs can detect opportunities for improvement, maintain the integrity of their processes, and adjust to the changing demands of the market thanks to this quality-focused approach. Sustaining competitiveness and keeping ahead with technical changes require constant improvement.

·         To Builds Customers Confidence: A dedication to excellence, reliability, and technical proficiency is evidenced by ISO 17034 accreditation. Customers are more confident as a result, knowing that the RMs they buy are made to the greatest standards. The assurance that these materials provide is vital for labs, manufacturers, and other users who depend on them to verify their procedures and uphold superior results.

·         Reduces Risks and Mistakes: RMPs are assisted by ISO 17034 in recognizing and controlling risks related to RM production. Producers can eliminate errors, minimize variability, and guarantee material traceability by following the requirements of the standard. This risk management strategy improves the overall dependability of RMs and helps avoid expensive errors.

Applications of ISO 17034 Standard

ISO 17034 used across various industries like,

·         Medicines: Using reliable testing and calibration to guarantee the effectiveness and purity of medications.

·         Environmental Testing: Keeping a check on contaminants and making sure rules governing the environment are followed.

·         Food and Beverage: Verifying quality and safety using precise contamination and nutritional content testing.

·         Healthcare: Assisting diagnostic labs in delivering precise test findings to patients.

·         Manufacturing: Using precise measurements and quality control procedures to guarantee product quality.

Understanding the Key Standards Documents and Importance of ISO 17021

 

The important standard ISO 17021 lays out requirements for organizations that audit and certify management systems. These organizations are essential in ensuring that companies follow globally accepted standards in a variety of industries.

Several important readymade ISO 17021 documents that describe the processes, standards, and requirements needed for certifying organizations to function efficiently and impartially are hidden behind the scenes of ISO 17021 audits.

Understanding ISO 17021

The purpose of ISO/IEC 17021 is to evaluate certification organizations to make sure they meet all kinds of management system requirements and are competent. Typically, these entities are referred to as registrars or Certification Bodies (CBs). In 2015, a revised version of ISO/IEC 17021 was released. The standard contributes to the assurance of CBs' objectivity and the consistency of their audit findings.

Important Key Documents for ISO 17021

·         Requirements for Audit and Certification Bodies, ISO/IEC 17021-1: The general conditions that certification organizations need to fulfil to successfully perform audits and certify management systems are outlined in these documents. It addresses standards including staff competency, impartiality, independence, and secrecy. Accreditation of certification bodies is contingent upon their demonstration of conformity with these conditions.

·         ISO/IEC 17021-2: Standards for Management System Audit and Certification: Additional standards unique to the audit and certification process for different management systems are outlined in ISO/IEC 17021-2. It contains standards for organizing audits, carrying them out, and deciding which ones to certify. This document guarantees uniformity and dependability in the way that audits are carried out and certification judgments are made amongst various certification authorities.

·         ISO/IEC 17021-3: Requirements for Competency in Environmental Management System Auditing and Certification: The competency standards for individuals conducting audits and certifications of environmental management systems (such as ISO 14001) are outlined in this section of ISO 17021. It guarantees that auditors have the know-how, expertise, and experience needed to evaluate environmental management systems successfully.

Why ISO 17021 Documents Are Important?

·         Ensuring Consistency and Impartiality: ISO 17021 standards provide certification bodies with explicit criteria and recommendations to ensure impartiality and consistency. By doing this, audits are carried out impartially, free from bias or conflicts of interest, and auditing methods are encouraged to be consistent.

·         Enhancement of Credibility: Certification organizations increase their dependability and credibility by adhering to ISO 17021 standards. Accredited certification bodies have proven their competence and ability to perform thorough audits in compliance with international standards, so organizations pursuing ISO 17021 accreditation can feel secure in their qualifications.

·         Encouraging Worldwide Accreditation: ISO 17021 certification encourages worldwide recognition of credentials from recognized organizations. Ensuring that certifications are acknowledged and accepted globally, facilitates trade and improves certified firms' access to markets.

·         Continuous Improvement: To keep ISO 17021 compliance, certification bodies need to keep an eye on and refine their procedures on regularly. Because of this dedication to ongoing development, auditing procedures are guaranteed to adapt to new legal mandates and industry best practices.

To sum up, ISO 17021 and the documents that go along with it are essential for guaranteeing the reliability, consistency, and objectivity of audit and certification procedures for management systems all over the world. These standards give certification bodies the structure they need to function effectively and independently, giving stakeholders and certified firms trust. Certification organizations exhibit their dedication to quality and bolster the dependability and credibility of the certification procedure by complying with ISO 17021 standards. Organizations aiming to achieve operational excellence and sustainability are supported in their efforts by the strong framework offered by ISO 17021. In summary, ISO 17021 is more than just a series of guidelines; it is the foundation of quality control in the certification sector, encouraging transparency,

 

 

 

Explore the Steps for ISO/IEC 17065 Audit Preparedness

 

When considering an ISO/IEC 17065 audit, the sense of excessive complexity is frequently evoked. The rigorous requirements specified by ISO/IEC 17065 guarantee the knowledge and objectivity of conformity assessment agencies. A complex web of processes, documents, and systemic complexity must be navigated to prepare for the audit. This guide provides a clear road map for navigating the necessary strategies and advice to prepare for an ISO/IEC 17065 audit.

What is ISO 17065?

An important international standard called ISO/IEC 17065, describes what organizations must do to certify goods, procedures, and services. It guarantees expertise, consistency, and objectivity and acts as a standard against which certifying bodies can compare their performance, giving stakeholders confidence and assurance.

Maintaining certification validity and ISO/IEC 17065 compliance requires regular audits. The standard's development aligns with other standards for conformity assessment, providing an integrated approach for certification processes.

Sector Standard Relevant to Compliance:

·         ISO/IEC 17020: Inspection Bodies

·         ISO/IEC 17021: Management Systems Certification Bodies

·         ISO/IEC 17024: Personnel Certification Bodies

·         ISO/IEC 17025: Testing and Calibration Laboratories

·         ISO/IEC 17065: Product, Process, and Service Certification Bodies

Understanding the ISO 17065 Auditing Process

An ISO/IEC 17065 audit serves several purposes.

·     As defined in ISO/IEC 17065:2012, it aims to guarantee adherence to particular international standards and management system criteria.

·   A certification body's operating procedures and certification activities are intended to be improved in areas that are identified through the audit process.

·   Checking the certification body's procedures against relevant standards like ISO/IEC 17020, ISO/IEC 17024, ISO/IEC 17025, and others that fall within its scope is a crucial goal in ensuring the processes are as effective as possible.

ISO 17065 Audit and Its Criteria

Specifying the parameters and extent of the audit process is part of defining the audit's scope. Usually, it involves the examination of:

·         Requirements for the Certifying Body's Structure: Making sure it has the right kind of structure.

·         Resource Requirements: Assessing the availability and administration of essential resources.

·         Process Requirements: Determining certification state and doing certification scheme analysis.

·    Requirements for the Management System: Assessing the quality management system's efficacy, taking remedial action and reviewing procedures.

Each of these elements is necessary to guarantee that the certification body complies with ISO/IEC 17065, offering dependable and skilled service certification.

Steps in Preparation for the Audit

Carrying Out a Gap Analysis: Start with a comprehensive gap analysis to ensure a strong basis for the ISO/IEC 17065 audit. Finding the differences between your present procedures and the strict rules of the ISO/IEC 17065 international standard is part of this process. To effectively

·         Perform a gap analysis: Examine the requirements of ISO/IEC 17065:2012 about the practices of your certifying authority.

·         To identify differences, compare your current procedures with the standard.

·         To create a precise action plan for filling the gaps, record the results.

Building a Team for Preparation: An efficient audit preparation team is the first step towards an effective audit. To explain the significance of the audit to the entire strong, high management participation is essential. The group should have clear responsibilities, like:

·         Head of the Project: Supervising the setup and making sure that all deadlines are fulfilled.

·         Internal auditor(s): Evaluating internal procedures and proposing ideas for advancement.

·         Quality Manager: Ensuring that the requirements of the quality management system are met.

·  Technical Expert(s): Offering advice on the complicated procedures involved in the certification process.

Allocate Resources: Completing an ISO/IEC 17065 audit successfully depends on obtaining the required resources. The following should be included in resource planning:

·         An established budget to pay for the planning and execution of the audit.

·         Sufficient infrastructure and technology support to fulfil the requirements of the conformity assessment body.

·         Levels of staffing to assist the auditing process and carry out any corrective measures.

Documents and Record Keeping

Keeping Accurate Records: Precise record-keeping and readymade ISO 17065 documents are essential for a certifying body preparing for an ISO/IEC 17065 audit. Internal audit reports, remedial action records, certification decision records, and complaint and appeals records are among the many types of documents that must be kept. Correct internal audit records that show compliance with management system specifications and product/service certification programs are essential to the effectiveness of audits.

Document Control System: Ensuring that all required records are arranged, easily accessible, and protected from loss or unauthorized changes requires a strong document control system. This system needs to be able to manage different versions of documents, maintain the confidentiality of the certification operations, and keep the integrity of the management review process.

Review and Update the Documents: To ensure continual improvement, conformity with ISO/IEC 17065:2012 standards, and preparedness for internal and external audits, certification documentation must be reviewed and updated regularly.

Training and Awareness

Staff Training Programs: Programs for staff training like ISO 17065 awareness training are crucial for preparing for ISO/IEC 17065 audits because they guarantee competence with procedures of certifying bodies and global standards and encourage ongoing development.

To Build Audit Awareness: Audit awareness is crucial for compliance with ISO/IEC 17065 and other standards, and personnel should be educated on audit processes and objectives during preparation.

 

The 12 Essential Components of an ISO 15189 Quality Management System in Medical Laboratories

 

In medical laboratories, quality management is more important than anywhere else. Even a small mistake, such as misidentifying a patient or mixing up a specimen, might have disastrous consequences. The life sciences laboratories are subject to rigorous quality management regulations that cover everything from equipment to customer service. Understanding the 12 key components of quality management implementation in medical laboratories will enable you to confidently push your lab's quality management to new heights in 2024 and steer clear of potentially fatal errors.

Maintaining the highest standards of quality is critical in the field of laboratory operations. The foundation of a laboratory's operations is its Quality Management System (QMS), which guarantees process and procedure dependability, correctness, and consistency. Under the guidance of prestigious institutions such as ISO 15189 and the Clinical and Laboratory Standards Institute (CLSI), laboratories endeavour to exemplify excellence in all aspects of their functioning. Let's take a closer look at the 12 crucial elements that make up a strong QMS.

·         Establishing a Quality System in Organization: A structured QMS that promotes a culture of quality is the cornerstone of any successful laboratory. Every person, from the management group to the quality unit, is essential to maintaining standards and guaranteeing uniformity in practices. The structure of the organization should facilitate continuous evaluation and enhancement of the quality procedures.

·         Employee Development in Terms of Skill and Knowledge: The people working in a laboratory are its most precious resource. Employees who possess these qualities are the foundation of high-quality operations. Using all-encompassing ISO 15189 training, incentive, and engagement programs, laboratories enable their employees to continuously provide quality work. Transparency and accountability are ensured through the QMS's documentation of training procedures.

·         Equipment that Ensures Reliability and Safety: To ensure safe operation, all laboratory equipment needs to be maintained. To maintain the best possible quality, laboratories must also keep an eye on the installation of equipment, the suppliers of that equipment, calibration procedures, and the need to replace that equipment.

·         Purchasing and Inventory for Safeguarding Supply Chain Integrity: For supplies and raw materials to be consistent in quality, effective supply chain management is essential. Good inventory management procedures ensure that items are stored without contamination or deterioration. Sustaining greatness requires collaborating with reliable suppliers who adhere to strict quality management requirements.

·         Process Control for Ensuring Accuracy and Precision: The basis of laboratory quality assurance is process control. Rigorous Quality management procedures guarantee testing techniques' precision and accuracy from sample collection to validation. Laboratories maintain the integrity of their results by following defined processes, which gives stakeholders confidence.

·         Information Governance: Maintaining Data Integrity: Data from test findings to patient information are produced in enormous quantities in laboratories. It's critical to handle this data precisely and safely. To preserve data integrity and comply with legal requirements, controlled access protects confidentiality while making information accessible to authorized workers.

·         Create and Maintaining Records and Documents: Standardized records and editable ISO 15189 documents, most notably Standard Operating Procedures (SOPs), are essential to efficient quality management. These records provide as a guide for procedures, guaranteeing uniformity and adherence to industry standards. The core values that guide document management in the QMS are security, accuracy, and accessibility.

·         Occurrence Management for Finding and Solving Problems: Errors or non-conformances in laboratory activities are inevitable. Through thorough surveillance and investigative processes, a strong QMS makes it easier to identify and address such incidents. Laboratories reduce hazards and maintain quality standards by addressing the underlying causes and putting corrective measures in place.

·         Evaluation: Comparing laboratory performance to internal quality standards or external data sets, like industry benchmarks, is the process of assessment. The actions of lab or quality management managers, internal auditors, or external inspectors are all included in laboratory quality management assessments.

·         Enhancement of Process that Encouraging Ongoing Improvement: An efficient QMS places a strong focus on ongoing improvement. Laboratory operations promote a culture of innovation and improvement by combining quality assurance, control, and corrective actions. Processes are improved by rigorous analysis and feedback loops, which raise productivity and produce higher-quality results.

·         Client Support: A laboratory's ultimate purpose is to serve its customers. The creation of consistently high-quality products or other missions that consistently give a positive customer experience should be supported by a laboratory's QMS. To progress, the laboratory must comprehend its clients' demands and make use of their input.

·         Maintaining Highest Quality Standards for Safety: Maintaining a clean, safe, and secure environment is essential to laboratory operations. Thorough protocols oversee the operation of the facility; these include ergonomic concerns, hazard containment processes, and physical security measures. Laboratory safety and environmental management are given top priority, demonstrating the labs' dedication to excellence.

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What Do You Need to Know About ISO 17025 Accreditation?

 ISO / IEC 17025 is one such regulation that includes a list of requirements for testing laboratories. Testing laboratories need to be accredited by ISO / IIC 17025 to demonstrate their technical competence and ensure the accuracy of test results. In this article, we will highlight the importance of ISO / ICI 17025 for your laboratory.

First of all, ISO / IEC 17025 are the most significant accreditations for all types of laboratories, universities, and research centers conducting tests and calibration. ISO / IEC 17025 include management and technical requirements that enable the testing or calibration laboratory to claim their technical competency. Second, accreditation by regulatory bodies certifies that results are consistent and accurate and are generated using industry-standard protocols.

ISO 17025:2017 Accreditation consultancy helps laboratories in confirming and recognizing the competence of laboratories from MRA partners as per ISO/IEC 17025:2017. 

The ISO 17025 Accreditation Consultancy services available offline and online that can help to prepare documents for quick accreditation. The following are the ISO 17025 documents that conform to the compliance assessment requirements of certified Bodies as per ISO 17025: 2017 listed below:

• ·        ISO 17025 Manual
• ·        ISO 17025 Quality Policies
• ·        ISO 17025 Procedures
• ·        Standard Operating Procedures
• ·        ISO 17025 Audit checklist

Accreditationconsultancy.com offers ISO 17025:2017 documents that cover all such requirements of the upgraded standards and can be used for ISO/IEC 17025:2017 re-accreditation also. Our ISO 17025:2017 manual, ISO 17025:2017 audit checklist, and ISO 17025:2017 procedures are provided in editable format. They serve as the primary source of documentation by which the auditors and consultants carry out the process of assessment.

What are the benefits associated with ISO/IEC 17025 accreditation?

ISO/IEC 17025 is an international standard for continuous improvement and self-correction. A laboratory that complies with ISO/IEC 17025 benefits in the following ways:

• Helps in fine-tuning the processes and establishing a good ISO/IEC 17025 system.
• Saves much time and cost in document preparation.
• Easily modifiable templates according to your requirements

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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.

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