Tuesday, December 24, 2024

Importance of ISO 15189 in Medical Laboratories In Terms of Accuracy, Reliability and Quality

 

The precision and dependability of laboratory results are crucial to patient care and results in the medical field. The foundation of diagnostic services, and medical laboratories help clinicians make judgments and shape treatment strategies. To guarantee that laboratories meet the highest criteria, ISO 15189, the globally accepted standard for medical laboratory competence and quality, was created. This is why the healthcare industry needs ISO 15189.

What is ISO 15189?

The International Organization for Standardization (ISO) created ISO 15189:2012, which outlines the standards for medical laboratories' competency and quality management systems. Although it is specifically designed for the particular difficulties of medical testing, it is based on ISO/IEC 17025 and ISO 9001. To ensure that laboratories not only conduct correct tests but also uphold procedures to produce consistent findings, this standard place a significant value on technical proficiency and the quality management system (QMS).

Making Sure Accuracy and Reliability

·    Consistent Procedures: From sample collection to result reporting, ISO 15189 requires consistent procedures for every aspect of laboratory operations. This reduces unpredictability and guarantees consistent output, regardless of the staff or facility involved.

·  Technical Competence: The standard specifies that laboratory personnel must possess the necessary ISO 15189 training and education. Competence is confirmed through frequent evaluations, guaranteeing that experts can perform complicated assessments accurately.

·   Calibration and Equipment: ISO 15189-recognized laboratories are required to maintain and calibrate their equipment properly. By doing this, the possibility of mistakes brought on by defective or outdated equipment is decreased.

·      Mistake Reduction and Risk Management: ISO 15189 promotes active risk identification and mitigation in laboratories. Resolving problems before they become more serious can preserve laboratory quality.

Developing Confidence and Trust

·       Clinical Trust: The cornerstone of clinical trust is reliable laboratory data. Accreditation by ISO 15189 guarantees that medical professionals may depend on the laboratory's data to properly diagnose and treat patients.

·      Patient Confidence: Patients anticipate speedy and accurate test findings. They can be sure that their tests are carried out to the highest standards and will produce the best results thanks to ISO 15189 certification. A competent medical laboratory must have well-structured and well-written ISO 15189 documents to be accredited.

·    Regulatory Compliance: As a standard for laboratory operations, ISO 15189 accreditation is required in several countries and hospitals. Fulfilling this requirement guarantees adherence to both domestic and global regulations.

Improving Productivity and Quality

·  Constant Improvement: ISO 15189 promotes a culture of ongoing development. It is recommended that laboratories conduct routine reviews of their procedures and implement improvements to boost accuracy and efficiency.

·      Elimination of Faults: ISO 15189-accredited laboratories encounter fewer errors in test findings by following strict procedures, which improves healthcare outcomes and lowers retesting expenses.

·      Streamlined Operations: By putting in place a strong quality management system, labs can run more efficiently, cutting down on delays and speed up test result returns.

Encouraging International Cooperation: ISO 15189 promotes international cooperation by offering a standard framework for laboratory procedures in a world that is becoming more interconnected by the day. The ability of laboratories in many nations to trust one another's findings promotes global patient care and research. In times of global health emergencies, when coordinated efforts depend on precise and comparable data, this is especially crucial.

ISO 15189 is an accreditation of quality in medical laboratory services, not just a certification. By following this guideline, labs not only guarantee the precision and dependability of their findings but also enhance patient care, foster more confidence among interested parties, and strengthen the healthcare system. An essential standard for competence and quality in medical laboratories in an era when accurate diagnosis can save lives is ISO 15189.

Tuesday, November 26, 2024

Understanding ISO/IEC 17020: Legal Structure, Regulatory Compliance, and Emerging Trends

 


ISO/IEC 17020:2012 is an international standard that outlines the competence and impartiality of inspection bodies. It focuses on methods, personnel training, rights, and records control. ISO/IEC 17020 enhances the credibility of inspection reports and certificates, ensuring their recognition and respect. It sets a benchmark for inspection services, harmonizing activities and promoting cooperation between regulatory agencies. This article explores how ISO/IEC 17020 contributes to conformity and compliance in inspection practices.

ISO 17020

The internationally accepted ISO/IEC 17020 standard describes the proficiency of inspection bodies. The International Organization for Standardization (ISO) adopted it to guarantee the dependability, uniformity, and impartiality of inspection services. The standard includes a wide range of inspection tasks, including material analysis and design data inspection. The legitimacy and authority of inspection reports and certificates are its main concerns. For a professional inspection body to become accredited, its ISO 17020 documents must be well-written and structured. Because it gives inspection bodies a methodical foundation for their operations, this standard must be enforced across industries. The reliability of inspection results is ensured by adhering to structural and legal criteria, which demonstrate technical competence and impartiality.

Based on their relationship with the parties concerned and their degree of independence, inspection bodies are divided into three categories. These are:

  • Type A: Organizations are completely autonomous and only perform inspection and associated tasks.
  •       Type B: Organizations that have separate and recognizable bodies that carry out additional tasks while being operationally independent.

  •    Type C: Organizations involved in the design, production, supply, installation, usage, or maintenance of the products they check as well as those that conduct inspections on behalf of their parent companies.

Legal Structure and ISO/IEC 17020

To guarantee safety, quality, and compliance, regulatory standards in the inspection industry are crucial. Standards and rules that control inspection activities are specific to each industry. Public safety, environmental preservation, and compliance with legal requirements all depend on these inspections. These regulations are enforced by regulatory agencies and authorities, which also supervise the performance and proficiency of inspection bodies.

An important international standard that describes the impartiality and competency of inspection bodies is ISO/IEC 17020:2012. From material examination to the issue of inspection reports or certifications, it establishes guidelines for each stage of the inspection process and guarantees a smooth fit with the regulatory environment. For compliance and continuous development, ISO/IEC 17020 requires regular internal audits and corrective measures. This adapts to the changing nature of laws and standards while also meeting structural needs and addressing the intricacies of regulatory requirements. Additionally, ISO/IEC 17020 offers an accreditation structure that enables accrediting organizations to evaluate inspection agencies and guarantee adherence to both ISO/IEC 17020 and certain legal requirements. This ensures that inspection services exhibit operational integrity and technical proficiency, winning over stakeholders and the public.

Regulatory Compliance with ISO/IEC 17020 Implementation

For inspection bodies to make sure that international standards are being followed, ISO/IEC 17020:2012 is essential. Using a stepwise method requires the commitment of top management, which determines organisational direction and distributes resources. To ascertain the present state in relation to the standard's requirements, a gap analysis is subsequently carried out, highlighting areas that require improvement prior to attaining compliance.

The findings from the gap analysis form the basis of the ISO/IEC 17020 implementation action plan. It describes how the inspection body will improve procedures, make adjustments, and fix flaws. Employees must take awareness training on ISO/IEC 17020 as well as management employees of the organizations should have taken ISO 17020 auditor training and develop their competencies in order to become skilled in new inspection methodologies. Compliance and operational consistency are guaranteed by the standard's interaction with current systems.

Conducting routine audits is crucial for ensuring adherence to inspection guidelines and pinpointing areas that require remedial measures. To help inspection bodies navigate the first certification phase and get ready for accreditation, this procedure places a strong emphasis on their structural criteria. The foundation for a strong inspection procedure is provided by ISO/IEC 17020, which covers laboratory calibration and material examination.

Upcoming Trends and Advancements

Technological developments and shifting regulatory requirements have created a constantly shifting environment that inspection bodies must traverse. Organizations must quickly adjust to stay compliant with anticipated regulatory revisions. Additionally, these changes have a significant impact on the way that inspections are carried out and reports are created.

The precision and efficiency of inspections are increasing with the use of digital instruments and remote inspection methods. The COVID-19 pandemic and other worldwide restrictions make this particularly crucial. Inspection services are changing their procedures and standards as risk management and sustainability gain importance. To reflect these aims, inspection agencies are improving certificates and streamlining procedures. Best practices are being fostered by regulatory authorities and inspection organizations working together.

To maintain their position of authority, inspection bodies constantly assess materials and processes using the most recent developments, guaranteeing technical proficiency and accurate inspection procedure execution. Inter-organizational collaboration, information exchange, and methods to improve the standard and dependability of inspections across sectors globally will also probably be given more attention in this sector.

Wednesday, November 20, 2024

Why are ISO 17043 Important?


Preserving quality and uniformity throughout testing facilities crucial in the complicated industries and regulations of today. Throughout this process, ISO 17043, ‘Conformity assessment- General requirements for proficiency testing, is crucial. To guarantee that testing facilities across the globe can produce consistence and dependable finding, an international standard establishes the rules for proficiency testing (PT) providers. This article shows the relevance, advantages, and value that ISO 17043 provides to laboratories, industries and regulations to explain why it is significant.

The Importance of ISO 17043

The ISO 17043 is important primarily because it contributes to the assurance of laboratory competence. Reliability is vital in the testing environment. In particular, whether results impact safety, regularity compliance or important decision-making processes, laboratories must deliver precise and reproducible results. The importance of ISO 17043 as follows;

1)      To Ensure the Laboratory Competence: Laboratory performance can be assessed by comparing findings with those of other laboratories doing the same tests, thanks to the ISO 17043-certified PT providers. By use of these comparisons, laboratories are able to confirm that they are functioning at the necessary level. Participating in PT programs allows laboratories to identify any gaps in their personnel training, instrumentation, or testing procedures. By allowing laboratories to make necessary corrections and enhance their offerings, this identification promotes a continual improvement culture.

2)      Developing Results-Based Trust: Building confidence between stakeholders, such as clients, authorities, and businesses that depend on lab results, is facilitated by ISO 17043. Participating in accredited providers' proficiency testing lets laboratories show external stakeholders that their procedures and outputs have undergone independent evaluation. ISO 17043 accreditation offers assurance for sectors where accuracy and dependability of test results are critical, such as pharmaceuticals, food safety, environmental monitoring, and healthcare. ISO 17043 Accreditation requires well-organized, well-written ISO 17043 documents including manuals, procedures, SOPs, formats, and audit checklists for proficiency test providers. It shows that labs adhere to strict guidelines, which inspires confidence in their capacity to generate accurate and trustworthy data.

3)      Supporting Global Commerce and the Harmonization: Industries frequently collaborate with laboratories abroad in an economy that is becoming more and more globalized. A common understanding of quality and conformance standards is essential for international trade, particularly with regard to testing and calibration. An essential component enabling this harmonization is ISO 17043. The mutual recognition of ISO 17043-accredited PT providers enables companies and regulatory agencies to have confidence in the comparability of a laboratory's performance, regardless of its location, across borders. Harmonization reduces trade obstacles and promotes simpler interactions because results from PT providers authorized by ISO 17043 are recognized worldwide.

4)      Simplifying the Laboratory Accreditation Process: For testing and calibration laboratories, ISO/IEC 17025, and medical laboratories, ISO 15189, ISO 17043 is crucial for accreditation to other standards. Achieving and keeping these accreditations frequently requires participation in PT programs. Labs must regularly produce correct results in proficiency testing to show that they are technically capable. Labs can meet this criterion by giving them opportunities to frequently test their performance, which is made possible by PT suppliers with ISO 17043 certification. Participation in this program guarantees that laboratories maintain a high standard of competence over time in addition to assisting them in gaining accreditation.

5)      Promoting Ongoing Improvement: Promoting a culture of continuous development is a fundamental principle of ISO 17043. Labs that use proficiency testing regularly can evaluate their performance and identify areas where there might be lacking. These revelations have the potential to improve processes and raise the caliber of testing by inspiring the creation of remedial action plans. Laboratories are able to maintain current technology, procedures, and best practices due to this cycle of testing, review and improvement. Proficiency testing makes ensuring that labs are able to continue being competitive and providing high quality services even as industries change.

 

Saturday, October 19, 2024

Differences Between Certification Standards ISO/IEC 17065 and ISO/IEC 17024

 


ISO certificates serve as of quality standards in a world where standards and quality are essential to success. Organizations pursuing certification are frequently confused by misconceptions about the multitude of ISO standards. The purpose of this article is to clarify the differences between ISO/IEC 17065 and ISO/IEC 17024, two particular standards.

While ISO/IEC 17024 establishes standards for human certification procedures, ISO/IEC 17065 specifies the standards for product certification bodies, guaranteeing fairness and uniformity. To increase credibility and competency, it is essential for professionals and enterprises to understand these distinctions. The upcoming parts will examine the fundamentals of each standard, compare them in detail, offer implementation solutions, and share real-world case studies, all of which will lead to practical insights for individuals that are discussing certification.

To Know the ISO 17065 Standard

While ISO/IEC 17024 establishes standards for human certification procedures, ISO/IEC 17065 specifies the standards for product certification bodies, guaranteeing fairness and uniformity. To increase credibility and competency, professionals and enterprises need to understand these distinctions. The upcoming parts will examine the fundamentals of each standard, compare them in detail, offer implementation solutions, and share real-world case studies, all of which will lead to practical insights for individuals that are discussing certification. Well-written and structured ISO 17065 documents are essential for the product certification body to obtain ISO 17065 accreditation.

To Know the ISO 17024 Standard

Globally recognized ISO 17024 “Conformity Assessment – General requirements for bodies operating certification of persons,” establishes standards for organizations that certify individuals for a range of professions and occupations. The goal is to integrity, comparability, and recognition of certified personnel globally by ensuring consistent, comparable, and dependable certification processes across industries and nations. With an emphasis on the procedures followed by certifying organizations, the standard seeks to foster public and consumer trust in certified professionals while fostering confidence in the certification process through fairness and uniformity.

A Comprehensive Analysis of ISO/IEC 17065 and ISO/IEC 17024

Scope and Relevance: Organizations that carry out product certification, which verifies that goods fulfil particular standards, are primarily covered by ISO/IEC 17065. Various industries, including consumer goods, food safety, and manufacturing, use this standard. ISO 17024, on the other hand, deals with personnel certification and is used to verify a person's proficiency in a particular function or profession, usually in technical and professional sectors.

General Requirements: Both standards underline how crucial it is to manage issues of interest and be impartial to preserve the integrity of the certification process. However, according to ISO/IEC 17065, certification organizations must also control the legal and contractual risks connected to the product certification process. ISO/IEC 17024 focuses on the particular requirements for the persons being certified in terms of data protection and confidentiality.

The Structural Requirements: The primary areas of difference between the organizational structures under ISO/IEC 17065 and ISO/IEC 17524 are roles and responsibilities related to the certification scopes of each standard. In comparison with ISO/IEC 17024, which specifies processes that defend the interests of certified individuals, ISO/IEC 17065 calls for a committee to ensure objectivity in product certification decisions.

Needs for Resources: Resources appropriate for the particular product certification, such as test facilities, are required by ISO/IEC 17065, whereas ISO/IEC 17024 requires that certification process staff be carefully evaluated to guarantee competency.

Requirements for the Certification Process: The application, evaluation, and decision-making process for ISO/IEC 17065 product certification are focused on the market, periodic and product surveillance. Individuals are evaluated under ISO 17024, necessitating the use of various approaches for examination, re-examination, and surveillance tasks associated with preserving the personnel’s certification status.

System Requirements for Management: According to these criteria, an efficient management system that includes management reviews and internal audits is necessary. Both also require document control and record-keeping, but the specifics of these requirements are tailored to the procedures and structures unique to personnel or product certification by their particular standards.  

Strategies for Putting ISO/IEC 17065 and 17024 into Practice

It takes a systematic approach to implement ISO/IEC 17065, which deals with the requirements for certification bodies certifying goods, services, and processes, and ISO/IEC 17024, which deals with the certification of individuals. The following are some methods for putting both criteria into practice:

·         Gap Analysis: Conduct a comprehensive comparison between the requirements of the standard and current operations. To determine the extent of the necessary modifications, identify the areas of non-conformance for both ISO/IEC 17065 and ISO/IEC 17024.

·         Action Plan: Create a thorough strategy to fill in these deficiencies. Assign roles, establish due dates, and allot funds for things like ISO 17024 training, process modifications, and document preparation.

·         Training: Develop training programs that are specific to ISO/IEC 17065 requirements for personnel certification and ISO/IEC 17024 requirements for staff involved in product, process, and service certification.

·         Internal Audits: Plan and carry out audits regularly to evaluate adherence to the requirements. Utilize outcomes to motivate ongoing development.

·         Management Review: To make sure the system is still efficient and in line with the organization's strategic direction, top management should examine its performance regularly.

·         Documents: Create or update quality manuals, procedures, and ISO 17024 documents that adhere to standards. Make sure they are readily available and kept in a secure location.

To guarantee preparedness for the official certification assessment procedure, think about planning pre-assessment visits, doing mock audits, and hiring consultants if necessary.

Source Link: https://accreditationconsultancy.wordpress.com/

 

 

Friday, October 11, 2024

ISO 17025 and ISO 15189: A Comparative Study of Laboratory Standards

 


In a world where accuracy is highly valued, laboratory standards are overlooked icons that deliver quality and consistency. ISO 15189 and ISO 17025 are two strong competitors in the laboratory accreditation space, each with a unique emphasis. This article contrasts the two standards' intricacies and applicability to help laboratories in their search for certification excellence.

Maintaining high-quality services and guaranteeing proficiency across various laboratory types depend on laboratory standards. To consistently generate results that are valid and accurate, laboratories must adhere to international standards. The well-known international standards ISO/IEC 15189 and ISO/IEC 17025 were created for many kinds of laboratories. The quality management system requirements for medical laboratories are outlined in ISO 15189, with a focus on patient care and the criteria for the clinical environment. A general requirement standard for testing and calibration labs, ISO/IEC 17025 offers a framework for process control and quality assurance. By comparing these standards, one may determine which one is appropriate for a given laboratory activity, look into possible synergies, and adhere to international standards.

Understand the ISO/IEC 15189

An international standard called ISO 15189 was created especially for medical laboratories. This standard's main goals are to improve the calibre of laboratory services, guarantee the accuracy of test results, and verify the capabilities of medical laboratories—all of which will improve patient care. It discusses an extensive list of conditions that these labs need to fulfil to receive accreditation.

The following categories apply to ISO 15189's basic requirements:

·         General Requirements: Legal, moral, and regulatory requirements must be met by laboratories.

·         Requirements for Structure: A well-defined quality management system (QMS) and transparent organizational management are essential.

·         Requirements for Resources: It stipulates that all laboratory operations must be supported by sufficient facilities and equipment, as well as competent laboratory workers.

·         Process Requirements: Sturdy, well-organized procedures including pre-, examination-, and post-examination activities are needed.

·         Requirements for a Management System: To maintain the high standards outlined in this ISO, regular audits, recurrent management reviews, and a dedication to continuous development are crucial elements.

Understand the ISO/IEC 17025

An international standard developed especially for testing and calibration facilities is ISO/IEC 17025. The goal is to verify that these labs can generate reliable and precise results, fostering confidence in their work on a national and worldwide scale.

Key ISO/IEC 17025 requirements are as follows:

·         General Requirements: Laboratories are required to uphold impartiality principles and secrecy in all aspects of their operations, thereby removing any potential dangers of bias and guaranteeing information privacy.

·         Structural Requirements: Laboratory companies must adhere to the standard and have a clearly defined structure that includes suitable management systems and quality management processes.

·         Resource Requirements: The ISO 17025 documents outline the requirements for laboratory people, facilities, and equipment, making sure that each is appropriate for carrying out laboratory operations efficiently.

·         Process requirements: The correct management of testing and calibration procedures, including their validation, is outlined in ISO/IEC 17025. The requirement for measurements and calibrations to be traceable to approved standards is also covered.

·         Management System Requirements: Labs have to foster a continuous improvement culture, carry out frequent audits and management reviews, and put remedial measures into place as needed.

Competitive Analysis

·         Scope and Applicability: ISO/IEC 15189 is specific to medical laboratories, focusing on patient care quality, while ISO 17025 applies to testing and calibration laboratories across various industries.

·         Quality Management System (QMS): The demanding Quality Management Systems, ISO 15189 and ISO 17025, have more requirements for patient-focused services and a more comprehensive methodology for laboratory settings.

·         Personal Competence: The guidelines place a strong emphasis on the necessity of having skilled laboratory employees who can adapt to new techniques and technologies through intensive ISO 15189 training, education, and ongoing professional development.

·         Process Requirements: It is for pre-examination, examination, and post-examination activities are outlined in ISO 15189 and ISO 17025, respectively, to guarantee accurate and repeatable outcomes in testing and calibration procedures.

·         Resource Management: Both standards require properly maintained buildings and machinery, while ISO 17025 stresses the need for equipment calibration to guarantee traceability.

·         Impartiality and Secrecy: According to both standards, impartiality and confidentiality are essential, requiring laboratories to protect patient or client data and reduce any potential dangers related to conflicts of interest.

Depending on the goals of the laboratory and the needs of its clients, ISO 15189 or ISO/IEC 17025 should be chosen. With an emphasis on patient care and pre-analytical procedures, ISO 15189 is crucial for medical laboratories. The worldwide standard ISO/IEC 17025 guarantees technical competence and quality control in calibration and testing facilities. While they differ to meeting the needs of their different fields, both standards are dedicated to providing high-quality services and ongoing improvement.

 

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Thursday, September 19, 2024

ISO 17065 Certification: Importance, Future Directions, Challenges, and Opportunities

 


Technological improvements, rising customer demands, and growing globalization are all contributing to a fundamental change in the certification environment. ISO 17065 is the foundation of this development; it is the standard that establishes the level of competency for certification bodies. The future of ISO/IEC 17065 certification and its critical role in fostering confidence in certified goods and services are examined in this article, along with how ISO 17065 is influencing the industry.

The Changing Environment of ISO 17065 Certification

Consumers and businesses alike want greater trust regarding the quality, safety, and sustainability of goods and services in today's interconnected world. Providing this assurance has led to the importance of certification as a mechanism. However, the huge number of certification programs has created a complicated and frequently confusing environment. Robust and transparent certification processes are becoming more and more necessary to address this.

The Importance of ISO/IEC 17065 Certification

For certifying organizations to demonstrate their expertise and objectivity, ISO 17065 offers a framework. For the product certification organization to become accredited under ISO 17065, well-written and structured ISO 17065 documents are essential. An organization can increase their reliability and gain stakeholders' confidence by following this standard. Among ISO 17065's essential components are:

·         Competence: To successfully carry out certification operations, certifying organizations must have the necessary resources, expertise, and abilities.

·         Neutrality: To avoid conflicts of interest, certifying bodies must remain impartial and independent during the certification procedure.

·         Customer Focus: Certification bodies should strive to meet the needs and expectations of their clients while maintaining impartiality.

·         Management System: Certification bodies must implement a robust management system to ensure consistent and efficient operations.

The ISO/IEC 17065 accreditation has increased the trust and confidence of all stakeholders in the product's quality and regulatory compliance. Several parties and organizations can benefit from the certification, including:

·         Customers of certification bodies

·         Representatives of governments

·         Clients of the recognized organization

·         Clients and other members of the public

·         Non-governmental entities

Shaping the Future of ISO/IEC 17065 Certification

In multiple aspects, ISO 17065 is significantly influencing how certification will develop in the future:

  • Strengthening Credibility: Certification organizations can achieve more public trust in certification by proving compliance with ISO 17065. For the certification system to remain intact, this is crucial.
  • Promoting Innovation: Within certifying organizations, ISO 17065 promotes innovation and ongoing development. Certification bodies may respond to changing market demands and give their clients greater value by implementing new technology and procedures.
  • Facilitating Global Trade: Consistent application of ISO 17065 across different countries can facilitate global trade by reducing technical barriers and promoting mutual recognition of certifications.
  • Supporting Sustainability: Certification bodies can leverage ISO 17065 to promote sustainable practices and contribute to environmental and social responsibility.

Challenges and Opportunities of ISO/IEC 17065

Despite all of ISO 17065's benefits, there are disadvantages to implementing it. Certification bodies must invest in infrastructure, resources, and ISO 17065 training to meet the standards. It might also be difficult to stay current with changing rules and regulations. These difficulties do, yet, also offer chances for improvement and progress. Certification bodies can set themselves apart from rivals, draw in new business, and bolster their market position by adopting ISO 17065.

The development of ISO 17065 is a major factor in the promising future of ISO 17065 certification. The standard is propelling the certification business toward a more resilient, dependable, and sustainable future by encouraging trust, innovation, and international trade. The necessity of certification bodies in offering assurance and confidence will only increase as the world gets more complicated.

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Monday, September 2, 2024

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.