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/

 

 

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.

 

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