ISO 17025 Laboratory Accreditation

by Elina D

ISO/IEC 17025:2017 is a standard developed by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) that specifies general requirements for the competence of testing and calibration laboratories. ISO/IEC 17025:2017 is designed to ensure that laboratory results are accurate, credible, reproducible, traceable, and verifiable.

ISO 17025 accreditation Process

It was created to provide a framework for the continual improvement of products and services by setting requirements for developing, implementing, maintaining, and improving documented systems that meet all applicable regulatory requirements. It applies to laboratories where conformity assessment activities are performed by qualified persons using suitable methods, techniques, equipment, documentation practices, facilities, and sufficient resources which have been adequately evaluated beforehand.

What are Testing and Calibration Laboratories?

Testing and calibration laboratories provide testing, analysis, and inspection services for a variety of products. For example, they can test the quality of raw materials or finished goods. These services also include calibrating equipment like measuring devices, scales, thermometers, pressure gauges, balances (weighing), pH meters (measure acidity level), moisture meters (measure the amount of water in wood), resistivity testers (check if electrical current is flowing through wiring). Testing labs also offer environmental testing like checking for contaminants in drinking water or air pollution levels.

They help ensure that products meet required standards, regulations, and specifications. When a company is looking for testing labs, they should consider what types of services the lab provides, how much it would cost for their desired levels of service, and whether it’s ISO 17025 accredited (or certified). These laboratories can be found in various settings: factories, universities, research organizations, etc.

Why ISO 17025 is Important?

ISO 17025 is an internationally recognized quality management standard that sets requirements for organizations to use calibration and testing laboratories. The following are some of the reasons why it’s important:

  • It helps ensure higher levels of accuracy in measurements
  • It provides better customer service through faster turnarounds, more efficient work methods, and reduced costs.
  • ISO 17025 certification offers a competitive edge over noncompliant labs.
  • It enables faster compliance with ISO quality management standards.

ISO 17025 Requirements

ISO 17025 Requirements:

Requirements for laboratory accreditation are divided into five sections, each containing different needs and levels of compliance.

  • Section 4 – General Requirements
  • Section 5 – Structural Requirements
  • Section 6 – Resource Requirements
  • Section 7 – Process Requirements
  • Section 8 – Management system requirements.

Section 4 – General Requirements

ISO 7205 is a standard that specifies the general requirements for creating and using labeling systems. This includes information about making labeling that meets international standards and what should be included on labels to ensure they are informative and valuable. These guidelines cover everything from what type of font should be used to how much space should be allowed between lines of text. It also covers color schemes and other visual aspects important for legibility and aesthetics.

By following the general requirements specified in ISO standards like ISO-720, companies can ensure that their products and services are compliant with global regulations and expectations.

Section 5 – Structural Requirements :

Structural Requirements in ISO 7205 is a document that specifies the minimum structural requirements for the design and construction of buildings. The paper provides specifications for three types of structures: dwellings, non-dwellings, and mixed-use. In addition, it covers fire safety measures, access to facilities, height restrictions, and more.

Section 6 – Resource Requirements:

ISO 7205 sets requirements for the necessary resources to perform a particular task. There are five main categories of resources: equipment, information, personnel, facilities, and time. In each category, a set of specifications must be met to complete the task.

Example:

The equipment category includes tools, machines, and vehicles. The information category contains data and software. The personnel category includes workers who are responsible for completing the task. The facilities category has offices, factories, and other places where the work is done. Finally, the time category includes the hours of the day that the task can be completed.

Section 7 – Process Requirements :

The purpose of this standard is to provide guidance on process requirements for organizations that are implementing or have implemented a quality management system. There are seven fundamental elements in ISO 7205: customer focus, leadership, involvement of people, process approach, systematic analysis, and problem-solving techniques. These seven essential elements will help you improve your organization’s productivity because they will ensure that your business operates efficiently and effectively by focusing on continuous improvement.

Section 8 – Management system requirements.

The ISO 7205 standard provides the requirements for management systems. It defines how to design, implement, operate, and monitor an organization’s management system. The requirements are based on six principles:

  1. Policies and objectives should be established at the top of the management hierarchy.
  2. The process should be designed systematically to meet defined needs.
  3.  Measurements should be used to provide feedback about performance against policies, objectives, and targets.
  4. Management systems must include a risk assessment to identify hazards affecting quality or safety.
  5. Effective communication is vital for all stakeholders to understand what has been achieved so far and what remains to be done.
  6. Improvements made throughout the life cycle of a product or service should be monitored and tracked.

What are the Steps to Becoming ISO/IEC 17025 Accredited?

A list of five essential steps for you to take to become ISO/IEC 17025 accredited.

  1. Set your goals and define your scope of work
  2. Find an accrediting body with which you would like to be registered
  3. Develop a quality management system (QMS), including procedures, methods, forms, records, and reports that will help demonstrate compliance with ISO/IEC 17025 requirements
  4. Complete self-assessment Audits or External Quality Assurance (EQA)
  5. Visit the laboratory to collect Evidence.

What are the Benefits of ISO/IEC 17025 Accreditation?

There are many benefits of ISO/IEC 17025 accreditation, but these 5 stand out the most:

  1. Provides assurance to stakeholders that organizations have met the required standard for competence and can produce results that are accurate and dependable.
  2. Improves international recognition through global acceptance of the standard.
  3. Enables organizations to build trust with suppliers, customers, regulators, partners and stakeholders.
  4. Enhances marketing opportunities in international markets because accredited laboratories are often seen as more credible than non-accredited laboratories.
  5. Helps avoid potential penalties from clients or regulatory authorities who recognize ISO/IEC 17025 accreditation.


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