eSource 133: Frequently Asked Questions regarding ISO 9001 and ISO/IEC 17025 for ALS Tribology

eSource 133: Frequently Asked Questions regarding ISO 9001 and ISO/IEC 17025 for ALS Tribology

Posted 12 November 2020

1. What is the difference between certification and accreditation?

Certification is the demonstration of competency that the product, service, or system in question meets specific requirements as evaluated by a third party.

Accreditation is the formal recognition by an accreditation body that an organization operates according to an international standard, and is only granted after rigorous external examination that verifies technical competence.  Both the accreditation body and the organization must be evaluated by third parties to ensure compliance to the appropriate international standards.

The process of accreditation is more thorough and in depth then certification, and typically evaluates the quality management system of the organization for technical competence. 

2. What is ISO and ISO/IEC?

ISO stands for the International Organization for Standardization and is based in Geneva, Switzerland.  It is an independent, non-governmental, and international organization of national standard bodies (called ISO member bodies) that strives to bring together experts within a certain field to share knowledge and develop voluntary, consensus-based, market relevant Standards.  These Standards provide world-wide specifications for products, services, and systems that ensure quality, safety and efficiency.  It is through ISO that international trade is facilitated and enhanced. 

If an organization is certified or accredited to follow a specific ISO standard, then that company meets the specifications of the standard, no matter where that organization is found in the world.

Because the “International Organization for Standardization” would have different acronyms in different languages, the founders decided to shorten the name to ISO, which is derived from the Greek isos, meaning equal.

Some of the ISO standards are jointly owned by ISO and the International Electrotechnical Commission (IEC), which is also based in Geneva, Switzerland.  The IEC is the world’s leading organization that prepares and publishes International Standards for all electrical, electronic and related technologies.

3. What are the main differences between ISO 9001 and ISO/IEC 17025?

Certification is the demonstration of competency that the product, service, or system in question meets specific requirements as evaluated by a third party.

Accreditation is the formal recognition by an accreditation body that an organization operates according to an international standard, and is only granted after rigorous external examination that verifies technical competence.  Both the accreditation body and the organization must be evaluated by third parties to ensure compliance to the appropriate international standards.

The process of accreditation is more thorough and in depth then certification, and typically evaluates the quality management system of the organization for technical competence.

ISO 9001 is the international standard referenced in the certification process to evaluate the quality management system in place at the upper level of an organization.  It contains the requirements for leadership, management, and documentation to maintain an efficient quality management system.  It was written to be generic for multiple organization types operating across many different fields.

ISO/IEC 17025 is the international standard used in the accreditation process to evaluate the competence of testing and calibration laboratories.  It contains the specific requirements needed to implement an effective and comprehensive quality management system for organizations that provide laboratory testing or calibration services.  Clients may trust that results produced by ISO/IEC 17025 accredited organizations are accurate and reliable.

Although both ISO 9001 and ISO/IEC 17025 provide requirements for quality management systems, ISO/IEC 17025 is specific to the fields of laboratory testing and calibration.  ISO 9001 is more appropriate to implementing quality management systems in large organizations.  Since not all laboratories are large corporations, there are many requirements in ISO 9001 that are not needed to ensure accurate and reliable laboratory testing and calibration services.  Within the introduction of ISO/IEC 17025, it states, “Laboratories that conform to this document will also operate generally in accordance with the principles of ISO 9001.”  The specific differences are summarized in the following table.

ISO 9001
Category
ISO 9001 Requirement ISO/IEC 17025 Requirement
Context of the Organization define the context of the company

define the needs and expectations of interested parties

define the scope of the Quality Management System
All 3 categories covered in specific structural, organization, and quality requirements relevant to testing and/or calibration laboratories.
Leadership define policy

company roles, responsibilities, and authorities

commitment to quality
implied but no specific requirement for leadership

included, specific to testing and/or calibration laboratories

implied
Improvement specific improvement goals for QMS specific requirements to recognize improvement opportunities and evaluate effectiveness
Support Process organizational knowledge
operational planning and control

control of externally provided processes, products and services
This topic is not as detailed and support services are specific to laboratory requirements
Monitoring and Measurement more general and include more areas of the company specific to lab requirements

 

Does ALS Tribology have ISO 9001?

Only the Sydney, Australia and Belo Horizonte, Brazil locations are certified to ISO 9001.  All other locations (including Sydney) hold ISO/IEC 17025 accreditation.

ISO/IEC 17025 accreditation contains specific requirements for laboratories that offer testing and/or calibration services to ensure that clients receive accurate and reliable results.  As the requirements for the quality management systems indicated in ISO 9001 and ISO/IEC 17025 are similar, holding ISO/IEC 17025 accreditation implies that the requirements of ISO 9001 are also followed.

Refer to previous questions for more information on specific difference between accreditation and certification, and ISO 9001 versus ISO/IEC 17025.

For further information about ISO 9001, contact ALS Tribology at reliability@alsglobal.com.

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