Is ISO 17025 Certification Equivalent to The ISO 9001 Accreditation?

A quality management system is a basic need for how to maintain customer loyalty and a stable income potential. When talking about quality assurance/management aspects, most think of the ISO 9001, as it sets the global framework of clauses for compliance and management. The ISO 17025 certification is often mistaken to be the same as the ISO 9001. They both focus on the quality control aspect for better customer experience; however, the former is specifically designed for the laboratory and calibration facilities. The ISO 9001 is the basic rule book that applies to all, however the ISO 17025 sticks to the testing facilities and possesses a certain set of requirements, which are not relevant for any other business sectors.

This article will discuss two quality management certifications and highlights their similarities and differences.

ISO 17025

Full Name: General requirements for the competence of testing and calibration laboratories

Scope:

● Specifically designed for testing and calibration laboratories.

● Focuses on the technical competence of the laboratory to produce valid results.

● Covers both management requirements and technical requirements for laboratories.

Key Requirements:

● Management Requirements: Similar to the ISO 9001, including requirements for quality management systems, documentation, internal audits, management reviews, and corrective actions.

● Technical Requirements: Specific to laboratory operations, including personnel competence, method validation, equipment calibration, traceability, sampling, and handling of test/calibration items.

Objective: Ensures that laboratories are technically competent and can produce valid and reliable results.

ISO 9001

Full Name: Quality Management Systems — Requirements

Scope:

● Applicable to any organisation, regardless of type or size.

● Focuses on the overall quality management system (QMS) of an organisation.

Key Requirements:

● Quality Management Principles: Customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision-making, and relationship management.

● Management System Requirements: Documented information, planning, operations, performance evaluation, and continual improvement.

● Customer Satisfaction: Ensuring products and services meet customer requirements and enhance customer satisfaction.

Objective: Provide a framework for a quality management system to ensure consistent quality in products and services, improve customer satisfaction, and drive continual improvement.

Differences and Equivalence

Purpose:

● ISO 17025: Aims to ensure the technical competence of laboratories and the accuracy of their results.

● ISO 9001: Aims to ensure the overall quality management of a company to meet customer requirements and enhance satisfaction.

Applicability:

● ISO 17025: Specific to testing and calibration laboratories.

● ISO 9001: Generic and applicable to any type of organisation.

Technical Requirements:

● ISO 17025: Includes detailed technical requirements specific to laboratory operations.

● ISO 9001: Does not include specific technical requirements but focuses on general quality management principles and processes.

Certification:

● ISO 17025: Laboratories are assessed for their technical competence and compliance with the standard.

● ISO 9001: Organisations are assessed for their quality management system and compliance with the standard.

Relationship:

● A laboratory with the ISO 17025 certification can demonstrate it meets specific technical and quality management requirements, which include elements of the ISO 9001.

● A company with the ISO 9001 certification does not automatically meet the technical competence requirements of the ISO 17025 but demonstrates a commitment to quality management.

The ISO 17025 and the ISO 9001 are both standards related to quality management, but they serve different purposes and are not equivalent. To learn more about the ISO 17025 certification and the ISO 9001, get professional consultation from experienced consultants.

Author Bio — The authorhas served as an ISO consultant for over 25 years. He now invests his time in researching and writing content on relevant topics related to business management standards.