ISO 17025 and ISO 9001 are two fundamental reference standards in the pharmaceutical, scientific, aerospace, biotechnology and semiconductor sectors: compliance with them is the foundation for operating safely.
Consequently, laboratories performing calibration activities and validation services must ensure the quality and reliability of their processes in full compliance with the requirements of these standards.
But what are the differences between these two standards and why is it advantageous to rely on an ISO 17025 accredited laboratory? Let’s explore this together.
What is ISO 17025?
ISO 17025, or more precisely UNI CEI EN ISO/IEC 17025:2018, is the international standard that specifies the general requirements for the competence of testing and calibration laboratories. This standard is essential to ensure that laboratories are capable of producing technically valid and reliable results.
Technical requirements of ISO 17025
The technical requirements of ISO 17025 address key aspects such as:
- Personnel competence: the laboratory must demonstrate that its staff have the necessary skills to carry out testing and calibration activities.
- Testing and calibration methods: valid and accredited methodologies must be used to ensure the accuracy and reliability of results.
- Equipment and instruments: the instruments used must be suitable and properly maintained to guarantee precise results.
- Measurement traceability: every measurement must be traceable to national or international standards.
Benefits of ISO 17025 accreditation
An ISO 17025 accredited laboratory offers numerous advantages.
First and foremost, total reliability of results. It guarantees that testing and calibration results are accurate and repeatable.
Furthermore, given its international recognition, it facilitates the acceptance of results and makes access to new markets easier.
Compliance with the standard ensures that the laboratory meets all technical and regulatory requirements, thereby protecting the end client from the risk of sanctions or project delays.
What is ISO 9001?
ISO 9001 is the international standard for Quality Management Systems (QMS). This standard specifies the requirements for a QMS that an organisation must implement to improve efficiency and meet customer expectations.
General requirements of ISO 9001
The requirements of ISO 9001 include:
- Risk-based approach: identification and management of risks and opportunities to improve processes.
- Process management: focus on business processes to optimise efficiency and quality.
- Leadership involvement: commitment of top management to ensuring quality and continuous improvement.
- Customer satisfaction: monitoring and continuous improvement of customer satisfaction.
Benefits of ISO 9001 certification
Implementing a Quality Management System compliant with ISO 9001 ensures continuous improvement in the quality of products and services, which in turn leads to greater customer satisfaction and fulfilment of requirements.
It also increases operational efficiency by reducing waste and improving process effectiveness.
Key differences between ISO 17025 and ISO 9001
We can analyse the distinguishing elements by comparing them across different areas.
Purpose and scope
- ISO 17025: specific to testing and calibration laboratories, focused on technical competence and accuracy of results.
- ISO 9001: applicable to any organisation, focused on quality management and customer satisfaction.
Technical vs managerial requirements
- ISO 17025: emphasises technical requirements such as staff competence, validity of methods and measurement traceability.
- ISO 9001: focuses on managerial requirements such as process management, leadership involvement and the risk-based approach.
Accreditation vs certification
- ISO 17025: accreditation is granted by recognised accreditation bodies, such as Accredia, and specifically concerns technical competence.
- ISO 9001: certification may be granted by various certification bodies and applies to overall quality management.
