ISO 9001, 17025, & 13485 Certification: What’s a Common Element?

This article will discuss the requirements of ISO certifications; ISO 9001, ISO 17025, and ISO 13485 certification. It will also discuss how a Quality Management System (QMS) serves different purposes of these three ISO standards. 

The International Organization for Standardization or ISO has become a trusted institution upon which both the consumers and different industries rely. Over the years, the institution has come up with a number of standards while keeping in mind the diverse requirements of several industries. Some ISO standards are being adopted by every industry while other standards are industry-specific. Among 21740 ISO standards, three standards have earned immense popularity all across the globe. These three standards are- ISO 9001, ISO 17025, and ISO 13485 Standard.

  

ISO 9001 is applicable to all industries, while ISO 17025 is designed for testing and calibration laboratories and ISO 13485 is designed for the medical device manufacturing and supplying industry. You might be thinking,“What could be common in these three ISO standards?” These three standards require a management system to maintain the quality of the services or products. No matter whether you are trying to attain ISO 9001 certification, ISO 17025 certification or ISO 13485 certification, you must meet this requirement.

In this article, we will discuss these three popular ISO standards and their main requirements.

ISO 9001:2015 set out a couple of requirements for a management system when an organisation

a. Wants to establish its ability to maintain the consistency of product/service quality,

b. Intends to increase customer satisfaction through proper use of the management system.

 

Most requirements of ISO 9001 Standard are centered on the Quality Management System or QMS. QMS is a series of scopes, processes, and procedures which are required for planning and implementing the core business area of an organisation. To achieve ISO 9001 Certification, your QMS should:

• Identify that requirements of interested parties (such as trade license, guidelines, customer requirements, chosen management system standards, etc.) and customers and ensure all requirements  are met,

• Assure that all the employees (who are responsible for dealing with quality management) are well trained and efficient,

• Document the procedures and records,

• Conduct internal audits to assess the QMS and correct nonconformities,

• Ensure continual improvement.

ISO/IEC 17025:2017 defines the general requirements for the competence, impartiality, and consistent improvement of calibration and testing operations. This standard is applicable to organisations which are dealing with laboratory activities. Requirements for this standard are divided into four categories:

• Structural requirements - The calibration or testing laboratory should be a legal establishment with a management structure and well-defined roles and responsibilities, and range of activities. 

• Resource requirements - The laboratory should meet requirements related to individuals, team members, environmental conditions, equipment, metrological measurement, and externally imported services.

• Process requirements - The laboratory should include review request, verification controls, tendering controls, methodology, and sampling.

• Management system requirements- This set of requirements includes management system documentation, management system controls, record controls, actions to resolve risks. It should also include opportunities, continual improvement, internal audits, and an assessment of management’s performance. To meet this set of requirements, a laboratory will need an effective QMS that is able to help meet the requirements of ISO 17025 accreditation.

 

A laboratory must meet these basic requirements to obtain ISO 17025 certification. 

ISO 13485 Standard introduces a set of requirements to ensure the effectiveness of a QMS that is structured for maintaining the quality of medical devices. It clearly implies that the ISO 13485 standard is specific to medical device manufacturers and suppliers. This standard wants the companies to develop a QMS based on the “Plan-Do-Check-Act” model. This is a four-step management method that is able to control and maintain continual improvement efficiently. This QMS is expected to:

• Demonstrate compliance with regulatory and legal regulations,

• Ensure the quality and ongoing improvement,

• Increase good practices within the business,

• Reduce and mitigate risks effectively,

• Create a competitive advantage.

Though ISO 9001, ISO 17025, and ISO 13485 standards are structured differently, the QMS is common among them. An effective QMS enhances the chance of gaining certification with these three standards. Before starting the certification process, top management must educate themselves about the standard they are looking for, and understand the general concept of QMS as well as the QMS related requirements of the standard they are looking into. 

Damon Anderson is a knowledgeable ISO expert and blogger, and he has been working with an ISO quality consulting firm for years.  His blogs are focused on numerous ISO certifications such as ISO 9001, ISO 14001, ISO 17025 certification, etc. He has knowledge and skills in developing and maintaining the Quality Management System as well.