ISO 9001

Services according to ISO 9001

Our team of experts have over 25 years of experience and can help you implement the applicable Quality Management System (QMS) according to ISO 9001.

ISO 9001
Summary

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Achieving your ISO 9001 Quality Management System

A Quality Management System (QMS) is implemented in order to help an organisation to continuously develop the quality of their products and services. Thus, it is important when building a quality system that one conforms to the requirements and guidelines set in standard ISO 9001. Additionally, the QMS needs to be continuously maintained, meaning its documentation must be kept up to date. Whether your QMS meets the ISO 9001 requirements is determined by means of an internal audit.

Challenges of obtaining an ISO 9001 Quality Management System

Obtaining an ISO 9001 Quality Management System can be a complicated process. For this, it is important that any organisation seeking to implement ISO 9001 QMS must be aware of the costs involved in both implementation and maintenance aspects of the system.

Guidance from start to finish

Our team of experts can aid in helping you to achieve the ISO 9001 QMS and ensure that your company meets the requirements that will guarantee that your devices and services consistently meet customer expectations and relevant regulatory requirements.

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ISO 9001

Your partner for ISO 9001 Quality Management System (QMS)

ISO 9001

ISO 9001 is one of the most internationally recognized standards for Quality Management Systems (QMS). ISO 9001 provides a framework and set of principles that ensure a common-sense approach to the management of your organisation to consistently satisfy customers and other stakeholders. ISO 9001 certification aims to continuously improve processes and aims to provide products and services that live up to the demands and wishes of customers and other stakeholders. The following steps are required in the framework:

Ensure and maintain your Quality!

Difference between ISO 9001 and ISO 13485

ISO 13485 is the standard that is set specifically for chain partners of medical devices, and states that a company must guarantee the quality, safety and effectiveness of their medical devices. This starts with the manufacturers, where the medical device is designed, developed and produced, and can also be applied to distributors, importers and suppliers in the chain. This applies to all medical devices from class I, IIA, IIB, III and requires more documentation for the procedures and registrations within the QMS. ISO 13485 certification can only be obtained when you are involved in the life cycle of a Medical Device.
ISO 9001 standard defines general quality requirements, and every company can achieve its certification, whereas ISO 13485 explicitly addresses the requirements for medical devices. ISO 9001 is more focused on how the company is organised to keep the satisfaction of customers and stakeholders, and continuous improvement central. It is also an option for manufacturers of products that belong to Class I for which ISO 13485 is too complex, too heavy or not mandatory. The MDR related processes for Medical Devices can be implemented herein. This way, you meet the requirements of the MDR and you immediately have a demonstrable quality management system in accordance with an internationally recognised standard for quality management systems. ISO 9001 gives more freedom in the interpretation and design of the described processes. ISO 9001 mostly focuses on the following:

  • Customer focus
  • Leadership
  • Involvement, knowledge and competence of people
  • Process approach
  • Continual improvement

The Roadmap for ISO 9001

Certification Experts’ method to obtain your QMS certification varies from client to client. In most cases our team implements the following 6-step plan:

  1. Gap analysis: The performance of your business unit is assessed to determine whether business requirements or objectives are being met and, if not, what steps should be taken to meet them. Based on the gap analysis, your company has a clear view on how much time is spent, which costs are associated with this and how much effort it will take
  2. Management system: Set up and implement a practically manageable, digital management system in accordance with the standard and your needs
  3. Internal audit: Testing of the management system against standards, the law and your own requirements. The internal audit is also the preparation for the certification audit
  4. Management review: Assessment of the effectiveness of the management system by management or management
  5. Guidance and certification: Guidance during the external audit by the certification body. Your company is now certified
  6. Maintenance: Periodically update and update the management system, so that your organisation continues to meet the requirements of the standard
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Carolina Koster Operations Manager
Your expert conducted an internal audit for ISO 13485 at our company. The pre-audit communication was clear and brought valuable expertise. Despite some challenges, your expert was understanding and fostered a relaxed atmosphere. The audit was thorough and effectively pinpointed our areas for improvement. We are grateful and will be working on the feedback.

Van Heek Medical

Wilma Peereboom Quality Coordinator
The cooperation with Certification Experts is satisfactory. They are decisive from the start and one of their main strengths is their excellent problem-solving skills.

Ensure and maintain your Quality!