Quality Management Systems

Obtain your Quality Management System with us to guarantee a compliant QMS

Certification Experts is your full-service compliance partner and guides you through the complete Quality Management System (QMS) process according to the various types of QMS standards. With over 25 years of experience, our team of experts will help your organisation to continuously develop the quality of your products and services.

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Summary

A quick overview of this page

Quality Management System

Quality Management System (QMS) is implemented in order to help an organisation to continuously develop the quality of their products and services. Due to this, it is important to keep in mind that when building a quality system, it must conform to the requirements and guidelines set in a standard or regulation, especially if one plans to have a QMS audit.

Challenges of a Quality Management System

Implementing a Quality Management System (QMS) can be a complicated process. For this, it is important to consider which type of QMS you want to use. This will require time and knowledge of which regulations are applicable to which systems. Additionally, the QMS needs to be continuously maintained, meaning its documentation must be kept up to date.

Guidance from start to finish

Our team of experts can determine which QMS is necessary for your organisation in relation to your products and or services within your industry of choice and then guide you through this process.

Who We Serve

Quality Management System (QMS)

Your partner for Quality Management Systems

What is a Quality Management System?

The most commonly used and referenced type of quality management system is the ISO system. The ISO family of quality standards is used in various industries and deals with both quality and sustainability. Whilst the ISO 9001 is the most common standard that companies seek and achieve, there are also other accreditations and standards which can be more applicable to specific industries. These can be read below:

IndustryManagement System
All IndustriesISO 9001
AutomotiveIATF 16949
Medical DeviceISO 13485
Article 10 Quality Management System of the MDR
FoodISO 22000
ServicesISO 200000
ITISO 27001
AerospaceAS 9100D

The biggest challenge of implementing a QMS is defining and writing down the relevant processes for the organisation and the products/services. Quality is often thought of as a subjective concept, making it difficult to define in measurable terms. However, quality is essential to the success of any product startup. A product that is of poor quality will likely be unsuccessful in the marketplace. The challenges of implementing a quality management system in a product startup can be overcome by taking the time to properly define quality processes for your product/service. By doing so, you will be able to develop a QMS that is tailored to the unique needs of your product and your company. Certification Experts can ease this process for through the following steps:

  • Determine baseline of current state (performance) and relevant processes
  • Set-up and implement a quality management system
  • Internal audit
  • Management review
  • Guiding the QMS certification process 
  • Maintenance QMS

Ensure and maintain your Quality!

QMS Audit and Consulting

Different management systems require different audits, making this a difficult and time consuming process that often requires expertise and knowledge. Therefore, it is essential for most manufacturers to involve a third party to guide or carry out an internal audit before the official QMS certification. With a QMS audit checklist we can evaluate an organisation’s existing system to ascertain its conformance with company policies, contract commitments, and regulatory requirements and verify your systems are consistent and manufacture safe products. At Certification Experts, our team of experts can provide QMS consulting with an assessment of the management system against standards, law and your own requirements, QMS training and an internal audit, which is also the preparation for the certification audit. This will ease the difficult and lengthy process for you. Our team specialises in Quality Management Systems for Medical Devices based on the following procedures:

How to implement the applicable QMS with Certification Experts?

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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New Compliance

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.

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