European Union Market
Quality Management System (QMS) and Audits – ISO 13485 Standards
Medical Device
IVD
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What are QMS and Audits?
A Quality Management System (QMS) is a set of processes, procedures, and policies that ensures the consistent quality of a medical device throughout its lifecycle. Auditing is an important part of the QMS, as it helps to identify areas of improvement in the system and ensure compliance with ISO 13485 standard, which is a regulatory requirement.
Why are QMS and Audits important?
Compliance
QMS is very important to medical device manufacturers to ensure all the product and facility requirements comply with the
ISO 13485 standards or not.
Process Flow for QMS and Audits
Implement a QMS: Develop and implement a robust Quality Management System that complies with relevant international standards.
Conduct Internal Audits: Regularly perform internal audits of your QMS to assess its effectiveness, identify areas for improvement, and ensure compliance with ISO 13485 standards and applicable regulations.
Seek Certification: Engage with an accredited certification body to undergo a third-party audit of your QMS.
Obtain EU Market Access: Alongside implementing a QMS, ensure your products meet the specific requirements of the EU market. This may involve conformity assessment procedures, compliance with applicable directives or regulations, and obtaining necessary certifications.
Maintain Compliance: Continuously monitor and maintain compliance with your QMS and regulatory obligations. Conduct regular audits to verify ongoing conformity and make necessary improvements.
How can we help in QMS and Audits?
Choose to appoint CliniExperts as your trusted partner for comprehensive compliance solutions.
We can encompass processes, procedures, and documentation that ensure consistent product quality and adherence to regulatory requirements.
We can help in conformity assessment procedures, compliance or regulations, for obtaining necessary certifications.
CliniExperts can assist you in engaging with an accredited certification body to undergo QMS audit.
We can help you with MDR Compliance.
Regulatory requirements for QMS and Audits
Timeline
The timeline for conducting QMS audits can vary depending on the specific requirements and circumstances. The timeline between your first contact with a notified body and the QMS audit can be as long as six months.
External audits by certification bodies are usually conducted once a year or as per the certification cycle.
Regulatory Body
Audited by a notified body, which is a third-party organization that has been designated by an EU member state to assess the conformity of your QMS. In the EU, for example, the European Accreditation Cooperation (EA) provides accreditation services to certification bodies. The accreditation ensures that the certification bodies are competent and impartial.
Fees
The fees associated with QMS audits can vary depending on several factors, including the size and complexity of the organization, the chosen certification body, and the specific standard being audited.
Validity
The validity of QMS audits also depends on the type of audit. Internal audits are performed for ongoing monitoring and improvement of the QMS and do not have a specific validity period. External audits conducted by certification bodies usually result in the issuance of a certificate with a specific validity period, typically three years.
