United Kingdom Market
Quality Management System (QMS) – ISO 13485
Medical Device
IVD
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What is QMS - ISO 13485?
QMS UK is a service that provides quality management system solutions for medical device and in vitro diagnostic manufacturers in the UK.
The service helps clients implement and maintain compliance with the ISO 13485 standard, which is a requirement for obtaining and maintaining regulatory approval for medical devices in the UK and the European Union. QMS UK offers a range of services, including gap analysis, documentation development, internal auditing, and training.
Why is QMS - ISO 13485 important?
Compliance
It is especially important for manufacturers to ensure compliance with ISO 13485 post-Brexit to maintain access to the UK market. With the expertise of QMS UK, manufacturers can achieve regulatory compliance and ensure the quality and safety of their products.
Process Flow for QMS - ISO 13485
Understand UK Quality Management System Requirements: Familiarize yourself with the specific quality management system requirements applicable to your product category in the UK market.
Identify Qualified QMS Consultants: Research and identify qualified QMS consultants or consulting firms that specialize in UK regulations and have expertise in your industry.
Conduct a Gap Analysis: Collaborate with the QMS consultant to perform a gap analysis of your current quality management system. Identify areas that need improvement or alignment with UK regulations.
Develop a QMS Implementation Plan: Work closely with the QMS consultant to develop a comprehensive plan for implementing or adapting your existing QMS to meet UK requirements.
Update QMS Documentation: Review and update your QMS documentation to align with UK regulations. This may involve revising procedures, work instructions, quality manuals, and other relevant documents to reflect UK-specific requirements and standards.
Training and Awareness: Provide necessary training and awareness programs to your employees to ensure they understand the updated QMS processes and procedures.
Internal Audits and Reviews: Conduct internal audits and reviews of your QMS to ensure compliance with UK regulations and identify any areas for improvement.
Seek Certification: Collaborate with the QMS consultant to pursue certification from a recognized certification body. The certification process typically involves an external audit to verify that your QMS meets the UK standards and requirements.
Continuous Improvement: Implement a culture of continuous improvement within your organization. Continuously monitor the performance of your QMS, gather feedback, and implement corrective actions to enhance the effectiveness and efficiency of your QMS.
How can we help in QMS - ISO 13485?
The CliniExperts professionals will -
Implement QMS in compliance with UK standards.
Develop a comprehensive plan for implementing QMS.
Monitor and evaluate the effectiveness of your QMS.
Regulatory requirements for QMS - ISO 13485
Timeline
The timeline can range from a few months to over a year as it involves several stages, including planning, documentation, implementation, and continuous improvement.
Regulatory Body
In the medical device industry, the Medicines and Healthcare products Regulatory Agency (MHRA) is the regulatory authority responsible for ensuring compliance with QMS requirements outlined in the UK medical device regulations.
Fees
The fees associated with implementing a QMS in the UK are primarily related to the costs of training, documentation development, certification, and ongoing maintenance. The fees can vary depending on the chosen QMS framework.
Validity
The validity of a QMS in the UK is ongoing and requires regular monitoring, assessment, and improvement. Organizations need to maintain and update their QMS to ensure continued compliance with regulatory requirements.
