United Kingdom Market
Quality Management System (QMS) – ISO 13485
Medical Device
IVD
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What Is QMS - ISO 13485?
ISO 13485 is the internationally set standard of quality management systems (QMS), issued by the International Standards Organization, for the manufacturing, design, installation, and servicing of medical devices. QMS UK is a service that provides quality management system solutions for manufacturers dealing in medical devices and in vitro diagnostics in the UK.
The service aids 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 boasts a range of services, including gap analysis, documentation development, internal auditing, and training.
Why Is QMS - ISO 13485 Important?
Compliance
Adherence to ISO 13485 is essential for manufacturers and suppliers dealing in medical devices, as it provides a structure to guarantee uniformity in the design, development, production, and delivery of medical devices for the safe intended use. This standard not only supports market access into various countries, including the UK market, but also builds confidence among stakeholders by showcasing a commitment to safety and quality. 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: Familiarise 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 the employees with necessary training and awareness programs 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 recognised 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 organisation. Continuously monitor the performance of your QMS, gather feedback, and implement corrective actions to enhance its effectiveness and efficiency.
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 organisation's QMS.
Regulatory Requirements for QMS - ISO 13485
Timeline
The timeline may range from a few months to over a year as it involves several stages, including establishing processes for quality planning, documentation, resource allocation, implementation, analysis, conducting reviews, 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 enhancement. The fees may 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.
