Quality Management Systems
Build a Strong QMS Foundation for Global Compliance and Customer Satisfaction
QAEC Limited is an expert in quality management systems for ISO 13485, ISO 9001, and MDSAP compliance in the medical device and in vitro diagnostic industry. We have decades of hands-on expertise in quality assurance and regulatory affairs.
At the core of every successful medical device company is its Quality Management System (QMS), as it is the bedrock upon which innovative design principles and solid manufacturing protocols are established.
A well-implemented Quality Management System ensures that medical devices are efficient and effective, meet customer expectations, adhere to stringent global regulatory standards, and deliver project deliverables. Attaining ISO 13485, ISO 9001, and MDSAP certification is a regulatory obligation and signifies your commitment to quality and patient safety.
Whether you have a paper Quality Management System or wish to align to eQMS we can help you attain and maintain ISO 13485: 2016, ISO 9001: 2015, and MDSAP Quality Management Systems.
Every organisation is unique, and our approach is flexible, customised and cost-effective to align with your quality objectives, processes, compliance requirements, and budget.
Assessing your QMS is a path to Continuous Improvement
Consider the last time you evaluated the effectiveness and efficiency of your Quality Management System.
- Is your Quality Management System robust enough to pass an FDA or Notified Body audit confidently?
- How secure do you feel about its current state without an external expert review?
- Are you always ready for an unannounced audit?
- Do you have the resource to evaluate the effectiveness and efficiency of your quality management system?
Key Pillars of an Effective Quality Management System
A comprehensive QMS must encompass critical processes to maintain operational excellence and compliance:
- Document and Record Control
- Supplier Chain Management – Critical Suppliers
- Management Review
- Design Control
- Regulatory requirements
- Change Control
- Validation
- Corrective and Preventive Action (CAPA)
- Internal and External Auditing
- Risk Management
- Clinical Evaluation
- Customer Feedback and Vigilance Reporting
- Distribution Agreements
- Labelling
An effective Quality Management System must be robust and measurable:
- Personnel Training
Ensure that all personnel are trained and that their training records are maintained.
- Record Maintenance
Maintain all records and documentation, in particular your technical files.
- Regular Internal Audits
Conduct internal audits regularly to assess the effectiveness of your procedures and processes and identify areas of improvement and consideration of training needs.
- Continuous Improvement
Foster a culture of continuous improvement by encouraging feedback from all stakeholders, including customers, suppliers, and employees.
Creating a robust QMS will help you accurately identify and address non-conformances, ultimately preventing their occurrence and improving the overall quality of your medical devices.
Auditing and Maintenance of your Quality Management System (QMS)
If you are finding it difficult to keep your internal audit schedule on track and struggling to find the time to conduct thorough and valuable audits, we can help by managing your annual internal audit schedule for you.
We are industry experts and can assist you in staying on track, identifying areas for improvement, and bringing attention to any issues before they are flagged by your Notified Body.
Additionally, if you simply need extra support in maintaining your Quality Management System (QMS), we can support you as your Quality Assurance function on a temporary, regular, or long-term basis.
Tailored Solutions to Enhance Your Quality Management System
QAEC Limited offers specialised solutions to ensure your business remains compliant with the latest Quality Management System requirements, including ISO 13485, ISO 9001, and MDSAP standards and their alignment to MDR.
Our goal is to bolster your Quality Management System, making it a source of confidence rather than concern, especially in the face of audits and regulatory scrutiny.
Let’s discuss how we can help strengthen your Quality Management System, prepare your organisation for the demands of the global market and regulatory expectations, create a robust Quality Management System for your medical devices, and ensure its compliance and patient safety.
Contact us today at +44 (0)1452 341913 or enquiries@qaeclimited.co.uk to explore the support you need.
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