Quality Management System Development and Certification
At ISO Sense, we specialise in developing and implementing tailored quality management systems to help clients achieve independent certification. Our comprehensive services include gap assessments, quality strategy development, procedure writing, staff training, and auditing, all customised to meet your specific operational needs.
We focus on creating solutions that align with your business processes rather than imposing standardised methods. With our specialist expertise in ISO 13485, ISO 17025, and ISO 9001, we ensure that your quality management system is not only compliant but also enhances your overall business performance.
Medical Device Compliance
Launching a new medical device? Transitioning to the new European Medical Devices Regulations? ISO Sense can help you prepare your management system and technical files for assessment.
Our extensive experience in preparing businesses for CE marking under the Medical Devices Regulation (EU) 2017/745 and the In-Vitro Diagnostics Regulation (EU) 2017/746, as well as for UKCA marking under the UK MDR 2002, ensures that you can successfully navigate the regulatory landscape and bring your products to market without disruption
Auditing
ISO Sense offers a comprehensive range of audit services to support your management system audit commitments. Auditing is a crucial component of continual improvement and forms the foundation of all international standards. Our solutions include assistance with internal audit programs, conducting pre-certification readiness audits, and performing supplier audits.
We work closely with you to ensure that your audits not only meet regulatory requirements but also drive improvements within your organisation, helping you maintain compliance and enhance overall performance.
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Training
ISO Sense empowers your teams with the essential knowledge and skills needed to eliminate reliance on external support. Ongoing maintenance of a management system and regulatory compliance can be challenging without staff who understand the requirements and know how to implement them effectively. We ensure your team is equipped to navigate these complexities, fostering internal expertise for sustained compliance and continuous improvement.
Whether you require training on a specific topic or seek general knowledge in quality and regulatory principles, we are here to assist you with all your training needs.
Problem Resolution
ISO Sense provides support across a range of quality and compliance issues to ensure thorough and timely resolutions. Challenges can arise in any business, often consuming valuable staff time to rectify. If left unresolved, these issues can significantly impact business operations, making it essential to investigate them fully and swiftly.
Whether you've received findings from regulators or certification bodies that require support, or if you're facing recurring issues in your operational processes that you cannot resolve, ISO Sense can help. We utilise root cause analysis and quality management principles to effectively address and resolve these challenges, ensuring you achieve a satisfactory and lasting outcome.