ISO 13485 certification consultancy
What does our ISO 13485-certified consultancy service include?
- On-site ISO 13485 consultancy, tailored to your needs. You can also contact us at any time via flexible video conference meetings. We handle almost all the work; you simply need to provide the necessary information to ensure the documentation is useful and tailored to your needs.
- Digitisation, using our agile ‘paperless’ methodology based on Microsoft 365. We’ll show you tools for implementing documents and records that will easily involve all relevant staff and will be useful for other company activities.
- No paperwork or red tape. It is easy to access all documentation and records via various devices and channels, the document management system and the ticket management system, amongst others. The management system will be agile and efficient because it will only contain the necessary documentation.
- Staff training, either face-to-face or remotely via our training campus. We always tailor it to your specific needs, covering 100% of the staff involved in the implementation and 100% of the workforce.
- Internal audit. We carry out the internal audit prior to certification. This involves reviewing all documentation and records. This ensures you are fully prepared for certification without any issues.
- Support during the external audit. We will be on hand to assist you on the days of the external certification audit. We also guarantee that you will achieve ISO 13485 certification by helping you to resolve any non-conformities or observations that may arise.
Benefits of ISO 13485: what is it for?
ISO 13485 helps organisations to:
- Demonstrate compliance with customer requirements (legal and regulatory). These apply to medical devices and related services.
- Facilitate the CE marking of medical devices. Certification is a requirement for obtaining the CE marking for medical devices. The CE marking is the process by which the manufacturer/importer indicates to users and competent authorities that the equipment placed on the market complies with the legislation.
- Applicable to any organisation involved with medical devices. All the requirements of the ISO 13485 standard are applicable to any organisation, regardless of its size or type.
- Integrate it with other certificates. ISO 13485 certification can be integrated with other certificates such as ISO 9001, ISO 14001 and ISO 45001.
What is the 13485 certificate?
ISO 13485 certification is designed for medical devices involved in any stage of a product’s lifecycle.
The ISO 13485 standard involves identifying and documenting processes. For example, company representatives must identify all processes that have even the slightest connection to manufacturing. They must then draw up written procedures to establish which elements could introduce risks to the product.
These threats can range from contaminated equipment to poorly trained staff. After identifying the risks, company representatives must specify and describe the measures to mitigate potential problems.
The ISO 13485 standard is compatible with the ISO 9001 quality management standard, the ISO 14001 environmental management standard and the ISO 45001 occupational health and safety standard, which makes the integration of management systems more effective and efficient.