ISO 13485 certification consultancy
Our practical and streamlined ISO consultancy service for achieving ISO 13485 certification stands out for:
- A preliminary, no-obligation visit to draw up a plan for implementing the ISO 13485 standard, tailored to your needs. Analysis of the current situation.
- This involves reviewing the documents and records used to adapt the standard to the reality of your business.
- Preparing the documentation required by ISO 13485. We use the “Gesttic – Paperless ISO” methodology. This makes it easy to involve all staff, so they can contribute to the new certification.
- Implementing the records. We train staff and address any queries that arise, both in person and via Microsoft Teams.
- Internal audit with senior auditors. We identify non-conformities, corrective actions and opportunities for improvement to assist with their subsequent resolution.
- Support during the certification audit, with any of the leading ISO certification bodies.
- ISO outsourcing. Once you have achieved certification, we can help you maintain the Management System.
ISO consultancy, with over 20 years’ experience. We guarantee ISO 13485 certification.
Benefits of ISO 13485 with EmasConsultors
ISO 13485 certification instils a mindset that quality is built into every stage of the manufacturing process and that continuous efforts ensure high standards are maintained.
- Reduction of risks and incidents. The ISO 13485 standard requires reviews to determine whether the controls in place (customer feedback, audit results, legal requirements, etc.) are working as intended or whether further adjustments would yield better results. Process-based management keeps information up to date and accessible to facilitate comprehensive reviews related to ISO 13485.
- Increased competitiveness. Certification ensures that subcontractors also comply with the standard. ISO 13485. Furthermore, it helps management expand into other countries and increase their chances of success. Certification helps convince stakeholders of the efforts to prioritise quality, as medical devices directly affect people’s lives.
- Helps products remain on the market. Implementing ISO 13485 prevents product recalls. A recall involves a loss of revenue and damage to reputation, leading many people to perceive a brand in trouble as unsafe. The corrective and preventive actions of ISO 13485 help to identify and address problems more quickly than would otherwise be the case.
- ISO 13485 certification strengthens medical device companies. People praise innovation provided it does not compromise user safety. ISO 13485 certification helps to drive continuous improvements in quality and processes. As a result, ISO 13485 contributes to the company’s resilience.