We offer comprehensive consulting within the Quality Management System EN ISO 13485:2016 – creating, implementation, maintenance and supervision.
Depending on your company profile we identify applicable law regulations and other requirements. Then we develop the strategy of their implementation.If you are new in this area and you want to undertake the challenges with medical devices – manufacturing or servicing
We offer:
- Performing Risk Analysis and determining the scope of the system
- Elaborate the concept of the Quality Management System and its implementation schedule
- Proposition of Quality Policy
- Development of procedures: QMS Planning and Quality objectives, Management Review
- Developing of documentation and records system and control of the system
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Developing necessary (depending on the company profile) system documentation:
- process maps - flow-charts
- procedures, instruction, forms, templates
- Development of training system (preliminary and improving) including training for employees in scope of applicable procedures and standard requirements
- Help in selection of Notified Body
- Participation of our expert in external certification audit (on request)
- Development and implementation of corrective actions (if necessary).
If you have the quality system already
Important: Notified bodies have adopted three-year transitional period to adapt the management system to new version of standard: 2016. It means that all certificates issued for compliance with previous version of EN ISO 13485 will expire at 28 February 2019.Therefore we offer:
- Analysis of existing management system of the organization against the requirements of ISO13485:2016 (pre-audit)
- Carrying out Gap-Analysis and identification of organizational differences that needs to be considered to meet new requirements
- Development of implementation schedule
- Performing trainings and awareness raising of all interested parties which have an influence on organization efficiency
- Updating current management system to meet changed requirements and verification of its efficiency – developing corrective and preventive action, creating and implementation of lacking system elements
Changes in new version of the standard include extending its applicability for the whole life cycle of the product: beginning from design, purchasing, manufacturing - till the end of its life cycle. The new version emphasizes greater alignment with regulatory requirements and vigilance, post-market surveillance, including whole complaint and post-complaint proceeding.We can also offer:
The emphasis has also been placed on appropriate infrastructure, particularly in the production of sterile medical devices, as well as greater emphasis on Risk Management.
- Internal auditing performed at client`s site (one-time audit as well as audits performed based on annual contract)
- Being a Quality Representative for the client
- Ad-hoc consultations when improving management system
- Help in Risk Management
- Performing supplier audits
- Purchasing control – SQM Supplier Quality Management (including Quality Agreements)
- Help in complaint proceeding and PMS (Post-market surveillance), developing (if necessary) FSCA (Field Safety Corrective Action) and FSN (Field Safety Notice), reporting to authorities