Quality Management System
In relation to the Quality Management System [QMS] the OBL will be expected to maintain a QMS which covers the requirements as defined in the Medical Device Directive or IVD Directive as relevant. This does not mean that a fully compliant ISO13485 system must be in place although if this is the case it will simplify the process as ISO 13485 is the harmonized standard under both the MDD and IVDD for the QMS requirements.
The OBL documented quality system must cover the following areas as a minimum
- Internal Audit,
- Management Review,
- Regulatory Requirements [e.g. Vigilance, Post Market Surveillance, Post Market Clinical Follow Up, informing regulatory authorities of vigilance issues],
- Quality Objectives,
- Order processing and client communications
- Document Control and Records
- Organizational Structures and Responsibilities,
- Control of the Manufacturing Process including any in-line or final performance testing and Non-Confirming Product,
- Corrective and Preventive Action
- Purchasing and Control of 3rd parties [including the OEM and other critical suppliers] must be included in the OBL quality system
These areas will be reviewed during your yearly assessment audits.
For those companies who OBL Class IIb or Class III medical devices, or List A / List B / Self Test IVD devices under Annex IV, it is mandatory to have Design Processes within your QMS. This does not have to cover design to first principles but as a minimum it must include how you as the legal manufacturer agree any changes to the design of the product.
As stated above this requirement cannot be delegated to the OEM it must also be under your control, so a formal procedure detailing how you manage design changes is required and a lack of such a procedure will result in a Major Non-Conformance.
Unannounced audits are required to be conducted at the place of manufacture of the devices and it is likely that these audits will be conducted at the premises of the OEM.
The costs will be charged to you as the legal manufacturer.
In your agreement with the OEM there will need to be a clause where the OEM allows these audits to take place without hindrance. If an unannounced audit is refused by the OEM, a Major Non-Conformance will be raised which may lead to suspension of your certification and you will still be liable for any costs associated with the audit.