Diagnosis: This diagnosis should be considered as an inventory of the organisation as much in terms of the products/services as in term of the methods, in comparison to the requirements of the EN ISO 13485 standard.
This diagnosis is followed by an action plan that should be implemented in a context of continuous improvement.
Awareness-raising/training programme: It is necessary to set up different awareness-raising/training meetings on the requirements of the EN ISO 13485 standard.
This training plan includes:
- Information on the requirements of the EN ISO 13485 standard.
- Training on the control of processes
- Training on the implementation of the quality management system (training action with Quality Manager and/or project team).
- Training on internal audits.
In the frame of this implementation, we can integrate (according to the strategy defined) the requirements of the MDASP and the countries where your products are distributed
Identification, formalisation of processes (or activities) and the quality management system: Identify and describe all the company’s processes, internal and external customer/supplier relations, human and material resources, and the information system. The processes or activities are:
- Operational processes (those that the customer buys).
- Management processes (company’s strategy and policy).
- Support processes (human and material resources).
- Drafting of all documentation associated with processes and registrations (controls) that should be systematised.
- Setting up of document management.
- Definition and formalisation of the strategy and objectives.
- Drafting of the Quality Manual.
IMPLEMENTATION OF THE QUALITY systEM
Systematic setting up of formalised processes and the action plan: The actions to implement are classified by priority and it is possible to start either by completing the actions that are the easiest to carry out, or by those that provide the most relevant results in terms of working methods, non-compliant products/services rate, etc.
Tracking of implementation: This implementation should cover a period of 3 to 6 months according to the activities and/or products.
Internal audits: An internal audit, or audits, should be carried out regularly during the system’s implementation to verify the application of requirements.
FINALISATION AND PREPARATION OF THE CERTIFICATION AUDIT
Management review: The results of the mock audit and the setting up of the quality management system are examined during a management review. This management review enables the validation of the methods (tools, training, etc.) implemented, the working methods and rules defined, and the quality report presented.
Certification audit: The certification audit is carried out by a notified body.