I subcontract a large part of my activities to specialised subcontractors. How can I control them and make sure they are working properly?
As a manufacturer, you are solely responsible for the authorities, regardless of the number of subcontractors you need to produce your MD. Therefore, you have to formalise relations with each subcontractor with a contract that clearly defines the roles, responsibilities and expectations / deliverables of each party. You need to audit your subcontractors to assess, on site, the quality of the service and its ability to meet your expectations. You must develop measurement tools to assess the effectiveness of your subcontractors / suppliers.
nex’audit allows you to evaluate your subcontractors over time:
- Sort your subcontractors / suppliers by type of service and criticality;
- Formalise agreements with subcontractors;
- Carry out on your behalf subcontractor audits to validate its ability to meet the contract issued and the standards and regulatory requirements applicable to your products;
- Establish a control procedure for subcontractors / suppliers and tools to facilitate the collection of information and analysis.
Result of nex’audit for your business
- Relationships with your subcontractors are facilitated: the role, expectations and constraints of each are defined;
- Detected non-conformities are handled more efficiently by your contractor and you now have systematic feedback on corrective actions implemented;
- Your subcontractor keeps you informed of all upcoming changes that may have an impact, even positive, about your products;
- Audits enable you to ensure that the level of demand is maintained by your subcontractor over time and demonstrate to your notified body that your outsourcing is fully under control.
- You are now much more comfortable to engage a new subcontracting partner and the risk of selecting the wrong service provider is limited.
What are the risks in poor control of your subcontractors?
- The relationship with your subcontractors may deteriorate because everyone’s responsibilities are poorly defined;
- Your notified body may raise critical non-compliance to lack of control of your subcontractors that may include suspension of your ISO 13485 certification;
- Your customers may receive non-compliant products, degrading the image of your company brand.