Maintaining a quality system requires an effective audit programme, including external processes: supplier and subcontractor audits.
What are the legal requirements relating to supplier and subcontractor audits?
The European regulations for in vitro diagnostic medical devices as well as the international standards ISO 13485 and ISO 9001 contain a very large number of requirements that govern the activities to be performed as part of the product conformity and quality management system. Maintaining this quality system requires an effective audit programme, including external processes: audits of sub-suppliers and subcontractors as part of the purchasing process.
How can we help?
As auditors with many years of experience, we can conduct supplier and subcontractor audits on behalf of your company, while ensuring our independence and impartiality.