AUDIT – INSPECTIONS
More and more often, organizations decide to entrust inspection visits to external staff, mainly because they are not conditioned by preconceptions, relations with the staff under surveillance, so as not to compromise what has been established with the interlocutor, etc.
But if you want to perform this delicate activity to achieve the set goals, you must contact professionals in the sector who have specific characteristics, as well as well recalled by the reference standard: UNI EN ISO 19011 !
MEQUIPE Inspectors carry out different types of inspections visits and for different for different purposes:
Part I - Within the organization
For the verification of product and system (trend of business processes, staff behaviour, product realization process, management of technical files, etc.)
Part II - Outside the organization
For the verification of the fulfilment of contractual requirements, such as , Technical Specifications, Contracts, Framework Agreements, Quality Systems, etc., signed with Suppliers, Partners, Distributors…
Part III - Certification Bodies, Notified Bodies
For Product and System Certification in medical field.
with the role ofLead Auditor, Auditor, Mystery Auditor e Technical Expert for the competence regulatory and legislative framework, i.e.:
- Medical Device Directive 93/42/CE, s.m.i. 2007/47/CE,
- (UE) Regulation 2017/745,
- Product technical standards, harmonized in the accordance with the aforementioned regulatory framework, from Aerosol to MRI,
- ISO 9001, ISO 13485 Quality Management Systems
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