AMETEK EMC’s Harmonized Quality Policy for all facilities and their employees are responsible for:
A. Delivering defect free products and services on time.
B. Meeting or exceeding all customer requirements and expectations.
C. The continued suitability and effectiveness of the Quality System.
This quality policy is used as a basis to ensure that the QMS, as documented and implemented, is compliant with ISO 13485. However, certain product specifications or Customer Agreements may require QMS document compliance with statutory or regulatory standards outside of these ISO standards. This may include, but is not limited to: 21 CFR (parts 11 or 820), UL, or possible foreign body directives (i.e, RoHS, REACH, Conflict Minerals, CA proposition 65, etc.)
We have proven our commitment to quality by registering ISO 13485:2016 at all of our FDA-registered manufacturing facilities. Our manufacturing experts and process engineers will partner with you to ensure effective and efficient production control. Our manufacturing teams are agile and responsive and execute a high mix/high capacity/fast turn operations model.
