Mayo provides consulting, training and related contract support services to client organizations in the following compliance standards/specifications:
ISO 9001: the standard that defines quality management requirements for any organization.
ISO 13485: the standard that defines quality management requirements for manufacturers of medical devices. Key focus on process controls, compliance and safety.
21 CFR 820: the US Quality System Regulation Medical device manufacturers who sell products in the USA have a legal requirement to comply with 21 CFR Part 820 of US federal law.
AS9100: the standard that defines quality management requirements for organizations in the aviation, space and defense sectors. Key focus on safety, airworthiness, product conformity, configuration control, risk management and reliability.
AS9110: It is based on AS9100.Its focus is specifically on organizations that perform overhaul facilities and the maintenance repair for the aircraft industry at all levels of the MRO (Maintenance, Repair & Overhaul) process.
AS9120: It is based on AS9100.Its focus is specifically on organizations that are pass-through distributors of aerospace commodity items. This standard addresses chain of custody, traceability, control and availability of records.
NADCAP: Manufacturing special processes must be certified to NADCAP audit criteria requirements for control of processes and products. It recognizes AS9100 as the quality system standard.
ISO/TS 16949: the standard that defines quality management requirements for organizations in the automotive supply chain that manufactures and/or adds value to parts being supplied in the automotive industry.
OHSAS 18001: the standard that defines safety management requirements for organizations. It includes guidance on identifying health and safety hazards, and developing a program to manage hazard/risk reduction programs.
ISO 14001: the standard that defines environmental management requirements for organizations. It includes guidance on identifying environmental aspects, and controlling the impacts on the environment of those identified aspects.
ISO 22000: the standard that defines the requirements for a food safety management system that involves interactive communication, system management, prerequisite programmes and HACCP principles.
To find out more about how we could help your company:
Call: 617-852-3015 or Email: info@mayomanufacturingmanagement.com