Mayo Consulting, Inc.

Our experience will be a valuable resource for your company when you need to deal with compliance standards or specifications. Our objective is to ensure that you have a system that is cost-effective, right for your needs, and not bureaucratic or burdensome. A sample of some of the compliance standards we cover include:

ISO 9001- Quality System Standard

This Standard is aimed at companies that design, develop, produce, install or service products and/or service companies for any business sector. It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide consistent products and/or services to its customers. Some key requirements include business goals, process management, continuous improvement and customer satisfaction activities.

AS 9100- Aerospace Quality System Standard (AS9110, AS9120)

This Standards is aimed at companies that design, develop, produce, install or service products and/or service companies for the Aerospace industry sector. It specifies requirements for a aerospace quality management system where an organization needs to demonstrate product safety and reliability. Some key requirements include configuration management, purchasing, product realization and product monitoring and measurement. AS 9110 is for maintenance organizations. AS 9120 is aimed at stockist distributors.

ISO 13485 - Medical devices - Requirements for regulatory (GMP's, MDD's, 21 CFR 820 etc.)

This Standard and corresponding GMP's, MDD's, 21 CFR 820, etc. are aimed at companies that design, develop, produce, install or service medical devices and specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements. The primary objective is to facilitate harmonized medical device regulatory requirements for quality management systems. All Medical Devices being marketed in the European Community must bear CE marking.

TS 16949 -Technical Specification for Automotive quality management systems

This Standard is aimed at companies that supply to the automotive sector. It specifies requirements for a quality management system with specific automotive system requirements. It includes Business and Resource Planning, Advanced Quality Planning, Supplier/Subcontractor Development, Planned and Predictive maintenance, Control & Use of Special Characteristics, Delivery Performance, Material Control and employee motivation.

ISO 17025 - Requirements for the Competence of Calibration and Testing Laboratories

This Standard is aimed at companies that provide calibration and/or testing services and wish to demonstrate technical competence of their activities. It includes technical competence of personnel, ethical behavior of staff, use of well-defined test and calibration procedures, participation in proficiency testing, uncertainty analysis, and contents of test reports and certificates.

OHSAS 18001 - Occupational Health & Safety Management Systems

This specification is aimed at companies who develop and implement a management system to enable them control its occupational health and safety risks (OHS) and improve its OHS performance. It includes identification of risk assessment, management and control of the risks, safety management objectives, continuous improvement and compliance with legislation.

ISO 14001 Environmental Management System Standard

This Standard is aimed at companies that are committed to sound environmental management practices by implementing an environmental management system. It includes a systematic approach to dealing with the environmental aspects of an organization, identification of environmental impacts of company activities, identification of environmental aspects, management of aspects, objectives, continuous improvement, employee training, communication, and compliance with legislation.

If you have a specific question on any compliance standard, or would like a quotation, call us @ 617-852-3015 or email us at mayoconsult@comcast.net for more details.