Portland Oregon, ISO 9000-9001, ISO 13485, ISO 14000-14001 & NFPA 1999 Services Company & Consultant
IQA provides since 1992 common-sense, non-bureaucratic consultancy and interim management services for organizations seeking conformance with / compliance to the ISO 9001, 13485, 14001 and NFPA 1999 Consultancy standards:
- ISO 9001:2008 – Quality management systems — Requirements
Medical (with or without CE marking support)
- ISO 13485:2003 – Medical devices — Quality management systems — Requirements for regulatory purposes
- ISO 14971: Medical devices — Application of risk management to medical devices
- ISO 14001:2004 – Environmental management systems — Requirements with guidance for use
National Fire Protection Agency
- NFPA 1999:2008 – Standard on Protective Clothing for Emergency Medical Operations
Other standards, such as AS 9001 (Aerospace) and TS 16949 (automotive) can be addressed.
IQA implementations differ from other implementations by focusing on quality and environmental management by an organizations’ management team. Some documentation is required, but when you think of it, it is usually not lack of documentation that is at the base of poor organizational performance.
Hence, working with IQA is different. In our pursuit of perfection, we bring organizations to the next higher quality level to the benefits of customers, the organization, and the shareholders (bottom line).
We provide auditing, consulting, training and interim management services for:
- Quality Management Systems (ISO 9001, ISO 13485, ISO 14971, NFPA 1999)
- Environmental Management Systems (ISO 14001)
- Public and In-House Internal / Lead Auditor Training (ISO 9001, 13485, 14001, RABQSA)
- EU Directives (MDD, AIMD, IVD, PPE, ROHS and WEEE)
- Health Canada & Other Countries – Medical Devices Regulations
- EU Authorized Representative Services (MDD, AIMD, IVD) with CEPARTNER4U(R)
- Electronic QMS/EMS Implementation using ISOXPRESS(R) and Taskmap(R) software
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