ISO Consultant, Certification & Training
9001, 13485, 14001 & NFPA 1999
9001, 13485, 14001 & NFPA 1999
“Any bureaucracy in a QMS or EMS is created by the company, not by the standard!”
IQA is a common-sense, non bureaucratic ISO 9001/13485/14001 and NFPA 1999 consulting, internal auditing and training company serving Mikwaukie Oregon and Portland metro since 1992.
- We require management experience from external auditors
- We do not subscribe to the common notion that more product or process documentation leads to improvement
- We are keenly aware that many quality and environmental management systems (certified or not) add no value nor reduce a risk (for non-believers: check the FDA recall site)
- Do the right things right (question as needed everything)
- Get the best (wo)man for the job
- Keep the cost low
ISO Training: 3-Day and 5-Day Sessions
IQA has provided internal and RAB-QSA lead auditor trainings ever since these standards were released and all of our trainers have at least 10+ years experience in the field. Most IQA trainings are delivered in-house; occasionally we schedule a public training class.
- 3-Day IQA Internal Auditor Training — $950 pp
- 5-Day / 36-Hour RAB-QSA Lead Auditor Training — $1700 pp
Consultancy and Interim Management Services for Organizations
- 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
- Electronic QMS/EMS Implementation using ISOXPRESS(R) and Taskmap(R) software
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).
Since 1992, IQA has been providing common-sense, non-bureaucratic consultancy and interim management services for organizations in Mikwaukie Oregon seeking conformance with / compliance to the ISO 9001, 13485, 14001 and NFPA 1999 Consultancy standards, including:
- 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.