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DEFINE MEASURE ANALYZE IMPROVE CONTROL
ISO-aid LLC | Santa Barbara, CA | phone: (805) 682-0291 | email: iso@iso-aid.com | www.iso-aid.comIndustry standards for companies who design, manufacture, market,
and/or distribute products or services.
Quality Management System with
emphasis on customer satisfaction
and continuous improvement.
ISO 9001:2015
Medical Device Quality
Management System with emphasis on regulatory requirements.
ISO 13485:2016
Quality System requirements for
medical device companies
selling product in the US
21 CFR 803, 806, 820
Medical Device Single Audit Program
Emphasis on regulatory requirements for the US, Brazil, Australia, Canada and Japan with a single audit.
Reference FDA website
EU market precondition of demonstrating conformity to EU requirements. Current Regulations
90/385/EEC, 93/42/EEC, 98/79/EC.
Reference European Commission website
EU MDD regulations that have been amended and must be adopted by May 26th 2020:
MDR EU 2017/745, IVDR EU 2017/246
Reference European Commission website
Standard based on ISO 9001 2015 with emphasis on requirements from the DOD, NASA and FAA
ISO 9100D
What every business should
know about Quality
Quality is the benchmark in all industries, but over time complacency sets in and this compromises the quality and product or service. Quality can only improve by means of review, verification and validation.
Addressing risks and opportunities
for medical devices and the
entire Quality System
ISO 14971 and ISO 31000
Gap analysis
Full-system Internal Audits
Assistance with third-party certification
Quality Manuals, procedures, forms
Corrective/Preventive actions
Root-cause analysis
Management Review
Process flow-charts
Statistical analysis
Analytics for quality objective metrics
Professional Quality Management guidance in northern, central and southern California
