Quality always matters

Businesses with a Quality Management System
receive more orders

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ISO, International Standards Organization, established in 1947


DEFINE MEASURE ANALYZE IMPROVE CONTROL

ISO-aid LLC | Santa Barbara, CA | phone: (805) 682-0291 | email: iso@iso-aid.com | www.iso-aid.com

Businesses are requiring their external providers
to have a verified and validated Quality System


Industry standards for companies who design, manufacture, market,
and/or distribute products or services.


ISO 9001

Quality Management System with
emphasis on customer satisfaction
and continuous improvement.
ISO 9001:2015


ISO 13485

Medical Device Quality
Management System with emphasis on regulatory requirements.
ISO 13485:2016


FDA

Quality System requirements for
medical device companies
selling product in the US
21 CFR 803, 806, 820

Companies who engage in global trade must
comply with world-wide regulatory requirements



MDSAP

Medical Device Single Audit Program
Emphasis on regulatory requirements for the US, Brazil, Australia, Canada and Japan with a single audit.
Reference FDA website

CE/Technical Files

EU market precondition of demonstrating conformity to EU requirements. Current Regulations 90/385/EEC, 93/42/EEC, 98/79/EC.
Reference European Commission website

 Current Revisions

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


AEROSPACE

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.


Risk Management

Addressing risks and opportunities
for medical devices and the
entire Quality System
ISO 14971 and ISO 31000

ISO-AID LLC has been providing Quality Management
consulting since 2014



Audits

Gap analysis
Full-system Internal Audits
Assistance with third-party certification


Documentation

Quality Manuals, procedures, forms
Corrective/Preventive actions
Root-cause analysis
Management Review


Data Analytics

Process flow-charts
Statistical analysis
Analytics for quality objective metrics


If your business is not compliant with standards that apply
to you, your competition will take your competitive edge.

Kristine Witzel, Managing Partner, ISO-aid LLC

Professional Quality Management guidance in northern, central and southern California

View Kristine Witzel's profile on LinkedIn

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ISO-aid LLC | Santa Barbara, CA | phone: (805) 682-0291 | email: iso@iso-aid.com | www.iso-aid.com

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