Quality Value Associates provides auditing, consulting, training, and advisement services to help companies achieve quality and compliance standards more efficiently. Led by principal Mark Loewen with over 30 years of experience in manufacturing, the company specializes in value-add audits, ISO certification, and hands-on training in topics like risk management, process validation, and cost of quality reduction. Customers benefit from expert assistance on regulatory submissions, documentation, and data management systems.

1. QUALITY VALUE ASSOCIATES
PO Box 12; Woolrich, PA 17779-0012
Phone: 570-769-5059
Email: pamark368@gmail.com
Mark Loewen- Principal
“Making quality and improvement second nature while reducing cost of
quality and compliance”
Over 30 years in manufacturing of consumer products, medical devices,
cosmetics, and electronics.
AUDITING
“VALUE ADD AUDITS”
Assess compliance, while looking for ways that reduce
complexity, confusion, redundancy, and other wastes that
increase your cost of quality.
Track record of first-time achievement of ISO certification
+ ISO 9001, ISO 13485 (medical device), ISO 22716 (cosmetics)
+ GMP standards- FDA, EU & Canadian
+ Internal audits +Supplier audits +Gap analysis
+ Process effectiveness audits + Risk management audits
+ Auditor training + Audit templates
CONSULTING
TRAINING
PRACTICAL HANDS-ON TRAINING WITH FOLLOW UP
+ Risk Management
+ Process validation + Effective corrective action
+ Statistical Process Control + Problem solving/root causes
+ Procedure writing + Quality data management systems
+ Managing audits/responses + Cost of Quality
+ Technical documentation + Sanitation and microbial control
ADVISEMENT
ASSISTANCE
EXPERT ASSISTANCE
+ Notification of industry trends and updates to standards
+ Adverse event reports and pre-market submissions (510K)
+ Procedure writing, flowcharting, process mapping
+ Specifying and implementing quality data systems
Call or email for more information or references.