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Quality Systems Compliance, LLC Now Certified for ISO 9001:2015 and ISO 13485:2016

Posted on November 10, 2024February 17, 2025 by QS Compliance
ISO 9001-2015 and ISO 13485-2016 Certification

We’re pleased to announce Quality Systems Compliance, LLC has recently been awarded certifications for maintaining a Quality Management System under ISO 9001:2015 and ISO 13485:2016.

QM15_10018706 QM15_EN 9001
MP2016_10018706 MP2016_EN 13485
This entry was posted in Articles and tagged Certifications, ISO 13485:2016, ISO 9001:2015.
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Mark Durivage Books

Buy Online ►

The Certified Supplier Quality Professional Handbook

The Certified Supplier Quality Professional Handbook

The Certified Reliability Engineer Handbook

The Certified Reliability Engineer Handbook

The Certified Pharmaceutical GMP Professional

The Certified Pharmaceutical GMP Professional

The ASQ CSQP Study Guide

The ASQ CSQP Study Guide

The ASQ CSSBB Study Guide

The ASQ CSSBB Study Guide

Practical Process Validation

Practical Process Validation

Practical Engineering Process, and Reliability Statistics

Practical Engineering Process, and Reliability Statistics

Practical Design of Experiments

Practical Design of Experiments

Practical Attribute and Variable Measurement Systems Analysis MSA

Practical Attribute and Variable Measurement Systems Analysis MSA

Training

Quality Systems Compliance provides
CUSTOMIZED COURSES to meet your training requirements, available in the following topics:

  • Medical Device Single Audit Program (MDSAP)
  • Statistical Process Control
  • Design of Experiments (DOE)
  • Introduction to Quality Systems
  • Sampling Plans (Variable and Attribute)
  • Introduction to Metrology
  • Introduction to Process Validation
  • Documentation & Audit Preparation
  • Mechanical Blueprint Reading
  • Welding Blueprint Reading
  • FDA Inspection Readiness
  • Good Documentation Practices (GDP)
  • Good Manufacturing Practices (GMP)
  • ASQ Certification Preparation
  • Corrective and Preventive Actions (CAPA)
  • Quality System Requirements (QSR Overview)
  • Introduction to Measurement System Analysis (MSA)
  • Animal Tissue
Specializations

Quality Systems Compliance specializes in the following areas:

  • Internal Audits
  • Supplier Audits
  • Gap Assessments
  • FDA 483 and Warning Letter responses
  • FDA 483 and Warning Letter remediation
  • Risk-based auditing systems (internal & supplier)
  • External regulatory and certification audit support
  • Document and Procedure Writing & Review
  • Process Optimization
  • Management Review
  • Regulatory Affairs support
  • Mock FDA Inspections
  • Design of Experiments (DOE)
  • Measurement System Analysis (MSA)
  • Test Method Validations (TMV)
  • Corrective and Preventive Actions (CAPA)
  • Process Validations
  • Process Monitoring
  • Quality Metrics
  • Procedures and Work Instructions
  • Sampling Plans (Variable and Attribute)
  • Training
  • Medical Device Single Audit Program (MDSAP) Audits
  • Animal Tissue
Awards & Memberships

Recognized as a Top Ten Medical Device Consulting Company in 2019 by MedTech Outlook.
Read Full Article ►

Top 10 Medical Device Consulting Companies 2019
Member, Society of Reliability Engineers (SRE)
Member, Regulatory Affairs Professionals Society (RAPS)
Member, Association for the Advancement of Medical Instrumentation (AAMI)
Contact Us
3118 Chanson Valley Rd
Lambertville, MI 48144
mark.durivage@qscompliance.com

(419) 265-2862

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