Skip to content
  • Add anything here or just remove it...
Quality Systems ComplianceQuality Systems Compliance
  • Home
  • About Us
  • Services
  • Resources
  • Blog
  • Contact Us
Resources

Integrating Risk Management In The Quality Management System

Posted on February 28, 2018March 7, 2018 by QS Compliance

Integrating Risk Management In The Quality Management System — A Primer

This entry was posted in Resources and tagged Quality Management System, Risk Management.
Using Risk-Based Thinking To Manage Suppliers
How To Establish Sample Sizes For Process Validation Using LTPD Sampling…
Recent Posts
  • Quality Systems Compliance, LLC Now Certified for ISO 9001:2015 and ISO 13485:2016
  • 21 CFR 11 Electronic Records Electronic Signatures with TOC
  • 21 CFR 210 cGMPs General with TOC
  • 21 CFR 211 cGMPs for Drugs with TOC
  • 21 CFR 801 Labeling with TOC

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)
Member, American Association of Tissue Banks (AATB)
Contact Us
3118 Chanson Valley Rd
Lambertville, MI 48144
mark.durivage@qscompliance.com

(419) 265-2862

Site by AKSYS | Managed by 10:31 Marketing
Privacy Policy | Sitelist [admin]
  • Home
  • About Us
  • Services
  • Resources
  • Blog
  • Contact Us
Home » Integrating Risk Management In The Quality Management System

Copyright 2024 © Quality Systems Compliance, LLC
  • Home
  • About Us
  • Services
  • Resources
  • Blog
  • Contact Us
    • WooCommerce not Found
  • Newsletter