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Quality and ISO 9000 Compliance Best Practices & Articles
This section contains Best practices for processes in Quality and ISO 9000 industry. Browse this section to find ISO 9000 regulation related articles, best practices published by many world renowned experts. View compliance trainings and standards for enhanced knowledge of Quality and ISO 9000 industry.
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Compliance Best Practices for Quality Management
What is Six Sigma?
Quality in an Outsourced Economy
Internal Audit - the ISO 9001 Standard Requirements for Internal Audits and the Audits Program
ISO 14644-1 - In-Depth Look at the Requirements Related to Pharmaceutical Industry – Part 2
White Paper: APR-PQR Process Automation: Six Steps for Successful Execution
General Articles
IEC 62304 – Medical Device Software Life Cycle Process Standard – Overview and Summary of Requirements for Software Development
Medical Device Quality System Regulations – A Brief Overview of FDA Requirements
ISO 14644-1 - An In-Depth Look at the Requirements Related to the Pharmaceutical Industry
ISO/IEC 17025 – Applicability, Use and Summary of Requirements
Regulations & Guidances
21CFR Part 820 - Quality System Regulation-Part02
21 CFR Part 820 - Quality System Regulation-Part-1
Title 21: Food and Drugs Part 120 — Hazard Analysis and Critical Control Point (HACCP) Systems
Compliance Standards for Quality Management
ISO/TS 16949 Gap Checklist
Price: $59
ISO/TS 16949 Quality Manual
Price: $97
Intro to ISO/TS 16949 Presentation Materials
Price: $85
ISO/TS 16949 Quality Manual & Procedures Package
Price: $397
Compliance Trainings
How to Internal Audit to ISO 9001:2008
On Demand Access Anytime
Value Stream Mapping - the What, the Why and the How - Service Provider Industry and Office Applications
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Design Control for Compliance and Fast Cycle Development
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Outsourced processes and ISO 9001:2008 - understanding the guidance changes and approach to take for supplier evaluation and assessment
On Demand Access Anytime
Supplier Evaluation and Assessment
On Demand Access Anytime
Effective Process Audit Discussion - A practical approach
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Contributing Authors/ Experts
Diane G Kulisek, Founder, CAPAtrak LLC
Rick Saldivar, Co-Founder and Chief Technology Officer, ISOmatrix Inc.
Holly Duckworth, Principal, Savvy Consulting