Quality Works Academy  ISO 9001 Documentation Structures ISO 13485 Certification Tactics ISO 14001 Implementation Approaches FDA 21 CFR 820 Processes Canadian MDR Requirements

Want to learn about ISO 9001, ISO 13485 and ISO 14001 Standards? Check the list below:

International Organization for standardization

• What is ISO?

ISO 9001 Standard

• ISO 9001 2008 Changes Explained

• ISO 9001 2008 quality manual

• ISO 9001 2008 quality manual review checklist

• ISO 9001 2008 quality policy

• What is a quality manual?

• What is ISO 9001?

• Why do we need ISO 9001? 

ISO 13485 Standard

• What is ISO 13485?

• ISO 13485 / ISO 9001 / cGMP Integrated Quality Manual

FDA 21 CFR 820

• ISO 13485 / ISO 9001 / cGMP Integrated Quality Manual

ISO 14001 Standard

• What is ISO 14001?

Procedures and tools for all management systems

• Document Distribution Matrix

• Document Template Procedure

• Documentation Management Procedure

• Documentation Master List

• Forms: to control or not to control?

• Naming your documents

• Numbering your documents

• Organizational Chart

• Process Interaction Matrix

• Quality Management - Corporate Manual

• Quality Objectives

• Records Procedure

Certification business

• ISO Certification - Hidden Revenue Streams for ISO Registrars

Revised services (for reference)

• Revised services ToC

Call us today to discuss your ISO 9001, ISO 13485 or ISO 14001 management system needs.