ISO Documentation Training

Documentation Training for ISO 9001, ISO 14001, ISO 13485, AS9100, AS9110, and ISO/TS 16949
Description: Learn the types of documents in an ISO system and how to write documentation for an ISO process-based system.

This course is based on the ISO 9001 requirements for the control of documents and records that also apply to other ISO standards.

Length of course: 1 day or 2 days (7 hours or 14 hours)

Who should attend: ISO Project Manager, Implementation Team Members, Management Representative, Quality Assurance Manager, Document Control manager

Fee Schedule for On-Site Training

One Day Training:
1 to 10 people: $3,200.00
11 to 20 people: add $150.00 for each additional person

Two Day Training: $1,100.00
QRC Trainer and your ISO Project Manager work with individual Departments to identify the Documentation Work Plan for the Department.

Date(s): To be arranged

Agenda:
1. Types of Documentation

  • Quality Manual and its structure
  • Operating Procedures and format for this type of document
  • Work Instructions
  • Flow charts (standard flowcharts and deployment flowcharts)
  • Records
  • Other Documents — Detailed Instructions and Specifications (Training documents, task instructions, job descriptions, technical specifications, standards, safety codes, regulatory documents, etc.)
  • Master List of Documents
  • Records Matrix

2. Documenting the System

  • ISO 9001 requirements for control of documents
  • Identification of documents and records
  • ISO 9001 requirements for control of records
  • Evaluating your current documentation
  • Determining what needs to be documented
  • Types of records that must be maintained (for the Standard you are using)

3. Writing a Procedure that includes requirements for a Process Description
What is included in an effective process documentation

  • Document identification
  • Purpose
  • Objective
  • Responsibilities
  • Inputs and Outputs
  • Establishing measurable goals
  • Procedure steps
  • Identifying interactions with other processes
  • Preventive, Detective and Corrective Controls
  • Records
  • Change History
  • The Impact of Change

4. Class Activities
Write an Operating Procedure that applies to your Department
Draw a Flowchart of a process
Write a Work Instruction

Day 2: Work with Departments
The QRC Trainer and your ISO Project Manager work with each Department

Work Sessions include:
Identify documentation and records needed by the Department
Create documentation Work Plan for each Department