ISO 9001 Lead Auditor Training

MODULE 2  - ISO 9001 QMS Documentation

2.2   ISO 9001 Quality System Documentation
Two of the most important objectives in the revision of the ISO 9000 2000 series of standards have been to develop a simplified format that address:
• Small, as well as, medium and large organizations
• The need for the amount and detail of documentation required must be more relevant to the desired results of the organization’s process activities.

Organizations (and in particular small organizations) may be able to demonstrate conformity without the need for extensive documentation

This ISO 9000 lead auditor training course emphasizes an analysis of the processes as the driving force for defining the amount of documentation needed for the quality management system, taking into account the requirements of ISO 9001:2000. It should not be the documentation that drives the processes. For a more detailed understanding of ISO QMS documentation visit "Understanding ISO 9001"

ISO 9000 Training - Management should define the documentation needed to implement, maintain, and improve the quality management system. This documentation may include:

• Policy documents (including the quality manual)
• Documentation for the control of processes
• Work instructions for specific job tasks
• Standard formats for data collection and reporting

See Figure 2.2

Level 1: ISO 9001 Quality Manual 
The quality manual, sometimes referred to as the policy manual, typically includes:

• Organization quality policy and objectives
• Policies related to the ISO 9001 requirements
• Any exclusions of ISO 9001 requirements and related justification
• Overview of the organization and its functions
• Overview of its products, services, and sites
• Sequence and interaction of the processes
• Management responsibility for policies and processes
• Marketing or promotional information
• Inclusion or references to the next documentation level (procedures)

The quality manual is useful to:
• Customers  - provides assurance
• External auditors - facilitates the audit
• Employees - useful as a training aid

ISO 9001 Auditor Training - The quality manual must be approved by management and placed under document control.
It may be structured:

• In the order of the ISO 9001 clauses
• In the way the company does business
(With references to where the ISO 9001 requirements are addressed)

Level 2: ISO 9001 Quality System Procedures
• Describes the who, what, when, and where of the quality system processes
• Describes the inter-departmental controls that address the ISO 9001 requirements
• May be in ISO 9001 order or any order practical to the company
• Should describe the process flow, linkages, combination and interaction among departments
• Should reference the lower level documentation (operational documentation)
• Should involve participation of department personnel in writing them
• Must be available, known, and used by pertinent personnel
• Must be kept up to date and changes controlled

Level 3: Operational documentation
• Explains details of specific tasks or activities – the how of performing a specific task, making or verifying process and product activities
• Includes documents such as quality plans, forms, drawings, flowcharts, workmanship standards, work instructions, product or service specifications, machine manuals, visual displays, computer templates, photographs, and illustrations
• Need for documentation may be based on the complexity of products or processes, skills, training, education, stability of the work force, past problems, customer and regulatory requirements, industry standards, and requirements
• Must be available, known, and used by pertinent personnel
• Must be kept up to date and changes controlled

Level 4: Records
• Provide objective evidence that quality activities were carried out and results achieved in accordance with levels 1, 2, and 3 documentation
• May be mandatory or implied for each ISO 9001 clause
• May have records beyond ISO 9001 requirements
• Examples are records of inspection, calibration, management review, training, audit reports, design review, purchasing, and nonconforming product reports

"Understanding ISO 9001" provides a detailed explanation of each ISO 9001 clause (requirements).

ISO 9001 FAQ provides answers to commonly asked questions about the ISO 9000 family of quality management standards.