Structure of the ISO 9001:2000 Standard

The ISO 9001:2000 Standard is compiled of eight Clauses. The first three are introductory in nature. The subsequent five clauses include the requirements the organization must address. They are as follows:

Clause 4 – Quality Management System

Process Management, Documentation Requirements, Records Control

Clause 5 – Management Responsibility

Customer/Patient Focus, Policy, Objectives, Planning, Responsibility & Authority

Clause 6 – Resource Management

Human Resources, Infrastructure, Work Environment

Clause 7 – Product / Service Realization

Planning of New Products & Services, Customer Interface/ Communication, Design, Purchasing/Supplier Management, Production/ Service Operations, Calibration

Clause 8 – Measurement, Analysis, and Improvement

Internal Audits, Customer/Patient Satisfaction, Monitoring/Measurement of Products/Services and Processes, Handling Nonconformance, Corrective & Preventive Action, Continual Improvement