ISO 9001 QUALITY MANAGEMENT

The ISO 9001 requirements provide a set of standard elements that will guide you in the
implementation of a Quality Management System (QMS). The requirements are designed to be
applicable to any company in any industry – both production and service based, and as such the
requirements tell you what elements are mandatory in a QMS, but not how to implement these
necessary elements.

The ISO 9001 requirements are broadly separated into eight sections (called ISO 9001 clauses),
five of which contain mandatory requirements for a QMS: general Quality Management System
requirements (clause 4), Management Responsibility (clause 5), Resource Management (clause 6),
Product Realization (clause 7), and Measurement, Analysis and Improvement (clause 8). All
elements of these five clauses are mandatory with the exception of the Product Realization section,
which allows for a company to exclude portions that are not applicable. Clauses 1 through 3 include
no requirements, but instead deal with the scope of the standard, references to understand the
standard better, and terms and definitions.
Quality Management System
This section deals with general requirements for a QMS, as well as all documentation requirements.
It also includes the requirements for the necessary Quality Manual, Control of Documents, and
Control of Records.