Description
The structure of ISO 9001:2000 provides a focus on the processes that comprise the quality management system (QMS). Also, the general requirements in Clause 4.1 state that the organization must identify all processes of the QMS, their sequence and interaction, and must ensure their effectiveness and the availability of needed resources, and monitor, measure, analyze and improve them. The characteristics defined in Clause 4.1 are a foundation for auditing a process-based system. Additional information used by auditor includes identifying the process owners, inputs and outputs, suppliers and customers, controls and resources of each process. Using this information, the audit team will be able to judge if the processes are functioning effectively.
In preparing for the audit the auditor will create a description of each process based on the ISO 9001 standard and the Plan, Do, Check, Act (PDCA) process structure. There are eight basic processes that an organization must have to function effectively. These are (1) Management of the quality system, (2) Top management involvement, (3) Customer focus, (4) The improvement process, (5) Design and development, (6) Supplier management, (7) Product provision (including control of outsourced processes) and (8) Resource management.
There are a number of other processes that organizations may use. These include (1) corrective action, (2) preventive action, (3) calibration, (4) continual management dynamics, (5) customer focus, (6) design and development, (7) document control, (8) ESD Control, (9) final inspection, (10) internal audits, (11) control of nonconforming product, (12) production planning, (13) receiving, (14) records management, (15) repair turnaround, (16) shipping, (17) supplier management, (18) training and (19) orders & quotes.
