Organizational chart exists which reflects the current reporting structure.
Evidence exists which indicate organizational freedom to exercise authority and responsibility.
Job descriptions include responsibilities for supporting quality objectives.
There is a management representative with defined authority and responsibility for meeting customer compliance.
Qualified technical personnel available for design, process, product, and service support.
Quality manual has been developed which details the quality system of policies and procedures.
Procedures identify:
l Who is responsible for action
l What has to be done
l When the actions are required
Responsibility for updating and revising the quality manual and system is defined.
Quality manual is supported by top management.
Written procedures and instruction define the methods for performing work affecting quality for those:
l Managing the work
l Performing the work
l Verifying the work