8 Measurement, analysis and improvement

8.1 General

The organization shall plan and implement the monitoring, measurement, analysis and improvement

processes needed to:

a) demonstrate conformity of product;

b) ensure conformity of the quality management system;

c) maintain the effectiveness of the quality management system.

This shall include determination of appropriate methods, including statistical techniques, and the extent of their use.

8.2 Monitoring and measurement

8.2.1 Feedback

As one of the measurements of the effectiveness of the quality management system, the organization shall gather and monitor information relating to whether the organization has met customer requirements. The methods for obtaining and using this information shall be  documented.

The organization shall document procedures for the feedback process. This feedback process shall include provisions to gather data from production as well as post-production activities.

The information gathered in the feedback process shall serve as potential input into risk management for monitoring and maintaining the product requirements as well as the product realization or improvement processes.

If applicable regulatory requirements require the organization to gain specific experience from post-

production activities, the review of this experience shall form part of the feedback process.

8.2.2 Complaint handling

The organization shall document procedures for timely complaint handling in accordance with applicable regulatory requirements.

These procedures shall include at a minimum requirements and responsibilities for:

a) receiving and recording information;

b) evaluating information to determine if the feedback constitutes a complaint;

c) investigating complaints;

d) determining the need to report the information to the appropriate regulatory  authorities;

e) handling of complaint-related product;

f) determining the need to initiate corrections or corrective  actions.

If any complaint is not investigated, justification shall be documented. Any correction or corrective

action resulting from the complaint handling process shall be  documented.

If an investigation determines activities outside the organization contributed to the complaint, relevant

information shall be exchanged between the organization and the external party  involved.

Complaint handling records shall be maintained (see  4.2.5).