Define a monitoring plan

You must define and plan the specific pre-established measures (types of controls, methods, means, specifications, etc.) implemented throughout the production process to demonstrate conformity of all product characteristics.

The monitoring plan is the backbone of quality assurance, in the sense that it constitutes the link between the characteristics deriving from the needs or expectations of the market (customers) and their satisfaction. It is a synthetic document whose role is to provide ongoing proof of conformity, and consequently to detect anomalies.

Specifically, it meets the following ISO 9001 requirements:

• § 8.3.5 "Design and development output" and § 8.5.1 "Production and service control" of Chapter 8 "Operational activities";

• § 9.1 "Monitoring, measurement, analysis and evaluation" in Chapter 9 "Performance assessment".

Sector-specific standards, such as IATF 16949 for the automotive industry and EN 9100 for the aerospace and defense industries, complement ISO 9001 requirements in this area.