Summary of clause 4 Context

Requirements ISO 9001

Determine external and internal issues

Monitor and review information about issues

Identify stakeholders

Clarify the requirements of the stakeholders

Monitor and review information about stakeholders and their requirements

Define the scope of the QMS

Take into account the external and internal issues

Take into account the requirements of the stakeholders

Take into account the products and services

Apply any requirement of the ISO 9001 standard applicable within the scope of the QMS

Address also customer and applicable statutory and regulatory requirements

Establish and maintain documented information that includes a general description of relevant stakeholders

Establish and maintain documented information that includes the scope of the QMS

Establish and maintain documented information that includes a description of the processes needed for the QMS

Establish and maintain documented information that includes the sequence and interaction of these processes

Establish and maintain documented information that includes responsibilities and authorities for these processes

Scope of the AQMS

Description of the AQMS

process performance