Quality Management (QMS) 12 items
Context of the Organization & Risk-Based Thinking
Verifies the organization has determined its context, interested parties, and QMS scope, and addressed risks and opportunities.
ISO 9001:2015
Free PDF · enter your email to download.
Understanding the Organization (Cl. 4.1)
- Have external issues (legal, technological, competitive, market, cultural, economic) been determined? *
- Have internal issues (values, culture, knowledge, performance) been determined? *
- Is information about these issues monitored and reviewed? *
Interested Parties (Cl. 4.2)
- Have relevant interested parties for the QMS been identified? *
- Have the relevant requirements of those interested parties been determined? *
- Are these requirements monitored and reviewed? *
Scope & Processes (Cl. 4.3–4.4)
- Is the QMS scope determined considering context, interested parties, and products/services? *
- Are QMS processes and their interactions determined, with inputs, outputs, and criteria? *
- Are process owners, resources, and performance indicators assigned? *
Risks & Opportunities (Cl. 6.1)
- Have risks and opportunities that could affect QMS conformity and customer satisfaction been determined? *
- Are actions planned to address these risks and opportunities? *
- Are these actions integrated into QMS processes and their effectiveness evaluated? *
Download the full Context of the Organization & Risk-Based Thinking checklist
Get it as a clean, printable PDF — free.