This checklist is designed to help your organization identify gaps between your current processes and the requirements of the ISO 9001:2015 standard.
Clause 4: Context of the Organization
| Requirement | Yes | No | Notes / Actions |
|---|
| Has the organization determined internal and external issues relevant to its purpose? | | | |
| Have interested parties and their requirements been identified? | | | |
| Is the scope of the QMS documented and available? | | | |
Clause 5: Leadership
| Requirement | Yes | No | Notes / Actions |
|---|
| Has top management demonstrated leadership and commitment to the QMS? | | | |
| Is the Quality Policy established, communicated, and applied? | | | |
| Are roles, responsibilities, and authorities assigned and understood? | | | |
Clause 6: Planning
| Requirement | Yes | No | Notes / Actions |
|---|
| Have risks and opportunities been addressed? | | | |
| Are Quality Objectives measurable and consistent with the policy? | | | |
| Is there a plan for achieving these objectives? | | | |
Clause 8: Operation
| Requirement | Yes | No | Notes / Actions |
|---|
| Are operational processes planned and controlled? | | | |
| Are requirements for products and services determined and reviewed? | | | |
| Is there a process for controlling externally provided processes/products? | | | |
