ISO Checklist
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Table of Contents
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- Requirements
- The organization established, documented, implemented, and maintained a quality management system in accordance with the ISO requirements.
- The organization determined the processes needed for the quality management system and their application throughout the organization.
- The organization determined the sequence and interaction of these processes.
- The organization determined criteria and methods needed to ensure that both the operation and control of these processes are effective.
- The organization ensured the availability of resources and information necessary to support the operation and monitoring of these processes.
- The organization monitored, measured where applicable, and analyzed these processes.
- The organization implemented the actions necessary to achieve the planned results and continual improvement of these processes.
- These processes are managed in accordance with the ISO requirements.
- The organization ensured control over any outsourced processes that affect product conformity with requirements.
- The type and extent of control of these outsourced processes been defined within the quality management system.
- Documentation Requirements
- System documentation includes documented statements of quality policy and quality objectives.
- System documentation includes a quality manual.
- System documentation includes documented procedures and records required by ISO.
- System documentation includes documents to ensure the effective planning, operation, and control of its processes.
- Quality Manual Requirements
- Quality manual includes scope of the quality management system, including details of, and justification for, any exclusions.
- Quality manual includes documented procedures established for the quality management system, or reference to them.
- Quality manual that includes description of the interaction between processes of the quality management system.
- Control of Documents
- The documents required by the quality management system are controlled.
- Records (a special type of document) are controlled according to the requirements.
- A documented procedure has been established to control documents.
- The documented procedure defines the controls to approve documents for adequacy prior to issue.
- The documented procedure defines the controls to review, and update as necessary, and re-approve documents.
- The documented procedure defines the controls to ensure that changes and the current revision status of documents are identified.
- The documented procedure defines the controls to ensure that relevant versions of applicable documents are available at points of use.
- The documented procedure defines the controls to ensure that documents remain legible and readily identifiable.
- Documents of external origin necessary for the planning and operation of the quality management system are identified and their distribution controlled.
- The documented procedure defines the controls to prevent the unintended use of obsolete documents.
- Control of Records
- Records are established and controlled to provide evidence of conformity to requirements and of the effective operation of the quality management system.
- A documented procedure has been established for controlling records.
- The documented procedure defines the controls needed for the Identification of records.
- The documented procedure defines the controls needed for the Storage of records.
- The documented procedure defines the controls needed for the Protection of records.
- The documented procedure defines the controls needed for the Retrieval of records.
- The documented procedure defines the controls needed for the Retention time of records.
- The documented procedure defines the controls needed for the Disposition of records.
- Records are kept legible, readily identifiable, and retrievable.
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Presented by:
Campbell Rodriguez
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Who it's for
This ISO Checklist is for teams that want consistent execution, less rework, and clear ownership.
- Standardize quality - run the same ISO steps every time, regardless of who executes
- Save time - reuse a proven ISO workflow instead of rebuilding processes from scratch
- Improve accountability - assign owners and see what's done vs. what's pending
- Onboard faster - use the ISO checklist as the SOP and training guide
- Coordinate across roles - handoffs are clear and everyone works from the same source of truth
How to use it
How to use this ISO Checklist:
- Start by saving it - save as a Template if you'll reuse it, or as a Checklist if it's a one-off project.
- Customize it once for your workflow - remove what doesn't apply and add your team-specific steps.
- Assign ownership and execute - set owners/due dates where needed and track completion as work happens.
- Reuse without rebuilding - when ISO comes up again, start from your saved version and run it with clear ownership.
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