ISO-90012015-Documentation-Checklist.pdf

ISO-90012015-Documentation-Checklist.pdf

1. ISO 9001:2015
Documentation Checklist
This checklist outlines essential documents for ISO 9001:2015 compliance. It
covers seven key areas, ensuring a comprehensive quality management system.
Use this guide to streamline your documentation process.

2. Context of the Organization
1
Context Document
Outline internal and external factors affecting QMS. Include market trends,
regulatory environment, and organizational culture.
2
Interested Parties Register
List stakeholders and their needs. Consider customers, suppliers,
employees, and regulatory bodies.
3
QMS Scope Statement
Define QMS boundaries. Specify products, services, and relevant sites or
departments.

3. Leadership and Planning
Leadership
Develop a clear Quality Policy. Create a roles and
responsibilities matrix. Ensure top management commitment.
Planning
Maintain a Risk and Opportunities Register. Document
measurable quality objectives. Establish a change control
procedure.

4. Support
1
Competence
Maintain training and competence records. Ensure employees
have necessary skills and qualifications.
2
Communication
Develop a communication plan. Address internal and external
QMS-related communication strategies.
3
Documented Information
Implement a document control procedure. Manage creation,
maintenance, and control of QMS documents.

5. Operation
Operational Control
Develop procedures for planning, controlling, and monitoring operations.
Ensure consistency in product/service delivery.
Customer Requirements
Document customer specifications. Maintain contracts, purchase orders, and
relevant communication records.
External Providers
Create supplier evaluation forms. Regularly assess and monitor supplier
performance against set criteria.

6. Performance Evaluation
1
Monitoring Plan
Develop a comprehensive monitoring
and measurement plan. Specify KPIs
for each process.
2
Internal Audits
Create an internal audit plan. Maintain
audit schedules, checklists, and
detailed reports.
3
Management Review
Document management review
meetings. Record minutes and
resulting action plans for QMS
improvement.

7. Improvement
Corrective Action
Implement Corrective Action Reports (CARs). Document root cause analysis and
effectiveness of actions taken.
Continuous Improvement
Maintain a Continuous Improvement Log. Track initiatives, progress, and
outcomes of improvement projects.
Nonconformance Management
Use Nonconformance Reports (NCRs). Record identified issues and their
resolutions promptly.

8. Optional but Recommended
Documents
Process Flow Diagrams Visual representations of key
processes and their steps
Training Matrix Correlation of employee training to
roles and required competencies
Supplier Performance Records Ongoing evaluations based on
quality, delivery, and other metrics
Customer Feedback Forms Tools to capture and analyze
customer satisfaction data