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Aligned with ISO 9001:2015, this document provides you with a framework for a Quality Management System in your business. This document is best suited as part of the whole Quality Management System but if you already have elements of a Quality Management System then this manual would complement that.
This manual is ideal for businesses that are looking to comply with ISO 9001:2015 with a starting point to tailor to your business.
1. Document Control
2. Introduction
2.1 General Requirements
2.2 Scope
2.3 Company Profile
2.4 Organisation Chart
2.5 Management System Process
2.6 Sequence and interaction of processes
3. Policies
4. Organisational Context
5. Leadership
5.1 Leadership & Commitment
5.2 Roles, Responsibilities & Authorities
6. Planning
6.1 Risks & Opportunities
6.2 Objectives & Targets
6.3 QMS Planning
7. Support
7.1 Resources
7.1.1 Human Resources
7.1.2 Infrastructure
7.1.3 Operational Environment
7.1.4 Organisational Knowledge
7.2 Training & Competency
7.3 Awareness
7.4 Communication
7.5 Documented Information
7.5.1 Creating & Updating
7.5.2 Document Control
8. Operation
8.1 Customer Communication
8.2 Determination of Requirements (Products & Services)
8.2.1 Review of Requirements (Products & Services)
8.3 Design & Development of Products & Services
8.4 Control of Externally Provided Products & Services
8.5 Production & Service Provision
8.5.1 Identification & Traceability
8.5.2 Property Belonging to Customers / External Providers
8.5.3 Preservation
8.5.4 Post-Delivery Activities
8.5.5 Control of Changes
8.5.6 Release of Products & Services
8.5.7 Control of Non-Conforming Process Outputs
9. Performance Evaluation
9.1 Monitoring, Measurement Analysis & Evaluation
9.1.1 Devices & Equipment
9.1.2 Customer Satisfaction
9.1.3 Analysis & Evaluation
9.2 Internal Audit
9.3 Management Review
10. Improvement
10.1 Non-Conformance & Corrective Action
10.2 Continual Improvement
