ISO 9001:2015
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As defined by ISO, ISO 9001:2015 specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. All the requirements of ISO 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.
The major workflows (topics) covered by this Playbook includes:
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Who Should Consider the Playbook?
Any organization which aims to comply with and become certified against the ISO 9001 standard.What's Included?
- 51 implementation toolkits across 7 workflows
- Multiple implementation tools, templates, and examples
- Links to relevant external content and resources
- Binary (yes/no) assessments against toolkit standards
Overview of Playbook Contents
Sections 1 - 3
- Scope
- Fundamental Concepts & Quality Management Principles
- Terms & Definitions
Sections 4.1 - 5.3
- Understanding the Organisation & It's Context
- Understanding Interested Parties
- QMS Scope
- Quality Management System & Process
- Leadership & Commitment - General
- Customer Focus
- Developing & Communicating Quality Policy
- Organisational Roles, Responsibilities & Authorities
Sections 6.1 - 7.1
- Address Risks & Opportunities
- Quality Objectives & Planning
- Planning of Chnages
- Resources - General
- Resources - People
- Resources - Infrastructure
- Resources - Environment for the Operation of Processes
- Resources - Monitoring & Measuring
- Resources - Organisational Knowledge
Sections 7.2 - 8.2
- Competence
- Awareness
- Communication
- Documentation
- Operational Plan & Control
- Requirements for Products & Services
Sections 8.3 - 8.4
- Design & Development - General & Planning
- Design & Development - Inputs
- Design & Development - Controls
- Design & Development - Outputs
- Design & Development - Changes
- External Provider Control - General
- External Provider Control - Type & Extent of Control
- External Provider Control - Information for Providers
Sections 8.5 - 8.7
- Production & Service Provision - Control
- Production & Service Provision - Identification & Traceability
- Production & Service Provision - Property of Customer or External Providers
- Production & Service Provision - Preservation
- Production & Service Provision - Post-delivery Activities
- Production & Service Provision - Control of Change
- Release of Products & Services
- Control of Nonconforming Outputs
Sections 9.1 - 10.3
- Monitoring, Measurements, Analysis & Evaluations
- Internal Audits
- Management Review
- General
- Nonconformity & Corrective Action
- Continual Improvement