ISO 9001 Quality Manual | ABR211MPM

ISO 9001:2015 Quality Manual

The ISO 9001:2015 Quality Manual  establishes and states the policies governing the company’s Quality Management System, or QMS.  These policies define management’s arrangements for managing operations and activities in accordance with ISO 9001.  These top-level policies represent the plans or protocols for achieving quality improvement and customer satisfaction.  

Note: the basic requirements of ISO 9001:2015 no longer require a Quality Manual. 

This sample quality manual covers the requirements of ISO 9001:2015 . It is intended only to provide an example of wording that might be used in a quality manual. This sample wording can be helpful in generating ideas for developing a manual for your own company.  However, quality policies should be drafted as appropriate and as necessary to accurately reflect your company’s unique situation and requirements, ensuring a quality management system appropriate for your organization. While, for clarity, this manual mirrors the section (clause, subclause, etc.) numbering in the ISO 9001:2015 Standard, it is not necessary for your quality manual to do the same.  A numbering scheme that is most useful to you should be used.

Use these sample Quality Manuals to generate discussion and ideas, so that your Quality Manual, including the referenced quality procedures, reflects your Company’s unique values and circumstances. It is not necessary for you to follow, item for item, the layout of this ISO 9001:2015 Quality Manual.  Rather, use this Quality Manual as a guide – shape it to suit your particular requirements, as well as those of your customers (of course).

Lean Quality Manual

You have two choices in this selection. The first is a lean quality manual. It covers the scope (4.3), justification for exclusions, the QMS procedures, and QMS processes. You can alternatively add the Quality Policy, Quality Objectives, and a description of the interested parties to explain a little about the context of your organization.  (8 pages, 602 words)

Long Quality Manual

The second choice it to use a longer quality manual that establishes and states the policies governing The Company’s Quality Management System.  These policies define management’s arrangements for managing operations and activities in accordance with ISO 9001:2015.  These top-level policies represent the plans or protocols for achieving quality assurance and customer satisfaction.  (28 pages, 6521 words)

1.0 Purpose

2.0 Scope

3.0 Relation To ISO 9001:2015

4.0 Our Company Quality Management System
4.1 Understanding The Organization And Its Context
4.2 Understanding Needs / Expectations Of Interested Parties
4.3 The Scope Of The Quality Management System
4.4 Quality Management System And Its Processes

5 Leadership
5.1 Leadership And Commitment
5.1.1 General
5.1.2 Customer Focus
5.2 Policy
5.2.1 Establishing The Quality Policy
5.2.2 Communicating The Quality Policy
5.3 Organizational Roles, Responsibilities And Authorities

6 Planning
6.1 Actions To Address Risks And Opportunities
6.2 Quality Objectives And Planning To Achieve Them
6.2.1 Quality Objectives At Relevant Functions
6.2.2 Planning To Achieve Quality Objectives
6.3 Planning Of Change

Fast ISO 9001:2015 Quality Procedures Templates in Microsoft Word.

7 Support
7.1 Resources
7.1.1 General
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment For The Operation Of Process
7.1.5 Monitoring And Measuring Resources
7.1.5.1 General
7.1.5.1 Measurement Traceability
7.1.6 Organizational Knowledge
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented Information
7.5.1 General
7.5.2 Creating And Updating
7.5.3 Control Of Information

8 Operation
8.1 Operational Planning And Control
8.2 Requirements For Products And Services
8.2.1 Customer Communication
8.2.2 Determining The Requirements For Products And Services
8.2.3 Review Of Requirements Related To Products And Services
8.2.4 Changes To Requirements For Products And Services
8.3 Design And Development Of Products And Services
8.3.1 General
8.3.2 Design And Development Planning
8.3.3 Design And Development Inputs
8.3.4 Design And Development Controls
8.3.5 Design And Development Outputs
8.3.6 Design And Development Changes
8.4 Control Of Externally Provided Products And Services
8.4.1 General
8.4.2 Type And Extent Of Control
8.4.3 Information For External Providers
8.5 Production And Service Provision
8.5.1 Control Of Production And Service Provision
8.5.2 Identification And Traceability
8.5.3 Property Belonging To Customers Or External Providers
8.5.4 Preservation
8.5.5 Post-Delivery Activities
8.5.6 Control Of Changes
8.6 Release Of Products And Services
8.7 Control Of Nonconforming Outputs

9 Performance Evaluation
9.1 Monitoring, Measurement, Analysis And Evaluation
9.1.1 General
9.1.2 Customer Satisfaction
9.1.3 Analysis And Evaluation
9.2 Internal Audit
9.3 Management Review
9.3.1 General
9.3.2 Management Review Inputs
9.3.3 Management Review Outputs

10 Improvement
10.1 General
10.2 Nonconformity And Corrective Action
10.3 Continual Improvement

Free ISO 9001:2015 Procedure Samples

Download your free ISO 90012015 Procedures  in Microsoft Word format. Save yourself some time in creating a Quality Management System and use these procedures as a guide.