The ISO 9000 guidelines were accepted as international standards in 1987, and amended in 1996, 2000, and 2008. The standards are being completely rewritten in 2015, and the committee draft is circulated the world over. This book is based on the document ISO/TC/176/SC2/N-1147 released on June 3, 2013 to help the industry align itself to the new standards by the time the rewrite is released. Written in advance so that companies can implement new systems proactively, this text aids in complying with the anticipated ISO 9001:2015 guidelines.
Preface
Foreword
Why the 2015 Version Is Being Discussed Now?
Quality Management Principle
QMP 1 – Customer Focus
QMP 2 – Leadership
QMP 3 – Engagement of People
QMP 4 – Process Approach
QMP 5 – Improvement
QMP 6 – Evidence-Based Decision-Making
QMP 7 – Relationship Management
Clause No. 1 – Scope
Scope
Application
Clause No. 2 – Normative Reference
Clause No. 2, viz. Normative Reference Reads as Follows
Clause No. 3 – Terms and Definitions
Clause No. 4 – Context of the Organization
Context of the Organization
Understanding the Organization and Its Context
Understanding the Needs and Expectations of Interested Parties
Determining the Scope of the Quality Management System
Quality Management System
Clause No. 5 – Leadership
Leadership and Commitment
Quality Policy
Organizational Roles, Responsibilities, and Authorities
Clause No. 6 – Planning
Actions to Address Risks and Opportunities
Quality Objectives and Planning to Achieve Them
Planning of Changes
Clause No. 7 – Support
Support
Resources
Competence
Awareness
Communication
Documented Information
Clause No. 8 – Operation
Operation
Operational Planning and Control
Determination of Market Needs and Interactions with Customers
Operational Planning Process
Control of External Provision of Goods and Services
Development of Goods and Services
Production of Goods and Provision of Services
Release of Goods and Services
Nonconforming Goods and Services
Clause No. 9 – Performance Evaluation
Performance Evaluation
Monitoring, Measurement, Analysis, and Evaluation
Internal Audit
Management Review
Clause No. 10 – Continual Improvement
Continual Improvement
Nonconformity and Corrective Action
Improvement
Difference Between 2008 and 2015 Versions
Appendices
A Typical Format for Work Procedure
A Typical Format for Job Description
A Typical Work Instruction
Typical Formats for Writing Internal Quality Audit Reports
A Typical Document Change Note
A Typical Format for Documenting Minutes of Meeting
References
Index
