The ISO 9001:2015 implementation handbook : using the process approach to build a quality management system / Milton P. Dentch.

Format:

Book

Author/Creator:

Dentch, Milton P., 1942- author.

Language:

English

Subjects (All):

ISO 9001 Standard--Handbooks, manuals, etc.

ISO 9001 Standard.

New products--Quality control--Standards--Handbooks, manuals, etc.

New products.

Industrial management--Standards--Handbooks, manuals, etc.

Industrial management.

Physical Description:

1 online resource (129 pages)

Edition:

1st ed.

Place of Publication:

Milwaukee, Wisconsin : ASQ Quality Press, 2017.

Summary:

Written by an implementer, auditor, and expert with decades of experience with ISO 9001, The ISO 9001:2015 Implementation Handbook is the practical guide organizations need.

Contents:

Intro

Preface

1

ISO 9000 History and Chronology

2

The QMS as a Process

Summary: ISO 9001:2015 Changes from ISO 9001:2008

3

ISO 9001:2015 Requirements

1 Scope

2 Normative References

3 Terms and Definitions

Clauses 4-10

4

Clause 4: Context of the Organization

4.1 Understanding the Organization and Its Context

4.2 Understanding the Needs and Expectations of Interested Parties

4.3 Determining the Scope of the Quality Management System

4.4 Quality Management System and Its Processes

5

Clause 5: Leadership

5.1 Leadership and Commitment

5.2 Policy

5.3 Organizational Roles, Responsibilities and Authorities

6

Clause 6: Planning

6.1 Actions to Address Risks and Opportunities

6.2 Quality Objectives and Planning to Achieve Them

6.3 Planning of Changes

7

Clause 7: Support

7.1 Resources

7.2 Competence

7.3 Awareness

7.4 Communication

7.5 Documented Information

8

Clause 8: Operation

8.1 Operational Planning and Control

8.2 Requirements for Products and Services

8.3 Design and Development of Products and Services

8.4 Control of Externally Provided Processes, Products and Services

8.5 Production and Service Provision

8.6 Release of Products and Services

8.7 Control of Nonconforming Outputs

Service Provisions and ISO 9001:2015

9

Clause 9: Performance Evaluation

9.1 Monitoring, Measurement, Analysis and Evaluation

9.2 Internal Audit

9.3 Management Review

10

Clause 10: Improvement

10.1 General

10.2 Nonconformity and Corrective Action

10.3 Continual Improvement

11

Interpretation Guidance: ISO 9001:2015 Standard

Clause 6.1, Actions to Address Risks and Opportunities

A1 Structure and Terminology

Appendix A

ISO 9001:2015 Gap Analysis

ISO 9001 Chronology

ISO 9001:2015 as a Process.

Transitional Periods of ISO 9001:2015

Context of the Organization and Expectations of Interested Parties

Integration of the QMS into the Business Processes

Actions to Address Risks and Opportunities

Top Management Commitment

Organizational Knowledge

Documentation

Programs to Achieve Quality Objectives

Preparing for Upgrade Audit to ISO 9001:2015

Appendix B

Failure Modes and Effects Analysis (FMEA)

FMEA Example

Appendix C

Stage-Gate® Idea-to-Launch Model

How Does a Stage-Gate® Process Work?

The Stages

The Gates

Flexible Implementation into an Organization

Appendix D

Quality in Healthcare: Five Whys and Five Hows

Appendix E

What Is Six Sigma?

Appendix F

What Is Lean?

Appendix G

Context of the Organization: Checklists for External and Internal Issues and Interested Parties

References

About the Author.

Notes:

Includes bibliographical references.

Description based on print version record.

ISBN:

9781951058913

1951058917