Cracking the case of ISO 9001:2015 for manufacturing : a simple guide to implementing quality management in manufacturing / Charles A. Cianfrani, and John E. (Jack) West.

Format:

Book

Author/Creator:

Cianfrani, Charles A., author.

West, John E., 1944- author.

Language:

English

Subjects (All):

Quality control--Standards.

Quality control.

ISO 9001 Standard.

Physical Description:

1 online resource (299 pages)

Edition:

Third edition.

Place of Publication:

Milwaukee, Wisconsin : ASQ Quality Press, [2017]

Summary:

This guide is intended to help everyone in an organization participate in creating and sustaining a foundation of integrity, meet requirements and customer expectations, and support robust processes, to the advantage of everyone in the organization and to each of its customers.It provides a simplified explanation of the clauses of ISO 9001:2015, including+G429:G439:What's requiredWhy to do itImplementation tipsQuestions to ask to assess conformityAlso included are included descriptions of 14 quality tools that may be helpful when you are structuring or deploying processes to effectively comply with ISO 9001:2015 requirements. For each tool, the authors describe (1) what it is, (2) where it's used, (3) how it's done, and (4) cautions to be considered when using the tool.

Contents:

Cover

Title page

CIP data

Table of Contents

List of Figures and Tables

Chapter 1 Why Do ISO 9001:2015?

Chapter 2 Key Differences with Past ISO 9001 Editions

Chapter 3 Principles and Key Concepts

QUALITY MANAGEMENT PRINCIPLES

CUSTOMERS-CUSTOMER FOCUS AND MEASURING SATISFACTION

PROCESS APPROACH-ACTIVITIES, PROCESS MANAGEMENT, AND THE SYSTEMS APPROACH TO MANAGEMENT

CONTINUAL IMPROVEMENT

TOP MANAGEMENT AND PEOPLE INVOLVEMENT AT ALL LEVELS

VISION AND MISSION

Chapter 4 What Are the ISO9001:2015 Requirements and How Do We Comply?

INTRODUCTION

CLAUSE 1 SCOPE

CLAUSE 2 NORMATIVE REFERENCES

CLAUSE 3 TERMS AND DEFINITIONS

CLAUSE 4 CONTEXT OF THE ORGANIZATION

CLAUSE 4.1 UNDERSTANDING THE ORGANIZATION ANDITS CONTEXT

CLAUSE 4.2 UNDERSTANDING THE NEEDS AND EXPECTATIONS OFINTERESTED PARTIES

CLAUSE 4.3 DETERMINING THE SCOPE OF THE QUALITY MANAGEMENT SYSTEM

CLAUSE 4.4 QUALITY MANAGEMENT SYSTEM AND ITS PROCESSES

CLAUSE 5 LEADERSHIP

CLAUSE 5.1 LEADERSHIP AND COMMITMENT

CLAUSE 5.2 POLICY

CLAUSE 5.3 ORGANIZATIONAL ROLES, RESPONSIBILITIES AND AUTHORITIES

CLAUSE 6 PLANNING

CLAUSE 6.1 ACTIONS TO ADDRESS RISKS AND OPPORTUNITIES

CLAUSE 6.2 QUALITY OBJECTIVES AND PLANNING TO ACHIEVE THEM

CLAUSE 6.3 PLANNING OF CHANGES

CLAUSE 7 SUPPORT

CLAUSE 7.1 RESOURCES

CLAUSE 7.2 COMPETENCE

CLAUSE 7.3 AWARENESS

CLAUSE 7.4 COMMUNICATION

CLAUSE 7.5 DOCUMENTED INFORMATION

CLAUSE 8 OPERATION

CLAUSE 8.1 OPERATIONAL PLANNING AND CONTROL

CLAUSE 8.2 REQUIREMENTS FOR PRODUCTS AND SERVICES

CLAUSE 8.2.1 CUSTOMER COMMUNICATION

CLAUSE 8.2.2 DETERMINING THE REQUIREMENTS FOR PRODUCTS AND SERVICES

CLAUSE 8.2.3 REVIEW OF THE REQUIREMENTS FOR PRODUCTS AND SERVICES

CLAUSE 8.2.4 CHANGES TO REQUIREMENTS FOR PRODUCTS AND SERVICES.

CLAUSE 8.3 DESIGN AND DEVELOPMENT OF PRODUCTS AND SERVICES

CLAUSE 8.3.1 GENERAL

CLAUSE 8.3.2 DESIGN AND DEVELOPMENT PLANNING

CLAUSE 8.3.3 DESIGN AND DEVELOPMENT INPUTS

CLAUSE 8.3.4 DESIGN AND DEVELOPMENT CONTROLS

CLAUSE 8.3.5 DESIGN AND DEVELOPMENT OUTPUTS

CLAUSE 8.3.6 DESIGN AND DEVELOPMENT CHANGES

CLAUSE 8.4 CONTROL OF EXTERNALLY PROVIDED PROCESSES, PRODUCTS AND SERVICES

CLAUSE 8.4.1 GENERAL

CLAUSE 8.4.2 TYPE AND EXTENT OF CONTROL

CLAUSE 8.4.3 INFORMATION FOR EXTERNAL PROVIDERS

CLAUSE 8.5 PRODUCTION AND SERVICE PROVISION

CLAUSE 8.5.1 CONTROL OF PRODUCTION AND SERVICE PROVISION

CLAUSE 8.5.2 IDENTIFICATION AND TRACEABILITY

CLAUSE 8.5.3 PROPERTY BELONGING TO CUSTOMERS OR EXTERNAL PROVIDERS

CLAUSE 8.5.4 PRESERVATION

CLAUSE 8.5.5 POST-DELIVERY ACTIVITIES

CLAUSE 8.5.6 CONTROL OF CHANGES

CLAUSE 8.6 RELEASE OF PRODUCTS AND SERVICES

CLAUSE 8.7 CONTROL OF NONCONFORMING OUTPUTS

CLAUSE 9 PERFORMANCE EVALUATION

CLAUSE 9.1 MONITORING, MEASUREMENT, ANALYSIS AND EVALUATION

CLAUSE 9.1.1 GENERAL

CLAUSE 9.1.2 CUSTOMER SATISFACTION

CLAUSE 9.1.3 ANALYSIS AND EVALUATION

CLAUSE 9.2 INTERNAL AUDIT

CLAUSE 9.3 MANAGEMENT REVIEW

CLAUSE 9.3.1 GENERAL

CLAUSE 9.3.2 MANAGEMENT REVIEWINPUTS

CLAUSE 9.3.3 MANAGEMENT REVIEW OUTPUTS

CLAUSE 10 IMPROVEMENT

CLAUSE 10.1 GENERAL

CLAUSE 10.2 NONCONFORMITY AND CORRECTIVE ACTION

CLAUSE 10.2.1 (UNTITLED CLAUSE)

CLAUSE 10.2.2 (UNTITLED CLAUSE)

CLAUSE 10.3 CONTINUAL IMPROVEMENT

ANNEX A: CLARIFICATION OF NEW STRUCTURE, TERMINOLOGY AND CONCEPTS

A.1 STRUCTURE AND TERMINOLOGY

A.2 PRODUCTS AND SERVICES

A.3 UNDERSTANDING THE NEEDS AND EXPECTATIONS OF INTERESTED PARTIES

A.4 RISK-BASED THINKING

A.5 APPLICABILITY

A.6 DOCUMENTED INFORMATION

A.7 ORGANIZATIONAL KNOWLEDGE.

A.8 CONTROL OF EXTERNALLY PROVIDED PROCESSES, PRODUCTS AND SERVICES

ANNEX B (INFORMATIVE) OTHER INTERNATIONAL STANDARDS ON QUALITY MANAGEMENT AND QUALITY MANAGEMENT SYSTEMSDEVELOPED BY ISO/TC 176

Chapter 5 Tools

TOOLS DISCUSSED IN THIS CHAPTER

TOOL 1: FLOWCHART

TOOL 2: PROCESS MAPPING

TOOL 3: BRAINSTORMING

TOOL 4: GANTT CHART

TOOL 5: RUN OR TREND CHART

TOOL 6: HISTOGRAM

TOOL 7: PARETO CHART

TOOL 8: FAILURE MODE AND EFFECTS ANALYSIS

TOOL 9: RELIABILITY ANALYSIS

TOOL 10: IDENTIFYING EXTERNAL AND INTERNAL ISSUES-USE OF SWOT ANALYSIS

TOOL 11: PROCESS CAPABILITY STUDIES

TOOL 12: CAUSE-AND-EFFECT DIAGRAM (FISHBONE/ISHIKAWA DIAGRAM)

TOOL 13: PROBLEM SOLVING

TOOL 14: HOW TO CONDUCT AN IMPROVEMENT PROJECT

Index.

Notes:

Includes index.

Description based on publisher supplied metadata and other sources.

Description based on print version record.

Other Format:

Print version: Cianfrani, Charles A. Cracking the Case of ISO 9001:2015 for Manufacturing

ISBN:

9781636940427

OCLC:

1356008527