a pocket guide to the basics demo

1

What Every Employee Needs to

Know About ISO 9001:2015

A Pocket guide to the Basics

DEMO

ISO

9001

:2015

Harry Steudel, Ph.D., P.E.

2

Overview of Employee

Training System

CD-Based, MP4 Digital Movie.

Four Modules of ranging from about 12 to 15 minutes each:

Basics of ISO and ISO 9001:2015

Quality Management Principles

QMS Documentation

Internal and External Audits

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Overview of Employee

Training System

Stand alone use or compliments

the ISO 9001 Pocket Guides for

employee training.

Many slides reference pages in

the pocket guide.

4

5

Overview of Employee

Training System

Comes with multiple choice

“quizzes” (10 questions) for

each of the 4 training modules.

Useful for assessing the

effectiveness of your training.

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Partial Quiz for Module 1

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Module 1: Basics of ISO and

ISO 9001:2015

Contents

The ISO Organization

The 9001:2015 Standard

Changes with ISO 9001:2015

The Requirements of ISO 9001:2015

Overview of the Seven Quality Management Principles

Registration and Benefits

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What Is ISO?

ISO is not the International Standards Organization.

The term ISO refers to the International Organization for Standardization.

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MISSION OF ISO

To develop and promote worldwide

common standards (manufacturing,

trade, and communication) to foster the

international exchange of goods and

services.

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The ISO 9001 Standard

What Exactly is ISO 9001?

IS0 9001 is an international standard

containing requirements for

establishing & maintaining

a company’s Quality

Management System (QMS).

See pages 4-5 in your pocket guide

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Seven Major Changes

with ISO 9001:2015

For example:

A need to enhance the use of the process approach to

consider both risks and opportunities in managing

the processes.

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Process: “A set of interrelated or interacting

activities which transforms

inputs into outputs”

INPUTSMATERIALS

ENVIRONMENTPEOPLE

CAPITALINFORMATION

FACILITIES

TRANSFORMATION

ACTIVITIES

OUTPUTS

Ÿ GOODS

Ÿ INFORMATIONŸ SERVICES

Ÿ ETC.

ORDER REVIEW

PROCESS

INPUTSCUSTOMER ORDERCUSTOMER

REQUIREMENTSREGULATORYREQUIREMENTS

PRODUCTION CAPACITYETC.

OUTPUTS

Ÿ PRODUCTION ORDER

EXAMPLE:

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Changes with ISO 9001:2015

A greater focus on continual improvement using

the Plan-Do-Check-Act (PDCA) cycle throughout

the organization.

CheckAct

Plan Do

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The Seven Requirement Clauses

of ISO 9000:2015

Clause 4: Context of the

Organization

Clause 5: Leadership

Clause 6: Planning

Clause 7: Support

Clause 8: Operation

Clause 9: Performance Evaluation

Clause 10: Improvement

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Module 2: Quality

Management Principles

Contents

The 7 Quality Management Principles

Implications in ISO 9001:2015

Implications for You and Your Organization

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Quality Management Principles

1. Customer Focus

2. Leadership

3. Engagement of People

4. Process Approach

5. Improvement

6. Evidence-based Decision Making

7. Relationship Management

See pages 12-14 in your pocket guide

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Module 3:

QMS Documentation

Contents

Types of QMS Documentation

Documentation System Structure

The Value of Documentation

Your Roles and Responsibilities

Documentation that Applies to Your Job

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The Documentation System

What Are The Different Types of

Documentation?

Quality Manual

Quality Procedures

Quality Work Instructions

Records and Forms

See pages 12 - 13 in your pocket guide

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How Is The Documentation System

Structured?

ISO 9001

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Module 4:

Internal and External Audits

Contents

The Two Types of Audits

Purpose of Audits and What Auditors Look

For

Typical Questions and How to Answer Them

Benefits of Audits for Continual

Improvement

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The Audit Process &

Requirements

Registration to ISO 9001 Requires That Your

Company Periodically Go Through Two

Types of Audits

Third-party audits

(audits by your registrar)

Internal audits

(self-audits by your company)

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EXAMPLES OF AN AUDITOR’S

QUESTIONS

What is your job function and how do you know what your duties are?

Can you show me how you perform your job?

What type of training did you receive to perform this job?

What documentation do you use in your job?

How do you know you have the most recent documentation to perform your job?

In order to do your job what items and or materials do you need? (series related questions)

Explain to me the corrective action process used at your company.

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QMS Audits

Any audit is an audit of the

quality management system –

not the people.

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More Information?

Contact:

Laura Acker

Steudel & Schultz, LLC

Toll-Free Tel: (866) 271-3121

Fax (608) 838-8985

Email: info@isopocketguides.com