a pocket guide to the basics demo
TRANSCRIPT
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
3
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.
6
Partial Quiz for Module 1
7
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
8
What Is ISO?
ISO is not the International Standards Organization.
The term ISO refers to the International Organization for Standardization.
9
MISSION OF ISO
To develop and promote worldwide
common standards (manufacturing,
trade, and communication) to foster the
international exchange of goods and
services.
10
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
11
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.
12
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:
13
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
14
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
15
Module 2: Quality
Management Principles
Contents
The 7 Quality Management Principles
Implications in ISO 9001:2015
Implications for You and Your Organization
16
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
17
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
18
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
19
How Is The Documentation System
Structured?
ISO 9001
20
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
21
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)
22
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.
24
More Information?
Contact:
Laura Acker
Steudel & Schultz, LLC
Toll-Free Tel: (866) 271-3121
Fax (608) 838-8985
Email: [email protected]