A crash course on navigating ISO certification, managing audits, and avoiding common mistakes

THE BASICS OF ISO

DOZUKI WORKSHOP SERIES

Taking Professional Photographs

THE WORKSHOP SERIES PRESENTS

Miro Djuricfeaturing

Chief Information Architect of iFixit

Achieving and Maintaining ISO Compliance

THE WORKSHOP SERIES PRESENTS

J.F. DeBetzfeaturing

CEO and Process Improvement Specialist for The Business Fixers

Cait Emma Smith Director of Outreach and Workshop Host, Dozuki

THE WORKSHOP SERIES PRESENTS

J.F. DeBetz CEO and Process Improvement Specialist, The Business Fixers

THE WORKSHOP SERIES PRESENTS

ISO Compliance

Engage During the Workshop

Type out your questions in the message field on the GoToWebinar interface.

or Email Cait and J.F. directly for

specific questions and comments.

ISO Compliance

1. What are we talking about when we say “ISO”?

2. Should you get a Certification?

3. The ISO Family

4. Business Benefits

5. Elements of Successful ISO 9001

6. Your Company: Setting up an ISO Ready System

7. Avoid These Common Mistakes

Workshop Roadmap

ISO Compliance

ISO 9001 Quality Management

ISO 14001 Environmental Management

AS9100 Aerospace

The Most Well-Known Standards

ISO Compliance

Refers to what the organization does to ensure that its products or

services satisfy the customer’s quality requirements and comply with any

regulations applicable to those products or services.

• enhance customer satisfaction

• achieve continual improvement of its performance

ISO 9001 Quality Management

• minimize harmful effects on the environment caused by its activities

• to conform to applicable regulatory requirements

• achieve continual improvement of its environmental performance

ISO Compliance

ISO 14001 Environmental Management

ISO 9001 and ISO 14001 are generic standards. This means that the

same standards can be applied to any organization—large or small—

whatever its product or service, in any sector of activity, and whether it is

a business enterprise, a public administration, or a government

department.

ISO Compliance

Generic Standards

ISO Compliance

Management Systems

ISO Compliance

Management system means what the organization does to manage its

processes, or activities in order that its products or services meet the

organization’s objectives, such as:

• satisfying the customer’s quality requirements

• complying to regulations

• meeting environmental objectives

Management Systems

ISO Compliance

Systemizing:

ISO Compliance

Systemizing:

• Nothing important is left out

• Everyone is clear about who is responsible for doing what, when,

how, why, and where

• Management system standards provide the organization with an

international, state-of-the-art model to follow

ISO Compliance

Systemizing:Large organizations—or ones with complicated processes—could not

function well without management systems. Companies in such fields as

aerospace, automobiles, defense, or health care devices have been

operating management systems for years. ISO 9001 and ISO 14001

management system standards now make these successful practice

available for all organizations.

Both ISO 9001 and ISO 14001 are concerned with the way an

organization goes about its work. They are not product standards or

service standards. They are process standards.

• ISO 9001 gives the requirements for what the organization must do

to manage processes affecting quality of its products and services.

• ISO 14001 gives the requirements for what the organization must do

to manage processes affecting the impact of it’s activities on the

environment.

ISO Compliance

Processes, Not Products

Should you get a Certification?

ISO Compliance

It means that an independent, external body has audited an

organization’s management system and verified that it conforms to the

requirements specified in the standard, like ISO 9001 or ISO 14001. ISO

does not carry out certification and does not issue or approve

certificates.

ISO Compliance

Certification or Registration

• Certification is not a requirement of ISO 9001 or ISO 14001!

• The organization can implement and benefit from an ISO 9001 or ISO

14001 system without having it certified.

• The organization can implement them from the internal benefits

without spending money on a certification program.

ISO Compliance

Certification or Registration

• if it is a contractual, regulatory, or market requirement

• if it meets customer preferences/requirements

• if it is part of a risk management program

• if it will motivate staff by setting a clear goal

ISO Compliance

Certification is a decision to be taken for business reasons:

• ISO does not carry out ISO 9001 or ISO 14001 certification.

• ISO does not issue certificates.

• ISO does not accredit, approve, or control the certification bodies.

ISO Compliance

ISO Does Not Certify

ISO Compliance

The ISO 9000 Family

The latest, improved version. It is the only standard in the ISO 9000

family that can be used for certification.

ISO Compliance

ISO 9001:2008

There are 16 other standards in the family that can help an organization

on specific aspects such as performance improvement, auditing,

training…

ISO Compliance

Other ISO 9000 Standards

Business Benefits

ISO Compliance

ISO Compliance

• International, expert consensus on state-of-the-art practices for

quality and environmental management

• Common language for dealing with customers and suppliers

worldwide in B2B

• Increase efficiency and effectiveness

• Model for continual improvement

• Model for satisfying customers and other stakeholders

• Build quality into products and services from design onwards

• Address environmental concerns of customers and public, and

comply with government regulations

• Integrate with global economy

• Sustainable business

ISO Compliance

• Unifying base for industry sectors

• Qualify suppliers for global supply chains

• Technical support for regulations

• Transfer of good practice to developing countries

• Tools for new economic players

• Regional integration

• Facilitate rise of services

• A documented quality/management system that is consistently

followed and maintained

• Consistent quality of product/service

• Certification is often required from suppliers/customers

• Document control

Elements of Successful ISO 9001

ISO Compliance

• Product Realization

• Planning of Product Realization

• Customer-related Processes

• Design & Development

• Purchasing

• Product and service provision

• Control of monitoring & measuring

equipment

• Measurement, analysis & improvement

• Control of non-conforming product/

service

• Analysis of data

• Continual process improvement

• Documentation requirements

• Management Responsibility

• Management Commitment

• Customer Focus

• Quality Policy

• Planning

• Responsibility, authority, &

communication

• Management Review

• Resource Management

• Provision of Resources

• Human Resources

• Work Environment

ISO Compliance

ISO Compliance

How do I set up an ISO ready system for my company?

Initial Assessment: Whether or not you are considering actually

certification, the benefits of implementing a quality management system

that conforms to ISO requirements can be extremely beneficial and not

as daunting as it may seem. An initial assessment can determine where

you are now and what needs to be implemented.

ISO Compliance

ISO Compliance

Action Plan: Once an initial assessment is complete, then an action plan

can be established to bring the organization to ISO compliance and an

internal audit performed.

Third Party: Once the company feels ready, then a 3rd party ISO

certification body can be hired to do a third party audit to establish ISO

certification. Periodic audits are then required to ensure the organization

is maintaining its compliance.

Outside Consultant: Although hiring an ISO/Quality consultant is

recommended initially, once a quality system is established the

organization will be able to maintain certification without the help of any

outside consultants. Over one million certification have been issued

since 2000. China has the most certificates (the US ranks #9 worldwide).

ISO Compliance

ISO Compliance

• Over documenting the processes

• Documenting too many processes

• Lack of Management Support/Review

• Lack of understanding of what is required

• Lack of maintenance of the system

Most Common ISO 9000 Mistakes

Do I really need an ISO 9000 quality system?

ISO Compliance

ISO Compliance

• You don’t if your organization makes more money than anyone can

ever spend.

• You don’t if your luncheons with Oprah and Bill Gates take up too

much of your time as it is.

• You don’t if everyone at your organization loves their jobs and are

always willing to work for free.

• You don’t if everyone at your organization gets along so well that it

feels like an episode of “Leave it to Beaver”

THE WORKSHOP SERIES

J.F. DeBetzCEO and Process Improvement Specialist, The Business Fixersdebetz@charter.com (805) 458-2342

Cait Emma SmithDirector of Outreach, Dozuki

cait@dozuki.com (805) 540-6325

Thanks for joining us today.

THE WORKSHOP SERIES

dozuki.com/Answers/Ask/ISO

J.F. DeBetzCEO and Process Improvement Specialist, The Business Fixersdebetz@charter.com (805) 458-2342

Cait Emma SmithDirector of Outreach, Dozuki

cait@dozuki.com (805) 540-6325