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AcrashcourseonnavigatingISOcertification,
managingaudits,andavoidingcommonmistakes
THEBASICSOFISO
DOZUKIWORKSHOPSERIES
Taking Professional Photographs
THE WORKSHOP SERIES PRESENTS
Miro Djuric
featuring
Chief Information Architect of iFixit
Achieving and Maintaining ISO Compliance
THE WORKSHOP SERIES PRESENTS
J.F. DeBetz
featuring
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. DeBetz
CEO and Process Improvement
Specialist, The Business Fixers
debetz@charter.com
(805) 458-2342
Cait Emma Smith
Director of Outreach, Dozuki
cait@dozuki.com
(805) 540-6325
Thanks for joining us today.
THE WORKSHOP SERIES
dozuki.com/Answers/Ask/ISO
J.F. DeBetz
CEO and Process Improvement
Specialist, The Business Fixers
debetz@charter.com
(805) 458-2342
Cait Emma Smith
Director of Outreach, Dozuki
cait@dozuki.com
(805) 540-6325

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The Basics of ISO Certification

  • 2. Taking Professional Photographs THE WORKSHOP SERIES PRESENTS Miro Djuric featuring Chief Information Architect of iFixit
  • 3. Achieving and Maintaining ISO Compliance THE WORKSHOP SERIES PRESENTS J.F. DeBetz featuring CEO and Process Improvement Specialist for The Business Fixers
  • 4. Cait Emma Smith Director of Outreach and Workshop Host, Dozuki THE WORKSHOP SERIES PRESENTS
  • 5. J.F. DeBetz CEO and Process Improvement Specialist, The Business Fixers THE WORKSHOP SERIES PRESENTS
  • 6. 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.
  • 7. 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
  • 8. ISO Compliance ISO 9001 Quality Management ISO 14001 Environmental Management AS9100 Aerospace The Most Well-Known Standards
  • 9. 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
  • 10. • 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
  • 11. 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
  • 13. 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
  • 15. 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
  • 16. 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.
  • 17. 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
  • 18. Should you get a Certification? ISO Compliance
  • 19. 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
  • 20. • 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
  • 21. • 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:
  • 22. • 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
  • 23. ISO Compliance The ISO 9000 Family
  • 24. 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
  • 25. 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
  • 27. 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
  • 28. 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
  • 29. Elements of Successful ISO 9001 ISO Compliance
  • 30. • 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
  • 31. ISO Compliance How do I set up an ISO ready system for my company?
  • 32. 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
  • 33. 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.
  • 34. 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
  • 35. 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
  • 36. Do I really need an ISO 9000 quality system? ISO Compliance
  • 37. 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”
  • 38. THE WORKSHOP SERIES J.F. DeBetz CEO and Process Improvement Specialist, The Business Fixers debetz@charter.com (805) 458-2342 Cait Emma Smith Director of Outreach, Dozuki cait@dozuki.com (805) 540-6325 Thanks for joining us today.
  • 39. THE WORKSHOP SERIES dozuki.com/Answers/Ask/ISO J.F. DeBetz CEO and Process Improvement Specialist, The Business Fixers debetz@charter.com (805) 458-2342 Cait Emma Smith Director of Outreach, Dozuki cait@dozuki.com (805) 540-6325