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Prepared by Debra Hay Hampton,
Certified Lead Auditor, ISO 9001:2015, ISO 14001:2015
Certified Management Consultant
Certi...
Debra Hay Hampton
ISO 9001 Lead Auditor
Debra Hampton has over 30 years of improving processes and systems with experience...
Course Objectives
 Present methods to have minimal documentation yet meet the requirements of ISO
9001:2015
 Encourage r...
Outline of Material
1. Replacing the Quality Manual and the Other Requirements for Specific
Documented Procedures
2. Revam...
Replacing the Quality Manual and the
Other Requirements for Documented
Procedures
Replacing the Quality Manual and the Other
Requirements for Specific Documented
Procedures
 Previously the Quality Manual...
ISO 9001:2000 and 2008 Stated
Requirements of the Quality Manual
 Quality Manual required to contain (ISO 9001:2008, 4.2....
ISO 9001:2000-2008 Quality Manual
 Often One Page
 A Picture of the Interactions of the Processes
 Reference to the Pro...
ISO 9001:2015
 Does NOT require any manual
 Does NOT require any documented procedures?
 So what will be our glue?
 Ho...
What is a Standard?
- Is a standard leading edge thinking?
- Is it progressive?
NO!
Where is the Glue? What Holds the
System Together? How Can We Know
What Documents We Need?
Risk-Based Thinking
 Not a new concept
 ISO 14001 and other risk based standards have NOT had a requirement for a
manual...
How do we know what documents are
needed?
 Determine the context of the organization
 Determine the risks
 Determine th...
Understanding the Context of the
Organization
 External and Internal Issues
 Relevant to its purpose and strategic direc...
Internal Issues that Affect Consistency of Meeting Customer,
Statutory and Regulatory Requirements
 Leadership and their ...
External Issues that Affect Consistency of Meeting Customer,
Statutory and Regulatory Requirements
 Customers
 Must unde...
What does all this have to do with minimal
documentation?
Manual one or two pages
Standard is the “STANDARD” Proven
Best P...
ISO 9001:2015 Standard Identifies the Sources
of Risk
Risk Consequence Control/Solution/
Mitigation
Lack of Leadership
and...
Sources of Risk – Competence (7.2)
Risk Consequence Control/Solution/
Mitigation
Lack of
Competence (7.2)
People doing wor...
Sources of Risk – Externally Provided
Processes, Products, and services (8.4.1)
Risk Consequence Control/Solution/
Mitigat...
What about Section 4.4, QMS and Its
Processes? How Do We Meet This?
Risk Consequences Control/Mitigation
Not establishing,...
The Risk and Control Table
Becomes the Glue!
Me: We don’t need a manual!
You: What will we send to our customers?
Me: Ahh,...
Summary of Risk-Based Thinking
 Understand the context of the organization (4.1)
 Determine the risks as a basis for pla...
Reminder of Documented Information
 2015 standard defines requirements to “maintain documented information” and to
“retai...
Should We Revamp Our Material vs. Retain
Current, Procedural Based System with
Minor Edits?
Will likely require an outside...
Verification – Presenting Evidence of
Meeting the Requirements to a Third Party
Auditor
Internal Auditing with a Risk-Control Table
Risk Control/ Mitigation Evidence Observed During
the Audit
Planned intervals ...
Summarizing – Implementing ISO
9001:2015 with Minimal Documentation
1. Create a Risk-Control Table based on the requiremen...
Our Team Working with Your Management Team
to Bring About Transformation to the Expectations
of ISO 9001:2015 – Section 5
...
Thank you to
PECB
Participants
?
QUESTIONS
123 456 789
name.surname@domain.com
www.domain.com
linkedin.com/name.surname
tw...
You’ve finished this document.
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How to successfully implement ISO 9001:2015 with a minimal documents approach

The webinar covers:
• Replacing the Quality Manual
• Replacing All Other Procedures
• Checking Yourself to Ensure You've Met All Requirements

Presenter:
This webinar was presented by Debra Hay Hampton, PECB Certified Trainer and Lead Auditor of Quality and Environmental Management Systems.

Link of the recorded session published on YouTube: https://youtu.be/PnCjPlGGb68

How to successfully implement ISO 9001:2015 with a minimal documents approach

  1. 1. Prepared by Debra Hay Hampton, Certified Lead Auditor, ISO 9001:2015, ISO 14001:2015 Certified Management Consultant Certified Professional Trainer Certified Quality Engineer Prepared on behalf of PECB
  2. 2. Debra Hay Hampton ISO 9001 Lead Auditor Debra Hampton has over 30 years of improving processes and systems with experience from hospitals, schools, and many types of manufacturing facilities, a methodical approach is used to focus on building a system of processes that collect data to make decisions that create sustainable, continual improvement and consistent product. Companies she works with become better at “turning effort into dollars”. +1 229 798 0277 debrahampton54@hotmail.comwww.ce-q.com linkedin.com/debra-matthews-hay-hampton
  3. 3. Course Objectives  Present methods to have minimal documentation yet meet the requirements of ISO 9001:2015  Encourage revamping of current management system documentation for those who still have procedurally based systems  Encourage creation of a method to verify meeting requirements – simply, efficiently, and effectively.
  4. 4. Outline of Material 1. Replacing the Quality Manual and the Other Requirements for Specific Documented Procedures 2. Revamp Material vs. Retain Current System and Edit 3. Verification – Presenting Evidence of Meeting the Requirements to a Third Party Auditor
  5. 5. Replacing the Quality Manual and the Other Requirements for Documented Procedures
  6. 6. Replacing the Quality Manual and the Other Requirements for Specific Documented Procedures  Previously the Quality Manual was the GLUE  Where you started to explain the rest of the system  Many organizations (still) have a manual that is a regurgitation of the standard….does not support the teaching of the ISO 9001:2000 and 2008 standard.
  7. 7. ISO 9001:2000 and 2008 Stated Requirements of the Quality Manual  Quality Manual required to contain (ISO 9001:2008, 4.2.2)  Scope and justifications of exclusions  Documented procedures or reference to them  Description of an interaction of the processes of the system  No Requirements for any documented procedures  Nothing left to hold the organization together!
  8. 8. ISO 9001:2000-2008 Quality Manual  Often One Page  A Picture of the Interactions of the Processes  Reference to the Procedures of the System  The scope and any exclusions Quality Manual more than one or two pages? Email me so we can discuss how we can help you begin revamping your management system to the 2000-2008 standard. Debra@CE- Q.com
  9. 9. ISO 9001:2015  Does NOT require any manual  Does NOT require any documented procedures?  So what will be our glue?  How can we do this without a manual and documented procedures?
  10. 10. What is a Standard? - Is a standard leading edge thinking? - Is it progressive? NO!
  11. 11. Where is the Glue? What Holds the System Together? How Can We Know What Documents We Need?
  12. 12. Risk-Based Thinking  Not a new concept  ISO 14001 and other risk based standards have NOT had a requirement for a manual  (Although many organizations do waste efforts and have a manual)  Determine the context of the organization (ISO 9001:2015, 4.1)  Determine risks as a basis for planning the system and its processes (ISO 9001:2015, 4.4, 6.1)  This analysis determines the extent of documented information
  13. 13. How do we know what documents are needed?  Determine the context of the organization  Determine the risks  Determine the methods to mitigate the risks.  Determine the documents needed to ensure the risk is mitigated
  14. 14. Understanding the Context of the Organization  External and Internal Issues  Relevant to its purpose and strategic direction  That affect its ability to achieve the intended results of its quality management system  Intended results of quality management system  Demonstrate ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirement (ISO 9001:2015 1.a)  Aim to enhance customer satisfaction (ISO 9001:2015 1.b.)
  15. 15. Internal Issues that Affect Consistency of Meeting Customer, Statutory and Regulatory Requirements  Leadership and their commitment  Assigning of Organizational Roles, Responsibilities and Authorities  Lack of Planning  Meeting Risks  Meeting Objectives  Addressing Changes  Lack of Support for the Plan  Lack of Competency in their People  Lack of Awareness and Communication of What is Expected  Inadequacies in Documented Information  Lack of Operational Control of Production and Services  Poor Design and Development Process  Poor Evaluation of the planned methods to ensure they are being followed  Poor methods of addressing nonconformity and corrective actions
  16. 16. External Issues that Affect Consistency of Meeting Customer, Statutory and Regulatory Requirements  Customers  Must understand their expectations and agree upon the expectations to be met  Interested Parties  Shareholders?  Union?  Community?  Statutory and Regulatory Bodies  External Providers  Providers of Components, Raw Materials  Providers of Services
  17. 17. What does all this have to do with minimal documentation? Manual one or two pages Standard is the “STANDARD” Proven Best Practices for an organization Sources of Risk both Internal and External in Context  Minimize Risk  Address All Potential Sources of Risk  Do Only What is Necessary
  18. 18. ISO 9001:2015 Standard Identifies the Sources of Risk Risk Consequence Control/Solution/ Mitigation Lack of Leadership and Commitment (5.1.1) Leaders not accountable for effectiveness of QMS (a) Top Manager must ensure measurement of effectiveness of leaders is tied to effectiveness of QMS Strategic Direction becomes incompatible with QMS (b) Align QMS and Strategic Direction QMS not integrated into business processes (c) Use QMS to plan business processes Process Approach and Risk Based Thinking not Promoted (d) Use process approach and risk based thinking for managers to know their responsibilities
  19. 19. Sources of Risk – Competence (7.2) Risk Consequence Control/Solution/ Mitigation Lack of Competence (7.2) People doing work that affects the performance and effectiveness of the QMS are not competent (a) Define the skills and knowledge needed for each job. Create Competency Matrix per job. People do not have the appropriate education, training, or experience (b) Compare workforce against these to determine training needed. Document in Competency Matrix. People do not acquire competencies they are lacking Create Training Plan and Follow up to Determine Effectiveness of Training No evidence people are competent Retain record of competence on Competency Matrix and in Training
  20. 20. Sources of Risk – Externally Provided Processes, Products, and services (8.4.1) Risk Consequence Control/Solution/ Mitigation Failure to ensure externally provided processes, products and services conform to requirements. (8.4) Delays in provision of products & services due to poor quality or late deliveries from suppliers. Increases in warranty costs and losses in customer satisfaction. Materials Control Manager prepares a Supplier Performance graph to show current performance of suppliers and a Performance Improvement Plan to improve their performance. Product or Service intended for incorporation gets to point of use and can’t be used. Quality Manager determines controls to be followed when items are received based on the risk and previous history. Documents controls on Receiving Inspection Plan.
  21. 21. What about Section 4.4, QMS and Its Processes? How Do We Meet This? Risk Consequences Control/Mitigation Not establishing, implementing, maintaining or continually improving the quality management system Efforts are not planned or focused to ensure the processes continually improve Top Manager expects each Department Manager to plan their methods using Process Maps which meet the requirements of
  22. 22. The Risk and Control Table Becomes the Glue! Me: We don’t need a manual! You: What will we send to our customers? Me: Ahh, the manual is for marketing use? You: Our customer will expect us to have one. Me: Fair enough… then create a manual that markets you and your products, an advertising tool, a beautiful work of art that describes your organization and what it can do for them.
  23. 23. Summary of Risk-Based Thinking  Understand the context of the organization (4.1)  Determine the risks as a basis for planning (6.1)  Demonstrate how the application of risk-based thinking affected the implementation of the qms processes (4.4)  Use the risk-based thinking to determine the extent of documented information
  24. 24. Reminder of Documented Information  2015 standard defines requirements to “maintain documented information” and to “retain documented information”  Replaces references to documents or records  Same “documented information” may meet many requirements of the standard  Where the standard references “information” rather than “documented information”, No requirement the information be documented
  25. 25. Should We Revamp Our Material vs. Retain Current, Procedural Based System with Minor Edits? Will likely require an outside service to work with managers to prepare them for the 2015 changes and make the changes in your organization, unless they listen well to you.
  26. 26. Verification – Presenting Evidence of Meeting the Requirements to a Third Party Auditor
  27. 27. Internal Auditing with a Risk-Control Table Risk Control/ Mitigation Evidence Observed During the Audit Planned intervals not frequent enough An Internal Audit Schedule is used to ensure all sections of the standard are audited and all processes with processs maps are audited Don’t verify if planned arrangements are met or if Standard met Audit using the Risk-Control Table as the criteria Don’t verify if effectively implemented and maintained Ensure auditors are trained to look for duplication of efforts and lack of improvement
  28. 28. Summarizing – Implementing ISO 9001:2015 with Minimal Documentation 1. Create a Risk-Control Table based on the requirements of the standard. 2. If it is a document that is used as a control or mitigation, it has value. If it isn’t in the list, why do you have the document 3. Let internal auditing be a method of verification that what is listed in the Risk- Control Table is what is actually in use. www.CE-Q.com can assist, even remotely through electronic media; debra@CE-Q.com or 229-798-0277 What will be difficult? Getting the Top Managers to understand their role. You’ll most likely need someone from the outside to help with that.
  29. 29. Our Team Working with Your Management Team to Bring About Transformation to the Expectations of ISO 9001:2015 – Section 5 Top Management “shall”  take accountability for the effectiveness of the qms  Ensure policy and objectives are established for the qms and are compable with the context and strategic direction of the organization  Ensure the integration of the qms into the organization’s business processes  Promote the use of the process approach and risk-based thinking www.CE-Q.com can assist, even remotely through electronic media; debra@CE-Q.com or 229-798-0277
  30. 30. Thank you to PECB Participants ? QUESTIONS 123 456 789 name.surname@domain.com www.domain.com linkedin.com/name.surname twitter.com/name.surname fb.com/name.surname THANK YOU
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The webinar covers: • Replacing the Quality Manual • Replacing All Other Procedures • Checking Yourself to Ensure You've Met All Requirements Presenter: This webinar was presented by Debra Hay Hampton, PECB Certified Trainer and Lead Auditor of Quality and Environmental Management Systems. Link of the recorded session published on YouTube: https://youtu.be/PnCjPlGGb68

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