We will cover: • How to maximize the power of control of your QMS while minimizing the words and number of pages • Methods used and understand why they meet the requirements of the standard • How to lean your documentation and establish an effective, efficient quality management system Presenter: This webinar will be presented by Debra Hay Hampton, PECB Certified Trainer and Lead Auditor of Quality and Environmental Management Systems.

1. Minimizing ISO 9001
Documentation
QMS Systems with Less Than 50 Pages
Presented by Debra Hay Hampton
debra@CE-Q.com www.CE-Q.com
On Behalf of WWW.PECB.COM

2. 50 Pages or Less – What They Say
• Can’t be done
• Our Quality Manual is 30 pages!
• Impossible to truly control the system with that few pages
• Maybe in a small company of 10 or so people but, not in a large
company.

3. Why Isn’t 50 Pages Common?
• People haven’t read the standard.
• Too many didn’t comprehend what they read.
• The standard clearly states what is required.

4. What Does the ISO 9001:2008 Standard Say?
• 4.2.2 Quality Manual
• The organization shall establish and maintain a quality manual that includes
a. The scope of the quality management system, including details of and justification for
any exclusions
b. The documented procedures established for the quality management system or
reference to them and
c. A description of the interaction between the processes of the quality management
system

5. The scope of the quality management system,
including details of and justification for any
exclusions
Our Scope is the design, manufacture and
distribution of “things”
The documented procedures established for
the quality management system or reference
to them
Our Documented Procedures are found in the
Folder “QMS” or here is a list of our
documented procedures.
A description of the interaction between the
processes of the quality management system
Click “here” to see the picture that describes the
interaction of our quality management system
This Manual would only have 3 sentences! And still
meet the requirements of the standard!!!

6. Example of a Quality Manual
• Our Scope: “Design,
Development, and
Manufacturing of
Toiletry Items”
• Our Documented
Procedures are
noted in the
diagram of how our
processes interact.
This manual (picture) identifies the
processes of the organization and how they
interact.

7. Example of a Quality Manual
• Our Scope: “Design,
Development, and
Manufacturing of
Toiletry Items”
• Our Documented
Procedures are
noted in the
diagram of how our
processes interact.
This manual (picture) identifies the
processes of the organization and how they
interact.
Our Quality Policy is “Get Better Every Day
as Shipping Quality Products, On-Time.”
Objectives:
100% on-time and no
customer complaints

8. Keeping Count
Document Number of Pages
Quality Manual 1

9. What Does the Standard Require
for Processes?
It clearly states what each process must contain.

10. The ISO 9001:2008 defines what must be documented
for each process in section 4.1.
4.1 The organization shall establish, implement and maintain a quality
management system and continually improve its effectiveness.
The organization shall
a. Determine the processes needed for the quality management system
and their application throughout the organization
b. Determine the sequence and interaction of these processes
c. Determine the criteria and methods to ensure that both the operation
and control of these processes are effective
d. Ensure the availability of resources and information necessary to support
the operation and monitoring of these processes
e. Monitor, measure where applicable and analyze these processes and
f. Implement actions necessary to achieve planned results and continual
improvement of these processes

11. Defining Processes
Traditional
• Procedures
• Flow Charts
Progressive
• Deployment Flow Charting

12. Deployment Flow Chart
Graphical Representation of the flow of a process including who is
responsible for each step in the flow necessary to turn the inputs into
outputs
Value
• Identify areas for focus of improvement efforts
• Identify and eliminate non-value added steps
• Assist in root cause analysis
• Identify controllable parameters
• Identify data collection points
• Eliminate unnecessary data collection steps

13. Deployment
Flowchart/
Process Map
Example

14. Characteristics of a Deployment Flow Chart /
Process Map
• Process Owner is defined
• Process Objective is stated
• Inputs and Outputs are noted
• Shows interaction between functional groups
• Defines who is responsible for what
Email debra@ce-q.com
to get an example of a
deployment flow chart
and an example of a
quality manual.

15. Deployment
Flowchart/
Process Map
Example

16. Does Our Deployment Flow Chart Address
the Requirements of 4.1?
The ISO 9001:2008 defines what must be documented for each process in section 4.1.
4.1 The organization shall establish, implement and maintain a quality management
system and continually improve its effectiveness.
The organization shall
a. Determine the processes needed for the quality management system and their
application throughout the organization
b. Determine the sequence and interaction of these processes
c. Determine the criteria and methods to ensure that both the operation and control of
these processes are effective
d. Ensure the availability of resources and information necessary to support the
operation and monitoring of these processes
e. Monitor, measure where applicable and analyze these processes and
f. Implement actions necessary to achieve planned results and continual improvement
of these processes
YES
Did we meet the
requirements of
the ISO 9001:2008
standard?
YES
YES – We have Shipping Lead Times, Schedules
Yes – We made sure kits were ready
NO
NO
We still have work to do!

17. Deployment
Flowchart/
Process Map
Example
Monitoring and Measuring is Used
to Determine What to Improve:
On-Time to Schedule
Nonconforming

18. We’ve Met the Requirements of
the ISO 9001:2008 Standard for
Processes!
Have we Kept the Pages to Less
Than 50?

19. Keeping Count
Document Number of Pages
Quality Manual 1
One Document for Each Process 12
Estimate Three Other Documents
(forms or work instructions) per
Process (This is a high estimate from
experience.)
36
To receive a sample of the manual and a
process map, email debra@CE-Q.com

20. Can We Do It With ISO
9001:2015?

21. ISO 9001:2015
• Does not require a manual
• Does not require any documented procedures
• Has more requirements for what a process must address
We still need some
glue to help us
know what we are
doing! Don’t we?

22. What If…
We listed our processes in a spreadsheet….
Processes
Quoting and Order
Processing
Purchasing and Receiving
Production
Shipping and Invoicing
Competency Assessment
Maintenance of
Equipment
Compliance

23. What If…
Identified the risks of not performing the process well …
Processes Risks
Quoting and Order
Processing
Not understanding
customer requirements
Committing to Something
We Can’t Do
Giving the Wrong Price to
a Customer
Purchasing and Receiving
Incompetent Suppliers
Not prescribing what we
want
Getting something we
didn’t order
Purchasing and Receiving

24. What If…
Put Controls in Place to Mitigate the Risks….
Processes Risks Controls to Mitigate
Quoting and Order
Processing
Not understanding customer
requirements
Review with customer and get their signature on Quote
Form
Committing to Something We
Can’t Do
Review of Purchase Orders Against Schedule Using the
Lead Time Spreadsheet
Giving the Wrong Price to a
Customer
Quote prices from Price Sheet.
Verify prices on customer purchase orders to the Price
Sheet.
Purchasing and
Receiving
Incompetent Suppliers Supplier Selection Process
Not prescribing what we want Review of purchase order and signature before sent.
(Documented Information)
Getting something we didn’t
order
Receiving Inspection Process
Items in Controls that are underlined are
documents in the system.
Documented Information is identified in
parenthesis.

25. Even with ISO 9001:2015
Keeping Count
Document Number of Pages
Quality Manual
Spreadsheet of Risks
1
One to Two Documents for
Each Process
24
Hasn’t been audited by a third party
auditor yet …. But should meet all
requirements.

26. "Any intelligent fool can make things bigger and more complex... It takes a touch of
genius --- and a lot of courage to move in the opposite direction." - Albert Einstein

27. Simple is Better
• Easier to Read
• To Communicate to Others
• And Follow
• To Edit When Needed
EMAIL debra@CE-Q.com
and request a sample of a
manual and a process map

28. Auditing Minimally Documented Systems
• Easier to Audit
• Quicker to Audit
• Saving Investments in Auditing Time
• More Confidence in Audit Results

29. Cornerstone Engineering, Training and
Consulting
• Our Slogan: “Foundations for Your Future”
• We want to help you minimize your documentation and can do this
remotely using Skype, Go To Meeting or other modern technology.
• Contact us to give you a quote.
• debra@ce-q.com
• www.CE-Q.com

30. Thank You for
Participating Today!
Minimizing the Documents Needed for an
Environmental Management System
Presented by Debra M Hay Hampton, Debra@CE-Q.com
On behalf of PECB.com,
www.CE-Q.com
Questions?