1. ISO 9000:2000 “Cracking the Case”
Brenden: I love you mom Eddie:I Love you mom David Like my mommy.
Agent of Change: C.
Agent of Compliance: E.
Agent of Customer Focus: J
Agent of Improvement : T

2. Case # ISO9001:2000 New ISO Standard + New Auditors = New Questions
Pre-Assessment April 24th – 25th
The Certification Audit week of August 11th
Every six months to maintain certification
New ISO Standard +
New Auditors
Big Change from last year
= New Questions

3. Things I will be inspecting and asking about
Inspector Compliance
Things I will be inspecting and asking about
Quality Policy
Quality Objectives
Document Control
ISO Mgmt. Rep.
Calibration
Non Conforming Mat’l
Input /Outputs
Resp. & Authority
ISO 9001

4. Quality Policy Insert new quality policy here!!
“To continually improve our business systems to support the products and environment that will satisfy the needs of our customers.”
Put in your own words what it means to you
Know where you can find it
The Quality Policy is the framework for the Quality Objectives

5. Quality Objectives 1.5 BPM’s are our new Quality Objectives
Must be measurable
Consistent with the Quality Policy
Know how you contribute to the success of the quality objectives
Communicate the actions needed when not meeting the QO
Know how to find them

6. Document Control Know where your procedures are
Make sure your working with the most current rev.
Need to be in the work area
Must be approved before use
DO NOT write on controlled documents
No Renegade procedures!!!
Know what a Controlled Document Is

7. Document Control A controlled document will have the follow items:
Title
Control Number
Revision indicator
Page Number
Date issued / revised
Approval Signatures
Revision History
“Controlled Document” statement

8. Document Control Request a document change if needed Follow DCR’s
Document What you Do...Do What You Document
Request a document change if needed
Follow DCR’s
Keep a look out for expired DCR’s
Sign off on the DCR’s
Prove it…and Improve it

9. Management Representative
Ensures that process needed for the QMS are established
Reports to SLT on the performance of the QMS and any need for improvement
Ensures the promotion of awareness of Customer requirements
ISO Management Rep- AKA: DRP Inspector 

10. Calibration Equipment used directly or indirectly must be calibrated.
Ensure calibration is not past due
If the label is missing, not legible, or past due, you must contact the Calibration Administrator or anyone in QA.
Calibration
I.D. # By
Date:
DUE DATE: