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

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

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

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

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

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

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

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

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 

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: