1. QMS Deployment Kickoff Meeting
S. K.
8/1/06

2. What is a Quality Management System?
A Quality Management System is a web of interconnected processes that are used to manage a business.

3. What is ISO 9001:2000? Why Choose ISO 9001:2000?
ISO 9001:2000 is an internationally recognized model for a quality management system to which a company may register by successfully showing that they meet the requirements of the standard.
Why Choose ISO 9001:2000?
Because ISO 9001:2000 is the most general of all the internationally recognized QMS’s. Other ISO standards are applicable to specific industries such as medical devices, aerospace, automotive, etc.

4. Process Approach
When ISO updated the 9000 series from 1994 to 2000 they decided to focus on a process approach to the QMS versus the old functional approach.
All work is a process. This means that in everything we do there are inputs and outputs, suppliers and customers, and means to get the work done.
ISO wants us to document the processes that that we use to supply a product in order to ensure that we are supplying product consistently.

5. ISO 9001:2000 Process Diagram

6. Why do we need a quality management system?
Managing business processes leads to standardization which, in turn, leads to good things like better efficiency, fewer rejects, fewer customer complaints, etc.
Certain customers require that their suppliers to have a documented QMS.
PED requires us to have a documented QMS and with every audit (our notified body) steers us more towards implementing ISO standards.
We already have a QMS. The goal of this effort is to make it more robust and use it for registration to ISO9001:2000

7. Deploying an ISO9000 QMS Kickoff Initial Training (awareness)
Document Processes (Say what we do)
Training (procedural, ongoing)
Monthly update meetings (First Wed. of every month)
First Audit (To prove that we do what we say)
First Management Review
Pre-Registration
Registration
Continually Improve (customer feedback, auditing, CAR’s, PAR’s, Management Review Meetings, etc.)

8. What do we need to document?
ISO SPECIFIES 6 procedures:
Control of Documents
Control of Records
Internal Audits
Control of non-conforming product
Corrective Action
Preventive Action
ISO also requires a Quality Manual (that may or may not include all or some of the above procedures) and a Quality Policy.
Quality Records always need to be documented and controlled as evidence of compliance with the system.
As far as ISO is concerned, everything else we choose to document in a procedure is up to the needs of our business.

9. What is “Document Control”?
Controlling a document means to allow only authorized changes and to prevent use of obsolete documents via a standardized system.
What needs to be controlled:
The Quality Manual
Procedures, Policies, Work Instructions if the document is needed to ensure “effective planning, operation, and control of” the company’s processes.
Forms, if the completed form results in a quality record or the form contains a quality standard or specification
Drawings, specifications, and standards – of internal and external origin.
The goal is to control only what is absolutely necessary and not document ourselves into a corner. Remember, if it’s documented it can be audited and we will be held accountable for doing what we say we do.

10. How do these documents get created?
The Quality Manual
Scott is responsible for writing the quality manual.
It is drafted and will be finalized once the core procedures are approved.
The Document Control Procedure is written
There will be training for Management and hourly personnel
The Role of QA in document creation
Jim and Scott are here to assist in creating documents
But they cannot define the processes themselves.
They will teach process mapping and coach process owners in drawing out the processes.
Then they will help format the documents.
The process has to come from the process owner.

11. The Implementation Team
What was formerly the Document Control Team will change into the ISO Implementation Team.
Expanded responsibilities of the team will include:
Auditing
Training
Advising Process Owners
Reporting Progress
QC inspectors will have their daily roles expanded into watching for process nonconformances as well as part nonconformances.

12. Management Support
The single most important thing in implementing a new QMS is visible support for the effort from all management.
How Upper Management can show support:
Participate in training, come to training sessions.
Show interest in the processes that are being documented by your people. Give them constructive criticism.
Embrace audits as a means for improvement.
Never allow double standards from any of your staff (i.e. when they turn the other way if one of their people ignores a procedure while everyone else complies).
Treat Corrective Actions as a means for improvement. They are not traffic tickets to be bargained down.
Add quality system related goals to your staffs’ goals and objectives (a goal for response time to CAR’s, a goal submitting PAR’s, etc)

13. Communication
Regular communication on the progress of the deployment will be provided to all employees via charts and graphs on the bulletin board and via to those with accounts.
It is very important that this entire process is transparent for all to see in order to dispel any mistrust or feelings that we are “binding” people with rules.
Regular communication also serves the purpose of keeping the effort in the forefront of everyone's thoughts.

14. Training General Awareness Training Document Control Training
Training for all employees on the purpose of a QMS and how it will impact their jobs.
Document Control Training
Process Owners will receive training in the creation of documents.
All other employees will receive training on how to find documents that affect their jobs.
Training on specific documents
As required as documents are published

15. How long will this take?
Forever. The name of the game is Continuous Improvement so it should never stop.
Practically speaking, however, with focus we can get to the point of an ISO9001:2000 registration audit in a year. The rule of thumb is: Once the system is built and implemented you should run with the system for 3 months in order to gather evidence that the system is working.

16. Thank You.