1. Introduction to ISO
&
The Quality Process

2. “Say what we do………Do what we say Prove it”
ISO 9001:2008 Certification – What does it mean?
ISO (Internal Standards Organization) Certification is being required by more and more customers as proof that our company delivers quality products. In simple terms, it means one thing:
“Say what we do………Do what we say
Prove it”

3. Introduction to ISO 9001:2008
The ISO 9001:2008 Standard is an International Standard that specifies requirements for a Quality Management System where an organization meets two criteria:
Demonstrates its ability to consistently provide product that meets customer and applicable regulatory requirements
Aims to enhance customer satisfaction through the effective application of the system, including processes for the continual improvement of the system and assurance of conformity to customer and applicable requirements
Certification to an ISO 9001 Standard does not guarantee the quality of end products and services; rather, it certifies that consistent business processes are being applied

4. Quality Management System
Mission Statement
Insert your mission statement here
Core Competency
Insert your Core Competency here
Core Value
insert your core value here

5. Standard consists of 8 Elements 0-3 are introductory and administrative4 5 8 6 7

6. 4 – Quality management system
ISO Broken Down
4 – Quality management system
4.1 General requirements:
Say what you do - Do what you say
Prove it
4.2 Documentation requirements:
Write down the important things – Quality Manual
Make directions available to the users
Identify needed records and keep them up to date
Quality Manual
Procedures
Instructions
Records & Documents

7. 5 – Management Responsibility
ISO Broken Down
5 – Management Responsibility
5.5 Responsibility, authority, and communication:
Provide the vision and show commitment
Insert your vision statement here
Define your quality policy
Insert and discuss your Quality Policy here

8. 5 – Management Responsibility ( Continued)
ISO Broken Down
5 – Management Responsibility ( Continued)
5.6 Management Review:
Measure your progress
Make Improvements

9. ISO Broken Down 6 – Resource Management 6.4 Work environment:
Provide resources for the system and to satisfy the customer
Prepare people so they can do the job
Create and maintain a good workplace

10. ISO Broken Down 7 – Product Realization
7.1 Planning of product realization:
Determine the process steps ahead of time
7.2 Customer- related processes:
Clearly understand the customer requirements for the product or service
Make sure you can do it
Keep the customers informed and listen to them

11. ISO Broken Down 7 – Product Realization ( Continued)
7.3 Design and development:
Create a design plan
Know what you are designing
Identify measures for success
Review the work as it progresses
Verify that you did what you promised
Make sure it actually works
Scrutinize changes

12. ISO Broken Down 7 – Product Realization ( Continued) 7.4 Purchasing:
Know what you want
Check out your suppliers
Scrutinize changes
7.5 Production and service provision:
Control your processes
When you cannot check the product check the process
Match the specs to the job
Show whether items are acceptable or not
Don’t break your customers’ stuff
Keep good stuff good

13. ISO Broken Down 7 – Product Realization ( Continued)
7.6 Control of monitoring and measuring equipment:
Identify information needed for go / no-go decisions
Install equipment capable of providing that information
Use the equipment in the proper environment
Periodically check the equipment calibration

14. ISO Broken Down 8 – Measurement, analysis, and improvement
8.2 Monitoring and measurement:
Keep track of customer satisfaction
Examine your internal operations against requirements
Report the results to those in charge
Check to make sure problems were fixed
Watch the processes to ensure they remain capable
Check the product against requirements
8.3 Control of nonconforming product:
Keep bad stuff away from good stuff
Figure out what to do with the bad stuff

15. ISO Broken Down 8 – Measurement, analysis, and improvement (Continued)
Practice never-ending improvement
Identify problems and potential problems
Determine why the problem occurred
Fix the cause of the problem
Verify that your changes worked
We expect our employees to take a proactive role in our constant improvement. We want our employees at all levels to identify things that can make us continually better at what we do, in a way that supports our values

16. Reject Tag
Reject tags should be used to track any reject that was not created in the area found in.
Reject tags must have evidence of closure – if item was reworked upon closure state xx rework hours logged xx-xx-xx. Or if new work order was created for a scrapped part state work order xxxxxx created to replace part.

17. Quality
Responsibility for Quality lies with every employee, and is a key responsibility of every employee
If you pass along a Quality issue without reporting it, you become additionally responsible for it

18. Quality Techniques
THINK before you act
Check the print and work order for errors or questions before you begin the operations
If you have questions – Ask your supervisor!!
Understand the Quality requirements for the job
Complete the Quality checks and Quality sheets every time
If any changes are made they must be initialed and dated.
NEVER initial or sign off a Quality sheet if you have not checked the work completely

19. ISO NOTES TO BE AWARE OF
Calibration – Any tool used for accept/reject decision making must be calibrated.
Prints or any controlled Documentation – If there is a handwritten note it must be signed & Dated by lead or Project Manager, and Change process must be initiated.
Reject tags must be filled out and followed through – we must have evidence of closure
If an auditor asks you a question you are unsure of the answer it is ok to say “ I don’t know the answer to your question” it is much better to say this than pull something out of the air that you think they may want to hear.
Shelflife – Just be aware – very critical
Forklift – Do not operate a forklift unless trained and licensed to do so. If you get licensed make sure daily checklist is completed before operation of lift

20. Remember, ISO does not tell us how to do business, it supports and validates how we do it. When we can “say what we do……Do what we say” we can quickly build strong relationships with our customers.