Introduction to ISO & The Quality Process

“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”

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

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

Standard consists of 8 Elements 0-3 are introductory and administrative 4 5 8 6 7

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

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

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

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

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

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

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

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

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

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

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.

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

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

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

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.