ISO 101

Basics you need to know

What is ISO all about anyway?

•ISO is the world standardization authority for Quality Management Systems.

•The American version is ANSI/ISO/ASQ Q9001-2000.

•Yes, ASQ approves it.

•ISO gives credibility to an organization’s quality program

•It symbolizes management commitment to quality and customer service

So why do we need it?

•Many orgs look at it as too cumbersome and is not worth the cost and effort

•But many government and commercial contracts now require that you are ISO certified.

What are the mandatory reqs for an ISO QMS?

•Documented statement of a Quality Policy and Quality objectives•A Quality Manual•Documented procedures req’d by ISO (6)•Documented procedures req’d by the organization•Records req’d by ISO (many)•Any Quality System reqs as imposed by applicable regulatory authorities (such as FDA, FAA, etc.)

The big 6 documented procedures req’d by ISO

•Section 4.2.3 Control of Documents•Section 4.2.4 Control of Records•Section 8.2.2 Planning and Conducting Audits•Section 8.3 Control of Non-conforming product•Section 8.5.2 Corrective Action•Section 8.5.3 Preventive Action

These all should be addressed in the Quality Manual.

Sorry I don’t have a record for that….

•There are at least 24 clauses in ISO that require records as objective evidence of compliance•These may include management reviews, process and product design reviews, supplier evaluations and actions, customer property treatment, product conformity evidence, calibration records, non-conformity actions, concessions if any, results of corrective action, root causes, evidence reqs are fulfilled, quality record retention time, results of internal audits, education, training, skills and experience, among others.

What will the auditor look for ?

•Were there any major findings last time?•Was there any other findings?•Were there recommendations ?•What are problem areas that VP or Project Director want to address?•Review QPs and check to see they are adhered. •Records, records, and records

–Objective evidence can be when an operator explains a work instruction and demonstrates the procedure.

Some examples

•Labs/Metrology –Are there calibration stickers, log book, etc. What is the treatment for ESD? What is the process for it? Are they following process? Why not. Does all equipment need calibration?

•GFE property–Is there traceability? Has it been transferred? Where is it? What’s the value? What condition is it in?

•Shipping/Receiving–What is the process for accepting goods from suppliers? Where’s the log book? Do you have Non-Conforming product? What is the procedure for handling it?

•Contracts–Is there a PMP? Is there a template for the PM file? Is everything there that should be? Are there mods? Are they approved by the client? Is the company operating at risk? Is the customer satisfied? Have we delivered on time?

Ok, I conform. What else does ISO do?

•ISO pushes the plan, do, check, act improvement process. But auditors aren’t really looking for it.

•But it all boils down to having some type of improvement process in place. How do you get improvements into the system? How are those improvements measured, and shared?

•Join us in December to find out how to improve your bottom line by following ISO.