ISO 101

1
ISO 101

• Basics you need to know

2
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 organizations
  quality program
• It symbolizes management commitment to quality
  and customer service

3
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.

4
What are the mandatory reqs for an ISO QMS?

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

5
The big 6 documented procedures reqd 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.

6
Sorry I dont 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.

7
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.

8
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? Whats the value? What condition is
  it in?
• Shipping/Receiving
• What is the process for accepting goods from
  suppliers? Wheres 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?

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Ok, I conform. What else does ISO do?

• ISO pushes the plan, do, check, act improvement
  process. But auditors arent 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.