Why do root cause analysis?
Root cause analysis will help you make lasting corrective actions which will prevent recurrences.
Why do I need Internal Auditors as part of my Quality Management System staff?
Part of any quality management system (QMS) is checking to see if you are really doing what you claim.
What’s the difference between being ISO compliant and ISO certified?
Being compliant, but not certified, is like going through college but never taking the exams to prove you learned anything.
What is ISO 14001 & why do I need it?
ISO 14001 is a standard companies use to certify their businesses have made a commitment to reducing the company's impact on the environment
What is ISO 13485 & why do I need it?
ISO 13485 takes the core quality management concepts of ISO 9001:2008 and adapts them to the medical device industry.
What is ISO 9001 & why do I need it?
The concept of ISO 9001 certification can seem overwhelming. But the truth is, ISO 9001 is really just good business practices written down.
We Don’t DO Design. Can we exclude it from our ISO certification?
What do you think of when asked if you do design--engineers? Original concept development? What about processes development?
Using external consultants to perform internal audits
While auditor objectivity is indeed enhanced by using external auditors, someone internal must be responsible for ensuring complete follow t
The Purpose of Quality Objectives
My auditor says we need Quality Objectives. What are they and why do we need them?
Strategy. Why it matters--especially if you’re small or growing
The new version of ISO 9001, to be released late in 2015, has a heavy emphasis on strategy.
