Author Archives: Ask The Experts

Can a soon-to-be ISO 17025 certified charge its own fees as a company separate from its parent company?

Question: We are in the process of getting our new laboratory ISO 17025 certified. At this moment, our lab is a part of a parent organization. However, it has been requested that the lab should have its own name and … Continue reading

Posted in Other

Conducting an internal audit before a third-party audit

Question Shouldn’t a company audit its own processes and procedures to ensure compliance before a third-party audit is scheduled? Answer Thanks for contacting ASQ’s Ask the Experts Program.  In response to your inquiry, yes, it would be a good idea … Continue reading

Posted in Other

Receiving a signed audit report post-audit

Question Is it acceptable for an auditor to submit an UNSIGNED audit report in Word version? I’m QA director at a pharmaceutical CRO. We were recently audited by one of our clients. They refuse to provide a signed audit report … Continue reading

Posted in Other | 1 Comment

Audit Versus Inspection?

Question Would you please tell me what the differences between audit and inspection are? Answer This is a great question.   We can start with the definitions of inspection and audit per the new ISO 9000:2015 standard.  Inspection is “Determination of … Continue reading

Posted in Auditing, Other | Tagged | 1 Comment

Transitioning to ISO 9001: 2015

Question ISO 2015 has a 3 year implementation period. I recertified in 2014 and need to recertify in 2017. At this point I have a little under one year to transition instead of the 3 years identified. What alternatives are … Continue reading

Posted in ISO 9001 - Quality Management Systems, Other | Tagged , ,

Switching Rules

Question  We are planning to implement ANSI/ASQ Z1.4-2003(R2013) sampling inspection plan with our Finish products which are currently 100% inspected by QC Inspectors.  I read  about the importance of the switching rules  on a continuing stream of lots and have the … Continue reading

Posted in Other, Z1.4 & Z1.9 - Sampling

ISO 9001:2015 Documented Information Requirements

Question I am trying to ascertain if I need to write a Quality Manual to comply with ISO 9001:2015. I see some clauses require ‘documented information’. Do I just address those or the entire document? Answer Thank you for the … Continue reading

Posted in ISO 9001 - Quality Management Systems, Other | Tagged ,