Author Archives: Ask The Experts

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 , , | Leave a comment

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 | Leave a comment

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 ,

Value Stream Mapping

Question We produce plastic fittings and pipes. We only have one process: only one machine is needed to produce a product.  Can we still benefit from Value Stream Mapping? If yes, could you please explain how? Answer Thank you for … Continue reading

Posted in Other | Tagged

ISO 9001: 2015 Deliverables and Processes

Question Under the revised ISO 9001 2015 standard, what do you see as the key deliverables and processes owned by the Quality manager or QA department? Answer A project or process is made up of primary components aimed toward successful … Continue reading

Posted in ISO 9001 - Quality Management Systems | Tagged ,

ISO 9001: 2015 Design and Development Clause

Question We are service providers in NDT and inspection field. I want to know how to implement the design and development clause from ISO 9001-2015. Answer There are two ways to approach this: One is to use the process developed … Continue reading

Posted in ISO 9001 - Quality Management Systems | Tagged