"I am a QA/QC manager of spiral pipe manufacture. I met some difference issues between ISO 9001-2008 and ISO 9001-2015. Please clarify standard requirement. As you know pipe manufacturer use different types of raw materials for production. For example: Polyethylene, Epoxy, Coil. All of this raw material manufacturer needs to be audited?”
Audit preparation
" If one ever goes to audit a company, and the company hand in their documentation, prior to audit, and the person (auditor) is given an hour to go through, what must catch the auditor's eye to be efficient later during auditing?
Regarding the clause 6.3
"My doubt regarding the clause 6.3 are: 1. When new suppliers are added or removed should we use change request form and log?”
Performance objectives and strategic objectives
"I'm not sure to know how to distinguish performance objectives and strategic objectives especially for the monitoring at the level of the quality management system. Can you advise me?”
Processes and hospitals
"What are the examples of a process in hospitals? Say in the nursing service department. Is discharging a patient one of them? How can I find the legal requirements and obligations applicable to these processes?”
Selection of Quality Manager
So what is your suggestion toward the selection of Quality Manager(you said Project manager)? But as well what you advise us on the delaying of some process owner on preparing and submission of their procedures?
Conducting a full desk audit
How to conduct a full desk audit?
Performance against management system objectives
“Performance against the client management system objectives - This is an aspect identified on an LRQA visit report, due for audit. What aspects are these for a typical manufacturing company. Would the assessor expect to see...”
Excluding the Finance Department
"As stated on ISO 9001:2015 as basis of IATF 16949:2016, it is mentioned about the risk assessment. I would like to know if risk assessment is needed for our Finance Team
Determining risks and opportunities
"We need some examples for the risk and opportunities in the line of paint industries.”