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ISO 9001 - Expert Advice Community

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  • In-house verification instead of outside calibration

    "In ISO 9001 there is a section on calibration of equipment. Do you need to send verniers, dial gauges to a lab for calibration or can this be done in house as verification on a set of calibrated verification blocks?”
  • Stage 1 and stage 2 audits

    " I am also looking at what auditors look at when conducting stage 1 audit and stage 2 for ISO 22000 certification. Similarly, what questions i should expect for stage 2 audit of ISO 9001:2015
  • Implementation duration

    "I have recently began working for a new company that is not certified but has their QMS based on the ISO9002/ 1994 standard. (which is 18 years obsolete!) I came from a company that was ISO9001/2008 certified and my job/ goal is to bring the QMS up to date and follow the 2015 standard. How big of a challenge do you think this will be for one person and how long might it take to implement?”
  • Auditor certifications

    "I am taking the fundamentals of ISO for the 2015 revision and will also take the Internal auditing class. I used to be the general manager of a manufacturing plant in china where I oversaw the ISO implementation and participated heavily in it as I had a lot of experience in CSa standards (Canadian) and business process engineering working for Deloitte consulting. But it looks like for the auditor certifications themselves you still need actual auditing experience on ISO projects. Is this true and will my other experience and education be a substitute? If not then what will I actually get out of this when I pass the exams? "
  • Context and organizational chart

    "I’d like to understand context identification (ISO 9001:2015, Section 4.1) within the organizational chart.”
  • Objectives and KPIs

    "Is there a difference between an objective and a KPI? An auditor picked us up and said that our Objectives were KPI's. I'm still confused about the difference.”
  • Scope and external facilities

    "We have external warehouses located across the country and it was questioned if 1.-Do these need to be included in our scope and 2.-Do these warehouses require external auditing?”
  • Linking interested parties, processes, risks/opportunities and corrective action

    "How to link processes with interested parties, their needs and expectations, core issues w.r.t. interested parties and risk/opportunity with corrective action.”
  • Suppliers approved by customers and procedure requirement

    "If the suppliers we use have been approved by our customers, do we need to have a Procedure for Purchasing and Evaluation of Suppliers? or an approved checklist?”
  • Auditees and corrective actions

    "I am wanting to know reasons why corrective action procedures need to be agreed with auditees.”