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  • Before certification audit

    "For first time certification audit preparation, the organization must conduct management review and internal audit? Please explain.”
  • Recruitment and competencies

    "I Recruit for Cruise line and I need to be MLC compliant. They mention using the ISO standard, so I am wondering where to look for the section that would help me.”
  • Gap Analysis

    "I recently started working at CNC machine shop. They hired a consultant to do all paperwork that ISO 9001 required (QMS manual, QAM, etc.) it’s never been revised. I trying to work on it for the first time as a challenge to improve my qualifications and demonstrate that I can do more than I do right now. How would I know that what they have now it's good to be audit or revised?”
  • Selling consulting services

    "CONSULTING FOR A PHARMACEUTICAL COMPANY ON ISO 9001 CERTIFICATION. I WANT TO KNOW HOW TO GO ABOUT WITH WRITING THE PROPOSAL, AND ALSO HOW TO BILL THE COMPANY FOR MY SERVICES. WHAT PROCESS DO I NEED TO GO THROUGH TO ACHIEVE THIS?”
  • ISO9001: Integrating QMS and Business Processes

    How can I integrate business process with quality management system process? (Regarding article: https://advisera.com/9001academy/blog/2017/03/07/aligning-quality-objectives-of-the-qms-with-the-strategic-direction-of-the-company/)
  • QMS implementation priority

    "I am student currently working on my master thesis with the topic of the implementation of QMS in SMEs. The topic deals with the question, which parts/components of a QMS a SME should implement first in order to have the fastest results and the best cost/impact ratio. It might be important to know that because SME often don’t have the resources to implement the complete QMS at one time, but rather would implement the components that have the most positive impact in a short period of time. After successful implementation they can also implement step by step the other components. Like an evolutionary QMS. DO you have any literature or advice that could help me deal with that topic?”
  • Training or awareness

    "i have created a new attendance register for our contractors i am not sure under which clause it must be filed, 7.2 or 7.3?”
  • Internal auditor requirements

    "if the company hire a consultant/internal auditor to perform the internal audit, is a mandatory requirement for the organization/company still have a onsite internal auditor on its own?”
  • Considering processes

    "I have from a historical heritage 6 Business Units on which quality practices are so different. I want to implement a unique certified QMS, with a Top down approach: defining processes for the Whole system and deploying it on Business units. Can specific activities of some Business units not to be described?”
  • Maintenance as a main process?

    Hello, please we are implementing qms iso 9001 on several power plants of my company. Now we are in process identification. And we find that some consultant have identified préventive maintenance as a main process, because as they have said that without preventive maintenance there is no production and also because we have a lot of people work in maintenance Other consultant identified it as support and they choose with the production process the predictive maintenance, so I'M confused ! knowing that our core business is the production of electricity. We dont earn money from maintenance. Thank you much in advance