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Safety and ISO 9001:2015
"I would like to know - if safety is incorporated into the ISO 9001:2015 standard?” -
External and internal context and interested parties
"Can you please guide me on what all external and internal issues would be there for a lubricant quality control Lab. Also who all would be the interested parties and how would I know their requirements?” -
Design validation
"We manufacture standard product through a catalog with high customization adders. They are made to order applications. When standard product was originally designed, a full verification and validation process was performed. The ISO9001 auditor says I actually have no "validation" step. I cannot create a prototype for a one-time project. What is the implication of the "validation" in a make to order design and manufacturing?” -
Quality policy and quality objectives
"I want to know how to design Quality Policy and how to convert in measurable form. Need some examples” -
Risks and opportunities and organizational knowledge
1) What are the best samples to show on the auditor for R & O (Risk and Opportunities)? My company are doing the injection molding for plastics product. Our process need to do the FMEA for our customer but I am not sure how to link with the R&O. -
ISO 9001 certification
"I need set up ISO 9001 for our corp. if we are not manufacture, we are only purchase material from other manufacture, inventory and ship direct to our customer. Is that qualify for apply ISO9001? Or need ISO14001 or others?” -
Quality Manual content
"I am looking to simplify my organisation’s quality manual. Before I can do that, I am needing a comprehensive knowledge of the structure of the manual. What is a quality manual? What is the simplest way to structure it?” -
Deciding on what to check
"We are a ISO 9001-2008 company specialized in fabrication of various steel structures for construction projects. As a contractor or subcontractor company our scope include painting of fabricated steel structures prior to releasing to the client. Recently we are getting ISO auditions to get ISO 9001-2015 for our company. During audits we are requested by ABS auditor to witness testing of certified painting materials for viscosity or flow properties before application(painting). Auditor insisted on this and explained it as a requirement of ISO 9001-2015. Could you please explain if it is actually required by ISO 9001? or not? Can the auditor raise NCR to our company and refrain to submit the subject management standard?” -
Documenting the context
"I am working in cement plant and our management planning to implement the standard ISO 9001:2015 with in next 3 months. please explain the documentation for context of organization and legal requirement”