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Transition of ISO 13485 and maintaining ISO 9001
Our company is manufacturing of Customize Orthopedic shoes . As of now we are currently holding the ISO 9001:2008 and ISO 13485:2012 and have a plan to upgrade in to ISO 13485:2016 by next year. Is it possible to cancel the ISO 9001:2008 and focus to ISO 13485. what do you advice. -
Qualifications of the Management Representative
1.What if the appointed QMR has no background in ISO is she/he qualified to be QMR or not? -
Implementing ISO 9001 in hospital
I want to implement the ISO standard a in my Hospital . Can you guide me for the same . I need the standard manual , the step wise detailing for ISO certification -
Quality manual and procedures in small company
I need to write a quality manual for a small manufacturing company. I am confused by all the documents that are referred to in a Quality Manual -what should be included in a quality manual - are all the external docs required also? -
Risks assessment in ISO 9001
Hope you will be fine & in good health. -
Getting certified
I have a small accounting firm in FL. I would like to take it to the next level by getting certified. -
QMS in pharmaceutical distribution company
My company intends to import its own branded drugs from India and distribute same. We are still at the regulatory stage. Current Good Distribution Practices Guideline cGDP recommends a quality management system to be implemented, and so i started the course on ISO 9001 foundation. I am trying to define the scope of the QMS that will be implemented but am still confused on the types of documentation that will be required cause what am seeing mostly from your list is for manufacturers. -
Documentation for internal audit
Good afternoon first thanks in advance, I could answer this question ??, there is a document to be prepared as an auditor before an audit ?? I can give some examples of how I can use ??, Thanks