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Risks and context
"How are the internal and external issues identified in Clause 4 of ISO 9001:2015 related to the risks and opportunities also mentioned in clause 4? How are the issues defined as compared to the risks and opportunities?” -
Documentation and scope
"We are planning to implement ISO 9001 to our organization. Our organization is an IT firm where we develop web applications for customers. Our business is more than 5 years old. We are in the process of completing gap analysis checklist. We are not sure with few concepts. Can you please advice us, in general, how many documents or information we need on hand to show it to the audit firm? Also, how does organization's scope works with products and services along with international standard?” -
Main changes in documentation
"What are expected changes in procedures and manual as I have already certified QMS as per ISO 9001:2008.” -
Planning changes to the QMS
"What constitutes a “change to the QMS”? Since there are now more requirements when a “change” occurs, I’d like clarification of “changes to the QMS”. (I don’t want to create work for people just because we changed a form for example.)” -
Organizational knowledge and processes or individuals
"Do we have to fill up self-designed format on OK 7.1.6 for individual or for process like Production, Eng., R & D, Marketing, SCM etc etc.” -
Cómo presentar los documentos en la auditoria
¿Es necesario tener todo impreso para la auditoría? ó ¿es posible que se revise, en una computadora? -
Deadlines for acceptance of documents
Could you be able to suggest me the decent way to set the deadline for acceptance of individual documents in the course of QMS implementation – a) in accordance with Project Tasks listed 1 to 24 or b) in accordance with Project Files 00 to 16 (in logical order)? -
Starting off ISO 9001:2015
Could you please kindly provide any guidance for me to start off ISO 9001:2015 project as I am a bit overwhelm with where to start the project. Our project team comprises 3 person – myself, CEO, Director and another P.A to CEO. -
SMART and Good Quality Objectives
"I have seen many different variations for how to interpret the “SMART” acronym. Who would be the leading authority as to which is the correct interpretation? Is it simply up to the organization to decide which variation would best fit their quality objectives? Please advise at your earliest convenience.” -
Documented information format
"What is the meaning of the term "Format"? Our documents will be created in MS Word, stored on our server. I don't know how to determine what the format means”