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Rework is not mandatory
"I have question about the rework on finished goods. If the product is the plywood adhesive (eg: urea formaldehyde), and if the product is nonconforming to the specification in the final inspection, how can we do rework on it? Or we can't even rework on this kind of product and only can be scrapped?” -
Context of the organization and interested parties
Please help me determine our internal interested parties, issues, needs and expectations etc as applicable in our following context. We deliver Eye Care services on ambulatory ( day care) basis. Kindly help me interpret these terms in our scenario. -
Documenting in ISO 9001:2015
What are the changes that should be done in an existing document procedure in a company? Here my company the relevant officers have involved to obtain ISO 9001:2005 with a separate team for the purpose. We have no experience about ISO. I have prepared a proper filing system and document handling procedure in our company. This system is fully established and functioning now in all the sections. It is so methodical and practical. If you want I can give you examples too. But It says that all these numbering methods and procedure and formats should be changed up to ISO requirements. Is it necessary.? Because I will be in a mess with this huge change as I was the responsible person of total of this filing system and all the Documentation in the company. What are the requirement of this changes to ISO. Or is it OK to continue with our own numbering system? -
Awareness sessions
I would appreciate receiving your advise on the following: Currently I am working in a team that assist Local Authorities in a district of Moldova to set up a WSS Regional Operator based on an existing municipal operator. People never delt with ISOs.. My approach is to organize an Inception Training (4-6 Hours) on ISO 9001 for the Management level hat will migrate to the new operator. Do you think it make sense ? -
Gap analysis versus internal audit
"We have transitioned to the 2015 9001 & 14001 standards this year. As part of the preparation, we did a full gap analysis against each clause of the stds. Do we still need to do an internal audit? is it not answering the same questions?” -
Auditor's checklists
"We are in the final phase of the implementation of the quality management system (ISO9001 V 2015) in our power plant, we have been audited (white audit) and I found that the auditor focused on the mastery of the activity more than formalities More than the formalities. Since we have developed processes and procedures, we have to use the risk approach as well. My question is - does each auditor have his own checklist and can he focus only on formalities.” -
Exclusions in ISO 9001:2015
I want to ask a question or consult, if a company manufactures something under the variables established by the client. Do you think you should exclude the product development point? -
Cómo definir el alcance
Actualmente trabajo en una empresa de desarrollo de software y contamos con certificación en un modelo de calidad llamado cmmi , pero éste certifica al área de desarrollo (producción) mi duda es la siguiente: si yo cuento con departamentos como finanzas, área comercial, ventas, etc. ¿puedo separar todas esas áreas y certificarlas como una empresa "interna" y que el área de desarrollo sea mi cliente??? Esto tomando en cuenta que la norma te habla de un cliente y de una organización, pero aquí todo seria interno. -
Certification scope and international activities
"If a certification scope covers the activities carried out by the operatives of an international business unit of a parent organisation, must I nominate the countries, or the offices within those countries, in the defined scope (I mean on the certificate)? If my processes are central, does this not then mean that the business unit, wherever its operatives function from, is entirely in scope anyway. Would naming the countries make any geographical mention in the certification scope serve as a preclusive factor rather than an inclusive factor? I’d rather carry out audits and have my certifying body audit remotely based on projects undertaken rather than visit the offices in countries in which my operatives may operate from. Other than possible legislatory variations as the business is run internationally, I don’t see that my certification scope has any real geographical aspect. Do you have any advice?” -
Involvement of corporation
"Our site is owned by a company in the US. If our (UK) site is aiming for certification, would management review need to involve the US directors?”