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Lab Software
I am wondering if you could tell me which standards would be required for a piece of lab software. The software tracks actions include cell culture trees, electronic lab notebook, cell line inventory, collaboration, and gene sequencing capabilities. -
CAN I EXCLUDE CHAPTER 8.3 ON DESIGN AND DEVELOPMENT FROM THE SCOPE OF THE QUALITY MANAGEMENT SYSTEM?
I work in a metalworking company where stamped and machined parts are made, we make all the products according to the plans that the clients give us. In the company there is an engineering process that verifies whether or not this design can be carried out on the machines that the company has. so I have doubts whether or not to include the design process -
PUEDO EXCLUIR DEL ALCANSE DEL SISTEMA DE GESTION DE CALIDAD EL CAPITULO 8.3 DE DISEÑO Y DESARROLLO
Trabajo en una empresa de metalmecanica donde se elaboraran piezas troqueladas y maquinadas, nosotros realizamos todos los poductos segun los planos que nos entregan los clientes. en la empresa hay un proceso de ingenieria que verifica si ese diseño se puede realizar o no en las maquinas que tiene la empresa. entoces tengo dudas si incluir o no el proceso de diseño -
ISO 9001 8.3 in a fertility clinic setting
Client provides fertility services but they can't always guarantee they will be successful of course. But theyensure the service, the information patients are provided with, the tests they receive, and the way people are treated is consistent. Can I exclude Clause 8.3 do you think? I always struggle with this clause in a service situation -
Interested Parties
The current question is about interested parties. We identified our QMS scope as the custom software development. So that all our software development projects are unique and we don't have our own products. We get initial requirements from a customer and, generally speaking, transform the requirements into custom software. In connection to this I can't get what possible interested parties we could identify here taking into account that we deal almost always with new customers for any new projects? What could be examples of interested parties in our case?
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Surveillance audit
During a surveillance audit, how far back will the audit look for documentation? 12 months? More than 12 months? -
Normative Reference
Do I need to express normative reference in our new Manual according to ISO 9001:2015?
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ISO 9001 Audit
Is it a requirement for the company to provide a training record of employees who joined before ISO 9001-2015 implementation for audit purposes? -
Can the Procedure for Design and Development be applied in my company?
At the moment I intend to implement a QMS based on the ISO 9001: 2015 standard in my company, which is specialized in the sale of electronic products and provides technical assistance services. I would like to know if the procedure for design and development can be applied in my company? Although my company does not produce the products it sells. -
Implementing the ISO 9001 standard for an Information Technology company
I am working on implementing the ISO 9001 standard for an Information Technology company. They do not have any in-house manufacturing of equipment or hardware. They only offer IT services such as Managed Services, Cybersecurity, reseller or Hardware, a reseller of Software, VoIP, Access control. What clauses will be applicable for them in ISO9001? Also, do you have a toolkit that is specifically for the IT industry?