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  • Quality plan for service or colective

    I intend to implement the ISO 9001: 2015 standard in my company, which is a service company, so I am stuck in filling in the documents for the production and service delivery procedure. I would like to know if, while filling out the quality plan, should I fill in the quality plan for each service to be provided or should I fill in a single quality plan for the various services?

  • When to Do Internal Documentation Review

    When is the best time to do a company internal ISO 9001:2015 Documentation Review?

  • ISO 9001 Clause 8.2.3.2

    If we are a warehouse and distribution company would this section (Clause 8.2.3.2) be relevant to us? We do not manufacture any products. We provide storage and distribution of our client's products. 

  • 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?

  • 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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