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  • 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? 

  • 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?

  • Applicable ISO 9001 clauses for implementation in a software company

    I am working with a company who develops no hardware, only ML based software. What are the mandatory clauses of ISO 9001 that apply to them if they need to go for a certification? No manufacturing, no plants, only software. What is the best approach for them?

  • SWOT analysis and management structure in ISO 9001

    I want to understand the frame/process that is followed in creating an ISO management documentation - are you able to provide a structure.

    Also I liked that a SWOT analysis is carried out.  Is a SWOT always carried out?

  • Clause 8.5.4 Preservation

    Can you please clarify what this clause means? what is required? how can I demonstrate compliance? 

    8.5.4 Preservation


    The organization shall preserve the outputs during production and service provision, to the extent
    necessary to ensure conformity to requirements.


    NOTE: Preservation can include identification, handling, contamination control, packaging, storage,
    transmission or transportation, and protection.

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