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  • Prioridades en la implementación

    Qué es lo más importante, como priorizar, como aplicar?

  • Tackling clause 8.5.1

    Hi, I am a production manager at a soap manufacturing company. How do I tackle clause 8.5 production and service provision 8.5.1 F which says [the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement?

  • Framing Standard Process Conditions (SPC) and specifications

    We are manufacturing color concentrates for plastic industry. Daily we are adding new products in terms of new colors required by our customers, hence daily we are developing 10-15 new colors based on almost identical recipes and ingredients (RMs) by simply changing % of RMs. 
    How to frame Standard Process Conditions (SPC) and specifications and for individual product in such a scenario for reference and adhering to ISO requirements as it is highly impossible to frame new specifications and process parameters on daily basis. Please guide us how to address this issue. 

  • Mandatory roles in ISO 9001

    In ISO 9001, which roles are mandatory? Quality Manager I guess, something else?

  • ISO 9001 Implementation timeline and costs

    Hello, I'm just starting to evaluate the cost efficiency for obtaining an ISO 9001 certification.  I would like to know more about the process involved for a small electronics assembly contract manufacturing.  I would like to speak with someone about the timeline and costs involved.

  • ISO 9001 Internal audit clauses


    What are the exact clauses you have to include in ISO 9001 internal audits?

  • Remote audits recordings

    Can auditors request you to record remote audits?

  • Change of the quality manual's mandatory status

    A quality manual will not be a mandatory document for a quality management system (QMS), according to the available version of the ISO/DIS 9001:2015 standard. How did that happen? The quality manual was one of the first documents that a certification body asked for before the certification audit. How has it suddenly lost its purpose and importance?

    Where is this quoted in the ISO 9001:2015 standard?  Thanks for your help

  • Internal audit requirements

    Any single document which is fulfil requirement of Internal audit

  • ISO 9001 controlled document list

    Is ISO 9001-2015 controlled document lists should include all supportive document listed on QMS? 
    For example software programs ( engage , SAP, tags used day to day operations used) I really appreciate your help regards!
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