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  • Document signatures requirement

    How many signatures require on each document, like check & approval?

    For each document?
    I am working power plant, recently we start iso 9001 implementation

  • Exemption for design clause 8.3

    If we develop tools, jigs and fixtures for production operations, can we get exclusion for ISO 9001 clause 8.3 for design. Although we get drawings and product specifications from our customers, some time we have to make minor changes in the product because of our process capability constraints . Can we still get exemption for design clause 8.3? please advice

  • ISO 9001:2015 Questions

    What does Clause 6.2 exactly mean? Does every department of an organization should have a quality objective? Can operational business objective (operational target) be taken as Quality objective for an organization? What does " Organization shall establish quality objectives at relevant functions, levels and processes needed for QMS?

  • Intergaci√≥n de procedimientos

    Hola, queremos implantar las tres normas, 9001, 14001 y 45001, en este caso nos surge una duda, queríamos saber qué consejo nos daríais a la hora de decidir si deberíamos integrar en un mismo documento los tres procedimientos siguientes o si los haríais por separado, y que ventajas e inconvenientes le veis a ello. Los procedimientos serían los siguientes:

    • Procedimiento para abordar riesgos y oportunidades
    • Procedimiento dentro del plan de seguridad y salud ocupacional para abordar riesgos y oportunidades
    • Procedimiento identificación y evaluación de riesgos y aspectos ambientales
  • "Shall" statement

    I was wondering that how can we prove to the audit that a "shall" statement is fulfilled when there is no requirement in the standard about documenting the evidence of it?

  • The Auditing Process

    Please can you advise if the following is correct approach when auditing the various business areas we are in the second year of ISO Certification heading toward our first Surveillance Audit:

    The audit approach is this:
    1. Review previous comments made during Stage 2 Audit and design question accordingly.
    2. Design questions as per the process input/activity/output to establish evidence.
    3. Review Quality Management Principles to establish if the business area has applied Improvement, has leadership engaged staff, managed relationships with interested parties etc. and design questions accordingly.
    4. Review Risk Register to establish if the applicable risks to the area has been mitigated and if there are new risks and design questions accordingly.
    5. Review Goals and Objectives to establish if the targets have been achieved (process/business area dependents) and design questions accordingly.
    Other questions like do your new staff members aware of the Quality Policy and were it is situated.

    We are a small company so it makes sense for us to do the audits in one go with the above mentioned approach. It also reinforces the ISO principles and what is ISO all about with middle management.  

    Let me know what you think.

  • Input and output processes in manufacturing electronics processes

    What is the typical input and output processes in the manufacturing electronics processes in ISO9001: 2015 Quality management system?

  • Finance Dept documents that need to be controlled

    Does the ISO standard require any finance department documents need to be controlled? If so, what are they?

  • ISO 9001 exclusions

    I have an question with exclusions to the ISO 9001:2015. Since we do not do design and development we have been excluding this. However, when the new standard came into effect our external auditor said we can not exclude this section without replacing it. He suggested production management.
    From all the readings i have been doing on-line, I havent read you need to replace not exclude.
    Is this true? Can you clarify this exclusion?

  • Corrective Action Reports

    Hello, I just want to know when is the best time to follow-up the Corrective Action Report (CAR) from the date it was issued to someone. Thanks

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