audit scope

  1. F

    Information Technology in IATF 16949 audit scope

    Hello all, This is my first time post in the COVE. I have question regarding internal audit for IT dept that need your advise. I used Turtle diagram when commencing the audit. When we go through the "IT Infrastructure" part, I asked about the server room and the required control condition...
  2. S

    Initial Importer and ISO 13485 (MDSAP) - Will the US company be included?

    If a parent company has a branch in the US who acts as the initial importer, is the parent or head office required to do an internal audit of the US distributor/initial importer? Note: the parent company has full control of the child initial importer. For the MDSAP audit of the head office...
  3. nantmel

    Does 13485 auditor have a right to inspect non-CE products?

    Hi all, This is a debate that I've been having with my boss at the moment... We are an ISO13485 registered company making medical devices for the EU market predominantly. However, we also have a 510K exempt product being sold in America. We have a 13485 surveillance audit coming up, and there...
  4. K

    Internal Audit Scope and Criteria

    I am an internal auditor. ISO 9001 requires that an audit scope and criteria be set for each audit. My question is... can you have one audit scope and criteria for all audits? Here is an example of my generic audit scope/criteria that i put with my audit plan. Would this satisfy that...
  5. M

    Auditing a Contractor in EMS and Non Conformity Report

    Mabuhay! I am Ian and have been reading different posts in this site for several months now. Please help me clarify some issues: 1. When I am auditing our contractor against a Contractor Agreement (requirement) that we have provided them related to our EMS, am I right in saying that I could...
  6. K

    ISO 9001:2015 clause 9.2.2 a. - Define the audit criteria and scope

    Hello, i was recently going through the new standard (ISO 9001:2015) and was wondering what certification bodies will be looking for with this clause "The organization shall: define the audit criteria and scope for each audit" We do not have a "scope" per say, but we do have a matrix of...
  7. V

    Periodic Audit Trail Review - Scope, Content & Frequency

    'audit trail review' is required to reflect the state of 'control' and usually carried out at broadly two levels. 1. at the end and specific to the unit-operation / analysis (batch or unit operation or analysis for specific equipment)...there is broad clarity on the audit trail review criteria...
  8. GStough

    Nonconformance Found Outside the Audit Scope - Supplier Audit

    I'm wondering if anyone else has had this happen. During a supplier audit (which is not a full QMS audit), while interviewing and reviewing records for an element of the Standard (ISO 13485, in this case) that is part of the audit scope, you discover a nonconformance of an element that is NOT...
  9. E

    Audit Focus Area: Tribal Knowledge

    Our auditor started off this years audit stating that in their audit they had a finding in not identifying Focus Areas. This was all that I am aware of he mentioning during our 2nd Surveillance audit. Our 1st Surveillance Report indicates "No Focus Areas were identified" with no rating...
  10. F

    ISO/TS 16949 - Auditing supporting activities

    Hi, we have a remote location for a design function that was audited last year in october. Due the fact the site (plant) where the remote location is located will be audited in march this year. We would like to shift the audit for the remote location from october to march (cluster) but seems...
  11. F

    ISO/TS 16949 internal audit scope and annual plan

    Hi, in clause 8.2.2.4 stand "Internal audits shall cover all management related processes, activities and shifts, and shall be scheduled according to an annual plan". My question, means that: 1). that ALL "related processes, activities and shifts" must be audit within a period of one (1)...
  12. L

    Registrar Audit Scope and Limits

    I am getting ready to have an animated discussion with our company's EHS manager regarding our 3rd party registrar auditor's latitude in his auditing. In our last audit, a finding was written for failure to implement and maintain proper EMS training. This has now morphed into a much larger...
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