interpretations

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    New FAQ & SI -IATF 16949 - Effect in april and june 2018

    Hello everyone I share with you new IATF publications, to take into account in your transition audits: - IATF 16949: 2016 Frequently asked questions (FAQ) No. 1-20 - IATF 16949: 2016 Sanctioned Interpretations (SIs) # 1-11 (# 10-11 in effect in June 2018) I share the Link: International...
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    CSA Z299.3-85 Nuclear interpretation

    So glad Elsmar is back! Can I say that again?!! On to the question: I have a customer that is insisting we add our suppliers names to each part numbers ITP and their quality program. We sell many parts to them - and it is our policy to not include where we get everything. So we told the...
  3. S

    Interpretation or Definition of ‘Once Every 5 Days’

    In one of my documents, I require that all employees review the documents for their area 'once every 5 days'. The employees are now requesting the definition of 'once every 5 days'. The last time I was asked to clarify what the word 'weekly' meant. Give me some ideas before I pull my hair...
  4. B

    IATF 16949 Section 8.5.1.5 (Total Productive Maintenance)

    Section 8.5.1.5, Total Productive Maintenance, of the IATF 16949 standard has a requirement that states that the total productive maintenance system shall include f) documented maintenance objectives, for example: OEE, MTBF, MTTR, and Preventive Maintenance compliance metrics. Since the...
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    ME (Medical Equipment) Systems - IEC 60601-1 Clause 16.1 Interpretation

    60601-1 cl. 16.1 states that the ME system shall provide: outside the PATIENT ENVIRONMENT, the level of safety equivalent to equipment complying with their respective IEC or ISO safety standards. I need to understand better what "the level of safety equivalent to equipment complying with...
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    IFU and deviation 7 in ISO 14971 Annex ZA

    Hello all, I have some questions regarding interpretation of the requirements related to EN ISO 14971:2012 (I use ‘ISO 14971’ interchangeably below) and ISO 62304:2006. Note that I am fairly new to the Cove; I posted 1 question last year and couldn't even figure out how to find it again on the...
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    Interpreting Deviations 5 & 6 in Annex ZA in ISO 14971:2012

    Hello all, I have some questions regarding interpretation of the requirements related to EN ISO 14971:2012 (I use ‘ISO 14971’ interchangeably below) and ISO 62304:2006. Note that I am fairly new to the Cove; I posted 1 question last year and couldn't even figure out how to find it again on the...
  8. B

    Interpreting "misuse" when assessing Hazardous Situations

    Hello all, I have some questions regarding interpretation of the requirements related to EN ISO 14971:2012 (I use ‘ISO 14971’ interchangeably below) and ISO 62304:2006. Note that I am fairly new to the Cove; I posted 1 question last year and couldn't even figure out how to find it again on the...
  9. N

    ISO9001:2015 clause 7.1.5 "Resources" (Formerly "Equipment")

    I think I'm getting caught up in the word "resources" - for this clause, we need to ensure that we have equipment that is suitable and maintained, but when I see the word resources I think people... am I reading to much into this? I have been looking at this standard all day:bonk: Thanks Covers!
  10. M

    Is Identification of Risks and Opportunities required for QMS Processes?

    Dear all I searched in ISO 9001 requirements to find a requirement about the necessity for risk identification for any QMS processes. As you know, in 4.4.1 f) the standard requires that the QMS process shall address risks and opportunities determined in accordance with the requirement of...
  11. M

    IATF 16949 - 7.1.3.1 Plant, Facility, and Equipment Planning - Interpretation

    Hello all I have confused with the requirement of clause 7.1.3.1 about manufacturing feasibility. In that clause the standard states: Methods shall be developed and implemented to evaluate manufacturing feasibility for new product or new operations. Manufacturing feasibility assessments...
  12. D

    Interpretation of new IAQG ruling - Audit duration for nonconformance verification

    9104-001 Clauses 8.2.c) - Increased audit duration for nonconformance verification A standard increase in audit duration specific to corrective action verification (e.g. ½ day) is not required. The audit plan shall clearly indicate the corrective action verification activity with appropriate...
  13. Sorin

    Heat Treatment - Soaking time interpretation

    So..the spec in question requirement is as follows: ''60 minutes minimum plus a further 60 minutes per each inch (25.4 mm) of thickness or fraction thereof.'' My interpretation is that the soaking time will be 60 mins plus 60 mins for each inch or fraction of a inch of thickness. Ex...
  14. L

    Interpretation of "Any or All"'?

    L.S. We had an in-house discussion on how to interpret the phrase "Any or All" that is used in various clauses. My native English team-leader says that the common interpretation of the phrase is apply it on one, all or any combination. I am native Dutch and I try to interpret it the way it...
  15. M

    Recent ISO 9001 Re-registration Audit Questions

    Hello everyone, I'm actually looking to get some feedback on interpretations of a few things. We've just gone through our re-registration audit late last week. And while we didn't get any findings, our auditor's style is one that he hints towards things he's going to look at during our next...
  16. D

    Hot Line (Safety) Rescue Hook Testing - 29 CFR Part 1910

    Looking for interpretation of the OSHA regulation and feedback on how others in industry manage their hot line tools. OSHA Regulation for In-Service Maintenance and Electrical Testing of Live-Line Tools" 29 CFR Part 1910 - Federal Register Vol 59, No. 20, 1-31-94, 2(iii): "Live-line tools used...
  17. 0

    ISO 9001:2008 interpretation not the same per country? (Netherlands and France)

    Hi all, I came across a strange event last year. Our site in France was preparing for the ISO 9001:2008 certification. To support the site they had make use of a ISO person who helped them with their compliance towards ISO 9001. Due to some changes in the quality control...
  18. M

    Multiple Standard Interpretation Queries

    I have been lately plagued with a client who insists on dealing with a specific CB with whom I have witnessed multiple auditing issues whether in relation to auditing behavior, process or competence in accurately interpreting the standard. Please respond to some of the fillowing queries, as...
  19. S

    TS16949 - 8.2.3.1 - Processes for Key and Critical Characteristic Dimensions

    Hi everyone! I've searched the related threads and still find myself a bit confused on this section. Looking at section 7.2.1.1 and 7.5.1.1, I interpret section 8.2.3.1 as pertaining to processes for key/critical dimensions. Is that correct? Thanks for your help!
  20. M

    Differing interpretations in ISO 17025 and 21CFR820.72(b)(2)

    I need help with an interpretation of applying ISO17025 and 21CFR Part820.72(b)(2). I will start by saying we are using external calibration labs for our calibration services. When talking with a test tech in our company, I found out that some of our equipment that has been calibrated does...
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