qms (quality management system)

  1. T

    QMS Template Help - Small machine shop/job shop

    I am looking for a template for a QSM for a small machine shop/job shop
  2. Q

    Looking for a consultant to assist with CE marking self declaration

    Looking for a consultant in the Seattle area for help with our CE documentation for self-certification (testing completed) and implementing a non ISO - QMS system. The process started but expertise is needed at a high level to get the major components in place.
  3. J

    Choosing QMS Software for Aerospace Company

    First time to post here...I've been a Elsmar Cove viewer for years but never had the need to post. I have read through a lot of threads concerning QMS software but I haven't seen what I'm looking for. That in itself concerns me so I've decided to ask the question. I work for a small...
  4. J

    Control of nonconforming product issue (AS91000)

    Here's my issue. I work at a plastic injection / CNC machine shop. A few years ago when we were getting ready to conform to AS9100C and receive our first audit, the solution we were given by our consultant to address the need for control of nonconforming product was to build a type of cage that...
  5. U

    ISO QMS System Diagram

    If anyone has an editable version of the one I have attached or similar but for ISO 9001:2015, it would be greatly appreciated.
  6. S

    Source of QMS templates including templates for design verification/design validation

    Hi everyone, Does anyone know a good source of QMS templates including templates for design verification/design validation documents as well as device history record documents? While I have a good idea of what to construct for these templates, I would like to see what others have done to see...
  7. eule del ayre

    Lean Six Sigma for Quality Management System

    Can anyone sight me an insight on what to lean in the Quality System Management? For example? Give something to start with?
  8. K

    QMS Improvement - Analyze the systemic weaknesses of the QMS for improvement purpose

    Hello Cove members, Appreciate some reference explanation for the below : 1. If i would like to analyze the systemic weaknesses of the QMS for improvement purpose, how shall i start? 2. How could i perform benchmark and system process mapping to validate and identify best practices for the...
  9. QIE

    QMS and PLM software recommendations

    We are in the process of evaluating QMS and PLM software packages. Can anyone share experience with Arena, Propel, Master Control or Greenlight Guru? Are there others we should dive into? We're a small company with two manufacturing sites and need to get away from all this paper.
  10. M

    QMS Efficiency KPI as a Manager.

    I am a Quality Manager, using COPQ as a means of monitoring my QMS Effectiveness but the KPI I am using for QMS Efficiency is weak... Can someone provide examples of Quality Department or QMS Efficiency they use ?
  11. R

    ISO9001 & ISO13485 QMS for 2 types of products

    Hello everybody, first post on the forum :) I am currently working in a small company; our customers are mainly industrials and laboratories. We don’t have a complete QMS and we are not ISO 9001 compliant. The management want to get the ISO 9001 certificate; and I have started to work on the...
  12. V

    MAQMSR Checklist Wanted

    Does anyone have, or can direct me to an MAQMSR (Minimum Automotive Quality Management System Requirements for Sub-Tier Suppliers) checklist? I have the standard but am trying to not recreate a checklist if possible.
  13. Q

    Have you ever "excluded" certain job descriptions from the QMS?

    In order to fill gaps in our Training, I assigned relevant procedures for each Job Description at our company. I created this matrix based on on the documented job description and the extent to which I felt that position was involved with the documents/procedures. My Controlled threw a fit...
  14. J

    Training Personnel on the QMS - 7.3 Awareness or Competence

    Hi In regards to training personnel specifically on how QMS processes are addressed (QMS policies, written procedures, instruction, records, tags, forms, quarantine, etc.), would this be classified under 7.3 c) - contribution to effectiveness of the QMS, or 7.2 Competence? I see it...
  15. J

    Medical Devices in Japan - Conformity of QMS to ISO 13485

    I'm looking for confirmation of something I think is the case with regard to conformity of the QMS of a manufacturer marketing a device in Japan to ISO 13485. Since I can't read Japanese, I'm not 100 % positive that the following is true, but here goes...... Japan does not currently require...
  16. S

    When should a note-to-file be used in a QMS vs Deviation Report

    Hi everyone, When should a note-to-file be used in a QMS? When should a deviation report be filed? Thanks.
  17. D

    QMS Performance Based on how many NCRs were generated month to month

    Hello, All. I'm looking for opinions or any published articles on the problem of organizations who measure the performance of their QMS solely by recording and comparing how many NCRs were generated month to month. In my opinion, the simplistic task of counting the number of NCRs is not a...
  18. S

    What is a QMS change plan?

    Hi everyone, Can somebody kindly explain to me what is a QMS change plan? Under what circumstances will we need a quality change plan? I thought the change control form would cover it all. Thank you.
  19. E

    Example of 9001:2015 audit report with non-conformances

    Does anyone have a redacted example of a 9001:2015 audit report with non-conformances they are willing to share? :thanx:
  20. J

    AS9100 - Working Outside of Scope of Certification

    We are a small machine shop that is AS9100 certified. We also recently began performing fabrication work. However, fabrication is not listed under our scope. As long as we do not state that our fabrication work is AS9100 certified, there should be no problems when the auditor comes around...
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