iso 9001 - quality management systems

  1. Q

    Complying with ISO 9001:2015 - 9.1.1 b - Monitoring, measuring, analyzing and evaluation

    Hi fellows. (Methods for the monitoring,measuring, analazing and evaluation) To comply to standard, 9001 2015, in this clause, what specifically the standard ask us to do? How is this done? E.g. for processes performance, to explain that every month indicators, are collected, then are included...
  2. N

    Is consultant prohibited in ISO9001 audit?

    Hi, Anyone knows if consultant attending audit is prohibited by any accreditation or certification body rules? I know that for IATF16949 it states clearly this prohibition. How about ISO9001 audit?
  3. B

    IATF 16949 manufacturing cell in ISO 9001 factory?

    I've been tasked with conducting a gap analysis on our current facility. We are ISO9001 and are currently negotiating a new 5 years contract worth millions with a new customer. However, the new customer wants us to be IATF accredited, I'd just like press you for some guidance on this. The new...
  4. I

    ISO 9001 and VWAD (Verified-Accredited Wholesale Distributors certification)

    I am assisting a pharmaceutical company with their QMS documentation for ISO 9001 certification. They are also applying to VAWD (Verified-Accredited Wholesale Distributors certification) Based on ISO 9001 I am creating SOPs and processes and integrating VAWD criteria into those documents. The...
  5. S

    ISO9001:2015 6.3 - Planning of Changes - OFI from auditor

    All, Good day! I received OFI from auditor ~ (The Change Control Procedure could be est to outline control with regards to sudden changes with regards to internal/external aspect, such people, amendment in customer requirements, legal/regulatory requirements, technology, environment and QMS...
  6. T

    Reasons to change certification body and typical costs

    Two questions so I'll start with the last one. What's a typical fee for an auditor to certify to iso 9001: 2015? Based on size, number of sites and complexity in sure. But say 50 employees, one site and low to average level of complexity for an automotive manufacturer (2nd/3rd tier). Is there...
  7. Q

    ISO 9001:2015 Clause 8.3 - Is it possible to exclude one product but include it in other?

    Hi everybody Please help to clarify this situation. I have a manufacturing company toward the certification in 9001. Mainly sells two products, but only in one is applied 8.3. Is it possible to declare somewhere that one product doesn't apply 8.3, while the other does it? Both product in...
  8. Q

    Only manufacturing, non applicable - ISO 9001 Clause 8.3

    Hello everyone Just want to be sure my assumption, hope you can help me. In a work shop, fabricating mechanical components, mechanical valves, carbon steel bins, vessels, flanges assemblies,etc. We receive the detailed drawings from the clients, drawings including Bill of materials...
  9. Q

    Choosing between ISO 9001 (2015) & TL 9000 certifications

    Hello, I work for a small telecommunications company that specializes in Structured Cable Distribution, Fiber Distribution and Splicing, Data and Voice, Pathways, Enclosures and Termination, Communications Device Install and Troubleshooting, Wireless Systems, and Engineering. I've been tasked...
  10. R

    Specific ISO requirement to fill in all spaces on a move tag?

    I have a manager who tells me our registrar auditor will write non-conformances for tags that are not completely filled out. See attached picture. I admit the tag we use is not the best for the application. It is used as a move tag. The heading "Accepted" is unfortunate because it implies...
  11. M

    Case study - If the restaurant (ISO 9001:2015 certified) was run by 2 persons covering cooking and purchasing processes (Mother and Father) supported

    Case study of Restaurant - If the restaurant (ISO 9001:2015 certified) was run by 2 persons covering cooking and purchasing processes (Mother and Father) supported by their 2 Child, if the parents are hospitalized due to accident (caused by 3rd party) and children take over. a) Does the quality...
  12. M

    Does ISO 9001 mandates cooking procedure for restaurants

    Does ISO 9001 mandates cooking procedure for restaurants intending for ISO 9001 :2015 certification, in other words, does all the critical activities of the business shall mandatorily have a procedure.
  13. B

    Integrated management system - ISO 9001 and ISO 14001 - Is possible to have a joint certificate covering both standards?

    Hi My company has just had a successful 9001:2015 / 14001:2015 integrated audit - does anyone know if it is possible to have a joint certificate covering both standards? Thanks in advance Barbara
  14. A

    ISO 9001:2015 - How to apply 7.1.5 to an organization performing only design

    How to apply 8.5.3 to an organization performing only design? Will I have to take into account GDPR (for EU) and follow this trail in internal audit?
  15. eule del ayre

    IATF 16949 / ISO 9001:2015 audit criteria

    what are the criteria for ISO Audits? just in case anyone knows for certification purposes
  16. MichaelDRoach

    ISO 9001:2015 Clause 9.3.2c)3) - What process or processes is this focused on?

    I'm looking to find just what does it mean in 9.3.2c)3) "Process performance and conformity of products and services"? What process or processes is this focused on? I can understand the conformity of products and services.
  17. A

    Leadership Role in Designing QMS - Upper Management Support

    Considering that in 2015 Leadership commitment is an even higher aspect as previous 2008. I am responsible for managing the QMS in a small concern, 36 employees, and although I designed and implemented a system 10 years ago, the system has limitations as I cannot get management to discuss...
  18. K

    ISO 9001:2015 AVL - New Chinese standards requiring all testing of materials be done in China

    Has anyone had experience with these new Chinese standards requiring all testing of materials to be performed in approved Chinese Labs only? I'm trying to figure out how to approve these labs as a supplier as they will not send any documentation but we HAVE to use them to continue business in...
  19. R

    ISO 9001:2015 9.3 - Required inputs to the management review - Audit Nonconformance

    Good morning, just had our ISO audit and i had a CAT2 minor on Clause 9.3, The Non-Conformance was set as follows; Some of the required inputs to the management review are not always visible and/or included in the meeting minutes. Examples include the effectiveness of actions taken for risks and...
  20. Tagin

    Does ISO 9001:2015 require a full internal audit annually?

    Does ISO 9001:2015 require a full system internal audit every year? Or, can an internal audit plan be multi-year? E.g.: Year1: Audit processes A,B,C Year2: Audit processes D,E,F,G Year3: Audit processes H,I Year4 -repeat cycle- (Of course, there likely will be also top-level items that...
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