Questions for Auditing Utilizing a Process Approach

Whether facing a surveillance audit from a certification body or preparing for an internal quality audit – knowing what you face and being prepared puts you a step ahead.  Review this checklist which covers the majority of the QMS requirements.

  1. Who or what are the:
    • Processes
    • Process Owner
    • Personnel Interviewed
    • Documentation Reviewed
    • Records Sighted
  2. What are the resources needed for the process?
  3. Are these resources appropriate?
  4. Are authorities and responsibilities for required resources defined, documented and known throughout the organization?
  5. Are these persons competent?
  6. Are competency criteria defined? What are these criteria? How is competency evaluated, approved and monitored, and by which method(s)?
  7. Are these methods effective? – refer to outputs
  8. Are the resources adequate? Which are they?
  9. Are records available and appropriately maintained?
  10. What are the inputs to this process?
  11. Are these inputs documented and reviewed by competent persons?
  12. Is a description of the processes available and documented?
  13. Are these descriptions controlled? – Verify the effectiveness of the organization’s documented information control procedure.
  14. Who are the “customers” (internal and external) of the processes? What are the requirements of these customers?
  15. What are the characteristics of the intended results of the process?
  16. What are the characteristics of the unintended results of the process?
  17. Are correction and corrective action applied as appropriate?
  18. What are the criteria for monitoring, measurement and analysis?
  19. How are these criteria incorporated into the planning of the processes?
  20. Are the business performance issues taken into proper account?
  21. What methods are used for data gathering?
  22. What records are kept and how these are maintained?
  23. What are the communication channels?
  24. How is external and internal information about the process provided? What are the outputs of the process? – Identify outputs.
  25. Do these outputs provide evidence of effective implementation of the process?
  26. How is process performance monitored?
  27. Are appropriate controls defined?
  28. What measurements are applied?
  29. How is the gathered information analyzed?
  30. How are the results of the analysis taken into account?  
  31. How is feedback obtained?
  32. What data is collected?
  33. Is the issue of improvement of the processes properly addressed? How? What are the results?

 

Source:  Eagle Certification Group – 2017 Annual Bootcamp/Conference

SimpleQuE offers free sample manufacturing process audit checklists for AS9100, ISO 9001 and IATF 16949 which can be used as an example to examine a company’s key manufacturing process and prepare your company for the highest internal quality auditing possible.

Links to Checklists:

IATF 16949 Sample Manufacturing Process Audit Checklist – FREE

AS9100 Sample Manufacturing Process Audit Checklist – FREE

ISO 9001 Sample Manufacturing Process Audit Checklist – FREE

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ISO 9001 Resources and Tools to Prepare for Certification

Many companies aren’t sure where to start when it comes to implementing ISO 9001 or a new quality management system, so ISO 9001 resources and tools are useful.  SimpleQuE has been around since 2005 and over the years, we’ve developed some tools for organizations to utilize to “make quality excellence simple”.  After all, that’s what our name stands for. So see if one or more of the options below is just what you need to be on the right path.

Understanding what you need – A short video providing guidelines for choosing an ISO 9001 consultant.

Customized consulting services – ISO 9001 Gap assessment is one of the many tools we use to support and improve an organization’s overall processes.  A thorough ISO 9001 Gap Analysis identifies what needs to be implemented or changed based on the extent to which a company already complies with their current systems. The gap assessment results in an action plan that functions as a road map for each task that needs to be accomplished and is a great project management tool, as it assesses their own timing expectations based on the resources available. Additionally, using our gap analysis as a pre-assessment tool or readiness audit rather than a certification body’s allows our ISO 9001 consultants to coach and consult when problems are found.

Download our free ISO 9001 Sample Manufacturing Process Audit Checklist – This example is used to examine a company’s key manufacturing process and prepare for the highest quality internal auditing possible.

Customized on-site training – From ISO 9001 Implementation and Requirements Training to ISO 9001 Internal Audit Training, simpleQuE courses are designed to meet the specific needs of an organization.  The course – ISO 9001 Internal Auditor with the Process Audit Approach fulfills the requirements for competent, knowledgeable, and well trained internal auditors, including hands-on practice auditing.

Whether you have a mature system and an experienced quality team or are new to the quality arena, simpleQuE has the resources and expertise to help you achieve your objectives and ISO 9001 standard certification.  Contact us to learn more.

SimpleQuE’s IATF 16949 Gap Audit Checklist is Now Available!

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The automotive quality standard has come a long way since its first inception in 1994.  With the new standard and more than 200 changes, simpleQuE recognized the need for an IATF Gap Audit Checklist to assist companies with the transition. The checklist includes the new automotive requirements (IATF 16949:2016 and ISO 9001:2015) and is intended to be used as a tool to identify both compliance with the new requirements and the differences between IATF 16949:2009 and the new requirements.

The utilization of this checklist, when populated with objective evidence of compliance and non-compliance, will satisfactorily demonstrate you have audited the differences between IATF 16949 standard and the new requirements.  It should be used with your certification body as evidence of internal audits to the new IATF 16949 and ISO 9001:2015 requirements.  It’s one of the methods simpleQuE auditors and consultants use with our own clients.

A free half hour of phone or email consulting with a simpleQuE expert is included with the checklist for the purchase price of $300.

The simpleQuE team wishes you a smooth and simple transition!

3 simpleQuE Ways To Transition to ISO 9001:2015

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SimpleQuE was one of the first consulting companies in the world to become ISO 9001:2015 certified.  The transition is simple when utilizing our expert consultants or gap checklist to guide you through the process. 

  1. FastTrack your way to success – with our expedited approach to implement the 2015 changes based on lessons we have learned with numerous clients and through historical changes to various standards.    Through the FastTrack program your team will develop and complete a clear roadmap in four months (1 day/month for 4 months) and be ready to upgrade your certification in 5 months.  (The FastTrack model can be customized and accelerated with your implementation team to meet your timelines.)  Click here for more information.
  2. Customized on-site consulting and training – We offer unique quality consulting insights that result in customized solutions. We are known as the consultant that simplifies ISO implementation, transition, training and maintenance, by integrating simple solutions that fit in your company’s culture.  We perform a thorough gap analysis to identify what needs to be implemented or changed.  With our expertise, we help identify where you’re already in compliance and target only those areas that need work. Part of our job with the gap assessment is to educate you on how you already comply with your current systems. The result of the gap analysis is a thorough action plan of each task that needs to be accomplished.  The action plan is laid out against your timing and resources to successfully achieve your upgrade to ISO 9001:2015.
  3. Utilize our ISO 9001:2015 Gap Audit Checklist – Companies that have mature Quality Management Systems and experienced Quality Managers will find this a useful tool to identify the differences between the 2015 standard versus 2008.  The checklist can be shared with your certification body as evidence of internal audits to the new ISO 9001:2015 requirements. The purchase of this gap checklist comes with a free half hour of phone or email consulting.  Purchase checklist.

For more information or to obtain a quote for implementation consulting services or training, please call 740-305-0868 or contact us by email.

Are You Ready for ISO 14001:2015?

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Is your organization prepared for the transition to ISO 14001:2015? simpleQuE can help – our ISO 14001:2015 Gap Analysis Checklist a useful tool to identify compliance with the differences between ISO 14001:2004 and ISO 14001:2015. This completed checklist would be a supplement to existing ISO 14001:2004 internal audits. In addition, a free half hour of phone or email consulting is included in the purchase of the checklist.

Learn more.