Chart of top nonconformances

This chart is a comparison of the areas where Major and Minor nonconformances have been written over the last few years during Certification Body audits across 5 of the main standards – ISO 9001, ISO 14001, ISO 45001, AS9100, and IATF 16949.  Nonconformities can occur when: A system does not conform with the intended requirement…

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Digitalization, globalization, competition and the speed of technological advances has changed the nature of business. ISO 9001:2015 has been in effect for 5 years and it places a heavy emphasis on using “risk-based thinking” for managing quality-related processes. Risk has always been implicit in ISO 9001.  But this revision asks organizations to make a cultural…

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Don't forget to schedule your internal audit

  You’ve  probably got a lot on your mind these days…but don’t forget to schedule your internal audit, if you haven’t already done so. Fourth quarter is upon us and simpleQuE has experienced environmental and quality management auditors who can conduct your audit on site or remotely. Outsourcing your internal audits, can reduce the pressure…

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ISO 9001 Certifications

  The International Standards Organization just released the results for the annual ISO Survey with data for 2019.  It compiles the number of valid certificates for the 12 ISO management standards (ISO 9001, ISO 14001, etc.) submitted by Certification Bodies accredited by the International Accreditation Forum (IAF). Below are the totals for ISO 9001 and…

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Business Man. Business man put idea on board. Business man use pen for create business planning. Business accessory background. Business strategy. Business working. Business people concept. Business man over sunny. Business plan background

When it comes to Quality Management dos and don’ts, simpleQuE’s quality experts provide some tips for staying out of the red and keeping ISO 9001 systems robust and sustainable. 1. Meet Customer Requirements Surprisingly, some companies seek ISO 9001 certification just to satisfy one customer requirement. When a customer will only do business with vendors…

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    Attention all ISO 9001 certified companies and users – your feedback is requested!  ISO 9001:2015 is being reviewed by ISO/TC 176/SC2 (the ISO Subcommittee for Quality Systems). An online survey was created to obtain input regarding the standard and whether it is good as written or if it could be improved. The ISO…

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Saying about quality

One of the world’s leading certification bodies, DNV GL Business Assurance, NA shared their top 10 ISO 9001 findings of 2019.  Review these nonconformances to see if there are any weaknesses in your quality processes.  (Note:  ISO 9001 Findings and their rankings may vary slightly among Certification Bodies.) 8.5.1  Control of production and service provision…

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Business consulting and auditing

If your organization is certified to ISO 9001 or a standard that is aligned with it, like AS9100 or IATF 16949, and you perform internal quality audits, then you should know this: For ISO 9001:2015 and AS9100:2016, one of the top 10 clauses for registrar findings in 2019 was 9.2 Internal Audit. The IATF standard…

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Contingency planning is the topic of Part 4 of the Automotive Restart series.  As evidenced when the COVID-19 pandemic brought everything to a screeching halt, it’s critical to plan for unforeseen problems or circumstances.  The IATF 16949 defined tool to prepare for those issues, emergencies and disasters is the use of a contingency plan.  The…

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On the road to recovery changes will occur, and Part 3 of the five-part series considers the ISO 9001 and IATF 16949 requirements and managing changes. As mentioned in Part 2 of this series – Customer Satisfaction, disruptions due to the pandemic and affecting restart could include: Supply chain disruptions and limited allocations from the…

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