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ISO 9001:2015 - Clause 10 Improvement...All you need to know

Posted by Jim Moran, MA Ed. on

This is the final clause in the 'All you need to know' series. The series starts here with clause 4: http://simplifyiso.com/all-you-need-to-know-clause-4-0/ Most of what you have in place for Improvement will work just fine here. The jaw dropper is the removal of 'Preventive Action'. In all my years since 1992 I can honestly say that I saw only one or two good examples of 'Preventive Action'. And they were formal programs like 5S, Lean and Six Sigma. Today, TC 176, the authors of ISO 9001 view our entire management system as the preventive action tool, especially with Clause 6.1 (Planning for...

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ISO 9001:2015 Clause 9 Performance Measurement...All you need to know

Posted by Jim Moran, MA Ed. on

Of course we want to measure our performance to know how well we're doing. In fact, if we don't measure how things are going, we run the risk of experiencing 'unplanned results'. Never a good thing, unless the results are better than we had planned for. In order to meet the requirements of this section, we'll need to find useful activities to measure, as well as our product or service that we deliver to our clients. Those measures are important, of course, but we need more information that that to meet the requirement to '...evaluate the performance and the effectiveness of the quality management system...' (clause...

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ISO 9001:2015 Clause 8 Operation...All you need to know

Posted by Jim Moran, MA Ed. on

Seven changes you may not have noticed in this version of ISO 9001... One of the exercises we use in our Auditor Training is 'Where's Waldo?' Participants look through the new version of ISO 9001 and try to spot where the Standard has changed. These will be part of your 'how to..' information so you know where to tweak your current system, if necessary. Here are some of the results: Change #1 8.1 - Operational planning now requires us to '...implement the actions determined in Clause 6...'. You are probably doing this when you determine customer requirements and review your capability to meet...

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ISO 9001:2015 Clause 7 Support...All you need to know

Posted by Jim Moran, MA Ed. on

ISO 9001:2015 Clause 7 - Support Let's take a look at another one of the requirements that will help us carry out our processes – Clause 7: Support. Since we all need 'resources' to make any process produce results, this requirement is no surprise whatsoever. We've been audited for 'adequate resources' since 1987, and the importance of 'support' has not been diminished in the least. We see 'external providers' mentioned here (7.1.1 b). Makes sense to me – why not consider outsourcing when evaluating capabilities? After all, outsourced goods and services have become more and more prevalent. Another interesting tweak here is the use of the phrase,...

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ISO 9001:2015 Clause 6 Planning...All you need to know

Posted by Jim Moran, MA Ed. on

ISO 9001:2015 Clause 6: Planning The current version of ISO 9001 has some important requirements for managing change. This is no surprise, and we are wise to remember that change introduces risk into our organizations. So when you’re planning a change (and we hope you are planning it!) remember to assess the level of risk associated with ‘something new’. 1. System Changes Clause 6.3 in the Planning section wants us to make sure we plan the change. This helps reduce, or at least mitigate the risks associated with the changes. This clause highlights the importance of determining the reason for the change and...

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