ISO9001 and The Release of Products & Services

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What is the signal within your organisation that your product or service is ready to be handed over to the customer? That is essentially the question that ISO9001:2015 is asking in Clause 8.6 – Release of Products and Services. Previously we have talked about verification and validation of your product or service to ensure that it meets the end use...

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ISO9001 and the Control of Non-Conforming Outputs

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Unless you are operating in some mystical nirvana the reality is at some point you are going to have rework in your organisation, you have rework because you have a non-conforming output and so ISO9001:2015 has some requirements for you to meet in order to ensure that you control these adequately. The other thing that tends to happen around non-con...

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ISO9001 and the Internal Audit

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When we talk to people about ISO9001 there are a few things that come up as the reasons not to do it, one is the need to document things, the other is around non-conformance and the final one is always the need for doing internal audits. Typically, I get told we fail enough external audits to know what we need to fix anyway! Or worse – we never fai...

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ISO9001 and the Management Review

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The management review is possibly one of the most useful parts of the entire standard yet it's also one of the most underused! ISO9001:2015 Clause 9.3 is all about the requirements for that management review and the very 1st part 9.3.1 gives us a bit of a general overview of the point of the clause.   General Expectations of the Managemen...

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ISO9001 and the required Documents and Records

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As we have worked through all of the clauses within ISO9001 in this blog series we have highlighted a number of areas where you need a document or need to be keeping a record of things, but to be fair, it may be hard to keep track and to be honest with so many clauses it can be a little overwhelming. It's not unusual for people to believe that abso...

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ISO9001 and the Certifying Audits – Stage 1

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It's finally time, you have done all the hard yards and now it's time to actually get your new ISO9001:2015 system officially certified, so what exactly does that mean and how do you do it, there are a few steps to move through to get to that all important ISO9001:2015 certificate. In this post we will cover the 1st two steps.   Selecting a Ce...

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ISO9001 and the Certifying Audits – Stage 2

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Congratulations, you have got to the point where it is time for the stage 2 audit of your new ISO9001:2015 certification audit of your Quality Management System. You have spent many hours training all of your team on what the requirements are for running the organisation within your new system, people know where to find things, they are updati...

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ISO9001 and the Post Certification Journey

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You have done it, the ISO9001:2015 certificate is on the wall and all that hard work of building a Quality Management System that really delivers for your organisation is behind you, so why are we talking about a journey?   Celebrate Firstly, it is important to stop for a moment and celebrate what you and the team have achieved. It says a lot ...

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Why are You Really Implementing ISO9001:2015?

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When an organisation makes the decision that they need to achieve the ISO9001:2015 certification there are normally a number of factors that influence the decision, because let's face it, it's not a small decision, it's one that really needs to be considered carefully since you are about to fundamentally change how your organisation functions. The ...

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You Need A Standard

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I spend a lot of time talking to people about lean and ISO (International Standards Organisation) systems, especially ISO9001. People sometimes think that it's a strange mix of things but when you peel back the surface of ISO9001 what you have is a standard build around 2 things, understanding risk and the Plan, Do, Check, Act (PDCA) or if you are ...

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