How Does ISO Define Traceability?

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One of the questions I get asked a lot (and it really is a lot!) is "How does ISO define traceability?" that's always accompanied with: what do they want, what things do I need put in place, will it b

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Breaking Organisations with Corporate Speak

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There is a major problem in organisations, and we need to fix it. It is a problem so major that it is going to take years to fix it, and in some organisations it will be fatal, and they just will not

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Uncovering Improvements in your QHSE System

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 A short while ago I got the chance to catch up with Craig Thornton from Mango QHSE, of course both being lock-down along with the rest of New Zealand and most of the world it was via a web call.

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The Absolute Beginners Guide to ISO9001:2015 - Free e-Book

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Understanding exactly what you need to do in order to achieve ISO9001:2015 can be a bit of a challenge. Sometimes the language in the standard can be a little, well, unclear. Don't get me wrong the 20

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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 s

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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 tal

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Guest — Gayathri
I have been subsequently keeping track of all your articles and many other types of research done for ISO certification, but no on... Read More
Saturday, 25 May 2019 15:04
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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 trainin

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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

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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

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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

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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 alway

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ISO9001 and the Monitoring, Measurements, Analysis and Evaluation Clause

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Let's face it if you are working through ISO9001:2015 you already know that you need to monitor, measure, analyse and evaluate your quality management system, we talked about it way back in Clause 4.4

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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 ISO900

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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 – Releas

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ISO9001 and the Control of Changes

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Have you ever had one of those days when you are working through something you have done many times before only for someone to say, oh hey we changed how we do that, or we don't use those parts now we

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ISO9001 and the Post Delivery Activities

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ISO9001:2015 clause 8.5.5 – Post Delivery Activities is as the name suggests, all about how you support your customers after they get their hands on your products or services. Before going too much fu

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ISO9001 And The Preservation Clause

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Preservation may sound like an unusual thing to talk about when it comes to ISO9001:2015 but that's exactly what clause 8.5.4 is all about and as is the tendency for this standard it's a small clause,

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ISO9001 and Property Belonging to Customers or External Providers

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When I worked in subcontract electronics, we build products for a great range of organisations and a great range of industries. One of the challenges there is making sure you test things properly befo

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ISO9001 And The Requirements For Identification and Traceability

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Clause 8.5.2 of ISO9001:2015 is a very brief section which outlines the need for the organisation to (it's got that Shall word in it again meaning you must) be able to identify and trace their product

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ISO9001 and the control of Production and Service Provision

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Up till now Section 8 of ISO9001:2015 has been really dealing with the planning of the provision of your products and services, in clause 8.5 however that changes to the actual delivery of your produc

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ISO 9001 and the requirements for Information for External Providers

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How many times have you had issues with your suppliers or contractors and the root cause of that issue turned out to be that they just didn't have the right information or clear information from your

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ISO9001 and the Type and Extent of Controls

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 ISO9001:2015 Clause 8.4.2 is all about expanding on what type of controls and the extent that you need to manage these controls on your suppliers to ensure that they meet the necessary requireme

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ISO9001 and the control of externally provided processes, products & services

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ISO9001:2015 takes a fairly decent step forward in how it handles or rather requires you to handle your Supplier Management within your Quality Management System. It used to be that you just needed a

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ISO9001 and Design and Development Outputs and Changes

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ISO9001:2015 clause 8.3.5 Design and Development Outputs can sometimes cause confusion on it's purpose. It is not about the actual product that is being designed but about the outcome of the design pr

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ISO9001 and Control of Design & Developments Process

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Think about clause 8.3.4 Design and Development Controls within ISO9001:2015 as the Check section of the Plan Do Check Act (PDCA) loop. In earlier clauses of section 8.3 – (Design & Development of

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ISO9001 and Design & Development Inputs

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In this second part of the discussion about ISO9001:2015 Section 8.3 we are going to look at section 8.3.3 of ISO9001:2015 which is all about the Design & Development Inputs to your product or ser

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ISO9001 and The Design & Development Clauses – Part 1

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ISO9001:2015 Clause 8.3 is all about how your organisation carries out it's design and development of products and services. Now obviously if you do not actually carry out any design or development wo

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ISO9001 & Processes, Procedures & Work Instructions

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One of the questions I get asked a lot about ISO9001:2015 is what they heck is the difference between a Process, a procedure and Work Instructions (sometimes also called Standard Operating Procedures)

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ISO9001 and The Requirements for Products and Services

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How often have you got into the manufacture or design of a product and realise that you really don't either understand exactly what you should be making or that you are not capable of making it? ISO90

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ISO9001 and the Operational, Planning & Control Requirements

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If you think about the first 7 clauses of the ISO9001:2015 as building the framework of your Quality Management System then section 8 - Operation is very much about putting some substance on that fram

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ISO9001 and the Documented Information Requirements

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Clause 7.5 - Documented Information is a new section within the ISO9001:2015 standard, this section highlights what is required when creating and controlling documentation that is required to sup

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ISO9001 Awareness & Communication Requirements

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Although ISO9001:2015 splits out Awareness (Clause 7.3) and Communication (Clause 7.4) it seemed wrong not to cover them together since when you think about it is, is it possible to have awareness wit

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ISO9001 and the Competence Requirement

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ISO9001:2015 has split out Competency and Awareness which were combined in the 2008 standard, I'm not sure if this is a good or a bad thing as you can't possibly have any Competency without Awareness

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ISO9001 and Organisational Knowledge

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Clause 7.1.6 of the ISO9001:2015 Standard – Organisational Knowledge is a new section and can be a bit of a challenge for some. It's not uncommon for organisations to have differing views internally a

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ISO9001 and The Monitoring and Measuring Resources

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ISO9001:2015 Section 7.1.5 is all about the how you look after measuring devices, calibration and measurement traceability. It's not a massive change from the previous standard but what does it mean a

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ISO9001 and The Resource Requirements

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ISO9001:2015 Section 7, Support, has had a few changes, Clause 7.1 – Resources especially, it goes from only 31 words in the 2008 version of the standard to 2 pages! Resources required around your Qua

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ISO9001 and Changing Your Quality Management System

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Your Quality Management System must be a living and evolving system which means that over time you will make changes to the system either because of a business change, a new system, new staff or as a

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ISO 9001 And The Quality Objectives

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It's time to talk about your Quality Objectives which is ISO 9001: 2015's Clause 6.2 and is another of the sections which is a "shall" i.e. you must do this to comply with the standard. This time howe

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ISO 9001 And Actions to Address Risk and Opportunities

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As we have mentioned before  ISO 9001:2015 is very much focused on understanding the Risks in your Quality Management System and to your organisation and obviously how you will handle them.

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ISO9001 And The Roles, Responsibilities & Authorities Requirements

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For a lot of companies having crystal clear roles and responsibilities along with clarifying who has authority for what is something which is perhaps not the highest of priorities, which to me se

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ISO9001 And The Quality Policy

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The quality policy is one of those documents that is ubiquitous to ISO9001, we have all seen them, pinned to noticeboards inside the company handbooks and, if your really lucky, as part of a presentat

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ISO 9001 and the Customer Focus Requirement

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If you are familiar with the ISO9001:2008 standard you will know that it had a customer focus requirement so the need for it in ISO9001:2015 shouldn't be a surprise and it's similar. So what are the c

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ISO9001 And The Leadership Clause

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In ISO9001:2008 we had Management Responsibility, in ISO9001:2015 however we have Leadership as a clause, surely, it's just a simple name change, branding if you like. Actually no, it's quite a delibe

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ISO9001 and The Quality Management System Scope

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ISO9001:2015 Clause 4.3 is all about the scope of your Quality Management System, of what parts of your organisation will be included within your Quality Management System, in other words what ar

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ISO9001 and The Quality Management System and Processes

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ISO 9001:2015 Clause 4.4 is an interesting one, it says that you shall establish, implement, maintain and continually improve a quality management system. It says you should  include the pro

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ISO9001 and the Context of the Organisation

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Clause 4.1 of the ISO9001:2015 standard is a new and can cause a fair bit of confusion, hand wringing and general bewilderment for people, I know when I first read it I thought WHAT THE!? but then I read it again (and again) and did some research and thought, actually I see what they are doing here, that's pretty helpful, I can see how any organisation would benefit from it so here's my take on it, hopefully it helps.

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ISO 9001 And The Interested Parties

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Clause 4 if the ISO9001:2015 standard is broken into 4 sections in a bid to make it cleared, for the user which are: 4.1 Understanding the Organisation & its Context4.2 Understanding the needs &am

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ISO9001 and The Scope (and fine print)

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In our last post we pointed out that skipping the initial sections of the ISO9000 standard is dumb, it's like walking into the movies after the first 30 minutes and hoping you know what's going on so

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ISO9001 and The Initial Clauses (the ones everybody skips)

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When you go see a movie you don't turn up a third of the way through because you know that part is pointless or skip the first 3 or 4 chapters of your book because, well the interesting stuff is alway

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ISO 9001 and The Improvement Clause

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When I talk with people about their quality system or ISO9000 the one bit they all tell me is that they have lots of Non Conformances getting captured (which is good) or that they have just had a

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ISO9001 and The Customer Experience

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A lot of the time when you ask companies about their ISO9000 compliance they are ever so eager to show you their quality statistics, the Xbar charts and a multitude of other charts, talk about their o

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ISO9001 and The Process Approach

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When you ask people, what is the most important principal of a quality management system you will undoubtedly get a multitude of answers, some formed by facts, some not so much and some are just sitti

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Virtual Quality Management

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We are excited to launch our new Virtual Quality Management Service which is designed to provide companies who do not have a dedicated Quality Management resource the support normally associated

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