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    News and Commentary on ISO Management System Standards

    21 May 2025

    ISO/TS 9002 - Guideline to ISO 9001:2015 Implementation

    ISO 9001

    A Review of the Guide to ISO 9001 published by ISO/TC 176 Late 2016 saw the publication of ISO/TS 9002:2016 Quality management systems -- Guidelines for the application of ISO 9001:2015. Originally to have been published simultaneously with the revised ISO 9001 Standard in 2015, the delay resulted in it getting little publicity and so it has been largely ignored. It is full of valuable guidance ...
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    18 Apr 2025

    ISO 9001 Planning for Changes: DO's and DON'Ts

    ISO 9001

    ISO 9001:2015 Clause 6.3 Planning for Changes - Practical Advice The purpose of Planning the Changes is to maintain the integrity of the quality management system and the organization’s ability to continue to provide conforming products and services during the change. And you will need records or other credible evidence to demonstrate compliance here. NOTE: The advice given here also applies to ...
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    08 Apr 2025

    Combining ISO 17025 and ISO 9001 for Laboratories

    ISO 17025, ISO 9001

    It is not unusual for your lab to be simultaneously certified to both standards. But are you doing it effectively and efficiently? It's not uncommon for Laboratories to be certified to more than one Standard. For example, a Calibration Laboratory may be accredited to ISO 17025, the ISO standard for calibration of testing laboratories, and certified to ISO 9001, the ISO standard for quality ...
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    18 Mar 2025

    ISO 9001 Consultancy: do you have a future as a QMS Consultant?

    ISO 9001

    Quality Management System consultants are professionals or consulting firms specialized in assisting organizations in implementing, maintaining, and improving their Quality Management Systems (QMS) in accordance with the ISO 9001 standard. 
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    01 Feb 2025

    ISO 9001 Management Review: DOs & DON'Ts

    ISO 9001

    Practical advice on compliance with Clause 9.3 requirements: The periodic management system review is an opportunity not to be missed ISO 9001 Clause 9.3.1 requires that 'Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy, and effectiveness.' Is this just a 'rubber stamp' activity, or would you like to ...
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    04 Jan 2025

    ISO 9001 Internal Auditing: DOs and DON'Ts

    ISO 9001

    Wondering how to approach the requirements of ISO 9001 Clause 2? For whatever MSS you need to conduct internal audits, you have two basic approaches to choose from: Option 1: do the minimum necessary to satisfy the Certification Body (CB) Option 2: take the best advantage of the opportunity the mandatory requirement offers. You may well ask: Is it really worth my while putting time and effort ...
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    13 Dec 2024

    ISO 9001 Clauses

    ISO 9001

    Want the Helicopter view of ISO 9001? If yes, start here. ISO 9001 offers a comprehensive framework for establishing a solid Quality Management System (QMS). The key to this lies within its core clauses, a set of specific requirements that form the backbone of this standard. Let's look at each in turn to understand how they can transform your organization's approach to managing your business. ...
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    12 Dec 2024

    ISO 9001 Quality Objectives: DOs and DON'Ts

    ISO 9001

    Practical advice on ISO 9001:2015 Clause 6.2 implementation ISO 9001 Implementation frequently runs into difficulties when addressing the requirements of Clause 6.2. Here's how we think it should be done. NOTE: While the exact wording may differ from Standard to Standard, the advice given here also applies to ISO 14001, ISO 27001, ISO 45001, and other standards that have the same HLS structure as ...
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    13 Jun 2024

    ISO 9001 Analysis and Evaluation - DOs and DON'Ts

    ISO 9001

    Practical advice on implementing ISO 9001:2015 Clause 9.1.3 This article will consider a sub-clause in ISO 9001 Part 9, Performance Evaluation, of the Quality Standard, namely, 9.1.3, Analysis & Evaluation. NOTE: While the exact wording may differ from Standard to Standard, the advice given here also applies to ISO 14001, ISO 27001, ISO 45001, and other standards that have the same HLS ...
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    08 May 2024

    Open Letter to ISO/TC 176 regarding the ISO 9001 Revision

    ISO 9001

    Ladies & Gentlemen of ISO/TC 176, With renewed dismay, I read of the contents of ISO/CD 9001:2024 (albeit a leaked copy from a usually reliable source). It seems we have another revision that will do nothing to restore the esteem in which the ISO 9001 Standard was once held and nothing to provide tangible benefits to certified organizations and their customers. So, I challenge you to make ...
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