News and Commentary on ISO Management System Standards

21 Feb 2023

Unannounced Audits by Notified Bodies: What You Should Know

If your company is a supplier of components or materials to a medical device manufacturer, here’s information you need to be aware of taken from ISO 13485 Regulations. And it’s about unannounced audits of your business by Notified Bodies.
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16 Feb 2023

[Infographic] Route to ISO Certification

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09 Feb 2023

ISO 45001 needs Risk Management & not just Risk-based Thinking (RBT)

You'll need Risk Management Methods & Tools Unlike ISO 9001, the Occupational Health and Safety Management System (OHSMS) Standard requires the application of OH&S Risk Management Methods in Clause 6.1.
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07 Feb 2023

ISO 9001 Consultancy: How to be an effective QMS Consultant?

Considering a career as a quality management consultant? What skills, knowledge & experience are needed?  How do I go about it? What kind of ISO 9001 Training is necessary? Dr John FitzGerald writes ... "Having worked for 30+ years as a management system consultant I’ve learned a lesson or two (including some bitter ones) on setting up and running a successful consultancy business.  So I’d ...
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26 Jan 2023

The IAF Logo on ISO 13485 Certificates is essential

The IAF MLA mark is now available to all CABs accredited by The European Cooperation for Accreditation (EA) Members, and be recognised and accepted by all 433 IAF members from 72 countries. This is important for medical device manufacturers in countries where their accreditation body is not well known on the world stage. The IAF logo signifies worldwide recognition without any doubt as to ...
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24 Jan 2023

Doing an ISO 14001 Gap Analysis

Whether you are starting from ‘scratch’ or whether you already have an Environmental Management System, a Gap Analysis is essential to establish which are the issues and topics that require correction or improvement, and which may inform your ISO 14001 EMS Implementation Project.
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19 Jan 2023

Information Security Standards other than ISO 27001

  Many data security standards other than ISO 27001 remain in common use Frequently, cyber security standards other than ISO 27001, and the 47+ subsidiary standards of the ISO 27000 series, are incorporated into Information Security Management Systems (ISMSs).  Auditors of ISMS, and those negotiating with customers on information security issues, need knowledge of, and the use/application of, ...
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17 Jan 2023

ISO Internal Audit Programme best practice

Don't waste time and effort on ISO Internal Audits! For many, Internal Audits are a sterile and mandatory drudge, carried out solely to have some records to show an inane internal audit report to the external auditor.  Such audits add no value to the organization for the resources applied. And yet many organizations extract great value from the activity, including monetary value, which will ...
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12 Jan 2023

What Qualifications, Skills, and Knowledge does a DPO require?

There is no definitive answer to this question, and the GDPR only provide outline guidance. And there is no nationally or internationally recognized qualification that will make you an expert Data Protection Officer - DPO (regardless of any claims a training provider may make). Here's the situation...
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10 Jan 2023

Why training your ISO Internal Auditors is a ‘Must’

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