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01 Aug 2019

ISO 13485 Certification for those not making Medical Devices

iso certification, MDMS, iso 13485

ISO Certification for the Medical Device Supply Chain Where do I start if I want to get Certified to ISO 13485? This is a question frequently asked by those involved in the medical device supply chain (e.g. component manufacturers and logistics companies) who have no experience with Medical device manufacture. With a steady, if slow, increase in medical device companies requiring ISO 13485 ...
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30 Jul 2019

[Launch] ISO 17025:2017 Training now available Online

extension course, internal auditor, lead auditor, iso 17025, TCLMS, conversion course

There are 6 Auditor Courses for 2017 Standard. Conventional classroom-based ISO 17025:2017 Auditor Courses usually limit you to one choice, a 2-day Internal Auditor Course.  To select an appropriate ISO 17025 auditor course can be problematic and nigh impossible..  There are no such restrictions when it comes to online auditor training courses. And the choice of Six Auditor Courses for ISO 17025 ...
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26 Jul 2019

Why ISO 9001 matters to SMEs

iso certification, QMS, risk management, iso 9001, customer satisfaction

Even the smallest organization has a lot to gain from a certified Quality Management System (QMS) New businesses often ponder the benefits of ISO 9001 Certification and, being busy with start-up priorities, postpone certification until it is asked for by a prospective customer.  At that point it is, of course, too late. Optimistically, it takes a minimum of 5 months to get certified by which time ...
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23 Jul 2019

[Update] Seventeen ISO Guidance Documents for ISO 9001:2015 QMS

internal auditor, lead auditor, iso 9001, iso 14001, iso 22000, iso 17025, iso 45001, iso 13485, iso 27001, iso 50001

Essential Reading for Consultants, Lead Auditors and others working for Certification Bodies The ISO Technical Committee 176 (ISO/TC 176) on Quality Management, the committee responsible for the ISO 9000 family of QMS standards, also publishes several supporting documents (called Guidance Documents) for the purpose of supplementing the implementation and improvement of effective quality ...
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18 Jul 2019

How to become a Lead Auditor

certified training company, ISO 29990, lead auditor, e-learning

  The obvious question to begin: What is an ISO Lead Auditor? When the expression Lead Auditor is used it refers to an auditor who leads an ISO management system audit usually independent of the organization being audited.  That is, a lead auditor of a Certification Body providing independent third-party assessment of the level of compliance by an organization with the requirements of ISO 9001 or ...
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10 Jul 2019

[Video] New Learner Advisory for our e-Training

certified training company, internal auditor, ISO 19011, iso 9001, iso 14001, iso 17025, iso 45001, e-learning, iso 13485, iso 27001, iso 14971

Helps the New Learner get to know how our Learning Management System (LMS) works and delivers our Courses and to avoid the 'rookie' e-training errors.
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04 Jul 2019

[Video] When ISO Auditor Training is hard to find ...

certified training company, internal auditor, ISO 19011, iso 9001, iso 14001, iso 17025, iso 45001, e-learning, iso 13485, iso 27001, iso 14971

If you’re responsible for Learning & Development, you will frequently struggle to get the training you need when and where you need it. And if you want ISO Auditor Training now, forget it.  Well, not quite. Our online ISO Auditor Training may be your solution.  Have a look ...
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03 Jul 2019

PRRC requirements in MDR and IVDR - new guidance

MDMS, iso 13485, regulatory affairs

EC Guidance regarding a ‘person responsible for regulatory compliance’ (PRRC) The European Commission has recently published MDCG 2019-7, Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a ‘person responsible for regulatory compliance’ (PRRC). Meeting the requirements here will be a challenge for SMEs and start-ups but the ...
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01 Jul 2019

24 Reasons to use e-Training for ISO Auditor Training

certified training company, internal auditor, iso 9001, iso 14001, iso 17025, iso 45001, e-learning, iso 13485, iso 27001

 If you’re responsible for Learning & Development, you can reduce time, costs and your stress levels through e-Training And if you're an individual seeking Certified ISO Auditor Training the same reasons apply - essentially you can train when you want, where you want and on any device. For a list of all Courses currently available, click here. 
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27 Jun 2019

EC admits potential Medical Device supply issues

iso certification, iso 13485, regulatory affairs

EC at last admits potential Medical Device and IVD supply problems in coming years starting May 2020 Despite recent flat denials of problems with Notified Body designation and the medical device industry crying for help or some relief versus the May 2020 deadline for MDR, the European Commission has admitted the potential for supply difficulties in a document published  on 17-Jun-19 entitled ...
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