Tag Archives: audit

Two Schools of Thought Combine for Best-Practice EHS Auditing

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Environment, Health and Safety (EHS) auditing provides confidence to organizations that operational risks are measured through effective identification, control, monitoring and governance. Audits are conducted to gain better understanding of the management system and to evaluate the level of compliance with internal requirements and external regulations. Such audits utilize protocols to seek understanding of problems in an attempt to correct any deficiency before loss or a compliance issue is experienced.

EHS auditing is usually conducted for the following reasons:

  • Ensuring compliance to the requirements of internal, international and industry standards and regulations, and customer requirements,
  • To assess and determine the effectiveness of an implemented system in meeting specified objectives,
  • To explore opportunities for improvement,
  • To meet statutory and regulatory requirements,
  • To determine the management system risks, and,
  • To provide feedback to senior management.

There are two main schools of thought when it comes to EHS auditing. Most professionals are familiar … Read more...

3 Ways MDSAP Improves Audit Effectiveness

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What is the MDSAP program?
In Singapore in 2012, the International Medical Device Regulators Forum (IMDRF) began development of a Medical Device Single Audit Program (MDSAP). MDSAP allows approved auditing organizations to conduct a single regulatory audit of a medical device manufacturer. This single audit expands the scope of the audit to previously unaudited areas of large organizations, standardizes a consistent auditing model, and replaces as many as five separate . It also satisfies the regulatory requirements of the authorities participating in the program – even ISO 13485:2016. MDSAP focuses on defined and linked processes and is based on requirements for risk management. The goals of MDSAP are:

  1. to improve audit effectiveness and the influence the audit can have on outcomes that improve patient safety, and
  2. to reduce the resource demands on both regulatory bodies and auditees in organizations having to comply with a variety of global standards and .
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Understanding the business benefits of consensus-based standards

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Businesses seek ISO certification for a variety of reasons: attracting and retaining customers and clients, boosting brand image, and more.

Getting executive buy-in for ISO certification can sometimes be a challenge, and even leaders who have made the decision to seek standards certification – be it ISO 9001, ISO 14001, or any other widely used standards – often fail to consider the unsung rewards of certification.

Businesses that implement ISO standards often focus on the perceived burdens of adoption, such as expansive paper trails, demanding document management, and seemingly interminable audits. They forget that, when executed and implemented properly, certification can spell rich financial rewards.

Well, thanks to the folks at the World Standards Cooperative (WSC), an organization that promotes voluntary, consensus-based standards, business leaders have access to a variety of tools that illustrate the business benefits of adopting ISO standards. The WSC website contains links to dozens of such resources, including:

  • A
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‘If we don’t pass the audit, you can fire me’: Achieving the flawless EMS audit

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Joey Ebanks, EHS and Training Manager for Caribbean Utilities Company (CUC) and Intelex client, dropped by the Intelex offices in Toronto, Canada this week to make a presentation to Intelexians on how CUC is using Intelex software, and how it has boosted the performance of its EHS programs.

Below is an excerpt from his presentation, an excellent anecdote that reflects Joey’s confidence as he entered an audit of his environmental management system (EMS) last month:

“In April we had a surveillance audit. The auditor came back in to look at 50 per cent of our EMS system. And I actually took the weekend off and went to Fort Lauderdale, had some fun. My boss, our VP, was very upset that I was not there, making sure everyone was ready for the audit. But I was absolutely sure we were ready. In fact I said to him, ‘I’m 99 … Read more...

Intelex featured in Quality Magazine’s 2011 How-To Guide

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Here on the Intelex Blog, we love to preach the benefits of ISO 9001 certification, and how the right software solutions help facilitate fast, stress-free conformance.

Those interested in learning more about how to achieve ISO 9001 certification are encouraged to check out the latest edition of Quality Magazine’s handy annual How To Guide.

Head over to Quality Magazine’s website to view the latest issue of Quality Magazine. Click on the “How To” tab on the right and – in addition to reading the rest of the valuable magazine and guide – go to page 19 to read “How to Ensure Effortless, Ongoing ISO 9001 Certification and Perpetual Audit Preparedness” to learn, well, just that!

 
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