3 Ways MDSAP Improves Audit Effectiveness

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 .

Understanding the business benefits of consensus-based standards

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:

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


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

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!