We Achieved ISO Certification! Now What?

Global Medical Device Podcast powered by Greenlight Guru

What are ISO 9001 and ISO 27001? Once you have them, what can you do with them? These are the questions you’ll hear Mark Alpert answer in today’s episode.

Mark Alpert is the Director of Quality at Greenlight Guru and has a background working for a Notified Body, and was most recently the Vice President of Business Assurance Division for TUV SUD America.

Listen to the episode to hear what Mark has to say about how he uses a quality system as a competitive advantage, what companies should be doing after they achieve certification, and how a quality system connects to the business strategy of the company.

Some of the highlights of this episode include:

• What ISO 9001 and ISO 27001 are and what they’re needed for
• The challenges of going through the ISO processes
• What happens when a company achieves certification
• The disconnect between business strategy and quality management
• How to overlap systems or create strategic alignment
• What to include or not include in an audit
• How having a quality management system drives continuous improvement
• Pitfalls that companies get to once they get the certification
• Advice for other companies going through this process

Memorable quotes from Mark Alpert:

“What drew me to Greenlight was the fact that we weren’t certified.”

“Achieving (ISO) certification is not the destination. It’s the beginning.”

“It’s quality management, but it’s business management.”

“If you’re looking at your processes and you think everything’s under control, create the gap.”

Links:

Mark Alpert LinkedIn

Etienne Nichols LinkedIn

Greenlight Guru Academy

MedTech Excellence Community

Greenlight Guru