Hardware Podcasts

We Achieved ISO Certification! Now What?

Global Medical Device Podcast · 17 Nov 2022 · 43m · Episode 290

What this episode covers

Mark Alpert, Director of Quality at Greenlight Guru, explains that achieving ISO 9001 and ISO 27001 certification is merely the beginning of the journey, not the destination. He argues that companies must align their Quality Management System (QMS) with their broader business strategy to drive continuous improvement and use quality as a competitive advantage. Alpert highlights the common pitfall of focusing only on reactive Corrective Actions (CAPA) rather than proactive process improvement, urging leaders to create strategic gaps to drive performance. He emphasizes that a mature QMS integrates all functions, from sales to finance, to ensure the entire organization works toward the same high-level goals.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Greenlight Guru, TUV SUD America
Also
ISO 9001, ISO 27001, ISO 13485, FDA

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