# We Achieved ISO Certification! Now What?

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-11-17
- Length: 43m
- Episode: 290
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-11-17-we-achieved-iso-certification-now-what
- Listen: https://podcast.greenlight.guru/episode/we-achieved-iso-certification-now-what

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-11-17-we-achieved-iso-certification-now-what#t=0) Introduction: Mark Alpert and Greenlight Guru's ISO 9001 and 27001 Certification
- [2:54](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-11-17-we-achieved-iso-certification-now-what#t=174) Defining ISO 9001, ISO 27001, and the Integrated QMS Approach
- [5:40](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-11-17-we-achieved-iso-certification-now-what#t=340) The Challenges of Building a QMS from Scratch at Greenlight Guru
- [10:06](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-11-17-we-achieved-iso-certification-now-what#t=606) The Disconnect Between Business Strategy and Quality Management
- [15:28](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-11-17-we-achieved-iso-certification-now-what#t=928) Integrating All Business Functions (Sales, Finance, Marketing) into the QMS
- [19:58](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-11-17-we-achieved-iso-certification-now-what#t=1198) Driving Continuous Improvement and Creating Strategic Gaps
- [31:25](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-11-17-we-achieved-iso-certification-now-what#t=1885) Pitfalls: Working 'In' vs. 'On' the Business and Management Myths

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)
- [Scaling production](https://hardwarepodcasts.com/topic/scaling-production)

## Most relevant to

early-stage companies

## Mentioned

- Greenlight Guru (company)
- ISO 9001 (other)
- ISO 27001 (other)
- ISO 13485 (other)
- TUV SUD America (company)
- FDA (other)

## Related episodes from other shows

- [Digitizing Quality Management](https://hardwarepodcasts.com/podcast/the-manufacturing-executive/2022-08-09-digitizing-quality-management) (The Manufacturing Executive)
- [100 - PQMCoach, Our First Recording, Quality (Big Q/little q), Why Predictive Quality Management, and Communicating Quality with Larry Mager](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-30-100-pqmcoach-our-first-recording-quality-big-q-little-q-why-predictive-quality-m) (Let's Combinate)
- [205 - Why Less Than 20% of Companies Have Started Quality 4.0](https://hardwarepodcasts.com/podcast/lets-combinate/2025-09-11-205-why-less-than-20-of-companies-have-started-quality-4-0) (Let's Combinate)
- [127 - BIG Risk Management Changes in QMSR, Risk Acceptability, Risk Policy & Explaining vs. Justifying Risk Decisions with Naveen Aggarwal](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-13-127-big-risk-management-changes-in-qmsr-risk-acceptability-risk-policy-explainin) (Let's Combinate)
- [237 - ICH Q10: The Pharmaceutical Quality System](https://hardwarepodcasts.com/podcast/lets-combinate/2026-05-06-237-ich-q10-the-pharmaceutical-quality-system) (Let's Combinate)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-11-17-we-achieved-iso-certification-now-what. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.