We have Built a New QMS based on the New ISO 9001 and the New ISO 13485/21 CFR Part 820

Pia Lise Sandau, Team Leader, Novo Nordisk A/S, Soeborg, Denmark

Co-Speaker: Sabine Kornerup

Keywords: Continuous improvement, ISO 9001:2015, Differentiated QMS

Industry: Healthcare

Level: Intermediate

ABSTRACT

Novo Nordisk A/S is a continuously growing pharmaceutical company with headquarters in Denmark. Ensuring quality and compliance in such a large organization can be indeed challenging and therefore top management in the quality area has defined three focus areas for the next upcoming years that will help to secure our quality function:

  • Robust and Simple Quality Management System
  • Quality by Leadership
  • Scale for Growth

We are in the process of developing a new and robust Quality Management System (QMS) that is built on the new ISO 9001:2015 and ISO 13485:2016/21 CFR Part 820 standards. The new standards allows a more open dialogue about the requirements for a new improved Quality Management System, but also for creating a more differentiated Quality Management System in a large organisation such as Novo Nordisk A/S . The company adhere to the Triple Bottom Line covering our social, environmental and financial responsibilities all across the organization. Moreover, the Quality Management System is not a one size fits all system but a more focused one, that is dependent on the requirements specific for each area in scope. For example, in Research and Development there are areas that handle medical devices, and these areas need to be aligned with both ISO 9001 and ISO 13485/21 CFR Part 820 requirements. In contrast, other areas within Research and Development are working according to GxP requirements and some only have a few health care requirements that they need to adhere to.

As part of the implementation of our new improved Quality Management System we have in general:

Lowered the number of Standard Operating Procedures (SOPs) assigned to each employee

  • Limited the number of roles, that the SOPs apply to
  • Reduced frequency of internal audits
  • Lessened number of SOP s that describes each process

In addition, we have built a process landscape and added more focus on Quality by Leadership that in turn strengthens the governance of our processes. The responsibility for quality sits with the line manager and requires that mangers drive a culture where the leadership ensures a strong quality performance as well as a solid business result. Moreover, we have implemented a new way to make the Quality Management Review (QMR) where the focus is more on top management responsibilities and how to ensure better future strategic directions. In order to be prepared for expected growth in the organisation, Scale for Growth , we have introduced a global IT system that is used to register all nonconforming outputs including the CAPA investigations raised in the medical device areas.

Taken together, a Robust and Simple Quality Management System that contains only relevant and necessary internal and external requirements contributes to a more efficient quality function and increased on research and development. We have related all these initiatives to clauses in the new ISO 9001:2015 and ISO 13485:2016/21 CFR Part 820 we have done it, you can do it key words: Keep it simple.

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“ISO 9001 is used by millions of people and organisations around the world and the upcoming 2015 revision will have a big impact on those who work with the standard.

The impact of this revision will be similar to, if not greater than the 2000 edition, which was a major change for accreditation bodies, certification bodies, training organisations, implementing organisations, procurement organisations, consultants and customers.”

An excerpt from IRCA Resources on “ISO 9001: IRCA Supporting the 2015 Revision”, October 2013