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Using ISO 21500 as the PMO Backbone for Medical Device Development

Wed, 12/04/2013 - 1:44pm
Martine Janicki Ph.D., PEng, PMP, Medical Device Engineer and Project Management Officer, StarFish Medical

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It’s been a year since the International Standard Organization released its ISO 21500 –Guidance on Project Management. That’s about the same time StarFish Medical started its Project Management Office (PMO). This blog will explain the differences between ISO 21500 and the principles of Project Management as well as provide insight from my experience implementing a PMO at a medical device design and development company (StarFish Medical).

The main goal of a PMO is to raise corporate practice in Project Management, and more importantly provide Project Managers with training and tools to effectively manage their medical device development projects within allocated parameters of budget, target timeline and quality of deliverables.

The StarFish PMO incorporated procedures and forms from the ISO 21500 Guidance, and the principles of Project Management established by the Project Management Institute (PMI®). PMI has been around since 1969 and is a well-known international not-for-profit professional association, with over 700,000 members and volunteers advocating for the project management profession, and responsible for the project management professional (PMP) certification program1. Because PMI is long established, its terminology is very integrated in Project Management culture and vocabulary. However, the ISO standard brings a few areas of changes:

1.  The PMI’s Knowledge Areas are called ”subject groups” in ISO 21500

The subject groups essentially refer to the same grouping of integration, scope, time, cost, risk, quality, human resources, procurement, communication and stakeholder.

2.  The nine knowledge areas as outlined in PMI are extended to 10 subject groups by ISO 21500

The 10th knowledge area, called Stakeholder Management, is effectively an extension of the communication knowledge area for external communication. Stakeholder management has a primary focus of analysing various stakeholders’ influence and positions on a particular project, and managing their concerns and wishes.

3.  ISO 21500 puts an emphasis on “controlling” as opposed to the “planning” that seemed prevalent in PMI publications

The ISO standard clearly advocates maximizing the positive while minimizing the negative project impacts to control the project work, scope, changes, risks, resources, schedule and costs. There is an underlying requirement to constantly compare to baselines and justify any deviations.

4.  ISO 21500 emphasizes quality among all subject groups while PMI puts quality at the same level of importance as scope, time, cost, integration, communication, risk, procurement and human resources.

ISO 21500 defines Quality very well and requires attention to quality planning activities, quality assurance and quality control. Quality Assurance (QA) entails the establishment of corporate and project-wide systems to support quality requirements, while Quality Control (QC) focuses on the systematic review of a specific product or component against requirements, typically using a checklist.

Other than these minor distinctions, Project Management practice is very similar for both PMI and ISO 21500 particularly when it comes to the process groups of initiation, planning, execution, monitoring and control and closing. Systematic Project Management ensures that Project Managers have the knowledge, skills, tools and techniques to achieve project success while navigating the waters of the execution stage.



Hear from Martine Janicki about what she does at Starfish Medical

Project Management is global and applies to any type of organization, for any type of project, irrespective of complexity, size or duration. Its main objective to support and realize business objectives and benefits of organizational leaders. The emphasis of PM guidance is a pro-active approach to managing all aspects of a project including business, regulatory, technical, and environmental. The PMO takes a supportive approach and provides recommendations for managing technical projects as it is recognized that non-technical skills such as communication, stakeholder management and project risk management take a long time to develop.

The StarFish PMO is committed to providing ongoing training and providing recommendations to Project Managers while refraining from being too prescriptive in its approach. The ISO 21500 is primarily a guidance document, and reinforces good PM practice in the medical device development field. Integrating ISO 21500 in the PMO has been relatively straightforward at StarFish because the Project Managers and team members are already very familiar with the importance of implementing and conforming to standards.

The Medical Device industry is highly regulated, and in Canada must conform to ISO 13485 Medical Devices Quality Management Systems (similar to 21 CRF Part 820 as recognized by the FDA), which establishes the development environment and requires designers conform to a strict ‘Design Control’ Standard Operating Procedure (SOP).

The implementation of a systematic project management approach through the establishment of a PMO at StarFish is wrapping up; Project Managers have been trained and are now familiar with processes outlined with StarFish SOP for Project Management (QMS-224), and have now incorporated into their various project binders important documents such as project management plan, stakeholder registry, risk registry, and other useful documents to provide clarity, such as a strategic direction form. All Project Managers must attend QMS-224 training, and the Project Manager Officer continues to mentor Managers and monitor their practice against ISO 21500 and PMI standards.

The PMO is the primary vehicle to distribute knowledge around project management practice and support Project Managers in their day to day management throughout the life cycle of their projects. In addition to its governance and PM standardization role, the PMO coordinates and delivers PM training, assists in project planning and performs project monitoring. Reflecting on the past year, I can confidently say that the PMO brings new trends, knowledge and standards to StarFish helping technical and regulatory professionals deliver successful medical device projects. I’d love to hear from other PMO Managers about their experiences implementing PMO in medical device companies.

1 www.pmi.org PMI was established in 1969 by the US Army Corps of Engineers and launched its first credential in 1984. PMI established organization spans over 265 geographic chapters and 39 industry-based communities of practice

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