Service Provider or Supplier in the Medical Sector: What Quality Approach to Put in Place and How Far to Go?

Do you recognise this situation?

You are a service provider, subcontractor, CDMO, distributor or a company from another regulated sector, such as animal health, looking to offer its services in the human medical field. You already work with medical device manufacturers or want to, and you are wondering about the level of quality approach expected:

• Is ISO 13485 certification required?
• Is it sufficient to put in place a quality approach that meets your clients’ requirements?
• And where do you start?

These are questions many players in the medical value chain ask themselves whether they are entering this market for the first time, or companies already present for several years who feel their quality organisation could be strengthened.

What was at stake

The answer to “is ISO 13485 certification required?” is not universal and this is often where the thinking stops too soon. In reality, several levels are possible:

• ISO 13485 certification: it provides formal recognition, reduces the frequency of audits by your manufacturer clients and facilitates access to new markets. But it involves significant requirements and is not always necessary or realistic depending on the company’s size and activity.
• A quality approach compliant with applicable requirements: without formal certification, it is possible to put in place a quality organisation that integrates the requirements relevant to your activity and meets the expectations of your manufacturer clients. In this case, they will generally conduct more frequent audits particularly in the first years, to ensure the robustness of your approach. Well-designed tools and an adapted organisation can however constitute a solid and proportionate response.

The real challenge is therefore to define the level of quality approach best suited to your situation: neither too ambitious given your resources, nor insufficient given your clients’ expectations.

And in all cases, one starting point is common: process mapping. Identifying and defining the company’s processes, understanding their interactions, defining the inputs and outputs of each: this is the foundation on which any effective quality approach rests. Without this step, procedures and documents risk being disconnected from operational reality. And over time, as the company evolves, this mapping needs to be reviewed since scopes change, activities expand, new processes emerge.

What was done

I supported a service provider wishing to offer its activities to clients in the medical device and pharmaceutical sectors initially with no in-house quality expertise, in implementing a quality approach adapted to its size and actual activity. The mission covered two complementary areas:

• Process mapping. The fundamental first step: identifying and defining the company’s processes according to their nature that is to say management processes, operational processes, support processes. For this service provider, this led to the definition of eight processes covering all activities: leadership, quality management, commercial relations, medical writing, clinical studies, human resources, suppliers and infrastructure. For each, the inputs, activities and outputs were formalised through a collaborative exercise with the teams to ensure the mapping reflected operational reality rather than a theoretical ideal.
• Coaching the quality manager. In parallel, I supported the person identified internally to take charge of the quality approach: understanding the requirements applicable to the company’s specific context and progressive autonomy to manage the system without ongoing external dependency.

What changed

The company had an effective quality approach, proportionate to its size and activity, and mastered internally. The process mapping provided a solid and scalable foundation adaptable as the business develops. And the quality manager was able to meet the requirements of its medical device manufacturer clients autonomously and with proper documentation.

→ Are you a service provider, subcontractor, CDMO, distributor or looking to offer your services in the medical sector  and wondering about the level of quality approach suited to your situation? A One Health Compliance Technical Day allows you to explore the ISO 13485 requirements applicable to your context, identify the most relevant level of quality approach and define priorities.

→ Ready to move to implementation? A One Health Compliance Workshop supports you in building your quality approach from process mapping to team competency development.

Sandra Dejean, PharmD – Founder of One Health Compliance

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