Sarah Stone, Samtaler

Sarah Stone: Hello and welcome to Let's Talk Social Value. I'm Sarah Stone and I'm delighted to be joined by Chelsea Tooze, Global Director of Quality and Regulatory at 2San, a global distributor of medical devices and medical consumables. Today we're talking about risk, social compliance and the connection between quality management and social value. Thanks for joining us, Chelsea.

Chelsea Tooze: Thank you for having me.

Sarah Stone: Many of our listeners work in social value, sustainability and social impact. For those who aren't familiar with quality and regulatory functions, what do they involve?

Chelsea Tooze: In some organisations, quality and regulatory are separate teams. In ours, we're a relatively small organisation, so they're combined within one department.

In larger organisations, quality can be split into specialist functions. You might have separate teams for supplier management, quality control and document management. Smaller organisations tend to have more generalist quality professionals who cover the whole area.

Regulatory is usually more specialist because you're dealing with specific legislation and standards. In our business we're focused on medical devices and in vitro diagnostics, so we work within a highly regulated environment.

Sarah Stone: And when you talk about quality, what does that involve?

Chelsea Tooze: For me, quality falls into two areas: quality assurance and quality control.

Quality assurance focuses on internal process control. That's document management systems, SOPs, ISO standards and quality management systems.

Quality control focuses on product quality. That's things like release processes, specification testing, stability testing and shelf life requirements.

Interestingly, environmental sustainability often overlaps with quality control as well. In smaller organisations, packaging calculations and sustainability submissions can sit within quality because there isn't a dedicated ESG team.

Sarah Stone: I can immediately see overlap between quality assurance and social value.

Chelsea Tooze: Absolutely. Regulatory compliance sets the minimum standard we have to meet. What we're increasingly seeing is that social value and social compliance push that standard further.

The additional requirements aren't always coming from legislation. They're often coming from customers, whether that's the NHS, retailers or other organisations.

Meeting the minimum isn't enough anymore. We need to think about what extra layers we need to build on top of regulatory compliance to meet wider customer expectations.

Sarah Stone: That's such an important point.

Chelsea Tooze: Every new customer, product category or market brings different requirements.

From a quality management perspective, you're always trying to standardise processes and create repeatable systems. The challenge is that customer requirements continue evolving. Every time you think you've created a complete checklist, somebody adds something new.

Sarah Stone: You operate across multiple international markets. How do you keep track of all of this?

Chelsea Tooze: That's where quality management systems become really important.

A key part of quality management is supplier management and supplier quality. Within that sits ethical sourcing and supply chain integrity.

That includes activities such as modern slavery audits and supply-chain assurance. Those things aren't always legal requirements from a product regulation perspective, but they are requirements for responsible business and corporate social responsibility.

My quality team are responsible for supplier onboarding, audits and inspections. They ensure the correct audit standards are being used and that the evidence customers need is collected as part of supplier approval processes.

Sarah Stone: That's interesting because if someone was writing a social value response and needed information about modern slavery, I would probably tell them to speak to procurement.

Chelsea Tooze: I think it's both.

Procurement and quality overlap significantly. Environmental sustainability now appears within the quality management standards. At the same time, procurement activities overlap with supplier quality, ethical sourcing, supply-chain integrity and governance.

Quality management systems are fundamentally about risk management, governance and evidence. That's exactly the kind of information customers are now asking organisations to demonstrate.

Sarah Stone: So social value is becoming embedded within quality systems?

Chelsea Tooze: Yes. We're starting to see those requirements appear directly within quality management standards themselves.

The 2024 update to ISO 9001 included references to climate change and the need to consider relevant stakeholder requirements. Those requirements are beginning to flow through supply chains and supplier management processes.

It's becoming harder to separate quality, compliance, ESG and social value because they increasingly overlap.

Sarah Stone: One thing that's becoming clear to me is that quality teams and procurement teams should be working very closely together.

Chelsea Tooze: I think sometimes they do, and sometimes they don't.

Historically, procurement and quality teams can find themselves pulling in opposite directions. Procurement teams want products moving and deals progressing, while quality teams are focused on assurance and compliance.

That can naturally create tension.

What we need to do is change that dynamic and recognise that we're ultimately working towards the same objectives.

Sarah Stone: One of the reasons this conversation feels so important is because social value professionals often don't know where this information sits in their organisations.

Chelsea Tooze: Exactly.

The first time a social compliance questionnaire landed on my desk, it had already been passed around multiple people who didn't know how to answer it.

When I looked at it, I realised most of the questions related directly to work my team was already doing.

The problem wasn't that the organisation didn't have the answers. The problem was that nobody knew where those answers lived.

Sarah Stone: That's a huge insight.

Chelsea Tooze: Large organisations are often very siloed. People are busy doing their jobs and don't always realise there are overlaps with other teams.

As these social compliance requirements become more common, those overlaps are becoming more obvious.

People don't always know there's somebody within their own business who can help them answer these questions.

Sarah Stone: Another thing that's struck me is that social value isn't just about additional benefits. It's also about assurance.

Public sector buyers want confidence that they are buying from organisations that share their values and operate responsibly.

Chelsea Tooze: Absolutely.

Quality management systems are fundamentally about demonstrating control, governance and accountability.

Whether it's supplier approval, auditing, monitoring or risk management, those systems generate the evidence that customers increasingly want to see.

It's not enough to have a policy sitting on a shelf somewhere. People want to know how those commitments are embedded within the organisation.

Sarah Stone: Exactly. Having a modern slavery statement isn't enough. Customers want to know what you're actually doing.

Chelsea Tooze: And how it's being monitored.

Are you measuring progress? Are you reviewing KPIs? Is the commitment integrated into the organisation? That's where quality management systems become important.

Sarah Stone: It feels like we've identified a missing piece of the social value puzzle.

Chelsea Tooze: I think there is definitely an overlap that people aren't always aware of.

Most of the information customers are requesting already sits somewhere within the quality management system. People just don't always know where to find it.

Sarah Stone: So what would your advice be to someone working in social value, sustainability or ESG?

Chelsea Tooze: Find out who manages your organisation's quality management system and start a conversation.

Sit down for a coffee and explain what you do. Ask them how supplier management works. Ask where social compliance information is collected.

Most importantly, ask: "How can we help each other?"

Sarah Stone: That's brilliant advice.

Chelsea Tooze: One of the challenges today is that we don't talk to each other enough.

People sometimes see compliance professionals as blockers who create red tape. That's not what we're here for.

We're here to help organisations achieve market access and meet customer requirements.

We're not saying, "No, you can't do that."

We're saying, "How do we get there together?"

Sarah Stone: That's a fantastic note to finish on. Chelsea, thank you so much for joining me today. I've learned a huge amount from this conversation.

Chelsea Tooze: Thank you for having me. It's been great.

Sarah Stone: If people would like to connect with you, where can they find you?

Chelsea Tooze: LinkedIn is probably the best place.

Sarah Stone: Perfect. Thank you very much.

Chelsea Tooze: Thank you.