Maintaining Global Quality Standards at Intelsius

At Intelsius, we make it our priority to ensure the highest quality is maintained throughout all our processes from sourcing our component suppliers to the manufacturing and assembling of our packaging systems. As a global leader in sample transport and temperature-controlled solutions for the last 25 years, we understand the importance of maintaining quality across all aspects of our operations, so our customers are assured of the highest standards of products and services at all of our global sites.

To better understand how we implement and maintain quality at Intelsius, we sat down with Global Quality Manager, Felicity Neale to ask her about her role in the company and the management of international quality standards across our six global sites.

What do you do at Intelsius and what does your role involve?

I am the Global Quality Manager at Intelsius and my main responsibility is to manage our Integrated Management Systems (IMS). I oversee and assist our global sites to comply with and achieve the ISO9001 Quality Management System and 13845 Medical Devices standards. ISO9001 is a globally recognized standard that requires organisations to establish, implement and maintain a quality management system. Currently, our headquarters site in York is ISO9001 accredited, as well as our Ireland and India sites.

Complying with these international standards on quality management systems allows us to make informed decisions on how such a system should run within our business. The standards allow us to make informed decisions about maintaining and improving our quality control and helps us assess risks and opportunities in the business. For example, COVID-19 was a risk to the business but it also presented an opportunity to provide our customers with much-needed kitting services for their sample transport needs.

In other words, the ISO 9001 and 13845 standards help us to ensure that customers have full confidence in us running our business. I am in charge of overseeing and implementing these international quality standards to ensure compliance across all our global sites. I also oversee the day-to-day quality maintenance of incoming and outgoing goods.

How do we manage quality and deliver the best possible products and services?

We conduct internal audits of our processes from start to finish, including the initial sales orders, which then get processed by operations, and subsequently goes onto the warehouse floor as a build order. The orders are then assembled, palletized, labelled and shipped out to the customer by our third-party logistics provider.

We have qualified internal auditors within Intelsius who review our processes every two years to make sure we are complying with the relevant standards and that our SOPs are relevant and appropriate for each task we carry out. I do not carry out the audit on the quality management systems myself as it is within my remit, so we have qualified auditors from other departments within the business to conduct these audits.

Throughout this internal audit, we highlight any processes which are found to be non-conforming and issue the corrective actions needed to be done. The audit will then be signed off by a manager in charge and then by an internal auditor, helping us to ensure compliance to the standards. All these processes are tracked very closely by the quality depratment to ensure that we can maintain and improve them, if necessary. Once a year, we conduct a management review meeting which involves us reviewing how our quality management systems are running and whether they are fit for purpose for our business as a whole.

We are also externally audited every three years by a certification body against the ISO9001 and 13845 Medical Devices standards, with surveillance audits conducted yearly.

Besides meeting international standards, we also have a strict internal policy of using only approved suppliers to source our packaging components. I will liaise with the Purchasing department to make sure that all suppliers meet our internal standards. For example, we will only use a supplier that is either ISO9001 accredited or has a QMS system in place that meets our standards.

Once an order is placed with a supplier and the first sample comes in, every process is tracked. Once it arrives, the data of each component is logged, and we then check the colour and artwork of the components and we also check for consistency against our previous stock. There are detailed SOPs in place for these inspections where we create order processes and flow charts to track each process. All data is logged and stored, to be analysed later.

By putting in place these SOPs, it is easy for us to keep track of important details like any manufacturing defects and other issues so that we can improve our processes and highlight any recurring issues and trends. We also have a detailed system in place to track any customer complaints or concerns, including any issues that arise during delivery of products. All issues and complaints are logged so that we can easily rectify them and assist customers with any difficulties or damage that may have occurred to the products during transit.

To maintain consistency, we also conduct random checks of outgoing orders throughout the day. We also oversee how components are assembled into finished products in the warehouse. I make it a point to take an active role in overseeing the process from start to finish and then logging all relevant data.

This data is then assessed on a monthly basis to ensure that we are meeting the relevant quality standards and to assess if there are any improvements that need to be made.

Why do we invest in quality standards and measures at Intelsius?

From a customer perspective, it creates a sense of confidence and trust in our operations, as maintaining an international standard demonstrates that we have a system in place to track, implement and maintain quality standards. Investing in quality standards also enables traceability within our operations so that if there is an issue with a product or a component, it can be easily traced through our data systems and can be recalled from customers to rectify any issues.

The international standards also demand that our staff be adequately trained and are sufficiently competent, so customers are assured that whoever is handling the product in our business is competent and well-equipped to do so. We also purchase components from only our approved suppliers, which means that all our components are from trusted and verified sources. All our suppliers have to meet our criteria for purchasing and only then will they be added to our approved suppliers list.

Our meticulous data tracking system also ensures that we maintain these high standards and it also increases the transparency of our business and its dealing with customers as all movements of products can be easily traced. We also supply certificates of conformity to customers which assures them that all our packaging systems meet the relevant international dangerous goods regulations, whether they are shipped by road or by air.

All-in-all, we invest in quality standards to ensure customers that they will receive a packaging system that is designed by our in-house expert technical team and that all processes from supply to manufacturing undergo regular assessments and all related data is logged. The data is a very useful analysis tool which we use to improve and enhance our existing processes.

How are quality standards maintained across global sites?

We have a Business Continuity and Contingency Plan (BCCP)in place which ensures that if one of our sites failed for whatever reason, the other sites could step in to fill the gap and continue to fulfil orders and carry out operations. We have built-in redundancy, which is why we can ensure that customers receive the same high quality product time after time.

Customers can also be confident that our products are designed and developed by our technical team and these same specifications are used across all our Intelsius sites in the UK, Germany, India, Malaysia, the USA and Ireland. As all our processes and training are closely followed and vetted, it helps us to maintain consistency, quality and continuity of supply globally. Our packaging systems are also compliant with international guidelines on dangerous goods substances and our temperature-controlled systems are tested against international standard of ISTA 7D.

We also receive many customer questionnaires which are sent to us if customers need to find out more information about the relevant international standards we adhere to and how we go about meeting compliance with them.

What about future developments for quality at Intelsius – how do we plan to stay ahead of the curve and deliver high standards?

We are working towards gaining the ISO9001 accreditation for all our all our global sites which will ensure further adherence to the highest quality standards. We aim to manufacture and assemble the same quality of products throughout our business and to implement and maintain the same processes and standards so that our products and services remain consistent. Our Technical team will also continue to design and develop new innovative products for customers from our HQ in York.

Get in Touch

To learn more about our quality processes or if you have any questions about our sample transport or temperature-controlled packaging solutions, reach out to us at [email protected] and one of our helpful customer representatives will be happy to assist you.