The Importance of Quality Management Systems at PSL

August 24, 2022

Patient receiving an injection demonstrating importance of Biodegradable Microspheres

Quality management systems (QMS) encompass all business processes ensuring products and services meet customer requirements continuously. Manufacturers are not necessarily required to certify these processes, but adhering to established quality standards yields numerous advantages. ISO 9000 is the world’s best-known family of quality management standards, and companies looking to guarantee good quality products and services with absolute consistency can certify to ISO 9001.

Powder Systems Ltd. is an ISO 9001:2015 accredited company. Our quality systems are integral to our global efforts, and we have prided ourselves on our ISO accreditation since 1998.

This blog post explains why regulatory compliance with ISO’s quality management system standard is so important to us.

What is ISO 9001?

ISO 9001 is internationally recognised as the top accreditation for quality management systems, and it can be implemented by companies of all sizes in any industry. Various adaptations have been made to address specific niches, such as ISO 13485 for medical devices, but this article primarily will focus on the overarching standard, which is non-sector specific.

The ultimate goal of ISO 9001 is to guarantee customer satisfaction through ongoing improvement and consistent results. There are seven core principles underlying this initiative:

  • Engagement of people
  • Customer focus
  • Leadership
  • Process approach
  • Continuous improvement
  • Evidence-based decision making
  • Relationship management

What Accreditation Means to PSL

ISO 9001 is embodied within our entire business, driven by top management down. Our world-class quality policy is signed by our CEO, which demonstrates proactive leadership engagement and, along with Senior Management, is overseen by our dedicated Quality Team. It requires a process-based approach, meaning quality control objectives are met using a network of interrelated procedures. The output of one becomes the input of another, and so on, ensuring an unbroken chain of processes that enhances our ability to focus efforts wherever improvements can be made.

Our certificate includes a specific clause about product design and how we report on inputs and outputs, plus a similar section on procurement. Each of these aspects strongly emphasises objectively managing processes, enabling us to control critical metrics and implement evidence-based actions.

We ensure that our quality management system procedurally supports all departments, so the entire business is aligned toward high quality and customer satisfaction. This covers all requirements needed from interested parties, any relevant legislation, and how we support standards. Naturally, our first goal is the prevention of issues. However, employees across departments receive clear guidance from relevant managers and our quality team on correcting issues promptly. This ensures our uninterrupted quality history is maintained and any issues arising are always resolved through robust investigation.

How We Monitor Our Quality Management System

We are audited every six months and are continually assessed by the British Standards Institute (BSI) as part of our accreditation process. We also regularly audit our clauses to ensure consistent compliance, using Q-Pulse quality management software to manage our quality documentation. ISO 9001 compliance extends to our supply chain, who are also audited on a regular basis, setting the benchmark for quality.

As an OEM in the pharmaceutical industry, ISO 9001 is crucial. Our accreditation demonstrates our commitment to providing the expected level of quality and traceability of our products and services. Certification provides confidence and trust and our Quality Management System continues to provide greater efficiencies, to the benefit of PSL, our clients and partners.

Sylvain Querol
Head of Business Development, PSL

If you would like to learn more about PSL’s quality management systems, including how we comply with various additional industry practices and directives, why not contact a team member today.