A quality management system is abroad term with meanings varying according to the type of business. In general terms, the ‘Quality Management System’ (QMS) is a collection of business processes that focus on the quality of a product and with customer satisfaction (something that extends to patient safety in the GMP context). To be effective the QMS must be aligned with an organization’s purpose and strategic direction. There is also an in-built assumption that the QMS will drive continuous improvement. The basis of a QMS is outlined in ISO 9001. The standard does not specify what the objectives relating to “quality” or “meeting customer needs” should be, but it requires organizations to define these objectives themselves and continually improve their processes in order to reach them.

In the pharmaceuticals and healthcare context, the word ‘pharmaceutical’ appears within the GMPs, so we speak of the PQMS. This will include:

• Management controls.
• Design controls.
• Production and process controls.
• Corrective and preventative actions.
• Material controls.
• Records, documents, and change controls.
• Facilities and equipment controls.

A PQMS intersects with the concept of ‘quality’.

The term ‘quality’ can sometimes prove to be elusive and there are contested definitions. The internationally recognized definition of quality is outlined by ISO (the International Standards Organization) in the standard “ISO 9000:2005 – Fundamentals & Vocabulary”. Here quality is defined as: “the degree to which a set of characteristics fulfils requirements”. Whilst at first ephemeral the definition allows scope for us to embrace a whole set of “characteristics” (such as achievement of product specification, delivery on time and in-full, achievement in an effective and efficient manner) and a range of “requirements” (such as those of internal and external customers, shareholders, society, employees, and regulatory bodies).

Under GMP, manufacturers can determine the extent of the various quality elements and there is some leeway to develop and implement procedures tailored to their particular processes and products. However, a QMS, as defined by ISO and in the GMPs (the PQMS), must be risk based and embedded within the culture of the organisation.