Moore Environmental provide services including certification, validation, flushing, maintenance and other HVAC-related services, particularly in the pharma, healthcare, life sciences and IT sectors. Moore Environmental have been certified to ISO9001 for many years but felt that their QMS was cumbersome, difficult to administer and failing to deliver the benefits that the client required. The revision of ISO9001 to the 2015 version provided the perfect opportunity to completely strip the QMS back to the basics and rebuild it into a user-friendly and effective system.
We took the decision not to try to change the QMS but instead, we decided to park the old system and build an entirely new QMS. We began with the “context” exercise where we identified the issues, interested parties, scope and processes. We then determined the procedures that Moore Environmental felt that they need to ensure the effective operation of the processes. As they had a number of activity-specific SOPs which were effective, the necessity for other procedures was limited, so we decided to incorporate these new procedures within the quality manual. The manual, including procedures to address areas such as supplier control, document control, corrective action and training came to less than 20 pages.
As with all systems, once implemented, we let the system run and bed in and we returned a number of months later to conduct the internal audit. As well as the office element, the internal audit included site visits to 2 client sites where Moore employees were engaged in operational work. The internal audit issues were addressed and we were ready for our external audit. The client requested that we attend the external audit with them to ensure that things went smoothly. Being present at the audit meant that we could help the client interpret the auditor’s questions, and crucially, help explain our technical approach to the system and how we comply with the standard. The external audit took place over 2 days at the end of which, Moore Environmental were recommended for certification.
