Pharma Growth and Enhanced Quality Management Systems

AMR had a basic ISO9001 accredited management system in place, which was effective and broadly implemented. However, as the organisation evolved and AMR continued its success in the print packaging sector, they recognized the need to pursue further ISO9001 certification improvement. They aimed to fully explore and embed the disciplines of their continuous improvement QMS across the entire organisation. This approach would enhance customer focus, process thinking, and risk management, all while fostering ongoing improvement in their Pharma market management system.

The legacy management system was outdated and accredited at an 'as-required' state. Many core disciplines of the continuous improvement QMS were micro-managed by the Quality department and not fully embedded into the management thinking across the organization. There was mixed buy-in at the leadership level regarding the effectiveness of the QMS and the significance of its implementation, especially in relation to ISO9001 certification improvement. A change in mindset was required among various employees, some of whom had been with AMR for over 20 years, to adopt process thinking in the face of their extensive experience within the Pharma market management system.

Since 2018, the manufacturing engineer has collaborated closely with AMR and their Compliance team to enhance its management system, focusing on continuous improvement QMS initiatives, including:  

- A comprehensive overhaul and rewrite of the management systems manual to align with ISO9001 certification improvement standards.  

- Consistent identification and documentation of operational activities and processes to support ongoing development and enhancement.  

- Promotion of risk-based thinking at both operational and OHS levels across the business.  

- A revamp of process documentation, templates, and forms to improve the quality of information delivered for products and services in the Pharma market management system.  

- Ongoing maintenance and implementation of the Quality Management System (QMS).

AMR Hewitts has maintained accreditation to ISO9001 certification improvement in Quality Management Systems (QMS) since collaborating with the manufacturing engineer. The company has continuously improved its processing methods, enabling it to more effectively deliver leading products and services to an increasingly demanding customer base, thereby achieving exemplary DIFOT. 

AMR has successfully met the needs and expectations of its expanding Pharma market client base, adhering to stringent quality controls and demonstrating its capabilities in print packaging and the execution of its management systems.

If your operation demands similar expertise and you seek guidance on projects related to continuous improvement QMS or ISO9001 certification improvement, reach out to the manufacturing engineer to arrange an initial conversation and start the ball rolling for your Pharma market management system.