The International Organization for Standardization (ISO) is a global network of experts that are brought together to develop standards adoptable by almost every industry. The ISO 9001 and ISO 13485 focus on standards involving a quality management system by addressing customer expectations and improving the quality of products and services.
ISO 9001
Progressive holds the ISO 9001 certification for upholding the standards of a quality management system focusing on these main foundational quality management principles:
Customer Focus
The basis of all quality management is meeting the needs of your customers with the goal of exceeding their expectations.
Leadership
No matter what level of leadership our team members hold, they establish clear direction and unity as we work towards a collective goal.
Engagement of People
Creating and delivering value starts with passionate, engaged team members that know what they are responsible for and know that what they’re doing is important.
Process Approach
Stringently following interrelated processes that make up a cohesive system are crucial to achieving consistent and predictable results.
Improvement
The main focus is how our team can consistently deliver better products and services to our customers.
Evidence-Based Decision Making
Backing up decisions with an analysis of data or evidence will ensure operational effectiveness and smooth decision-making processes.
Relationship Management
Maintaining a strong professional relationship with interested parties helps us guarantee quality products and services.
ISO 13485
The ISO 13485 certification specifies the requirements for a quality management system for organizations, like Progressive, who are in any way involved in one or more of the life stages of a medical device. This includes:
- Design and development
- Production
- Storage and distribution
- Installation
- Servicing
- Final decommissioning and disposal of medical devices
- Design and development
- Technical support or maintenance
Progressive must identify our role in the life cycle of the medical device and follow those regulatory requirements applying to our role within our quality management system. The system must be documented and audited each year for continual improvement and accountability. This benefits our clients by ensuring our team remains qualified to serve your healthcare facility.
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Serving Critical Health Areas With Stringent Regulations
Progressive works in areas where people are in critical health such as nursing homes, hospitals, in-home care, and more. We are trained and certified to handle ventilators, ultrasound machines, patient monitoring devices, and other medical device activities. We are dedicated to following the rules set by the ISO 13485 standards and understand that what our team is responsible for makes a difference in people’s lives.
Culture of Nonconformity
This certification ensures the customer is always put first, errors are minimized, and the quality standards are maintained. When an error is caught, immediate action is taken by identifying the issue or event that took place, diving into what the root cause was, and finally correcting those actions.
Progressive focuses on risk assessment, and we have a team dedicated to creating and implementing new procedures for mitigating risks of issues arising in the future. Our team also takes pride in training and internally auditing themselves to constantly improve the level of service we provide our customers.
Progressive’s Investment, Customer’s Benefit
The investment of adopting these standards of quality management was made out of dedication to our customers and delivering the best experience at the highest quality. Our team is:
- Dedicated
- Disciplined
- Accountable
- Trained
- Passionate
Most Recent Audit Findings
No majors or minors were found in our latest quality management system audit.
Email linda.brock@pcians.com to Schedule a Consultation