Need for a QMS Tailored for Medical Device Companies

Some of the key aspects the regulations ensure include:

• Documentation: Documenting processes serve two purposes - it demonstrates compliance and ensures process continuity and standardization. This is essential for consistency and information sharing to help employees align their tasks with quality policies and standard operating procedures that are created based on internal and external quality requirements.
• Training: Employees’ skill sets in their specific areas of work and quality processes associated with the role are critical for compliance. Therefore, both these aspects are ensured through a focused training program so that the employees are equipped with the necessary knowledge and skills to meet their job requirements.
• Data Access: Though supply chains are now distributed, manufacturers need a unified view of data and process for informed decision-making. Standardization of operations across geographies and visibility into processes are key for ensuring uniform quality management across the medical device company’s different internal and external sites. Regulations therefore, require a cloud-based solution that provides leaders with anytime, anywhere access to enterprise-wide data.
• Proactive Risk Management: Access to data also helps identify potential threats, which can be ranked based on frequency and severity of occurrence. This ranking is crucial for allocating resources for high-risk threats on priority and empowering employees to handle other risks at their level without disrupting operations.
• Periodic Inspections and Audits: Periodic monitoring of sites and processes is crucial to ensure the health of the systems and the adherence to quality standards. Therefore, businesses need to have internal and external inspections and audits that can help them identify deviations and nonconformances early and ensure the robustness of the quality management system.

Creating and Maintaining an Effective QMS System

As mentioned above, most regulations and standards provide a framework for quality management, allowing manufacturers to tailor the specific processes based on their maturity level. Therefore, when creating the QMS, businesses must follow the process given below:

• Step 1: Goal Setting - Identifying the organization’s quality vision is step 1 in creating the quality management system. The goals must be realistic and achievable while challenging enough to be aspirational and inspiring for the employees.
• Step 2: Gap Analysis - After identifying the goals, the next step is to conduct a gap analysis. This helps understand where the company stands and what it needs to do to achieve its goals.
• Step 3: Scope and Plan - Based on the gap analysis findings, the leadership must create a strategy to fill the gaps and progress toward the goal within a given timeframe.
• Step 4: Create SOPs and Policies - The policies and standard operating procedures must be developed based on the plan and strategy. Involve stakeholders to gather their input and create comprehensive strategies aligned with the organization’s culture and vision.
• Step 5: Training and Orientation - Once the policies have been finalized, they must be shared with all the employees, and they must be provided with training on the new way of working to ensure compliance from the start. This is also important to get employee buy-in, which will ensure the sustenance of the new way of working.
• Step 6: Implement - The implementation can begin once the plan is in place, and the people are empowered with skills and information. Pilot the changes and assess the impact before making the changes across the organization. If the new approach throws up any challenges, it will be easier to rectify them before it is implemented across the organization. Following the PDCA model of the Plan, Do, Check, Act approach works best for any change of this scale.
• Step 7: Track and Monitor - It is also important to identify quantifiable metrics to determine whether the new approach is effective. Tracking and monitoring these key performance indicators will indicate whether the QMS has the desired impact or needs modification. Any deviation or new risks need to be analyzed for criticality and reviewed. Changes to the procedures will depend on cost-benefit analysis.
• Step 8: Documenting - Documentation is a key part of compliance. It helps with tracking, business continuity in case of discrepancies, and demonstrating compliance.
• Step 9: Continuous Improvement - Implementing a quality management system is not a one-time activity. Markets, regulatory requirements, and even the organization are constantly evolving, and the QMS must reflect these changes and growing needs. Therefore, it requires continuous improvement. This is made possible by systematizing inspections and audits and constantly using observations and feedback to fine-tune the quality management system. Creating an internal team of inspectors and auditors ensures that internal inspections and audits can be done periodically and reliably. Therefore, training the employees with the right experience and skills for these roles is also part of continuous improvement.

Implementing a cloud-based system such as ComplianceQuest can help automate the development and implementation of the quality management system. Find out how by visiting www.compliancequest.com.