The world's most broadly adopted standard, ISO 9001:2015, includes a series of quality principles that are frequently referenced in other QMS standards.
For many growing life sciences organizations, ISO 9001:2015 compliance causes significant strain on the company's workforce.
However, certification can deliver tremendous value to life science companies. As such, organizations use QMS frameworks to guide continuous improvement efforts and adopt data for evidence-based decision making. QMS adoption supports increased compliance, profitability, and the development of a quality-driven culture.
5 Essential Elements of a Quality Management Software
Unfortunately, finding the best quality management system software for your growing enterprise is easier said than done.
While it's technically possible to meet major regulatory requirements with paper-based systems, a cloud-based quality management system can situate your organization for rapid and sustained quality management success.
What's the secret to finding a great quality management system?
We recommend outlining your organization's unique system requirements prior to investing in an enterprise quality management solution (eQMS). With that in mind, here are the essential elements of a high-value quality management software system you'll need to consider.
1. Quality Objectives
Start by creating quality objectives. These are designed to encourage organizations to define strategic goals — and, as a result, establish a purpose for the eQMS.
Moreover, objectives translate an organization's vision into practice by creating a link between customer requirements and internal goals.
Examples of quality objectives could include:
- Obtaining total compliance with staff training requirements and raise average assessment scores from 90% to 95%.
- Implementing an eQMS successfully within three months and eliminating the need for paper-based quality management processes.
The objectives should provide a clear metric for measuring progress against strategic goals, including the timeline for achievement and a measurable parameter of improvement.
RELATED READING: 5 Objectives of a Quality Assurance in the Pharmaceutical Industry
2. Organizational Structure and Responsibilities
A results-driven eQMS will have a clear organizational structure with well-organized roles and responsibilities. Documentation of the organizational structure and associated responsibilities should include clear visual guides, such as flowcharts.
For a life sciences company in the early phases of the product development lifecycle, we recommend documenting the following:
- Information systems
- Tools for assessment
- Purchasing and inventory
- Process controls
- Documents and records
RELATED READING: 9 Helpful Document Control Tips You Can Implement Right Now
By implementing a process-driven approach to quality management and quality assurance, life sciences organizations can easily replicate quality outcomes.
Initial efforts to define processes should create a high-level picture of how processes serve the organization and intersect with resources such as employees or technology.
After identifying processes, organizations can begin to define success standards. Typically, the recommended path for identifying internal processes and establishing key performance indicators is as follows:
- Identify organizational processes
- Define process standards
- Establish methods for measuring success
- Document a standardized approach to ensuring quality outputs
- Commit to continual improvement
4. Continuous Improvement
For any growing life sciences organization, continuous improvement and adaptation are necessary. As such, management should demonstrate leadership and commitment with respect to the quality management system by taking account of its effectiveness or ineffectiveness and optimizing the process regularly.
The organizational processes to meet eQMS standards through continuous improvement requires clear and concise documentation in the following areas:
- Quality planning procedures
- Compliance requirements
- Safety design
- Risk-based thinking
- Corrective and preventive actions (CAPA)
- Gradual and breakthrough improvement
- Assessment of the QMS
RELATED READING: How to Create and Implement an Effective Quality System Plan
5. Document Control
Finally, keep records in all communications, evidence, conformity, and knowledge sharing. QMS outlines standards for the types of documentation which are necessary to support quality management at a minimum, which may not be reflective of all the documents needed for accurate quality control.
Effective record keeping is crucial to the success of the eQMS and the organization's ability to obtain certification and compliance with major regulations. While QMS standards do not typically prescribe a method for document management, being able to capture and retain all supporting evidence is generally best accomplished with eQMS solutions.
RELATED READING: What is a Document Control System and Why Does it Matter?
Qualio Powers Medical Device Manufacturers
Qualio is a cloud-based eQMS designed specially for the needs of startups in highly regulated life sciences industries.
Our platform offers an intuitive user experience and simple implementation with a design that's built to scale.
Qualio is the world’s leading enterprise quality management system for medical device companies with up to 500 employees and goals of growing quickly. We're committed to the success of the companies we work with. To this end, we can recommend several specialized medical device risk management consulting firms that work with Qualio and have an excellent track record.
To get started with eQMS solutions, download our free guide and learn about the 12 questions you need to ask eQMS vendors as you evaluate your options.
Find the answers to each of them and you can find an eQMS that is tailored to your company's growth stage, fits your current budget, and delivers the tools your business needs to comply with major industry-specific regulations.