ELEMENTS OF AN EFFECTIVE QUALITY MANAGEMENT SYSTEM
When implementing a QMS, organizations should keep these key elements in mind:
Quality policy and objectives
The quality policy outlines an organization’s purpose and mission and supports the business strategy. It also highlights the company’s commitment to continuous improvement and meeting regulatory and customer requirements. Quality objectives are measurable goals that stem from the quality policy. Examples include product performance, efficiency, safety, and delivery.
The quality manual outlines the scope of the QMS and includes information such as organizational objectives, expectations, and policies. The quality manual also specifies requirements for achieving compliance with regulatory standards like ISO, FDA, EU MDR, and EU IVDR.
Organizational structure and responsibilities
The QMS should include the roles and responsibilities of key stakeholders, resources, and infrastructure that contribute to an organization’s quality objectives. Flow charts or similar diagrams can be used to clearly illustrate how the organization is structured.
Organizations should define processes that require employees, machines, technology, or other resources to turn inputs into outputs. Standards and metrics for measuring the performance of these processes should also be documented to ensure that quality outputs are always the end result.
Organizations must utilize surveys, complaint reports, review websites, or other tools to monitor customer satisfaction and ensure that their quality objectives are being met.
The proper processes must be in place to ensure ongoing improvement of products and services over time. Six Sigma and lean are commonly used tools to ensure continuous improvement.
A system must be in place to ensure:
- Review and approval of documents for adequacy prior to release
- Review/update/re-approval of documents on an as-needed basis
- Identification of changes and current document revision status
- Prevention of obsolete documents from unintended use
- Policy or procedure for the identification, storage, protection, retrieval, retention, and disposal of documents
Enterprise quality management system (eQMS) software
To gain greater traceability and control of quality processes and simplify compliance, companies are making the switch from traditional paper-based systems to eQMS solutions. Cloud-based systems like Arena QMS help eliminate nonconformance issues, reduce audit risks, and improve new product development processes by improving quality controls and documenting policies, procedures, and practices.