If your organization is in the exploratory stage of implementing a quality management system (QMS), here are some commonly asked questions and answers to guide you in establishing a system that accommodates the needs of your business and helps you achieve your compliance goals.
A QMS is a set of policies, processes, and procedures that serve as the framework for helping organizations produce high-quality products that meet customer expectations and comply with industry regulations and standards.
A QMS provides organizations with a systematic approach to identify and resolve nonconformance issues and gain better control of business processes. In turn, this can improve efficiencies, drive continuous improvement, and reduce compliance risks.
Unlike other quality standards which are industry specific (i.e., ISO 13485, AS9100, IATF 16949), ISO 9001 is a globally recognized standard that can be applied to any business. It provides the framework for establishing and maintaining a QMS which includes a quality policy, quality manual, and supporting processes and procedures.
Implementing a QMS requires careful planning and involvement from all employees across an organization.
To ensure a successful implementation, follow these six steps:
Several tools can measure and monitor the effectiveness of a QMS and drive continuous improvement. Some of the commonly used methodologies include:
Manufacturing companies typically use these tools to monitor processes associated with product development, operational efficiency, product safety, delivery, and customer service.
Some of the key challenges of implementing a QMS include:
Today many companies are leveraging electronic quality management systems to maintain the high volume of records that are essential to meeting regulatory requirements. Housing standard operating procedures (SOPs), design history files (DHFs), training records, and other QMS documentation in an electronic repository enables organizations to gain better control over their quality processes and easily compile files in the event of a regulatory audit or inspection.
Whether it’s an enterprise system or a more conventional document-based system, organizations should periodically analyze the performance of their QMS to identify gaps and make the necessary adjustments. Analyzing product development processes (e.g., ECO cycle time), customer complaints, product nonconformances, corrective and preventive action (CAPA) resolutions, and other critical areas will help organizations drive continuous improvement and meet their compliance goals.
From entry level to upper management positions—employees at all levels play a vital role in maintaining a QMS and driving a culture of continuous improvement.
Senior management is responsible for developing policies and objectives around the QMS and communicating them to the organization. They also designate roles and responsibilities for carrying out core QMS processes and allocate the necessary tools and resources.
All employees should be empowered to identify areas for process improvement. Additionally, they should take part in key decisions that help the organization deliver better products and services and enhance customer satisfaction.
Advanced digital technologies like the Cloud can be used to eliminate data silos and communication gaps to help companies quickly resolve product nonconformances and other quality issues. Cloud-based QMS solutions aggregate quality records in a single source of truth, providing dispersed teams with convenient access to the latest information. By automating the management of quality information, organizations can apply best practices in document control, training management, design controls, and other critical areas.
To get the most value from a QMS and meet your business objectives, it is important to maintain a tight connection between product and quality information. Product-centric QMS solutions manage linked relationships between quality processes (e.g., engineering changes, CAPAs) and the product bill of materials (BOM) for greater control, traceability, and visibility. With everything connected in a single cloud-based system, teams can easily identify, track, and resolve quality and manufacturing issues throughout the product development process and avoid audit risks.
To learn even more about QMS software, check out our Ultimate QMS Guide.