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.

What is a quality management system (QMS) and why is it important?

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.

What is the difference between ISO 9001 and other quality standards?

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.

How do you implement a QMS in an organization?

Implementing a QMS requires careful planning and involvement from all employees across an organization.

To ensure a successful implementation, follow these six steps:

  1. Assign a cross-functional team (e.g., engineering, quality, operations, IT) to oversee the implementation. Team members will be responsible for handling quality processes and records. In the case of an enterprise QMS solution, they will oversee user administration, system configuration, access policies, integrations, and other key functions.
  2. Establish a deployment schedule. Consider data transfers, employee training, and other essential action items that need to occur before the actual deployment. Also consider any major business initiatives that will be impacted by the implementation (e.g., upcoming regulatory audit).
  3. Assess potential risks that may create bottlenecks in the implementation. Identify ways to avoid or mitigate all risks prior to go-live.
  4. Provide QMS education and training to all employees. If you are using an enterprise system, coordinate onboarding and application training with the software vendor and ensure that it addresses different types of users. As part of the training, distribute the quality policy, manual, and other key QMS documentation to ensure that employees have a clear understanding of their role in helping the organization meet its quality objectives.
  5. Deploy the system using an all-at-once or phased approach. A phased approach is best suited for an enterprise QMS, as it enables organizations to prioritize quality data and processes that are most critical to meeting their business objectives while getting acclimated to the new system.
  6. After a set period, measure the effectiveness of the QMS to ensure that your organization is meeting its defined targets.

How do you measure the effectiveness of a QMS?

Several tools can measure and monitor the effectiveness of a QMS and drive continuous improvement. Some of the commonly used methodologies include:

  • Control charts
  • Six Sigma

  • Cause and effect (fishbone) diagram

  • Pareto charts
  • Customer surveys
  • Customer complaint reports
  • Nonconformance reports (NCRs)
  • Internal audits

Manufacturing companies typically use these tools to monitor processes associated with product development, operational efficiency, product safety, delivery, and customer service.

What are the challenges of implementing a QMS?

Some of the key challenges of implementing a QMS include:

  • Lack of planning; no clear direction
    Without a clear plan and vision for what you want to accomplish, your QMS will not be effective. Before implementation, establish and document a plan that includes policies, processes, and performance metrics to support your QMS. The plan should align with your corporate goals and objectives as well as applicable regulations and standards. Employee roles and responsibilities should be clearly defined and communicated across the organization. Additionally, the proper resources should be allocated to help implement and maintain the QMS.
  • Lack of technology; reliance on manual, disconnected systems
    As part of their QMS, manufacturers must maintain a large volume of records regarding product design, development, and quality processes to comply with FDA, ISO, EU MDR, and other regulatory requirements. Teams cannot quickly locate files and track revisions if documentation is physically stored in multiple locations or electronically maintained using spreadsheets, Microsoft Word, and other ad-hoc solutions. Ultimately, organizations lack the control and traceability that is necessary to demonstrate compliance when using these manual processes and disconnected systems.
  • Resistance to change; lack of engagement
    Oftentimes, organizations establish a comfort level with doing things a certain way and are not receptive to change. The introduction of new processes or technology to support a QMS may seem daunting if employees do not have a complete understanding of the benefits or how these changes will impact their daily workload.
  • Lack of training
    If employees are not fully trained on the policies, processes, and functionality of the QMS, they will not embrace it. Training and engaging your teams will make them feel more confident about how the new QMS can help them drive continuous improvement and meet company goals to deliver high-quality products that meet customer expectations.

How do you maintain and improve a QMS?

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.

What role do employees play in a QMS?

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.

How can technology be used to support a QMS?

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.


To learn even more about QMS software, check out our Ultimate QMS Guide.