Achieving a quality management certification and maintaining compliance with them is challenging for all organizations. It takes time, resources and dedication to consistently and successfully meet or exceed the requirements. Quality Management Systems (QMS) are detailed and documented operational procedures for helping companies reach their quality goals.
Introduction to QMS
While QMS may be a relatively young acronym, the principles of quality management underlying the system have existed for centuries. Modern QMS programs trace their roots to the craftsmen guilds in Europe, when craftspeople first formed unions to set service and product quality standards for their professions.
What Is a QMS?
A QMS is a formalized approach to quality activities. The system includes and documents an organization’s quality procedures, processes, responsibilities and objectives.
Developing and implementing a QMS is crucial for compliance in certain industries to achieve certifications. Common standards like ISO 9001:2015 and AS9100 are often necessary for working with specific customers. Quality management systems help ensure an organization can meet the certification requirements by detailing the essential compliance activities and documentation involved in success.
Modern QMS approaches combine seven principles into a cohesive, formalized program contributing to overall quality goals:
- Leadership
- Process approach
- Relationship management
- Evidence-based decision-making
- Continuous improvement
- Engagement of people
- Customer focus
There are defined steps to creating, instituting and administering a QMS, and most rely on technology for assistance — QMS software helps organizations develop, execute and manage their plans simply and efficiently. Step one involves designing and building the system, followed by deployment. Once implemented, the QMS enters the control-and-measure stage, where regular audits become essential.
What Are the Purpose and Importance of QMS Audits?
QMS audits systematically assess how well the program meets its defined requirements and complies with regulations. These reviews also help ensure effective processes and identify improvement opportunities. Organizations gain visibility into how successful their current quality efforts are and actionable insights into the adjustments they need to make to reach their quality management compliance goals.
Common Types of Quality Audits
Three common types of quality audits exist — internal, supplier and third-party. Understanding the differences and what to expect during these reviews can help you decide the correct type and frequency for your organization.
Internal Audits
Internal audits are also often called first-party audits and, as their name suggests, are assessments that an organization conducts themselves. Many industries require these audits for regulatory compliance and specify how they must occur. For example, the Food and Drug Administration (FDA) mandates an internal audit for medical device manufacturers conducted by employees who aren’t directly responsible for the efforts being examined.
Inspection teams work from an exhaustive, department-customized checklist to determine continuous compliance for different system initiatives. Common key elements auditors evaluate include system documentation, records, practices, processes and procedures. They aim to assess compliance with established organizational priorities and guidelines necessary to maintain critical quality certification standards. Once auditing is complete, leadership can review the findings, analyze results and implement solutions.
Supplier Audits
Supplier audits are independent reviews of a vendor as part of healthy risk management. As customers, organizations want confirmation that a supplier is devoted to quality management compliance and can deliver on your specifications. These audits share the same goal and purpose as an internal audit — an objective and systematic assessment to gauge the program’s effectiveness and discover where conformance gaps exist. The scope is also similar, with independent teams using customized checklists to review QMS records, system documentation and more.
These examinations can focus on the overall QMS, each step of a defined process, regulatory compliance or a specific product. A thorough supplier audit offers organizational value in several ways. It helps companies uncover and understand where risks may occur so they can proactively develop risk-reduction strategies. Second-party assessments are also useful in fostering better supplier relationships. The increased visibility helps deepen trust, and any vulnerabilities are a chance to improve communication and collaborate for compliance success.
Third-Party Audits
Third-party audits are those conducted on an organization by an independent evaluator to evidence regulatory compliance or standard certification. For example, organizations achieve certification with ISO 9001:2015 through review from an objective third-party examiner called a registrar.
Similar to an internal audit, a third-party assessment empowers organizations to know where quality management compliance efforts are successful and where improvement opportunities exist. Companies and public sector agencies alike can leverage these insights to proactively address potential noncompliance issues.
How to Audit a QMS
A practical QMS audit has three broad stages — planning and preparation, conducting the review, and reporting the findings.
Planning and Preparation
Defining the audit’s goals and scope is the first step in creating an audit plan.
For any successful review, determining what criteria to measure against is essential. Organizations must understand the applicable compliance frameworks and requirements, including how often audits must occur. It’s also crucial to reference the most current guidelines and stay up to date with the standards and industry regulations since they frequently evolve.
The scope establishes what activities will undergo examination, such as a specific department or process. Detail the resources and evidence needed for assessment, like quality manuals and discrete process steps. The last step of this stage is to build an independent audit team and note who will handle what responsibilities.
Conducting the Audit
Once you finalize your audit plan and team, execute the audit. Have each team member collect and document the appropriate objective evidence according to your plan’s scope and objectives. This step includes reviewing typical process documentation and key performance metrics outputs, Pareto charts, histograms and flowcharts to help visualize and analyze the system’s successes and improvement opportunities.
Reporting Findings
This last stage of a QMS audit involves communicating the results to stakeholders. The audit team leader should create a cohesive, factual and clear report that details:
- The audit’s scope and objectives.
- Measurement criteria used, including the relevant compliance and industry standards.
- Evidence collected and analyzed.
- Identification of nonconformities and other findings.
- Recommended actions and follow-up steps.
Audit Follow-Up
Nonconformities reported in a QMS audit are the basis for refining the system and progressing toward enhanced compliance. Each references the specific requirement, what didn’t meet it and the evidence gathered to support the claim. Auditors can classify a nonconformity as minor, major or opportunity for improvement. Some of the most common nonconformity examples include:
- Incorrect measuring devices or tools used to capture a particular measurement.
- Ineffective plan development or implementation for managing changes to the QMS.
- Incomplete or absent training documentation.
- Improper documentation or ineffective processes for receiving and first-article inspections.
- Inadequate risk evaluation throughout the supply ecosystem.
Successful organizations leverage their QMS audit insights about nonconformities for preventive and corrective actions. Once leaders understand where the compliance vulnerabilities are, they can form well-developed strategies for addressing them. Investing in an audit follow-up helps ensure recommendations were correctly implemented, reducing the risk of future recurrence or similar issues emerging.
Boost QMS Compliance With NTS Unitek Technical Services
NTS Unitek specializes in helping organizations maintain QMS compliance and reduce their supply chain risk with comprehensive audit and survey services. Whether you need a supplier audit for a specific product or process or an independent evaluation of your vendor network’s QMS, we can help. Our professionals have over a century of collective industry experience and keep pace with regulatory and standards changes. We also have extensive expertise in identifying the root causes of nonconformities and developing corrective action plans.
Take the next step toward continuous improvement and better compliance by connecting with us online or calling 703-961-9901.
