BIZOPS-48 Quality Management System (QMS)

What is this control about?

‘Quality Management System’ (QMS) is a framework that establishes processes, procedures, and resources to ensure consistent quality in the organization’s products or services. It encompasses various quality-related activities, such as quality planning, control, assurance, and improvement.

Available tools in the marketplace

Available templates

TrustCloud has a curated list of templates, internally or externally sourced, to help you get started. Click on the link for a downloadable version:

• Quality Management System (QMS) Policy Template

Control implementation

Here are some steps to consider when implementing the control of a Quality Management System’ (QMS) program:

Understand Organizational Context:

   – Gain a clear understanding of the organization’s goals, objectives, and key processes related to quality management.

   – Identify internal and external factors that may impact the QMS, such as customer requirements, industry regulations, and organizational culture.

Define Quality Policy and Objectives:

   – Develop a quality policy that reflects the organization’s commitment to quality and customer satisfaction.

   – Define measurable quality objectives aligned with the organization’s goals and customer expectations.

   – Obtain senior management’s endorsement and support for the quality policy and objectives.

 Establish QMS Documentation:

   – Develop QMS documentation, including policies, procedures, work instructions, and templates.

   – Ensure the documentation aligns with relevant standards, regulations, and industry best practices.

   – Establish version control and document management processes to ensure the accuracy and availability of QMS documentation.

Identify Key QMS Processes:

   – Identify the key processes within the organization that are critical to achieving quality objectives.

   – Define the sequence and interactions of these processes, ensuring clarity and consistency.

   – Establish process owners and assign responsibilities for each identified process.

Implement QMS Processes:

   – Communicate the QMS processes to employees and stakeholders, ensuring understanding and buy-in.

   – Train employees on their roles and responsibilities within the QMS processes.

   – Implement the QMS processes across the organization, ensuring adherence to defined procedures and work instructions.

Establish Performance Metrics and Monitoring:

   – Define key performance indicators (KPIs) and metrics to measure the effectiveness of QMS processes.

   – Establish data collection methods and reporting mechanisms for the identified metrics.

   – Implement regular monitoring and reporting of performance data to track progress and identify areas for improvement.

Conduct Internal Audits:

   – Establish an internal audit program to assess the conformity and effectiveness of the QMS.

   – Conduct regular internal audits based on a defined audit schedule and audit plan.

   – Document audit findings, non-conformities, and opportunities for improvement.

   – Track and verify the implementation of corrective and preventive actions resulting from audit findings.

Continual Improvement:

   – Establish a system for capturing and analyzing customer feedback, complaints, and suggestions.

   – Encourage employees to contribute improvement ideas and initiatives.

   – Conduct periodic management reviews to evaluate the performance and effectiveness of the QMS.

   – Identify areas for improvement and take actions to address them, ensuring a cycle of continuous improvement.

Employee Training and Competence:

   – Develop training programs to ensure employees have the necessary knowledge and skills to perform their QMS-related roles.

   – Assess employee competence through training assessments or performance evaluations.

   – Provide opportunities for professional development and continuous learning related to quality management.

What evidence is the auditor looking for?

Most auditors, at a minimum, are looking for:

• Quality Policy and Objectives:

     – A documented quality policy that outlines the organization’s commitment to quality and customer satisfaction.

     – Well-defined quality objectives that are specific, measurable, achievable, relevant, and time-bound (SMART).

     – Records of management reviews discussing the quality policy and objectives, including decisions and actions taken to align the QMS with business goals.

• QMS Documentation:

     – Documented procedures, work instructions, and process maps that outline the processes and activities within the QMS.

     – Quality manual or similar documentation providing an overview of the QMS, including its scope and key processes.

     – Records of the development, review, and approval of QMS documentation, including version control and any updates or revisions.

Evidence example

For the suggested action, an example is provided below:

• Quality Policy and Objectives

Use the policy available  within TrustCloud program

• QMS Documentation

Use Quality Management System (QMS) Policy Template