BIZOPS-46 QMS Program

What is this control about?

‘QMS Program’ (Quality Management System Program) is a comprehensive framework that ensures the organization’s products or services consistently meet or exceed customer requirements and regulatory standards. It encompasses policies, procedures, processes, and resources to manage quality-related activities.

Available tools in the marketplace

EtQ Reliance IQS

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 QMS  program:

• Define Quality Objectives:– Determine the organization’s quality objectives aligned with business goals, customer requirements, and regulatory standards.

  – Document measurable targets and key performance indicators (KPIs) to assess progress and monitor the achievement of quality objectives.

  – Obtain buy-in from senior management and stakeholders on the defined quality objectives.

• Identify Applicable Standards and Regulations:– Identify and document the relevant quality standards, industry-specific regulations, and compliance requirements that the organization needs to adhere to.

  – Evaluate the impact of these standards and regulations on the organization’s processes, products, or services.

  – Establish procedures to monitor and keep abreast of any changes or updates to applicable standards and regulations.

• Develop QMS Documentation:– Develop and document the QMS framework, which includes quality policies, procedures, work instructions, and process documentation.

  – Define roles and responsibilities for quality-related activities, ensuring accountability and clear ownership of processes.

  – Establish a document control system to manage and maintain the integrity and version control of QMS documentation.

• Implement Documented Processes and Procedures:– Implement the documented processes and procedures across the organization, ensuring their adoption and adherence.

  – Conduct training programs to educate employees on the QMS processes and their responsibilities within the system.

  – Monitor the implementation of processes and procedures to identify any gaps or areas for improvement.

• Establish Quality Monitoring and Measurement:– Define a system for monitoring and measuring key quality parameters, such as product/service performance, customer satisfaction, and process effectiveness.

  – Establish data collection mechanisms and metrics to track and analyze quality performance regularly.

  – Utilize statistical techniques, such as Statistical Process Control (SPC), to analyze data and identify trends or patterns for quality improvement.

• Implement Corrective and Preventive Actions (CAPA):– Develop procedures for capturing, documenting, and addressing non-conformances, customer complaints, or quality incidents.

  – Implement a CAPA process to investigate root causes, implement corrective actions, and prevent recurrence of quality issues.

  – Monitor and track the effectiveness of implemented corrective and preventive actions.

• Conduct Internal Audits:– Establish an internal audit program to regularly assess the effectiveness and compliance of the QMS.

  – Conduct systematic audits of QMS processes, procedures, and documentation to identify non-conformances and areas for improvement.

  – Document audit findings, track their resolution, and ensure the implementation of necessary corrective actions.

 

What evidence is the auditor looking for?

Most auditors, at a minimum, are looking for:

• Quality Policy and Objectives:– Documentation of the organization’s quality policy that outlines the commitment to quality and customer satisfaction.

  – Documentation of 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 Program with business goals.

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

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

  – Evidence of the availability and accessibility of QMS documentation to employees, such as a centralized document control system or an intranet portal.

   

Evidence example

For the suggested action, an example is provided below:

• Quality Policy and Objectives

Document this within Quality Management System (QMS) Policy Template

• QMS Documentation

Document this within Quality Management System (QMS) Policy Template