BIZOPS- 36- Quality Compliance Updates

What is this control about?

Implementing the control of Quality Compliance Updates is important because it ensures that an organization stays up to date with relevant quality compliance requirements and maintains adherence to industry standards and regulations.

Available tools in the marketplace

Tools:

PRP QIMA

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:

• N/A no templates for this control

Control implementation

Here are some guidelines to implement an effective records of Quality Compliance Updates program:

• Identify Regulatory and Quality Requirements: Identify the relevant regulatory and quality requirements that apply to the organization’s products, services, and processes. This may include industry standards, regulations, guidelines, customer requirements, and internal quality policies.
• Establish a Compliance Monitoring Process: Develop a process for monitoring and tracking quality compliance updates. This involves identifying reliable sources of information, such as regulatory authorities’ websites, industry publications, trade associations, and professional networks. Establish a systematic approach to regularly monitor and capture updates related to quality requirements.
• Assess the Impact of Updates: Analyze the impact of each quality compliance update on the organization’s operations, processes, products, and services. Identify the specific areas or activities that may be affected by the updates. Consider factors such as changes in regulatory requirements, new guidelines or best practices, and any necessary modifications to existing processes or procedures.
• Determine Responsibility and Ownership: Assign responsibility and ownership for tracking and managing quality compliance updates. Designate individuals or teams who will be responsible for staying informed about updates, assessing their impact, and taking appropriate actions. Clearly define roles and responsibilities to ensure accountability.
• Develop Communication Channels: Establish effective communication channels to disseminate quality compliance updates within the organization. This may include regular email updates, newsletters, intranet portals, or dedicated communication platforms. Ensure that the communication channels reach the relevant stakeholders, including quality management teams, process owners, and employees responsible for compliance.

What evidence do auditors look for?

Most auditors, at a minimum, are looking for the below-suggested action:

• Regulatory Updates and Alerts: Auditors will examine documentation that demonstrates how the organization monitors and receives updates on quality compliance requirements. This may include subscriptions to regulatory newsletters, email alerts, industry publications, or notifications from regulatory authorities. The documentation should show that the organization has established processes to stay informed about changes to regulations, standards, guidelines, and best practices relevant to its industry.

Evidence example

For the suggested action, an example is provided below:

• Regulatory Updates and Alerts