
Create a Quality-based Approach for Internal Audits
Any organization with a compliance management program must regularly conduct internal audits. These audits assure that the business operates at maximum efficiency across all departments.
Internal audits for the entire quality system are usually conducted annually. By establishing a disciplined, integrated approach to policies, regulations, cybersecurity, risks, controls, and issues, organizations can demonstrate a firm grasp of the regulatory compliance necessities and provide transparency into overall business risks.
Related Assets
Manage your entire audit lifecycle with ComplianceQuest’s audit management software for flexible, scalable and configurable workflow.
How to perform a quality control audit in a Manufacturing Business?

Select Audit Type
Before starting the audit, identify the focus and goal that needs to be achieved. Once the goal is set, it is easy to ascertain which of the following audits must be performed.
- System audits evaluate a company’s management systems and ensure that all elements and processes are effective. This audit also ensures that the development and implementation of the systems consistently meet specified requirements. For example, a QMS audit will review its existing quality system to comply with company policies and the required regulations.
- Product audits examine a company’s services and products to ensure they’re compliant with government policies, performance standards, and company quality standards.
- Process audits review all company processes to ensure efficiency within their established limits. This audit also checks operation time and responsiveness and the effectiveness of each procedure and process specifications.
- A first-party audit is an internal audit designed to evaluate the performance of the organization’s objectives, identify problem areas and find processes that need continuous improvement. This audit is conducted by employees who take on the auditor’s role.
- The second-party audit is an external audit conducted by auditors hired from outside the organization. These independent audits may impact the buying decisions of the customer.
- A third-party audit is performed by an external organization. This is done to ensure there is no conflict of interest resulting in recognition, license approval, certification, or penalty being issued by the third-party organization.

List Tasks and Perform Audit

Record Findings in an Audit Report

Determine and Perform Corrective Action

Schedule a Follow-Up Audit
After corrective action is carried out, conduct another audit to measure changes instituted by the corrective action.
- If system processes, performance, or products show improvement, record the findings in a separate audit report and discuss it before closing the audit.
- If the findings indicate minimal or no changes in any processes, performance, or products, make a note in a separate audit report to determine the subsequent corrective action needed. Continue this pattern until there is an improvement.
Why Every Industrial and
Manufacturing Company Needs to
Embark on a Safety Transformation
Program
Get to know how a Modern EQMS platform like
ComplianceQuest can help
What is the Internal Audit Procedure for Manufacturing Companies?
- External auditor – the third party hired from an approved agency, customer, or client to evaluate the quality system or products
- Internal auditor – an employee of the company

Identifying Subject Matter Experts (SMEs)
To perform an internal audit, the organization must involve stakeholders from across the organization. For example, SCADA experts and internal IT experts must collaborate to create a holistic security-first compliance approach.
Document Internal Control Procedures and Reasons for them
Continuously Monitor for Control Effectiveness
Continuously Document Your Monitoring
Create an Internal Audit Workflow
Communication before, during, and after the audit helps maintain security and compliance. It is imperative to create a process for preparing, reviewing, and responding to the internal audit that ensures that all tasks are completed promptly.
How can ComplianceQuest Audit Software help conduct internal audit in manufacturing businesses?

Costa Rican Medical Device Manufacturer Soars in the EQMS Cloud
What is the role of ISO 9001 in an internal audit?
Clause 9.2 of ISO 9001:2015 states that “the organization should conduct internal audits at planned intervals to provide information on whether the quality management system conforms to the organization’s own requirements, the requirement of ISO 9001:2015 standards and is effectively implemented and maintained.” Essentially ISO recommends conducting an internal audit to ensure that the organization is compliant with regulatory requirements and take corrective action if necessary.

Simple and Easy to use QMS software
Appasamy Associates

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Quality-centric companies rely on CQ QMS
Manage your entire audit lifecycle with ComplianceQuest’s audit management software for flexible, scalable and configurable workflow.
Frequently Asked Questions
Why are Audits Necessary?
- Evaluating the conformity or nonconformity of the quality system based on specified requirements
- Identifying whether the quality policies meet quality standards
- Verifying objective evidence of processes
- Ensuring the usage and sale of products based on regulation
- Providing evidence to reduce and eliminate any problem areas
- Taking corrective action for deficiencies
- Recognizing improvement opportunities
What is the Importance of Using Audit Software for company internal audit?
- Faster and more efficient audit processing
- Meet product quality requirements and overall manufacturing business goals
- Improve manufacturing productivity and general business operations
What is the Role of ComplianceQuest EQMS in Audits?
- Complete alignment to ISO 9001, ISO 13485, CGMP, and other regulations.
- It is time-saving, cost-effective, paperless, and improves enterprise-wide data visibility
- Serves as the single source of truth for all quality-related data and information
- Documents and records are readily identifiable and traceable
- Facilitates cloud-based storage of documents and records
- Helps maintain data confidentiality and security
- Provides easy-to-navigate dashboards and reports
- Helps in risk identification, control, and monitoring
- Ensures integration of the entire quality workflow across customer, supplier, and internal processes
- The training management process is directly integrated with the EQMS workflow
- New changes made in QMS can be easily communicated to the stakeholders
- Employees are aware of the timelines and accountability