Events are Now Happening Go to Event Page Explore Medical Device Database Join Professionals and Ask Your Queries

Internal Quality Audits

Internal Quality Audits can be referred as Inspections also, which can be of any type like Self Assesment, Supplier Inspection etc. 

A QMS is a structured framework of policies, processes, and procedures required to plan, implement, and control quality in an organization. It encompasses the entire organization and aims to achieve customer satisfaction by meeting their quality requirements consistently.

Internal audits are systematic examinations of an organization's processes, procedures, and systems to ensure compliance with standards, regulations, and best practices. They serve as a vital tool for identifying areas of improvement, enhancing operational efficiency, and mitigating risks.

Purpose of Internal Audits

The primary objectives of internal audits are to:Evaluate the effectiveness of the organization's quality management system.
  • Identify nonconformities and areas of improvement.
  • Ensure compliance with relevant standards, regulations, and policies.
  • Enhance risk management practices.
  • Drive continuous improvement efforts.
  • Drive continuous improvement efforts.

Key Components of Internal Audits

  • Planning: Define audit objectives, scope, and criteria. Develop an audit plan outlining the schedule, resources, and responsibilities.
  • Execution: Conduct on-site audits, reviewing documentation, observing processes, and interviewing personnel.
  • Reporting: Document audit findings, including nonconformities, observations, and opportunities for improvement. Prepare an audit report with recommendations.
  • Follow-up: Track the implementation of corrective actions and verify their effectiveness. Close out audit findings and address any outstanding issues.

Benefits of Internal Audits

Internal audits offer numerous benefits to organizations, including
  • Enhanced compliance with standards and regulations.
  • Improved operational efficiency and effectiveness.
  • Identification of cost-saving opportunities.
  • Enhanced risk management and mitigation.
  • Increased stakeholder confidence and trust.
Internal quality audits and inspections are both essential components of a Quality Management System (QMS) aimed at verifying compliance with standards, identifying areas for improvement, and ensuring ongoing quality assurance. While they share similarities, there are also key differences between audits and inspections.

Internal Quality Audits

  • Purpose: Internal quality audits are systematic, independent, and documented processes conducted to determine whether QMS activities and results comply with planned arrangements and established requirements, including standards, procedures, and regulations.
  • Scope: Internal audits encompass the entire organization and its processes, including management systems, operations, and support functions.
  • Types: Internal audits can take various forms, including process audits, system audits, compliance audits, and product audits.
  • Independence: Internal audits are typically conducted by personnel within the organization who are independent of the audited area or process, ensuring objectivity and impartiality.
  • Methods: Audit methods may include document review, interviews, observations, and data analysis to assess conformity, effectiveness, and opportunities for improvement.
  • Reporting: Audit findings, including nonconformities and opportunities for improvement, are documented in audit reports and communicated to relevant stakeholders for corrective action and follow-up.

Basic Internal Audit Practices

Basic internal audit practices involve systematic processes for evaluating the effectiveness, adequacy, and compliance of an organization's systems, processes, and controls. Here are some key steps and principles:
  • Establish Objectives: Clearly define the objectives of the internal audit, including scope, frequency, and areas to be assessed. Align these objectives with the organization's goals, regulatory requirements, and best practices.
  • Plan the Audit: Develop a comprehensive audit plan outlining the approach, resources, timeline, and responsibilities for conducting the audit. Identify key risks, processes, and controls to be reviewed during the audit.
  • Conduct Fieldwork: Execute the audit plan by gathering evidence, conducting interviews, reviewing documents, and performing testing of controls. Ensure that audit procedures are performed thoroughly, objectively, and in accordance with audit standards.
  • Document Findings: Document audit findings, including observations, deficiencies, and opportunities for improvement. Maintain clear, accurate, and well-organized audit documentation to support conclusions and recommendations.
  • Analyze Results: Analyze audit findings to assess the significance of issues identified and their potential impact on the organization. Consider the root causes of deficiencies and their implications for internal control and risk management.
  • Communicate Results: Communicate audit findings, conclusions, and recommendations to relevant stakeholders, including management, process owners, and audit committees. Ensure that audit reports are clear, concise, and actionable, highlighting areas of strength and opportunities for improvement.
  • Follow-Up: Monitor and track the implementation of corrective actions and management responses to audit recommendations. Follow up on outstanding issues to ensure that deficiencies are addressed in a timely manner and that corrective actions are effective.
  • Continuous Improvement: Continuously evaluate and enhance the internal audit process based on lessons learned, feedback, and changes in organizational priorities, risks, and regulatory requirements. Foster a culture of accountability, transparency, and continuous improvement within the organization.
  • Professional Development: Invest in the ongoing training and development of internal audit staff to enhance their knowledge, skills, and competencies. Stay informed about emerging trends, best practices, and regulatory developments in the field of internal audit.
  • Independence and Objectivity: Maintain independence and objectivity throughout the audit process, avoiding conflicts of interest and bias. Uphold ethical principles, professional standards, and organizational policies to ensure the integrity and credibility of the internal audit function.


  • Purpose: Inspections involve examining products, processes, or services to ensure they meet specified requirements, standards, or criteria.
  • Scope: Inspections can be focused on specific areas, processes, or products within the organization, such as manufacturing processes, incoming materials, or finished goods.
  • Types: Inspections can be categorized based on their focus, including self-assessments, supplier inspections, regulatory inspections, and product inspections.
  • Methods: Inspection methods vary depending on the nature of the inspection and may include visual inspection, measurement, testing, sampling, and documentation review.
  • Responsibility: Inspections may be conducted by individuals or teams responsible for quality control, production, or procurement, depending on the nature of the inspection.
  • Outcome: Inspection findings may result in acceptance, rejection, or further action, such as corrective measures or process improvements.

Basic Inspection Practices

Inspection is a fundamental component of quality control aimed at verifying that products, processes, or services meet specified requirements. Basic inspection practices involve the following steps:
  • Preparation: Define inspection criteria, including acceptance criteria, sampling plans, and inspection methods.
  • Execution: Perform inspections according to defined criteria, using appropriate tools and techniques such as visual inspection, measurement, or testing.
  • Recording: Document inspection results accurately, including any deviations or nonconformities identified.
  • Analysis: Analyze inspection data to identify trends, patterns, or areas for improvement.
  • Feedback: Provide feedback to relevant stakeholders, including production teams, suppliers, or customers, based on inspection findings.

Relationship Between Audits and Inspections

While internal quality audits and inspections serve distinct purposes, they are complementary processes within the broader framework of quality management. Audits often include inspections as part of their methodology, with inspectors verifying compliance with requirements identified during the audit process. Inspections can also serve as a proactive measure to identify potential issues before they are detected during audits, contributing to overall quality assurance efforts.

Internal quality audits and inspections are vital tools for organizations seeking to ensure compliance with standards, regulations, and customer requirements while driving continuous improvement. By conducting both audits and inspections effectively, organizations can identify and address quality issues, mitigate risks, and enhance overall performance across their operations.

How to Conduct Internal Audit or Inspection

While conducting Internal Audit, below points shall be considered; 
  • List of Approved Internal Auditors: The list may contain who shall posses minimum 4 years of Auditing experinece in similar domain or undergone for a Training for Internal Audit/Lead Auditor.
  • Audit Schedule: Determine whether the audit will be conducted all at once or at intervals, and communicate the schedule accordingly.
  • Auidt Plan: Provide auditees with an audit plan detailing the objectives, scope, and methodology of the audit. Ensure that auditors do not conduct audits of their own departments or support processes to maintain impartiality.
  • Audit Report/Checklist: Conclude the audit finings in audit report/checklist whether positive or negative both.
  • Non-conformities: Report all non-cpnformities all together and approprite corrective/preventive actions shall be recorded.
While conducting Inspection, below points shall be considered; 
  • Nomination of the Person for Inspection: The nomination of the person shall be nominated considering his experince and technical expertise in the field. 
  • Inpection Notice: The notice shall be given atleast 24 Hours prior not less than that. 
  • Inspection Report: The inspection report shall depict the findings and its conclusive points. 
In both cases, it is imperative that auditors or inspectors remain impartial and free from any conflicts of interest or biases to uphold the integrity and credibility of the auditing or inspection process.

Post a Comment

Previous Post Next Post
New Notifications from Regulatory Authorities