Quality Audit

Quality Audit and Quality Auditing

A quality audit is a systematic and independent examination or assessment of an organization's QMS.

It is done to evaluate the effectiveness of an organization's quality controls, identify areas of improvement, and ensure all areas are quality-compliant.

quality audit
quality audit

Quality audit is a verification effort intended at evaluating the degree of conformance to meet a standard specification or procedure of the product, design, process, or system. The quality audit has two components: one is the analysis of the system within which the items of product or service are brought into being and is called the quality system audit. The other one is an analysis of the items themselves, which is called product or service quality audit.

What is quality audit?

A quality audit is typically conducted by an internal or external quality auditor or audit team at agreed time intervals, ensuring that an organization has a clearly defined system for quality monitoring. It is an essential element of the ISO 9001 quality system standard.

What is quality auditing?

Quality auditing is the systematic, independent, and documented review and evaluation of an organization’s quality management system (QMS) to determine whether quality activities and results comply with a strategic arrangement that is effectively implemented and appropriate to achieve the objectives.

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Why are audits important?

To ensure the greatest benefit for an organization, audits are crucial for assessing the success of processes, products, and systems whether it is existing or newly-implemented. This is an important tool for:

determining quality audit

Determining the conformity or nonconformity of the quality system elements with specified requirements

audit in quality management system objective verification

Verifying objective evidence of processes

quality audit providing evidences

Providing evidence for the reduction and elimination of any problem areas

audit in quality management system ensure

Ensuring whether the products are fit for use, safe for the consumers and regulations are being followed

quality audit identifying

Identifying whether the quality policies of organizations meet quality standards adequately

audit in quality management system to take corrective action

Taking corrective action for deficiencies

quality audit recognization

Recognizing improvement opportunities

role of quality audit

What is the role of the auditor?

An auditor is a person who understands the business and industry standards and conducts an audit as per the standards. Quality auditors can be one of two categories, external or internal. An internal auditor is an employee of the company being audited whereas an external auditor is a third party hired from an approved agency, customer or client to evaluate the quality system or products.

What are the types of quality audits?

There are different types of quality audits, broadly categorized as follows:

quality audit process

Process audit

A process audit specifies whether a company’s processes are working within defined limits. It measures conformance to any predefined requirements or industry standards along with the effectiveness and adequacy of the process controls as established by procedures, work instructions, training, and process specifications.

product audit in quality management system

Product audit

Product audit inspects whether a particular product or service complies with customer requirements, specifications, and performance standards.

quality audit system

System audit

A system audit confirms that all elements of a management system are effective and appropriate, and have been developed, implemented, and documented as per the specified requirements. A quality management system audit measures an organization’s existing quality management system to assure its conformance with contract commitments, company policies, and regulatory requirements.

First-party, second-party, and third-party audits

  • First-party audit:
  • A first-party audit is an internal audit designed to measure the performance of the organization’s objectives, identification of problem areas, and to find opportunities for continuous improvement. This audit is conducted by auditors who are employed by the organization being audited.

  • Second-party audit:
  • A second-party audit is an external audit conducted by auditors who are hired from outside the organization to conduct an independent audit. Second-party audits are more conventional than a first-party audit as the audit results may impact the buying decisions of the customer.

  • Third-party audit:
  • A third-party audit is performed by an external independent organization without conflict of interest resulting in recognition, certification, license approval, a penalty, or a fine being issued by the third-party organization.

Remote Audits of Quality and Safety Processes

Quality Audit process

Audit is carried out either by trained members of an organization’s own staff (internal quality audit) or by hired professional auditors from outside the organization (external quality audit). The process of quality audits can be divided as follows:

Audit Initiation

The initial step in the quality audit process is starting the quality audit. Initiating quality audits involves a preliminary discussion between the three parties concerned, the client, the auditee, and the auditing organization. The three parties discuss the objective of the proposed audit, the reference standards against which documentation and activities are compared, the auditors to be used, and the time of the audit. They can speak for and take decisions on behalf of the managers of their organization during the discussion. Mutual understanding and agreement will enable the auditee and the auditing organization to execute their activities efficiently.

Audit Planning

Audit planning by the auditing organization comprehends several activities by implying actions and reactions from the three involved parties in the audit including scheduling the audit, the number of resources needed for the audit, gathering working papers for the audit, reporting the results, determining the sampling procedures in the audit and following up on corrective actions.

Audit Execution

After the quality audit initiation and planning, the auditor starts to undertake various activities including evaluating process and system controls, interviewing employees, on-site audit management, and regular communication with other relevant parties within the organization. Audit execution is often called ‘fieldwork’ and it concludes with the final discussion between the auditor and the auditee.

Audit Reporting and Follow-Up

The audit report outlines the results of an auditor’s observation made, inspection, or test results obtained providing accurate data on management, conformances, and nonconformances found along with any recommended corrective actions that need to be taken. It also allows an organization to track performance and quality effectively, find out areas for continuous improvement, and emphasize any achievements.

Candelis Audit Management Case study

Customer Success

Winning Story of Two Businesses Using the CQ Training and Document Management Solution to Improve Their Quality Management Process

Candelis Audit Management Case study
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Common Reasons for Quality Audit Failure

Organizations implement the ISO 9000 group of standards to achieve compliance for their commitment to quality management. Often, manufacturers, large and small-sized businesses, and other companies address potential quality gaps to provide the best possible product or service to customers and clients. While many companies are making the move towards compliance, many do not. Here are some of the most common reasons for quality audit failure:

  • green check

    Unsatisfactory documentation

    To organize, store, and manage data simply and effectively, documentation is needed for a quality management system without which compliance audits can easily be failed.

  • green check

    Lack of ISO Understanding

    Lack of understanding ISO compliance and standardization are a common mistake because many think that ISO grants companies with certification, but actually independent certification bodies are there for certifying companies.

  • green check

    Poor Enforcement Strategies

    It is always a good idea to have a clear understanding of enforcement strategies within your specific industry and determine a good strategy that properly handles non-conformance within your company.

  • green check

    Insufficient Competency Testing

    Employee competency testing, another essential aspect of ISO 9001 quality management standard, is something that many ignore or leave out. Training should be done each year with a focus on promoting awareness of quality goals.

  • green check

    Poor Auditor Selection

    Poor auditor selection is another mistake that affects compliance. If auditors are selected too quickly or not carefully enough, then it could impact the auditing process.

ComplianceQuest enhances your company’s Quality Management

ComplianceQuest will provide your company with the opportunity to reach a new level of Quality Management. Everything from the well thought out and configured out of the box solution, to the system validation scripts, tractability matrix and end user guides, ComplianceQuest sets the standards high! Their customer service is superb, their employees are dedicated to the success of your project and learning about your company to ensure appropriate and effective solutions are provided. All quality leaders at Aphria Inc. have been very pleased and excited to launch all the capabilities ComplianceQuest has to offer to ensure quality remains our highest priority!

Amy McCrindle,
Project Manager

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Principle behind Quality Audit

Quality audit is an effective management tool conducted to check the causes of poor quality, corrective action taken, and the confirmation or verification activities undertaken related to quality. It not only detects the problems and defects in the quality management system but also helps improve and resolve them based on broad findings and recommendations. The principles behind quality audit are as follows:

  • Ethical standards

  • Accurate presentation

  • Professional support

  • Independence

  • Objectivity

  • Assessment based on evidence

  • Proficiency

  • Collaboration

  • Confidence

  • Ethical standards

  • Accurate presentation

  • Professional support

  • Independence

  • Objectivity

  • Assessment based on evidence

  • Proficiency

  • Collaboration

  • Confidence

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Quality-centric Companies Rely on CQ QMS

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  • lifescan mono
  • janssen mono
  • lundbeck mono
  • cdc logo mono
  • qlik mono
  • csa group mono
  • impossible mono
  • fluence mono

Frequently Asked Questions

  • There are various advantages of implementing quality audits properly in organizations.

    • Internal quality audit improves the quality of the system as well as the quality of the product.

    • Internal and external quality audits assess the cost-effectiveness of the quality systems and measure the effectiveness of the quality programs.

    • Quality audits increase productivity in the organization, which increases uniformity of output of product, reduces mistakes and wastages of manpower, machine, and materials.

    • Quality audits encourage employees in the organizations to disclose inadequacies in the interpretation of the basic quality requirements.

  • Auditors should have the knowledge and skills in audit principles, procedures and techniques, organizational understanding, quality management systems, and social interaction.


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