ISO QUALITY AUDIT

When contemplating the ISO audit, the initial thoughts are often the apprehension and anxiety it can evoke among employees. However, fostering a mindset centred on delivering top-quality service to clients can effectively alleviate these concerns.

What is an ISO Quality audit?

An ISO Quality audit is an evaluation of an organization’s processes and systems against the International Organization for Standardization (ISO) standards for quality management, such as ISO 9001. The audit serves as a valuable tool for the organization to pinpoint areas requiring enhancement and to ensure alignment with the requisite standards for certification, particularly in industrial and commercial sectors, thereby upholding international quality standards.

ISO auditors, skilled in evaluating organisational processes against industry standards, identifying weaknesses and offering improvement suggestions, enhancing efficiency and customer service. They also provide guidance for ensuring compliance with ISO standards, aiding organizations in meeting certification requirements. ISO quality audits can be internal, conducted by employees of the organization, or external, conducted by an independent third-party auditor. The audit can result in the organization receiving a certification, which can enhance its reputation and provide a competitive advantage.

Advantages of ISO Audit:

Enhanced Quality Assurance: ISO audits verify adherence to quality standards, boosting customer satisfaction and trust in products and services.
Legal Compliance Assurance: Aligning with ISO standards ensures legal and regulatory compliance, minimising the risk of costly legal issues.
Effective Risk Management: ISO audits focus on risk-based approaches, identifying and mitigating risks.
Improved Efficiency and Productivity: Streamlining processes through ISO standards leads to cost savings and heightened efficiency.
Competitive Edge: ISO certification sets organizations apart, signalling a commitment to quality and attracting more customers and partners.
Continuous Improvement: ISO audits drive ongoing refinement, enhancing performance and ensuring best practices are maintained.
Internal Control Strengthening: ISO audits bolster internal control and governance, promoting consistency and accountability.
Building Customer Trust: ISO compliance builds customer trust by showcasing adherence to recognized international standards.

ISO 9001

ISO 9001 is a single standard for quality management systems (QMS), and organizations can be certified as compliant with this standard. It’s worth noting that ISO 9002 and ISO 9003 were earlier versions of the standard that applied to specific aspects of quality management, but these have been superseded by ISO 9001.

There are different versions of the ISO 9001 standard, including:

ISO 9001:1987 – The original version of the standard.
ISO 9001:1994 – The revised version of the standard.
ISO 9001:2000 – The version of the standard that introduced the process approach.
ISO 9001:2008 – The version of the standard that was aligned with ISO 9000:2005.
ISO 9001:2015 – The current version of the standard, which focuses on risk-based thinking and the process approach.

Types of Audits

For the purpose of certification or recertification of ISO, there are three types of audits

1. First Party Audit or Internal Audit

These are conducted internally by an organization’s personnel to assess compliance with ISO standards and identify areas for improvement. These audits are crucial for ongoing self-assessment and process refinement, focusing on elements such as risk management, quality control, and operational processes. They can be carried out by designated internal auditors within the company or by ad hoc teams as needed. Internal audits are essential preparation for certification or recertification audits and often serve as gap analyses to uncover operational weaknesses. Their findings are communicated to stakeholders to foster a culture of continuous improvement and ensure compliance efforts are effectively managed.

2. Second Party Audit or Supplier Audit

This audit is conducted by an employee of a company in any of their parent or subsidiary companies to check conformity to customer requirements. This mostly happens when the companies you buy from come to check if your business is doing things the right way. This is important because if your suppliers aren’t doing things properly, it can cause problems for your business too.

These audits look at things like how safe your workplace is and if you’re following the rules properly. Supplier audits can be announced, unannounced, or conducted remotely through desktop audits i.e., only checking the paperwork. Overall, these audits help make sure that the companies you rely on to provide you with goods or services are doing their part to keep things running smoothly for your business.

3. Third-party audit

A third-party audit, also known as a certification audit, is conducted by independent auditors from a certification body accredited to assess organizations for ISO compliance. These audits aim to help organizations achieve ISO certification by evaluating their management systems against relevant standards. Certification audits typically involve two stages: a desk audit to review documentation completeness, followed by a compliance audit examining objective evidence in documented information and procedures. Upon successful completion and no major findings, the certification body recommends ISO certification, valid for three years. Surveillance audits are then conducted annually to ensure ongoing compliance, with recertification audits every three years to maintain certification.

Stages of Audit

Audit Planning: This step is about getting ready for the audit. It involves comprehensive preparation, deciding what the audit will cover, setting its goals, and ensuring it meets the client’s objectives.
Audit Execution or fieldwork: This is when the audit happens. This phase encompasses activities such as on-site management, interviews, and verifying system controls. It serves as the data-gathering portion of the audit.
Audit Reporting: Once the audit is done, a report is written to share what was found. The report needs to be clear and accurate, so it helps managers understand what needs to change. It concludes the audit process, though follow-up actions may continue subsequently.
Audit Follow-up and Closure: After everything planned for the audit is finished, any actions that were agreed upon need to be checked. This ensures that any problems found during the audit are fixed. It marks the closure of the audit process, with subsequent audits possibly conducted for further verification.
Corrective and Preventive Action: Following audit findings, corrective action is taken to eliminate existing nonconformities or defects and prevent recurrence, while preventive action aims to eliminate potential nonconformities or defects to prevent their occurrence in the future. These actions are crucial for continuous improvement and adherence to ISO standards.

Steps to get Better your ISO Audit

Thorough Employee Training Records: Complete documentation of employee training activities and qualifications is vital for demonstrating compliance with ISO 9001 requirements.
Regular Internal Audits: Conducting consistent internal audits helps identify and rectify weaknesses before external audits, ensuring readiness and continual improvement.
Active Management Involvement: Senior management’s active participation and support are indispensable for fostering a quality-driven culture and meeting ISO standards.
Robust Document Control: Implementing a robust document control system, adhering to ISO 9001 requirements, ensures accessibility, version control, and integrity of organisational documents.
Updated Management Review Procedures: Ensuring management review procedures align with the latest ISO standards prevents oversights and nonconformities during audits.
Appropriate eQMS Selection: Choosing a suitable enterprise quality management software (eQMS) that aligns with ISO requirements facilitates compliance and simplifies quality management processes.
Produce actual results: Most of the time companies try to fake certain results. One needs to understand that the certification aims to check facts as to quality and not find faults in the process. Thus, it is essential to ensure transparency. Misinformation can also become a red flag in the process.

Be thoroughly prepared for the ISO audit, recognizing its gravity, and promptly implementing corrective actions when necessary. Stay focused on meeting objectives and strive for zero errors to ensure a successful audit outcome.

Conclusion:

In conclusion, undergoing an ISO audit is essential for organizations aiming to uphold international quality standards and achieve ISO certification. Despite initial apprehensions, a proactive approach focused on delivering top-quality service to clients can ease employee concerns. The audit, whether internal or external, evaluates organisational processes against ISO standards, identifies areas for improvement, and ensures compliance with certification requirements. By enhancing quality assurance, promoting legal compliance, and fostering continuous improvement, ISO audits not only build trust and customer satisfaction but also provide a competitive edge in today’s market. For further information on ISO certification processes and costs, consulting an advocate familiar with ISO standards is advisable.

FAQ

Frequently Asked Questions (FAQs)

How can one prepare for an ISO Audit?

Preparing for an ISO Audit involves considering all relevant activities and processes according to ISO standards. Companies plan internal audits based on complexity, recurring issues, and past audit outcomes. Preparation includes understanding procedures, identifying audit areas, obtaining permission, and creating an audit checklist to systematically review processes and gather evidence, helping to get ready for external ISO audits.

How much time does it take to get ISO Certified?

The time to achieve ISO certification varies but typically it ranges from several months to a year or more, depending on factors like organization size of the business and readiness for compliance. Steps include assessment, process implementation, documentation, training, audits, corrective actions, and coordination with the certification body. Thus, it differs for each business. A general time frame is 3 to 6 months but as stated, might differ based on the size of the business.

How much does ISO Certification cost?

ISO certification costs vary based on organization size, industry, revenue, and the number of employees. Factors like surveillance audits, internal audit costs, and maintenance also affect expenses. It's advisable to get quotes from multiple certification bodies to find the best fit for your budget. For more detailed information, contact an advocate familiar with ISO certification costs and processes.

What are the types of ISO Audit?

ISO 9001 (Quality Management System) Audit
ISO 14001 (ENVIRONMENTAL MANAGEMENT SYSTEM) AUDIT
ISO 45001 (OCCUPATIONAL HEALTH AND SAFETY MANAGEMENT SYSTEM) AUDIT
ISO 27001 (INFORMATION SECURITY MANAGEMENT SYSTEM) AUDIT
ISO 13485 (MEDICAL DEVICE QUALITY MANAGEMENT SYSTEM) AUDIT

IS0 9001 deals with quality management and there are several classifications under it. It is a prerequisite for a few other standards too. ISO 13485 for medical devices requires ISO 9001 as a base. Undergoing an ISO 9001 audit fosters trust, ensures superior quality offerings, and cultivates robust business partnerships.

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ISO QUALITY AUDIT