What is an ISO Audit?

What is an ISO Audit?

In the ever-evolving landscape of Medical Devices, ensuring quality, consistency, and compliance is paramount for sustainable growth. One crucial aspect that plays a pivotal role in achieving these objectives is an ISO audit. Whether your company is well on it's way to delivering a Medical Device to market, or you've just started your adventure, understanding what an ISO audit does and how it will help your organisation will help to drive a culture of excellence within your organisation.

ISO, or the International Organization for Standardization, develops and publishes international standards to guarantee the quality, safety, and efficiency of products, services, and systems. An ISO audit, therefore, is an independent assessment conducted to ensure that a business complies with these globally recognized standards. It acts as a powerful tool to enhance organizational performance, gain a competitive edge, and build trust among stakeholders.

In this post we will delve into the nuances of ISO audits, demystifying the process for you. From the basics of what an ISO audit entails to the benefits it brings to your business, we will explore every facet to empower you with the knowledge needed to navigate this crucial aspect of modern business practices.

Whether you're considering undergoing an ISO audit or simply want to stay informed about industry best practices, this blog post aims to be your go-to resource for all things related to ISO audits. So, let's embark on this journey together, unraveling the mysteries and understanding the significance of ISO audits in the realm of business excellence.

Why an ISO Audit is important?

An ISO audit is important as it helps drive your focus on team & product innovation. Here are some of the key reasons highlighting the importance of ISO audits:

  1. Quality Assurance: ISO standards, such as ISO 9001, focus on quality management systems. Through systematic audits, organizations can ensure that their processes meet the specified quality benchmarks. This, in turn, can enhance consistency and reliability of products or services.

  2. Enhanced Credibility: Achieving ISO certification is a testament to a company's commitment to quality and compliance. It enhances the organization's credibility in the eyes of customers, partners, and stakeholders, fostering trust and confidence in its operations.

  3. Global Recognition: ISO standards are globally recognized and respected. Obtaining ISO certification provides businesses with a passport to operate in international markets. It signals that the company adheres to a set of universally accepted standards, facilitating smoother entry into global business landscapes.

  4. Operational Efficiency: ISO audits assess and optimize processes, leading to increased operational efficiency. By identifying areas for improvement and implementing corrective measures, organizations can streamline their operations, reduce time spent on project repeats, and enhance overall productivity.

  5. Legal and Regulatory Compliance: ISO standards often align with legal and regulatory requirements. Conducting ISO audits ensures that a company is in compliance with relevant laws and regulations, mitigating the risk of legal issues and penalties.

  6. Risk Management: ISO standards incorporate risk management principles. Through audits, organizations can identify potential risks to their processes and develop strategies to mitigate these risks effectively, enhancing overall business resilience.

  7. Customer Satisfaction: ISO standards prioritize customer satisfaction. By regularly auditing processes and making continuous improvements, organizations can meet or exceed customer expectations, leading to increased satisfaction and loyalty.

  8. Competitive Advantage: ISO certification sets businesses apart from competitors. It serves as a tangible demonstration of a commitment to quality and best practices, providing a competitive edge in the market and opening doors to new business opportunities.

  9. Employee Morale and Engagement: ISO standards often emphasize employee involvement and competence. Regular audits create a culture of accountability and continuous improvement, boosting employee morale and engagement by showcasing the importance of their contributions to the organization's success.

  10. Environmental and Social Responsibility: ISO standards, such as ISO 14001 for environmental management, promote responsible business practices. Audits help organizations monitor and improve their environmental and social impact, contributing to a more sustainable and responsible business approach.

What are the type of ISO Audit?

ISO (International Organization for Standardization) audits are conducted to assess an organization's compliance with ISO standards. There are various types of ISO audits, each serving a specific purpose. Here are 4 common types, which we ourselves have been audited for some at Matrix Requirements:

  1. ISO 9001 Audit: An ISO 9001 audit is an examination of an organization's quality management system (QMS) to ensure compliance with the requirements outlined in the ISO 9001 standard. The audit process involves a systematic and independent assessment conducted by internal or external auditors.

  2. ISO 13485 Quality Management System (QMS) Audit: ISO 13485 is an international standard that specifies requirements for a quality management system (QMS) in the design, development, production, installation, and servicing of Medical Devices and related services. The ISO 13485 audit is designed for organizations involved in the Medical Device industry and is intended to help ensure the quality, safety, and effectiveness of Medical Devices.

  3. ISO 27001 Information Security Management System (ISMS) Audit: This audit looks into the information security management system against the criteria set by ISO 27001. This audit assesses the effectiveness of security controls, risk management practices, and the overall management of information security.

  4. ISO ISO 14001 Audit: This audit reviews the environmental management system (EMS) to ensure compliance with the requirements set forth in the ISO 14001 standard. ISO 14001 is an international standard that provides a framework for organizations to establish and maintain effective environmental management practices. The audit process, whether internal or external, aims to assess the organization's environmental performance, identify areas for improvement, and ensure adherence to environmental management system standards.

What are the Stages of an ISO Audit?

There are different stages within the ISO audit that will be important for you to navigate correctly. It's important for organizations to continuously monitor and improve their management systems to remain in compliance and successfully pass surveillance audits.

Stage 1 Audit

  • Purpose: The Stage 1 audit is an initial assessment of your businesses management system documentation and readiness for the full audit. Auditors examine the business's documentation, policies, and procedures to ensure they align with ISO standards.

  • Site Visit: Auditors may conduct an on-site visit to familiarize themselves with the business's operations and management system.

  • Outcome: The primary outcome is to identify any potential gaps or non-conformities in the documentation and to assess the organization's preparedness for the Stage 2 audit.

Stage 2 Audit

  • Purpose: The Stage 2 audit involves a comprehensive on-site assessment of the organization's implementation of the management system. Auditors examine the organization's processes, procedures, and records to verify compliance with ISO standards.

  • Interviews and Observations: Auditors may conduct interviews with personnel, observe processes, and assess the effectiveness of the management system.

  • Outcome: The primary outcome is to determine whether the organization's management system effectively meets the requirements of the relevant ISO standard. Findings may include non-conformities and opportunities for improvement.

Certification Decision

  • Review of Findings: The audit findings from Stage 1 and Stage 2 are reviewed.

  • Certification Decision: Based on the audit findings, the certification body makes a decision regarding whether to grant ISO certification. If there are non-conformities, the business may be required to address them through corrective actions before certification is granted.

Surveillance Audits

  • Purpose: Surveillance audits are conducted at regular intervals after certification to ensure ongoing compliance with ISO standards. Shorter audits conducted periodically (e.g., annually) to verify that the organization continues to meet ISO standards.

  • Review of Changes: Assess how the organization has addressed changes in its processes and management system.

  • Outcome: The businesses continued compliance with ISO standards is verified, and any new non-conformities or areas for improvement are identified.

The combination of Stage 1 and Stage 2 audits leads to the initial certification decision. Surveillance audits are then conducted to ensure that the organization maintains its compliance with ISO standards over time. 

What are the ISO Audit types?

ISO audits are typically organised into three main types, each serving a specific purpose in assessing and ensuring compliance with ISO standards.

  1. Internal Audit:

    • Purpose: Conducted by the Medical Device Company themselves.

    • Scope: Internal audits assess the organization's management system against ISO standards and are usually run by internal auditors, who are employees or stakeholders of the organization to help the business identify areas for improvement, ensure ongoing compliance, and prepare for external certification.

  2. Supplier Audit:

    • Purpose: Conducted by an organization (or its representative) on its suppliers or contractors.

    • Scope: Focuses on assessing the supplier's adherence to contractual requirements, including compliance with specified ISO standards by representatives external auditors hired by the business to ensure that suppliers meet the required standards and contribute to the overall quality and conformity of the products or services.

  3. Certification Audit:

    • Purpose: Conducted by an independent certification body or registrar.

    • Scope: Assesses an organization's management system against ISO standards to determine compliance and eligibility for certification by external auditors from a certification body who are independent of the Medical Device company being audited. These audits aim to result in the issuance of an ISO certificate if the business meets the required standards. 

These three types of audits play crucial roles in the ISO certification process. Internal audits help organizations continuously improve their processes, supplier audits ensure quality throughout the supply chain, and certification audits provide an independent evaluation of an organization's compliance with ISO standards. Leveraging a tool that helps get through the ISO Audit process is exactly how Vivira saved 97% time on document generation.

How to prepare an ISO Audit?

Preparing for an ISO audit is strategic & requires meticulous planning and dedication. The first steps are to start by conducting a thorough internal audit cycle or program, evaluating existing processes against ISO standards. Here you can start to identify and rectify any non-conformities, ensuring all documentation is up-to-date and comprehensive. Next, you'll need to develop a clear roadmap for improvement based on the findings of internal audits. For startups going preparing for their first certification, it might be useful to have this first internal audits done by an experienced consultant (unless they have an experienced auditor in house available).

Finally, it's time to create a robust communication plan to ensure you keep all stakeholders informed about the upcoming audit. Conduct a pre-assessment to simulate the audit process, allowing your team to fine-tune their responses and processes.

If you approach the ISO audit proactively, you can not only meet compliance but also leverage it as a way to ensure your business is heading in the direction of continuous improvement.

Goals determination for an ISO Audit

Determining goals for an ISO audit involves aligning the audit objectives with the specific requirements and objectives of the relevant ISO standard. in general it's also important to keep regulatory requirements in mind. Especially for ISO 13485 certification as this standard focuses on regulatory requirements as well. That means you should not only look at the standard but as well at the applicable legislations

Step-by-step guide to help you establish meaningful goals

  1. Understand the ISO Standard, sounds simple, but make sure you have reviewed the ISO standard applicable to your Medical Device company (e.g., ISO 9001, ISO 14001, ISO 27001). For many management system standards, there are as well guidances or handbooks that explain the principles that are easily accessible.

  2. Identify business objectives & clearly define your business's overall objectives and goals. These could include quality improvement, information security, or other aspects covered ISO.

  3. Identify the specific requirements outlined in the ISO standard. These requirements will be your benchmarks for compliance. You need to meet these requirements to be compliant!

  4. Evaluate potential risks and vulnerabilities in your processes related to the ISO standard.

  5. Ensure that your goals are Specific, Measurable, Achievable, Relevant, and Time-bound (SMART). For example, instead of a vague goal like "Improve quality," a SMART goal would be "Reduce Medical Device product defects by 15% within the next six months."

  6. Engage key stakeholders in the goal-setting process & consider their input in achieving compliance with the ISO standard.

  7. If your Medical Device company is seeking ISO certification, align your goals with the requirements for certification. Ensure that your processes and systems meet the criteria set by the certification body.

By following these steps, you can establish clear, focused, and achievable goals for your ISO audit that contribute to the improvement and alignment of your organization's processes with international standards.

Creation of audit schedule

Creating an ISO audit schedule takes time but in the longtime will benefit the business and it's goals of achieving ISO certification. An audit schedule keeps all team members aligned as well as defining the scope, timing and objectives of the ISO audit. The audit plan can be risk-based as well and this is important to keep in mind.

By having a well structured audit in place, your Medical Device company can effectively manage your processes, priorities, and ensure that audits are contributing to your improvement and compliance efforts.

Audit Checklist

The 4-step audit checklist provide you with key steps to follow during your ISO audit process. Many of the details will be specific to your medical device, however you can leverage the following basic framework as a baseline as you prepare: 

  1. Clearly outline all the objectives of your ISO audit. Make sure all the key stakeholders are aligned and understand the workload required.

  2. Plan well & identify potential risks so that you're prepared for any questions the auditor might have!

  3. Summarize the audit results in a clear report so that the organization and stakeholders know what work is needed following the ISO audit.

  4. Follow up on your audit results, and monitor that the Corrective Actions have been implemented and actioned.

Starting and working through an ISO audit without prior knowledge or experience can be challenging. ISO standards often involve complex requirements and processes. However, if you find yourself in such a situation, perhaps it's time to leverage a tool that will help your Medical Device get to market faster, such as Matrix Requirements. 

Medical software & devices are subject to strict regulatory requirements. FDA and MDR have specific guidelines and standards that SxMD (Software As/In A Medical Device) must adhere to. These guidelines are time consuming and failing to comply with everything results in launch delays, fines, recalls, or product removal from the market. Companies aiming to sell in multiple markets must navigate different regulatory requirements in each region adding to the complexity. It's why Medical Device companies looking to accelerate development of their innovative medical device technologies come to Matrix Requirements. Our platform is an easy-to-use, flexible, all-in-one software solution that facilitates collaboration of employees on design control, and quality management to streamline medical device design, establish lean quality management, accelerate product certification and go-to-market, and maintain regulatory compliance.

About the Author
Adam Newman
Head of Marketing