ISO Audit Process: 5 Common Mistakes and Tips to Avoid Them

An ISO audit is a systematic examination of a company’s internal systems and processes to assess their compliance with ISO standards. Different ISO certifications enable companies to streamline their quality and productivity, boost customer satisfaction, and increase market share. 

However, clearing ISO audits and getting certified isn’t easy. It requires rigorous audit preparation and a deep understanding of the ISO standards for which you aim to get certified.

Read on to discover the top 5 reasons organizations fail ISO auditing and how you can overcome them using ISO audit software. But first, let’s start by understanding the importance of an ISO inspection and its types.

Purpose of ISO Audits: Why are They Important?

ISO audits help companies verify how well their systems and processes comply with different standards set forward by the International Organization for Standardization (ISO). In addition to obtaining the relevant ISO certification, ISO standards audits allow companies to improve their operations: 

• Compliance: Audits help identify nonconformances and spot the areas of improvement, allowing you to undertake corrective actions for better compliance.
• Risk Management: ISO audits involve assessing the organization’s risk management practices, ensuring potential risks are identified and addressed before they impact the operational areas. 
• Quality Assurance: Meeting ISO audit requirements enables companies to maintain consistent quality in their processes, products, and services, leading to increased profits and higher customer satisfaction in the long run.
• Efficiency: During an ISO audit, the auditor thoroughly assesses the production processes, policies, production SOPs, etc., to identify inefficiencies, creating an opportunity to streamline the operations for enhanced productivity and efficiency.
• Credibility and Competitive Edge: Passing the ISO standards audit and achieving certification demonstrates an organization’s commitment to quality, security, environment, and other aspects covered by ISO. Not all companies meet ISO audit guidelines and get certified, therefore obtaining ISO certification can help you stay ahead of the curve.

Types of ISO Audits

ISO audits are of three types differing in terms of purpose and who conducts them. 

1. Internal Audits (First-Party Audits)

Internal first-party audits are self-assessments conducted by teams within the company, using ISO audit checklists to identify gaps in compliance, operational inefficiencies, and areas for improvement. It is important to plan internal audits and schedule their implementation regularly.

2. Supplier Audits (Second-Party Audits)

Second-party ISO supplier audits check how well your suppliers and vendors comply with the ISO standards specified by your organization. The main purpose of this ISO audit type is to ensure that products delivered by suppliers align with your organization’s quality standards.

3. ISO Certification Audits (Third-Party Audits)

Third-party ISO certification audit processes are conducted by auditors associated with an ISO-accredited certification firm. The purpose is to evaluate compliance and issue certification. 

Depending on the objective, certification audits can be categorized into two types:

1. ISO Certification and Recertification (Renewal) Audits: A certification audit is conducted to get ISO certification, which remains good for three years. After three years, you need to initiate the recertification process, repeating the ISO audit cycle. 
2. ISO Surveillance Audit: After getting ISO certified, organizations must schedule surveillance audits at least once a year. During the surveillance audit, third-party auditors review ISO compliance during the certification period of three years.

ISO Audit Process: How are ISO Inspections Conducted?

The exact steps of conducting an ISO compliance audit depend on the audit type and what is being assessed – quality management system, environment management system, food safety, medical devices, etc.

Whether it’s an internal or external ISO audit, it will involve a thorough assessment of operational processes to check compliance and an analysis of the impact of the steps taken to mitigate non-compliance.

In the case of internal audits, the auditors would have to present the ISO audit findings along with objective evidence like photos to the management and suggest corrective actions.

Free ISO Standards Audit Checklists

Here are some free ISO compliance audit checklists to help you get started with the inspection process:

• ISO 31000 Risk Management Checklist
• ISO 13485 Checklist
• ISO 9001-2015 Gap Analysis Checklist
• ISO 19600 Compliance Management Checklist
• ISO 27001 Checklist
• ISO 14971 Checklist
• ISO 37301 Checklist
• ISO 50001 Checklist
• ISO 22301 Audit Checklist
• ISO 15189:2022 Checklist
• ISO 17020:2012 Checklist
• ISO 4210:2014 Audit Checklist

5 Common ISO Inspection Mistakes and How to Avoid Them With the Right ISO Audit Software

ISO certification signifies an organization’s commitment to quality and compliance. However, the path to achieving it is challenging, and many companies fail to meet the stringent ISO audit criteria.

Here are the top 5 challenges of passing ISO inspections and how to tackle them with ISO compliance audit software.

1. Neglecting Internal Audits

According to this expert discussion on The Elsmar Cove, many companies perceive internal audits as a waste of time and effort that derives zero business. This attitude prevents them from identifying and resolving nonconformances before the ISO certification audit (or surveillance audit), resulting in audit failures.

Therefore, companies need an efficient ISO audit plan to identify and address pain points and non-compliances well before the certification inspection. However, managing such an elaborate plan on paper or spreadsheets can become laborious and time-consuming.

With ISO audit management system software, managers can easily create internal audit plans taking into consideration audit date and location, audit type, auditor’s availability, and audit duration, avoiding overlaps. Furthermore, managers can track the status of individual audits in real time to assess their inspection plan’s efficiency.

Thus, employing audit software ensures businesses conduct regular internal audits efficiently without straining their resources.

2. No Effective Communication Channels

Ineffective communication can have a trickle-down effect on an organization. For example, it can become difficult for an auditor (or a shop floor worker) to communicate issues and initiate resolution if the company lacks clear communication channels, causing delays and more deviations, which require further communication. 

With digital quality audit software, there are three ways for you to automate the process of sharing real-time information with relevant stakeholders and establish clear channels.

1. Auditors can generate detailed inspection reports, which can be emailed to relevant parties with just a click.
2. Task assignees can get notified about tasks assigned to them. 
3. Managers can monitor task status in real-time.

3. Managing Multiple Standards

Businesses often need to comply with multiple ISO and other standards. Managing inspections for all of them simultaneously can create logistical challenges, especially if companies equip their auditors with a stack of manuals.

With audit software, you can create, update, and store custom ISO audit checklists on a centralized platform. While scheduling the audit, you can choose and assign the required checklist, which the auditor can access through their mobile or tablet devices during the inspection.

This centralized approach eliminates the need for bulky manuals and ensures auditors have the most up-to-date information.

4. Ineffective CAPA

Corrective and Preventive Action (CAPA) is more than a tool for fixing defects or preventing waste. It’s a crucial component of continuous improvement.

Two ways companies implement CAPA wrong: hiding actions (not wanting to reveal past mistakes) and not assessing the impact of corrective actions.

You can address both these pitfalls with digital ISO audit software. After implementing corrective actions, you can schedule a follow-up audit and compare its score with the previous audit to analyze the impact of the implemented measures.

Since all audit and corrective action data is stored on a centralized platform, it becomes easy to generate CAPA reports, demonstrating your organization’s efforts towards continuous improvement.

5. Lack of Proof of Employee Training 

ISO standards can be complex for workers to understand and adhere to, leading to non-compliance and inconsistencies. Additionally, some ISO standards, like ISO 9001, require auditors to test workers’ knowledge and verify the proof of training.

Therefore, training presents a two-fold challenge: training employees and maintaining the records. You can tackle both of these challenges with audit software. 

Start by creating digital SOP checklists for implementing ISO standards that your workers can use while actually doing the task, thereby getting trained on the job. You can also require a senior member of the team to e-sign the training document, demonstrating successful completion of the training program.

Since everything happens digitally and gets stored on the cloud, you can easily access and submit the training document for each employee during certification audits.

FAQs About ISO Inspections