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The 5 Fastest Ways to Fail an ISO Audit

The 5 Fastest Ways to Fail an ISO Audit

Preparing for an ISO audit is a necessary and complicated aspect of operating within a highly regulated industry. It is the job of the auditor to make sure all of your documentation and processes are running in line with every ISO regulation. Often, companies find themselves under scrutiny because, while they thought they had all of their bases covered, they failed to pay attention to the very common pitfalls cited during these examinations. Let's take a look at five things to avoid when preparing for an ISO audit to make the process run smoother and ensure your company is prepared.

  1. Not keeping track of CAPAs

Corrective Action Preventive Action (CAPA) refers to the process of inspecting and resolving the cause of identified non-conformances within your production processes. If your quality process is lacking in any way, CAPA solutions allow you to pinpoint an issue and solve it, preventing it from happening in the future. Having a well-structured and organized CAPA process is vital for any business, especially one that is undergoing an ISO audit. A company with very few CAPAs is often an automatic red flag. An auditor wants to see that you are using the procedures you should be using according to ISO regulation. Auditors also understand that no company begins with a perfect quality process. Even the most quality-driven organizations are continually updating and improving things; CAPAs allow the auditor to review this entire process transparently.

  1. No proof of employee training

In order to achieve your quality management goals and successfully pass an audit, your employees need to be trained on the policies and procedures that make up your quality management system. One of the most overlooked items of any quality plan is the adherence to policies and procedures by the people it’s written to protect. Moreover, one of the most targeted areas of a regulatory audit is the training records of everyone in the company that has a need to know and understand what they do and how they do it.

There are very strict ISO regulations that outline exactly what they expect in terms of employee training. To prove your organization meets them, your training records need to be comprehensive and accessible. You need to be prepared to prove that each employee has completed training activities and follow-up trainings. Relying on department and team leaders to track employee training is never enough. You need centralized record keeping.

  1. Not taking internal audits seriously

Internal audits are a great way to not only prepare for an ISO inspection but also ensure your company’s processes are meeting your quality standards and that you comply with any and all relevant laws and regulations. The overarching goal of an internal audit is to ensure that your company’s policies and procedures are followed and to alert you of any holes in policy compliance so that they can be resolved before they cause more serious problems. 

So, if your company does not look as an internal audit as a serious way to review how your company will stand up to an ISO auditor, you’re only doing yourselves a disservice.

When looking for a third-party audit service provider, or when putting together your own internal auditing program, make sure that the process will be much tougher than the audit you will experience during an ISO inspection. This will ensure that when the audit rolls around, your team will understand exactly what to expect and can feel relaxed knowing all of your business processes are thorough and compliant.

  1. Ineffective document control

Document control is the process of controlling how documents are created, maintained, and accessed within the quality management system. ISO 9001 lists clear requirements for the control of documents with significant flexibility;

  • A document can include paper and electronic files in a format that works best for your organization (including documents, spreadsheets, image files, or video)
  • Auditors need to be able to identify the document version to determine if the most recent copy is being distributed.
  • Your documents need to be easily identifiable (through a numbering system)
  • An individual with authority needs to approve a document each time it is updated.

Keeping up with these document control expectations can be extremely challenging if your company uses an ineffective paper or manual system. If you are trying to do document control without a central process your ISO audit could reveal inconsistencies in how your documents are organized or distributed.

  1. Choosing the wrong QMS

In addition to the requirements we mentioned above, ISO 9001 includes standards which lay out requirements for a quality management system (QMS). Adopting a QMS is not necessarily required under ISO, but it is considered best practice for highly regulated industries. When being audited, it is essential that your company can demonstrate how you operate within government regulations. With a quality management system, employees can assign, track, and verify action items, set up training requirements, and automate workflows to ensure that non-compliance issues are eliminated.

 Quality management empowers decision makers to track who oversees a document, where it is in its lifecycle, who has accessed a document, who has printed it, and who is responsible for maintaining and seeing it to its conclusion. It can also help to guarantee that the highest quality business processes are followed to ensure you are meeting the needs of customers, stakeholders and ISO requirements. Your entire quality management system can be implemented through the system to quickly and easily prove ISO compliance every step of the way, before an auditor even steps in the door.

However, the wrong QMS software can actually make meeting ISO standards harder. Picking a system that is either too generic or too robust for your company can greatly hinder your quality process and cause you to fail an audit – no matter how prepared you think you are. The right QMS provides value from day one by making it easier for you to meet ISO 9001 requirements; from quality processes to document control, training, and risk management. It is complex enough to meet all the requirements and simple enough that your staff benefits from its services because they understand it.

At DocXellent, we know that ISO audits can be time-consuming and stressful for your whole team. Luckily, using a Quality Management Software like ENSUR can help you tackle this process painlessly. With our document control and quality management features, you can organize all of your company’s documentation digitally – this includes CAPAs and all employee training material. So, when your company is facing an inspection, all of your important information is right at your fingertips.

Request a demo today to find out more about how ENSUR can make the FDA audit process easier for your company.

Tags: quality management, quality management process, ISO 9001, audit