We are changing our name from Blue Wolf to QIC Global
We are changing our name from Blue Wolf to QIC Global
The certification to ISO 9001 is a sign of a healthy management and customer-oriented business. However, obtaining and retaining this certification can only be achieved when one is ready to meet regular audits, and that is where most organizations get stuck. Whether it is an internal audit or an external audit, its usual pitfalls can cause undue stress, nonconformities, and even certification delays.
Being prepared for an ISO 9001 audit, it is essential to be aware of the most common pitfalls, so that one can remain clear-headed and self-assured throughout the process. These are the top seven common mistakes in ISO 9001 audits that organizations make and the solutions to these mistakes.
One of the greatest mistakes that companies make is to view audits as one-time occasions that need only a last-minute concern. The hustle and bustle of summarizing files, staff training, and obtaining processes right before an audit are in disorder, and corners are missed as a result.
How to Avoid It: Plan as early as possible (months) before. Make mock audits, document reviews, and maintenance of current records. Introduce workers to the audit procedure and inculcate a take-pride-in-quality mentality all throughout the year, and not immediately before an audit.
Numerous companies take into consideration the audit on the basic level of knowledge of the ISO 9001 requirements. Consequently, they can fail to identify important clauses, they can fail to include required documents, or they may fail to understand what the auditor is requesting.
How to Avoid It: Spend time to learn ISO 9001:2015 and the key principles of it, which include risk-based thinking, process approach, and continuous improvement. Educate the employees about the standard to enable them to talk during the audit with confidence.
ISO 9001 lays emphasis on information that is in writing. Out-of-date, inconsistent, or absent procedures, policies, and records can send up red flags like no business would want to hear in the event of an audit.
How to Avoid It: Check and revise your quality documents on a regular basis. Make sure procedures reflect actual practices and that necessary records—like training logs, calibration reports, and internal audit results—are properly maintained.
The auditors will always look to see whether your organization is assessing its system. Omitting internal assessments or management reviews can be interpreted to indicate the absence of management and the pursuit of ongoing improvements.
How to Avoid It: The internal assessments should be planned and carried out on a documented basis. Conduct scheduled management reviews and document results and decisions, as well as improvement measures made.
Other organizations feel that the disclosure of the problem in an audit will be a blow to the possibility of passing that audit. They might attempt to hide issues rather than resolve them.
How to Avoid It: Be candid and open. Organizations that handle problems and make the appropriate corrections are admired by the auditors. ISO 9001 is based on the idea of improvement and never perfection. Detecting weak points is also the process of developing a better system.
Unless the employees are knowledgeable of their responsibilities in the QMS or are knowledgeable about processes, it will adversely affect your audit. Auditors can talk to all the staff, including leaders, and their answers are important.
How to Avoid It: Train the employees regularly and not only once. Make them learn the quality policy, goals, and the procedures that are applicable in the work and the role that they could play in quality results.
It is a big error not to carry out or provide follow-ups on corrections of the past audits. It implies that the organization is not determined to solve problems or be able to enhance its system.
How to Avoid It: Make corrective measures your priority. Plan and document root cause analysis, actions to be followed, and planned implementation. Every time any corrective action is closed, it must be verified to be effective.
ISO 9001 inspections need not be a frightening experience if you prepare adequately to undertake them. A failure to avoid the common mistakes in ISO 9001 is likely to greatly improve your likelihood of a successful audit and improve your total quality management system. It is ensured by preparation, communication, training, and openness. We at QIC Global help organizations worldwide, especially organizations in the United States and Australia, to evaluate their ISO 9001 compliance by carrying out the certification process in a professional and precise way. Having a distinct interest in quality and constant self-improvement, you will be ready not only on the day of the audit, on the long run.
The frequency of internal audits must be configured under the threats to the processes, their complexity, and prior performance. As a rule, most companies perform at least an annual audit of all major processes, but areas that pose a higher risk could be audited more frequently.
The quality policy, quality objectives, procedures, internal audit reports, corrective action records, training records, management review minutes, and process performance data are the usual documents.
It is not necessary. A majority of the audits end up with certain findings. It is all about how the company responds to such findings. One or two minor nonconformances are not going to cause the certification to fail; however, serious or untroubled ones may slow down the certification.
A minor nonconformity is a less serious deviation, affecting an insignificant requirement and a minor degree of influence on the working capacity of QMS. A significant nonconformity refers to a serious nonconformity as a total lack of a process that has to be in place or a repeat failure, andhas to be eliminated before certification.
