An ISO Quality Audit is an audit conducted to ensure a company is compliant with the standards set by the International Organization for Standardization (ISO). The ISO is an international body that creates standards and guidelines for businesses to follow in order to ensure their products and services meet international quality standards.
An ISO Quality Audit is conducted either by a third party to assess whether a company is meeting the standards set by the ISO or they are done internally by the organization to assess themselves. The audit looks at a company’s processes and procedures to identify any non-conformance with the ISO standards.
The audit also looks at how the company is complying with the regulations and recommendations set out by the ISO. After the audit is complete, the auditor will provide the company with a report detailing any non-compliances and recommendations for improvement. This report can be used by the company to improve the quality of their products and services.
What is The ISO Audit Process?
The ISO audit process typically includes interviews, document reviews, and observation of work processes to assess the effectiveness of the management system. One reason to have an effective internal auditing procedure or program is to prepare for audits.
The fact that it is frequently necessary is another excellent reason. For instance, Clause 9.2.1 of ISO 9001 specifies unequivocally that the company must perform internal audits at predetermined intervals. Numerous other standards and laws also contain a comparable clause.
Internal audits, as mentioned above, can make sure your policies, procedures, and processes adhere to all necessary standards and laws. Do you really want to hold off on learning how well your organization's internal controls or Quality Management System is performing until external inspectors arrive?
However, if implementing a Quality Management System like ISO 9001 (and its associated Internal Audits) with ISO compliance as your sole objective, you may be losing out on a significant chance. Why not use the internal control and management methods your company or organization has put in place to continuously evaluate and enhance performance?
Additionally, internal auditing plays a significant part in the philosophy of continuous improvement. Using management and control only to ensure compliance is doing nothing more than the bare least. With that philosophy, few businesses actually thrive.
How Does the ISO Audit Process Work?
Setting up a method or program for internal auditing is neither difficult nor expensive. The secret to a successful internal auditing process is a willingness to invest a modest amount of resources in putting together and training an internal audit team, and then planning internal audits around the demands of your company.
In contrast to, say, a tool business that is ISO 9001 registered, a pharmaceutical company that is following FDA regulations will likely want to have a more aggressive internal audit schedule.
What Is Involved In The ISO Audit Process
The ISO audit procedure involves planning the audits, carrying them out, checking the results of the audits, and then modifying the audit plan in light of the findings of the initial audits. This is the auditing process method, also known as PDCA.
How Are Audits Planned?
The audit procedure should begin with the audit program plan, which outlines who will audit what by when. Establish a plan for when each audit will occur. Based on the auditor's ability, technical knowledge, or experience, determine the audit scope or area to be audited and who the suitable auditors would be for each audit.
Plan ahead for any new auditor training requirements as well as auditor refresher training for seasoned inspectors. This is crucial for IATF 16949 automotive auditing, which imposes many additional criteria on auditors, such as knowledge of Advanced Product Quality Planning (APQP), Core Tools, and different kinds of process audits. (product, manufacturing, and supplier).
Important Information: The ISO standard mandates that all Critical To Quality (CTQ) processes be audited and that your audit program include all of the standard's provisions that pertain to each process.
How Are Audits Conducted?
After that, carry out the plan by conducting a number of audits at predetermined times throughout the year. To ensure that each audit is truly completed, be sure to check the audit program schedule frequently.
This is a very typical assessment result. The audits are scheduled, but due to unforeseen circumstances, they are not finished on time. To make sure that all CTQ processes have been covered, keep in mind that you can always conduct a comprehensive system audit at the end of the audit year.
How Are Audits Verified?
Look over the audits program strategy. Did each investigation go as planned? How well was the planning for each audit? Each audit report contained clear, useful conclusions. A summary on an audit with no conclusions—positive or negative—is the worst kind.
Declare the process goals, process performance, and conclusion of perfection if the audited process is flawless and completely satisfies all metrics. Then describe the improvement's objective and the anticipated end date.
Though it's uncommon, it can happen. Since the procedure is probably not perfect, describe the steps being taken to reach the goal and the anticipated date. For the investigation, there is always a course of action to be taken.
How Are Audits Modified?
What outcomes did the check process produce? Was it done flawlessly? If so, set a higher standard and strive to perform at a higher level. If not, take action, modify the audit program plan, and repeat the pattern for another year.
Program Communication for Audits
The most crucial components of an internal audit process are training and clear communication, in addition to allocating the proper resources (personnel, money, and time). The standards or regulations that audits must adhere to as well as the audit procedure should be covered in training for the internal audit teams.
Internal and external audits should always be performed in accordance with a particular standard, rule, or internal control system. (policies and procedures). This enables auditors to build their impartial conclusions on extremely detailed requirements.
It's crucial to clearly communicate the internal audit process' goals to everyone in the company. The fear and dread can be greatly reduced if everyone in the company is aware that auditing is never about catching someone doing something wrong, but is instead always about improving the system. This may be particularly true if they are aware that the audit will offer valuable data for management and continual development, as well as for preparing for external audits.
Internal Auditor Training Programs
With your internal auditing program, Bizmasterz can assist. Recently, we enhanced and redesigned our Internal Auditor Training. The three-day course covers important topics that all members of the Internal Audit team should be trained in, including auditing techniques, the value of clear communication, appropriate auditor behavior, how to conduct audits that stay on schedule and within scope, and how to conduct audits that provide insightful data for compliance and ongoing improvement.
Although the ISO 9001 standard is used in the Bizmasterz Internal Auditor class, the methods and knowledge can be used when auditing to any standard or regulation, including:
IATF 16949
TL 9000
AS 9100
ISO 14001
GAAP
ISO 22000
Sarbanes-Oxley
OSHA
FDA
FAA
Internal Policies and Procedures
Dr. Chris Anderson, managing director of Bizmasterz, created and instructs the course. Chris has years of auditing experience in a variety of disciplines and industries, including aerospace (AS 9100), manufacturing (ISO 9001), automotive (IATF 16949), medical device (FDA/ISO 13485), accounting (Sarbanes-Oxley), and information technology compliance (ITIL). Chris is also certified by the American Society for Quality in quality management and monitoring. (ASQ).
If your company has an aggressive and effective audit system, nothing an external inspector finds or does when they visit (whether they are from a customer, a regulator, or a third party registrar) will come as a surprise to you. In reality, the majority of external auditors will view your proactive management very favorably if the internal audit system has already identified areas for improvement and plans and activities for improvement, including Corrective Actions, are in place.
The following time someone states, "I am here to audit you," consider it a chance to enhance your department and your organization rather than reacting in fear and dread. You can use Bizmasterz to make auditing enjoyable rather than unpleasant.