What to expect in an ISO 9001:2015 Certification Audit
An ISO 9001:2015 certification audit, or commonly referred to as an ISO registration or ISO certification, is a method in which a company can verify that they have successfully implemented the ISO Standard Requirements.
After establishing a quality approach and performing reviews, a company may then employ an independent auditing company (ISO Registrar) to review their processes and ensure that the company is adhering to both their processes and ISO 9001:2015 requirements.
The auditor will expect that your organization has established quality policies, measurable objectives, developed and deployed standard processes, and has been operating the QMS for a minimum of three months and collecting records to validate the effectiveness of your QMS.
The auditor won’t expect perfection – some things may need to be changed. What is important to an auditor is that you have deployed your processes, addressed risks and opportunities, managed changes, identified improvements, conducted internal audits, evaluated the effectiveness of the QMS, addressed any corrective actions, monitored and measured performance, and implemented any changes or improvements based on your continual review. The certification assessment will be comprised of two audits.
A Stage One Audit is usually one or two days onsite and is a review of your readiness for the Stage Two Audit. The stage one is generally focused on scope review, processes and documentation, and confirming that certain activities such as an internal audit and management review have occurred.
The Stage 2 Audit assesses the implementation and effectiveness of the QMS through conducting interviews, evaluating the results of performance, audits, and reviews, verifying that there is a record of actions taken. The expectation is that you are using your system and implementing corrective action to address any deficiencies.
At the end of the assessment, the company gets a Certificate of ISO 9001:2015 registration. Our certified ISO Certification Consultants can
- show you how to successfully prepare for an ISO Certification,
- strategically support your quality goals and objectives.
- manage your ISO Certification requirements and process,
- assist you with qualified ISO Registrars making the whole process painless and a value-add to your business objectives.
So when can I get my audit?
The answer is of course, “it depends”. However, generally your QMS should be active for a minimum of three months. Download our guide and contact our team so we can walk you through what is next.
What do I need to have done to be ready?
Before planning for a certification audit, there are certain items that need to be addressed. Review the following quick checklist to assess readiness:
- Has the organization established a plan for the QMS aligned to business goals?
- Has management committed to quality and provided resources along with assigning responsibility and authority to roles that support the QMS?
- Are stakeholder needs and requirements along with regulatory and legal requirements defined?
- Has the organization established a quality policy?
- Have measurable quality objectives been established, monitored, and reviewed?
- Have you established a method for identifying and addressing risks and opportunities?
- Have core business processes been defined and documented as appropriate?
- Have performance measures been established for key processes?
- Are customer requirements understood and aligned to the QMS?
- Do you communicate quality expectations to relevant parties?
- Have you established how documents, records, and information will be controlled?
- Have resources been allocated, expectations established, training provided, and communicated?
- Have you captured how suppliers are selected, evaluated, and reviewed?
- Is there a method for obtaining customer feedback, complaints, and evaluating customer satisfaction?
- Do you have a method to manage changes in specifications and ensure that they are communicated and controlled?
- Are there controls in place to manage inputs and output to design and customer specifications?
- Do you have a method to validate that the product or services will work as intended?
- Do you have a method to identify and trace products during product realization?
- Have you established what equipment needs to be verified or calibrated? Do you have records of calibration or verification of measuring equipment?
- Do you have a process for controlling non-conforming products or services?
- Do you have a process for ensuring that products or services that are provided meet quality and customer expectations without defects?
- Do you have a process for managing and addressing nonconformities?
- Have you established a program, procedure, and schedule for internal audits?
- Have you conducted management reviews, implemented any corrective actions, improvements, or changes to address performance, quality, or process issues or potential issues?Are you monitoring continual improvement?
This list above is not exhaustive but it is a good health check of your readiness. Contact us if you need help getting started and we can help simplify what is needed, required for the audit, and helps with process and performance improvement.…
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