ISO 9001 Certification Process

ISO 9001 Certification Process Steps

The following are general guidelines followed by ISO certification bodies throughout the ISO 9001 certification process: 

Pre-Audit Stage

The ISO 9001 certification process starts with a pre-audit which is conducted by the certification body. This will involve some on-site assessment that will last for a few days and an off-site evaluation with written documentation. The ISO 9001 audit team leader will be looking at records related to case studies, quality manuals, ISO 9001 procedures, and ISO 9004 guidelines to make sure that these are in place. 

During pre-audit, ISO 9001 processes shall be mapped to make sure that they adhere to all ISO requirements. ISO pre-audit will also include interviews with the employees, the management, and those involved in ISO 9001 certification process. Your company can hire third-party ISO consultants to guide you through the pre-audit stage of the ISO 9001 certification process, or you may opt to appoint a qualified employee within your organization. 

ISO 9001 certification process

Gap Analysis 

The appointed ISO audit team leader will be making notes of any gaps or discrepancies during ISO 9001 pre-audit. The ISO consultant will work with the management on these areas to make sure that ISO 9001 certification process meets all ISO requirements before the actual ISO 9001 certification audit is conducted by the certification body.

Documentation 

The ISO 9001 certification process requires that all ISO requirements be documented. Your organization will make sure that the quality manual is compliant with ISO 9001 requirements. In general, your organization will look at every aspect of ISO 9001 documentation to make sure it is complete before the ISO certification process can begin. If there are any discrepancies between ISO requirements and documentation, the management will discuss changes that need to be made before ISO 9001 certification process starts.

Training 

Prior to the ISO 9001 certification process, the organization will review ISO 9001 training records to make sure that employees are well-versed with ISO requirements. Your organization will also evaluate the effectiveness of ISO training by asking some key questions like how long did it take for employees to grasp the certification requirements, how effective were the trainers, was there any follow-up ISO 9001 training, and was the training consistent with ISO requirements.

Provide Resources 

ISO 9001 consultants will also look at the ISO resources used by the employees during the ISO 9001 certification process. ISO consultants will check that all ISO-related materials are up-to-date and meet ISO requirements. These may include ISO policies, forms, records, guidelines, manuals, etc. 

Implementation 

ISO consultants will work with the management to prepare the ISO project plan before ISO 9001 certification process begins. ISO consultants will also develop an appropriate risk management plan for ISO 9000 certification based on ISO guidelines and customer/regulatory requirements. Once the necessary plans have been addressed, the ISO consultants will help the organization begin implementing the quality management system. 

Internal Audit 

After measures have been put in place, the next step in the ISO 9001 certification process is to perform an internal audit to analyze how the ISO 9001 quality management system has been implemented. A management representative is usually hired within the organization to conduct the internal audit. The internal auditor will look at records related to ISO 9001 audit, samples of ISO documentation, quality plans, ISO training plans, ISO communication plans, etc. The results of the internal audit will be documented in an audit report, which will be shared with the certification body in the next stage of the ISO 9001 certification process.

Auditing

The pre-audit stage gets a company ready for the ISO 9001 certification process. The ISO 9001 certification audit is a review process where an ISO auditor from a certification body will go through ISO documentation, talk to employees and management, and check whether the ISO requirements are being met. There are 2 stages to this ISO 9001 certification process:

Stage 1 Preliminary Audit 

During this stage of the ISO 9001 certification process, ISO 9001 auditors will go through ISO documentation to ensure that all ISO requirements have been documented. If any discrepancies are found in ISO documents, your organization will need to update them before the actual ISO certification audit (stage 2) takes place. 

Stage 2 Implementation Audit 

Once your organization completes stage 1 preliminary audit, the ISO 9001 certification process enters the second stage (certification audit). ISO certification audits are conducted to ensure that ISO requirements are being met. ISO 9001 auditors will go through ISO documentation, talk to employees, and conduct audits of ISO system. ISO certification audit results are documented in an ISO certification audit report. 

Certification Decision by Certification Body

Once you pass both stages of the ISO 9001 external audit, the certification body will issue your business ISO 9001 certification. 

Surveillance Audit

The next stage in the ISO 9001 certification process is conducting surveillance audits. The certification body that issues your ISO 9001 certification will conduct two surveillance audits within the 3 year validity period of your certification. The purpose of surveillance audits is to make sure your organization is in compliance with ISO 9001 requirements throughout your certification validity period.

Re-certification Audit

The final stage of the ISO 9001 certification process is to conduct a re-certification audit. The purpose of a re-certification audit is to extend the validity of your organization’s ISO 9001 certification.

Duration of ISO 9001 Certification Process

The ISO 9001 certification process is, in general, a 6-month process if an ISO consultant is hired. However, the duration of ISO 9001 certification process depends on your organization’s readiness for ISO 9001 ISO compliance. If your organization is already ISO 9001 compliant, it will take less time to get ISO 9001 certification compared to an organization that has not yet implemented ISO quality management system requirements.

Cost of ISO 9001 Certification Process

The ISO 9001 certification process cost depends on a variety of factors including the chosen ISO 9001 certification body, ISO 9001 consultant fees, ISO document preparation costs, ISO audit fees, etc. ISO 9001 certification process costs will increase if ISO consulting fees are included. Your organization can reduce costs by hiring in-house employees to guide you through the pre-audit stage of the ISO 9001 certification process. To do this, you would need to hire and train competent staff who are knowledgeable when it comes to the ISO 9001 certification process.

Contact IAS today to learn more about ISO 9001 certification process, or visit our ISO 9001 certification process frequently asked questions page!