How to get ISO 9001 Certified: A Step-By-Step Guide
The ISO 9001 Certification is the most recognized certification in the world today. More than 65% of business organizations in the USA have already obtained it, including federal government agencies. An ISO 9001 certification means that your organization’s quality management system has been found to meet an internationally agreed-upon standard for effective Quality Management System (QMS). To achieve the ISO 9001 certification, you need to implement a quality management system following a stringent set of standards and procedures. The following is a guide on how to get ISO 9001 certified.
Pre-Audit Stage Steps
The ISO 9001 certification is a detailed process that involves various stages, each important for the overall success of the QMS. One of these is the pre-audit stage where you have to identify and document your organization’s current QMS, allowing a thorough understanding of what changes will be needed in order to meet the required standard. The following is a step-by-step guide on How to Get ISO 9001 Certified:
- Gap Analysis/Audit
Schedule a gap analysis/audit with a qualified firm that is knowledgeable in the ISO 9001 certification process. The gap analysis/audit will review your current QMS and provide a list of the changes needed to achieve the organization’s desired quality objectives.
Once the gap analysis/audit is completed, you will need to obtain quality management system documentation. This includes information on where to obtain copies of existing quality-related documents and records showing how the documented procedures are implemented in your organization. You can obtain this information by reviewing existing or new policies, procedures, and records that may not be readily available for review by an auditor.
You will also need to provide all employees with the necessary training on the new ISO 9001 quality management system. Schedule in-house training for your personnel using the documentation to ensure that all employees understand their role and responsibilities regarding the ISO 9001 certification. Training is essential in minimizing possible resistance resulting from changes required in your organization’s QMS.
- Providing Resources
Resources play a vital role in attaining ISO 9001 certification. Ensure that the necessary resources are available for your personnel to prepare documents and records needed for the audit, as well as training materials. Also, you will need to provide all equipment (e.g., machines) needed for implementing your new QMS.
Next, you will need to implement and monitor the QMS and its associated documentation. The implementation should include the establishment of a quality management system framework and an ongoing process for monitoring and evaluation. Start implementing the new quality management system documentation immediately upon receipt of ISO-related documents from your accredited registrar (and before receiving notification of accreditation). Implementing the documentation will help you develop a thorough understanding of your organization’s new QMS.
- Internal Audit
The ISO 9001 certification requires a successful assessment of your QMS. This is known as an internal audit wherein you will need to assess the system in terms of how it functions within your organization, its documentation, and employees’ roles and responsibilities. You will also need to review the effectiveness of the quality management system with respect to meeting the requirements and expectations of your customers.
The next step of how to get ISO 9001 certified is to conduct the audit itself. During this stage, your management system will be evaluated against the requirements of the ISO 9001 standard. However, before you start getting ready for an ISO 9001 certification audit, you need to identify the priorities of your organization by ensuring that all of the pre-audit stage steps have been thoroughly assessed and completed.
- Stage 1 Preliminary Audit
The first stage in the ISO 9001 certification process is known as a preliminary audit. This step involves evaluating how well your QMS and its associated documentation meet the requirements of the standard. The audit team actually visits your facility and evaluates how you manage and monitor your QMS. Using ISO 9001:2015 as a reference, the auditor will make sure that all of the requirements in terms of documentation, training, processes, procedures and practices are available in your organization. The audit team will also review the system documentation to ensure that it conforms with ISO 9001:2015 standards.
Your management system will be evaluated against the requirements of the ISO 9001 standard, and any non-conformities will be identified to resolve before the stage 2 audit is conducted. This means you need to review your quality management system documentation if any changes have been made. Also, you should consult your auditor about any questions or concerns regarding your QMS before the audit takes place.
- Stage 2 Implementation Audit
The Stage 2 Audit is also conducted by a team of external auditors from an accredited certification body to assess how well your QMS conforms to ISO 9001:2015 standards. The assessment will be made on the basis of criteria stated in ISO 9001:2015, with particular emphasis on the quality management system elements that are within your organization’s control. You or your representative are required to be present during the audit in order for you to answer any questions regarding your QMS, as well as to assess its performance.
The auditor will assess how well you perform in terms of meeting the requirements and expectations of both internal and external customers. The purpose of the audit is to determine whether or not your QMS meets all requirements of ISO 9001:2015 and if it fulfills its intended purposes. The main goal during this stage is to find out how well your quality management system functions within your organization and how it has contributed to the achievement of business goals. The audit team will also assess if you have resolved any non-conformities addressed in the Stage 1 Audit.
- Certification Decision by Certification Body
After the audit has been successfully conducted, your certification body will give you an overall performance rating called the “outcome of registration/certification.” They will then endorse or recommend that you pursue ISO 9001 certification. If they do not recommend that you proceed with the certification process, they will provide pointers on how to improve your quality management system.
At the end of the certification stage, you will receive your certificate which contains information about your organization’s registration details, as well as some other pertinent information. It is important to note that ISO 9001 certification is not permanent; rather it stays valid for a period of 3 years.
- Surveillance Audit
After you have received your certificate, the surveillance audit phase begins. During this stage, you will be monitored for a period of 3 years to ensure that your quality management system remains compliant with ISO 9001:2015 standards. The Surveillance Audit will be conducted once after every 12 month period of certification. (2 surveillance audits for a 3 year validity period). How well your performance is against these standards will determine if either of the following actions is taken:
- Your certification validity will remain as issued.
- Your certification will be suspended or revoked.
- Recertification Audit
After the surveillance period of 3 years ends, you will be required to go through the recertification audit stage. During this stage, your quality management system will be assessed by an independent certification body against ISO 9001:2015 standards and requirements. This means that apart from complying with ISO 9001: 2015 requirements and demonstrating its effectiveness over a previous 3 year period, you must also demonstrate that your QMS is effective and efficient enough to match the evolving demands of the business/sector you operate in.
How long does it take to get ISO 9001 Certified?
The amount of time it takes to achieve ISO 9001 certification depends on various requirements. Some companies are able to get ISO certified in less than 3 months while for others, the process might take much longer because an organization’s internal structure must be adjusted in order for it to qualify for certification. How long the overall registration/certification process lasts also depends on several other factors:
- The complexity and effectiveness of your QMS
- How well and quickly your company responds to audits.
- How committed you are towards achieving ISO certification for your organization.
- How accurately you manage the documentation requirements of the standard during the registration process.
- How quickly your certification body processes your application after it has been received.
What is the cost of getting ISO 9001 Certified?
The cost of getting ISO 9001 certification varies depending on the certification body you are choosing to work with. How much your company spends will also depend on other variables, such as the time required for processing your application and how complicated it is to get certified by the applicable standard. How much you spend also depends on whether or not there are added costs for additional consultants or audits. However, the long-term benefits of having an effective quality management system in place will offset the initial cost of getting ISO 9001 certified.
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