Getting certified to the ISO 9001 standard means that a business has met international requirements for establishing, implementing, and maintaining a quality management system.
This can be understood from the study published by Fact.MR stating revenue through ISO 9001 certification is expected to reach 15.2% CAGR by 2034 along with a market valuation of $66.25 billion.
For any business in the USA that is aspiring to gain this certification, it is important to understand the process of getting there.
This blog will explain how to get ISO 9001 certification in the USA, covering every step that needs to be followed. Let’s get started!
Struggling to Get ISO 9001 Certification in the USA? Follow These Steps For Better Results!
To obtain an ISO 9001 certification in the USA, there is a need to implement a quality management system that meets the standard outlined in ISO 9001.
Here’s a breakdown of the procedure:
Step 1: Understand the ISO 9001 Standard
Begin by familiarizing yourself with the ISO 9001:2015 requirements. The standard aims at improving the customer’s experience and increasing efficiency.
Some of the elements include leadership, planning, support, operation, performance evaluation, and improvement.
You can obtain one from the ISO or any of its accredited distributors because ISO 9001 is a purchasable standard.
Step 2: Conduct a Gap Analysis
Conduct a ‘gap assessment’ to determine the areas of your current processes that are below par the standard ISO 9001.
This will assist in identifying what amendments, enhancements or supplementary contents may be required.
Step 3: Develop Your Quality Management System (QMS)
Develop your QMS and support documentation to the requirements of ISO 9001. This includes:
Quality policy and quality objectives.
Task and activity documentation, process flowcharting, and procedure charting.
Duties and responsibilities of employees.
Policies for using resources, controlling outcomes, and responding to risks.
Concentrate on recording activities that create value and could be used to assess conformity to customer needs.
Step 4: Train Your Team
Inform all the employees in training about the ISO 9001 standard and their position in the QMS.
It needs to be communicated to everyone that quality matters and that they have a role to play in the quality management systems.
Step 5: Implement the QMS
Start implementing the established QMS in your organization.
It is about keeping control of the consistency, control of crucial processes, and managing nonconformities.
Step 6: Conduct Internal Audits
Conduct internal audits in a bid to evaluate the efficiency of your QMS.
Internal audits help to find such opportunities and guarantee the company’s compliance with the requirements of ISO 9001.
This should involve addressing and recording any nonconformities that have been identified during the audit process.
Step 7: Management Review
Schedule a management review meeting in order to assess the performance of the QMS.
Some of the factors that should be considered by the top management include audit results, customer feedback and overall effectiveness of the process.
Step 8: Select a Certification Body
Select an accredited certification body to undertake your external audit. Make sure that the certifying organization is accredited by the International Accreditation Forum (IAF).
Some of the leading accreditation bodies prevalent in the USA are the ANAB (ANSI National Accreditation Board).
Step 9: External Audit (Certification Audit)
The external audit is conducted in two stages:
Stage 1 – Documentation Review: Assessment of QMS documentation to confirm that it complies with ISO 9001 provisions.
Stage 2 – On-Site Audit: The auditor comes to your organization with the intention of assessing the level of compliance and efficiency of the QMS.
Correct all the nonconformities that may be observed during the audit and offer their resolutions.
Step 10: Get Your ISO 9001 Certificate
After a successful audit, your certification body will issue the ISO 9001 certificate.
Certification is valid for 3 years with annual surveillance to check for compliance with the standards.
Step 11: Maintain and Improve Your QMS
ISO 9001 is based on the concepts of continuous improvement.
Continuously monitor and review your certification and increase performance across processes.
Following these steps will enable a business to get ISO 9001 certification in the USA without much obstacles.
Conclusion
Obtaining ISO 9001 certification in the USA is easy when you know the right procedures to follow in the right manner. Need expert help? KSQA facilitates businesses to connect with the best ISO 9001 consultants and guides businesses in the whole process of certification.
Let KSQA lead you to success!
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