Getting ISO 13485 Certified in Tulsa, Oklahoma (OK)
ISO 13485 is an international standard for quality management systems in the medical device industry. Some local regulations have been implemented in different countries to control the quality of these medical devices. In the United States, for instance, companies in medical technology are all required to comply with the specifications of FDA quality system regulations. However, for individuals who are seeking global market share, they are also required to comply with ISO 13485.
If you are in this sector, then you need to get certified to make your presence in the global market known. ISO 13485 certification is the only entry into the world market for companies dealing in medical device design and manufacturing.
Implementation and Certification Service to Use in Tulsa, Oklahoma
It is one thing to implement an ISO 13485 in your organization and another thing to get certified for it. You need an accredited organization or individuals to audit your company or business for compliance. We are pleased to inform you that ISO Pros has been on the frontline in ensuring that as many organizations in the United States as possible achieve ISO 13485 certification. Contact us now to schedule audits and certification to show the world that you are ready for global trading.
Steps to getting ISO 13485 Certification
There are basic steps that you need to get right if you are planning to achieve certification for ISO 13485. That is our main focus in this article. We are going to talk about them in brief. So, you should not feel that we leaving out some information as you can always inquire from us or do your own research. These are the steps that you need to follow:
Create a quality plan – You need a proper plan that will meet the quality expected by the customers and as required by the ISO 13485. You should identify all the processes and activities that you need to adjust to get everything right.
Identify the market – You need to know what your potential customers are and where they come from. You should be able to identify all their needs and expectations. You can then design and manufacture medical devices that meet their requirements and at the same time comply with the regulations.
Document control – Documentation is the core of any effective quality management system. You can train your staff on how to document everything that will be later used for quality improvement and maintaining compliance with this standard.
Implement the system – Once you are ready with the previous steps, you can then proceed directly to implement it within your organization. You can then monitor the progress and continually improve it as required for not less than 3 months.
Schedule pre-assessment and certification audit – This is the last stage where you will verify whether or not you comply with the standards of ISO 13485. Contact professional auditors from a reputable organization to handle it. This should follow an internal audit that you do yourself as a self-evaluation.