The Best Affordable ISO Certification - ISO 9001 & ISO 13485

Vendor approval/evaluation is part of ISO implementation; getting products and services from an iso certified company may be a clause in your customer’s purchasing procedure, which will help them to avoid an expensive onsite audit.

ISO - International Organization for Standardization - is located in Geneva, Switzerland. ISO is an independent, non-governmental international organization with a membership of 167 national standards bodies, including ANSI (American National Standards Institute). There are a lot of American certification bodies, accredited and non-accredited. You can find a list of accredited American certification bodies at ISO CERTIFICATION BODY

ISO develops different standards for different scopes. If you are looking for a general management system certification, ISO 9001 is recommended. ISO 13485 is the best option for medical device companies developed specifically for medical device establishments. If you want to improve your environmental performance, you can use ISO 14001. Similarly, ISO sets industry-specific standards; please find the different standards and their applicability at ISO Standards

It depends on the scope of certification; for ISO 9001 Certification, you can go with certification for the company or some process. Suppose you are a manufacturing company with a process design and don’t want to add it to the certification scope. You are free to do so.

The certification body issues an ISO certificate for three years assures that the management system is in place and is working well as long as the certificate is valid; to keep the assurance, the certification body needs to conduct surveillance audits at least once a year.

The duration may change with factors like scope, number of employees, number of products, departments, etc. The certification body selected also plays a vital role in certification time. Some certification bodies accept the “readiness” if you are new to ISO certification, but some certification bodies need to see the evidence for 1-2 years.

Reducing costs is one of the primary objectives for small businesses. Good planning is essential for this. Also, at least one ISO expert must be available during the certification process. If you do not have an ISO expert in your facility, it is advisable to get help from an external ISO Consultant. Since there are several certification bodies available, you need to schedule the audit only after an internal audit, which will help assess the quality system's strengths and weaknesses.

For small companies, it is always better to hire an ISO consultant unless they have an ISO expert. It may be a financial hurdle for small companies to keep an ISO expert year around. ISO Certification for Small Companies

LMG provide complete assistance from documentation through certification. Our experienced consultants can help you to

• Define the scope of certification
• Identify the requirements
• Prepare quality manual
• Prepare quality system procedures
• ISO implementation
• Internal audit
• Certification body selection
• Certification body audit
• Closing certification body NC’s

Yes, we will help you find a certification body that best fits your establishment and coordinate with the certification body.

Minor NCs and observations are usual on ISO certification body audit; this will not affect the certification process; we will help you to raise CAPA and close the NCs. In the case of major NC, the certification body will issue the certificate only after closing the NC.

Your customers can verify the certificate’s authenticity on the certification body’s website or write to the certification body.

Sure, if all ISO certificates are from the same certification body, you can request a combined audit.

US FDA is a federal government agency that will not accept third-party certificates. FDA registration is a mandatory requirement for food, drug, and medical device companies. ISO certificate cannot use in place of FDA registration.