ISO 9001 CERTIFICATE

How to get an ISO 9001 Certificate?

ISO 9001 Certificate is issued by an independent third-party certification body (registrar), not by ISO. ISO 9001 is a management system standard for implementation. Proper implementation and maintenance of the ISO 9001 system help to improve quality and productivity.

Why do I need an ISO 9001 Certificate?

Even though ISO 9001 is a standard for implementation, most organizations opt for certification and get ISO 9001 Certificate from an independent registrar (ISO certification body) for the below purpose.

  • An independent third-party audit will help to find non-conformities
  • An Experienced auditor can provide guidance in corrective and preventive action
  • A third-party audit will improve the overall performance of the management system
  • ISO 9001 Certificate issued by the registrar is evidence for your customer that you are in compliance with ISO 9001 Standard, which will help them in vendor selection.

Steps in getting ISO 9001 Certificate

  • Be familiar with ISO 9001 Standard
  • Select an MR (Management Representative)
  • Prepare Quality Manual
  • Prepare quality system procedures
  • Prepare documents and forms
  • Implement QMS
  • Provide training and awareness to the employees
  • Conduct an Internal Audit
  • Conduct Management Review Meeting (MRM)
  • Take corrective and preventive action as per MRM
  • Select certification body / registrar
  • Certification body audit
  • Get certified
  • Maintain the quality management system
  • Maintain the ISO 9001 2015 Certificate
ISO Certificate
ISO 9001 Certificate ISO 13485 Certificate ISO Certificate - FAQ

ISO 9001 Certificate

ISO 9001 certificate is the most common quality system certificate accepted worldwide. For most global tenders ISO 9001 certificate is considered the entry ticket for participation. ISO 9001 is the commonly used international standard in service and manufacturing industries with no industry-specific standard.

ISO 9001 certificate is issued for three years with a yearly surveillance audit; the certification body will cancel the certificate in case of surveillance audit failure. After the third year, the certification body will conduct a recertification audit, and the certificate will be valid for three years, the same as the initial audit.

ISO 9001 certificate clearly mentions the scope of certification, expiry date, certificate issue date, and certificate number. If you want to verify the certificate validity, you can confirm it on the certification body’s website; if there is no option for verification on the website, you can contact the certification body for the certificate validity.

ISO 13485 Certificate

ISO 13485 certificate is issued specifically for the medical device industry. ISO 13485 certification is a mandatory requirement for medical device CE marking. The latest version of the standard is ISO 13485:2016, which is reviewed every five years.

Medical devices marketed in EU countries must have ISO 13485 certification; usually, the notified body that issue the CE certificate will also issue the ISO 13485 certificate after the onsite audit.

ISO 13485 certificate is also issued for three years with a surveillance audit each year. US companies with ISO 13485 certificate from US certification bodies may need to get a new 13485 certificate from the CE-notified body when applying for CE Marking.

ISO Certificate - FAQ

What is ISO Certificate?

ISO Certificate is the evidence that your company has a quality system per the ISO standard.

Who issues the ISO Certificate?

ISO certification bodies, also called registrars issue the ISO Certificate

Can I have ISO 9001 and ISO 13485 certificates for my company?

Yes, if you are a medical device company.

Which certificate do you prefer for a medical device company, ISO 9001 or ISO 13485?

We prefer ISO 13485 for medical device companies, which is the standard for the medical device industry.

Do a management review mandatory for the initial ISO audit?

Yes, the quality objectives, customer-compliant status, CAPA status review, etc., are discussed in the Management review meeting.

Is the certification fee the same for ISO 9001 and ISO 13485?

It depends on the certification body, in most cases, ISO 13485 Certification fees are more than ISO 9001.

LMG offers ISO 9001 Certification assistance to Chicago and suburbs from Aurora, Illinois, and New York & surrounding states from New York. We provide complete assistance from ISO 9001 implementation through certificate issuance; our experienced consultants assist you with

For more information, Please contact us with detailed information.