ISO 9001 vs. ISO 13485

ISO 9001 Certification means an organization has met the requirements in ISO 9001. It defines an ISO 9000 Quality Management System (QMS).

What is ISO 9001?

ISO 9001 Certification means an organization has met the requirements in ISO 9001. It defines an ISO 9000 Quality Management System (QMS). ISO 9001 certification in Australiais focused on meeting customer expectations and delivering customer satisfaction so you must pay attention to the customer.

In ISO 13485 Certification is the international standards requirement for the quality management system for medical devices and related services that consistently meet customer and applicable regulatory requirements. In quality management system for special purposes the ISO 13485 Certification is standard for based on requirements of ISO 9001 Certification.ISO 13485 Certification services in New Zealand includes the entire ISO 9001 standard with additional requirements. One of the major distinctions of ISO 13485 is that it is intended to also be requirements for regulatory purposes as well as non-statutory requirements for a quality management system.

What is ISO 13485 based on?

In ISO 13485 Certification is current version is released in 2003. In version is based on the version 9001 released in 2000 and it was updated the ISO 9001 Certification in 2008. Most of the changes in ISO 9001 Certification in Lebanon were clarification and added notes, with only a few minor updates that would affect processes and procedures. In these changes is not necessary for medical devices industry. So no updates to ISO 13485 Certification.

What are the additional requirements in ISO 13485 Certification?

When it comes to the quality management system requirements in sections four through eight, there are several small additions, mostly involved in the identification and application of pertinent legal requirements for the medical devices produced by the organization. Here is a brief listing of the main additions:

Quality management system:

  • In ISO Documentation requirements per regulations.
  • Actions required maintaining effectiveness of the QMS.
  • Records maintained for at least the lifetime of the medical device or as specified by law.
  • Quality manual, to include scope of the QMS and outline of documentation used.

Management Responsibility:

  • Responsibility authority communication and interaction of personnel to be ensured.
  • Management Rep to promote awareness of regulatory requirements.
  • Management commitment to ensure effectiveness of the Quality management system.
  • Quality policy, to include commitment to comply with requirements and QMS effectiveness.

Product Realization:

  • Need for documented product requirements.
  • Purchasing procedures need to be documented.
  • In ISO 13485 Certification in Australia documented procedures needed for monitoring and measurement.

Measurement, Analysis and Improvement:

  • In ISO measurement, analysis and improvement to include quality management system effectiveness.
  • Feedback included in analysis of data.
  • Documented procedure required for a feedback system to establish if the company has met customer requirements.
  • Including update of documents in the actions taken for corrective actions.
  • Including records of investigations for corrective and preventive actions.

By looking all reason everyone getting how the ISO 9001 certification will helps to employees in the your office. If you're looking to get ISO 13485 Consultants services in Mumbai?

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