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ISO 13485:2016 Certification
Auditing, Consulting & Training

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QSE: 27+ Years of Experience in Consulting, Auditing, & Training

ISO 13485 Overview:

The ISO 13485 standard is based on ISO 9001:2008 with 8 element structure unlike ISO 9001:2015(10 element structure). International Standard ISO 13485 specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services.  The ISO 13485 certification provides a different kind of approach in the manufacture and distribution of medical equipment and there is no doubt that many medical practitioners have preferred equipment from providers and producers who have been certified by the ISO 13485 standard. The standardization criteria are a global initiative that aims at creating a professional medical equipment production through world class management practices that are all within the ISO 13485 medical device compliance standard.

The rationale that is taken in the audit for ISO 13485 compliance involves manufacturing and distribution of medical equipment, as well as considering the potential risk that is involved in their use. The ISO 13485 certification allows medical equipment manufacturers to meet global standards of safety in developed countries and comply with the existing legislation in those nations. The ISO 13485 standard initiates management systems to analyze the production of medical equipment and to come up with instructions on how to assess strength and weaknesses in the ISO 13485 Quality Management System. The requirements for ISO 13485:2016 certification is very basic and all aim at promoting high safety standards in the production and distribution of medical equipment.

For effective implementation for ISO 13485 standard,  the organizations develop ISO 13485 audit checklists to conduct ISO 13485 Gap analysis, develop ISO 13485 training materials to disseminate to all interested parties related to ISO 13485 requirements, develop ISO 13485 Quality Management System, conduct ISO 13485 internal audits, using ISO 13485 audit checklists and conduct management review of the ISO 13485 Quality Management System for ISO 13485 standard compliance  prior to ISO 13485 certification audit.  Any organization seeking ISO 13485 certification may use ISO 13485 Consulting, ISO 13485 Auditing and ISO 13485 Training entities. A competent ISO 13485 consultant may be present during ISO 13485 certification audit to defend the established ISO 13485 Quality Management System without interfering with ISO 13485 certification auditors

Among the basic and fundamental ISO 13485 requirements, the following are the most significant ones:

  • ISO 13485:2016 Medical Device Standard requires that organizations develop and establish a quality medical equipment management practice and system in all sectors of production and distribution.
  • ISO 13485 compliance calls for organizations to conduct comprehensive assessments using ISO 13458 Audit Checklists of their production system to determine the strengths and weaknesses of their existing management system and further move on to develop possible solutions regarding their findings.
  • ISO 13485 compliance requires detailed presentation of the organization management system to make sure that all requirements of regulatory agencies have been taken into consideration.
  • ISO 13485 Standard requires companies to implement and evaluate an internationally recognized quality management system in the production of their medical equipment.
  • ISO 13485 Standard ensures that medical equipment management system has documentation of procedures as well as development of an effective manual.
  • ISO 13484 Standard promotes proper documentation of medical devices service and medical devices equipment management practices.

Who should get ISO 13485:2016 Certification

Any facility offering Products or Services and is desirous of having a globally acceptable quality assurance system for medical devices needs to get ISO 13485:2016 certification

Any facility desirous of assuring customers about their quality systems and FDA compliance should get ISO 13485 certification.

Any facility desirous of having interests of all stake holders covered in their system and has adequate provisions for mitigating risks in their processes must get ISO 13485 Certification

Any facility desirous of having a strong marketing tool to showcase their quality capabilities for medical devices must get ISO 13485 certification

Any facility desirous of having a complete system which covers all aspects of operations in one single system for management review and comply with statutory and regulatory requirements must obtain ISO 13485 certification

Any facility whose management desires to have one single system for medical devices manufacturing or services, through which management can build teamwork, review progress, measure, monitor, make corrections and give impetus for continual improvement must get ISO 13485 Certification

  • All facilities engaged in the production medicinal products require a Quality Management System (QMS) for ISO 13485 certification. Developing a comprehensive system to meet all the requirements of ISO 13485 standard, for effective implementation to achieve desired results, a competent ISO 13485 consulting company or a competent ISO 13485 consultant is essential
  • ISO 13485 consulting companies are required to have a QMS that is developed to comply with all customers and regulatory requirements and the organization can demonstrate that the facility has a robust system and can produce quality products and ensure safety for consumers
  • ISO13485: 2016 is an international standard dedicated to build QMS for medical devices of any class and pave way for continual improvement in any facility
  • A competent ISO 13485 consulting company or ISO 13485 consultant can provide detailed explanation on the intent of the standard while developing an ISO 13485 compliant Quality Management System(QMS)
  • Facilities need to implement the prepared QMS for a minimum of 3 months and gather adequate data and record to show as evidence
  • Managements of the facilities need to conduct one full scale review of the entire QMS and ensure its adequacy for their organization. Management Team needs to identify Action items to make corrections to any ISO requirement not being fulfilled
  • Once a QMS is ready, Internal audit is performed and one full set of Management review takes place, the facility needs to contact a certification Body for certification audit
  • Certification Bodies conduct Audit in 2 stages. During Stage 1, ISO audit will evaluate the documentation system and basic requirements of meeting ISO Requirements
  • Certification Body will return for final audit where all ISO 13485 Requirements will be thoroughly audited to ensure that requirements are met and documentary evidence exists to demonstrate compliance
  • Once certification Body is satisfied, recommendation is sent to accrediting agencies to issue ISO 13485 certification

The QSE Difference in Training, Auditing, & Consulting Services

  • Quality Systems Enhancement Inc. (QSE) is a Premier Consulting, Auditing and Training firm engaged in the field of ISO 13485 certification to international standards
  • QSE has a unique 10 steps disciplined path for ISO 13485 certification which is insensitive to failure
  • QSE has assisted over 700 facilities achieve ISO certifications
  • QSE’s unique document simplification tools result in smooth   implementation to achieve ISO 13485 certification
  • QSE identifies all processes from “Quote to Cash” in other words all activities from submission of quote, processing of the order, quality control, dispatch to customer and receive cash. All manufacturing and non-manufacturing processes are covered
  • QSE provides ISO 13485 medical devices documentation covering all requirements of customers and other interested parties, statutory and regulatory requirements
  • QSE Provides simplified documented system for ISO 13485 compliance that is easy to integrate to other management systems
  • QSE engages qualified and competent auditors to conduct internal audits using ISO 13485 checklists
  • QSE’s internal audits using ISO 13485 checklists are more stringent than Certification Bodies audits and will help companies pass ISO 13485 certification audits with minimum nonconformities or no nonconformity
  • 98% of QSE assisted facilities passed the initial ISO 13485 certification audit with zero deficiencies with a 100% passing rate first time around
  • QSE covers all the requirements of the ISO 13485 standard including the implicit intent of the standard
  • QSE provides system development involving all relevant employees leading to effective implementation of requirements for ISO 13485 compliance
  • Document Simplification provided by QSE is unique comprehensive single level documentation which ensures effective implementation of ISO 13485 standard
  • QSE’s documentation is unique, simple, lean and easy to implement and sustain ISO 13485 certification in the long run
  • QSE provides ISO 13485 standard, implementation assistance and complete understanding of the documentation for ISO 13485 standard requirements
  • QSE provides unique management review format for ISO 13485 standard resulting in no nonconformities against management review during certification audits.
  • QSE does not simply tell our customers what to do but assists them on how to do in meeting ISO 13485 requirements
  • QSE’s 10-step disciplined path for ISO 13485 certification achieves organizations certification in the shortest possible time. Usually within 5 months
  • QSE provides ISO 13485 post auditing services if required and can take the disputes to the highest levels for resolution

The benefits of implementing ISO 13485:2016 management systems are diverse and will be seen in all departments of your company. The following are some of the benefits that you should take into consideration:

  • ISO 13485:2016 allows your organization to meet the customer requirements in the production of medical equipment.
  • Provides necessary ideas to standardize quality management in the medical equipment fields.
  • ISO 13485 Certification will reduce or eliminates FDA audits
  • Well-built QMS for medical devices help avoid the need to recall medical devices
  • Well-built ISO 13485:2016 QMS shows the way to adhere to all statutory and regulatory requirements associated with medical devices.
  • ISO 13485 compliance helps companies produce good quality medical devices which help extend human or animal life expectancy
  • ISO 13485 Certification is critical in providing a competitive edge for your organization


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Frequently Asked Questions​

ISO 13485 Certification can minimize FDA audits and product recalls through robust compliant system development and effective implementation techniques

3rd Party audit Certification Bodies (Accredited by International Accreditation Forum =IAF) perform the audits on the organizations to grant ISO 13485 Certifications with demonstrated evidence of conformity to all the requirements of ISO 13485:2016.

The certification is renewable every three years

Yes! ISO 13485 Certification is universally accepted certification. However sometimes different countries issue directives on how Medical Device Files (MDF) are to be maintained, for implantable devices. These directives are to be followed when exporting to those countries while certification remains the same

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