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ISO 13485:2016 Certification

ISO 13485:2016

ISO 13485:2016 Certification

ISO 13485 Standard is Known as – Medical devices — Quality Management System -Requirements for Regulatory Purposes

ISO 13485:2016 outlines the parameters for a quality management system that demonstrates an organization’s capacity to consistently offer medical devices and related services that fulfill customer and regulatory requirements. Design and development, production, storage and distribution, installation, or servicing of a medical device, as well as design and development or provision of connected operations, are all possible roles for such entities (e.g., technical support). Suppliers or external parties who provide goods, including quality management system-related services to such entities, may apply for ISO 13485 Certification.

What are the requirements of ISO 13485 for Implementation and Certification?

As per the ISO 13485 :2016 Standard, the requirements for implementation are given as ,

Clause # 4 – Quality management system

Where this clause has two sub-clauses, such as

4.1 General Requirements – which has six sub clauses – 4.1.1 to 4.1.6

4.2 Documentation requirements- which has Five sub clauses – 4.2.1 to 4.2.5

Where the key requirements are – Quality Manual, Medical device file, Control of documents and Control of records

Clause # 5 Management responsibility Where this clause has six sub-clauses, such as

5.1 Management commitment

5.2 Customer focus

5.3 Quality policy

5.4 Planning- which has 2 sub clauses – 5.4.1 to 5.4.2

5.5 Responsibility, authority and communication- which has 3 sub clauses – 5.5.1 to 5.5.3

5.6 Management review- which has 3 sub clauses – 5.6.1 to 5.6.3

6 Resource management

Where this clause has 4 sub-clauses, such as

6.1 Provision of resources

6.2 Human resources

6.3 Infrastructure

6.4 Work environment and contamination control– which has 2 sub clauses – 6.4.1 to 6.4.2

Clause # 7- Product realization

Where this clause has 6 sub-clauses, such as

7.1 Planning of product realization

7.2 Customer-related processes — which has 3 sub clauses – 7.2.1 to 7.2.3 -such as Determination of requirements related to product, Review of requirements related to product and Communication

7.3 Design and development- which has 10 sub clauses – 7.3.1 to 7.3.10 -such as Design and development planning, Design and development inputs, Design and development outputs, Design and development review, Design and development verification, Design and development validation, Design and development transfer, Control of design and development changes and Design and development files

7.4 Purchasing – which has 3 sub clauses – 7.4.1 to 7.4.3- such as Purchasing process, purchasing information and Verification of purchased product

7.5 Production and service provision- which has 11 sub clauses – 7.5.1 to 7.5.11 – such as Control of production and service provision , Cleanliness of product, Installation activities , Servicing activities , Particular requirements for sterile medical devices , Validation of processes for production and service provision , Particular requirements for validation of processes for sterilization and sterile barrier systems, Identification, Traceability , Customer property and Preservation of product

7.6 Control of monitoring and measuring equipment

Clause # 8 Measurement, analysis and improvement

Where this clause has 5 sub-clauses, such as

8.1 General

8.2 Monitoring and measurement- which has 6 sub clauses – 8.2.1 to 8.2.6 – such as Feedback, Complaint handling, Reporting to regulatory authorities, Internal audit, Monitoring and measurement of processes and Monitoring and measurement of product

8.3 Control of nonconforming product – which has 4 sub clauses – 8.3.1 to 8.3.4 – such as Actions in response to nonconforming product detected before delivery, Actions in response to nonconforming product detected after delivery, Rework,

8.4 Analysis of data

8.5 Improvement- which has 3 sub clauses – 8.5.1 to 8.5.3 -such as Corrective action, and Preventive action

These are the key requirements of ISO 13485 :2016 – So the organization looking for ISO 13485 Certification, implement these requirements in the organization by proper Training on ISO 13485 requirement by self-learning or with support of professional competent Management System Consultant (ISO Consultants). After the completion of implementation apply for ISO 13485 Certification.

While implementing ISO 13485 for Certification, the following important points must be considered, if the organization Looking for Exclusion of any clauses of this ISO 13485:2016

If applicable regulatory requirements allow for design and development controls to be excluded from the quality management system, this might be used to justify their absence. Alternative techniques to be handled in the quality management system can be found in these statutory requirements. It is the organization’s obligation to ensure that any omission of design and development controls is reflected in claims of conformance to ISO 13485:2016.

If any of the requirements in ISO 13485:2016 Clauses 6, 7, or 8 do not apply to the organization’s operations or the nature of the medical device for which the quality management system is used, the organization does not need to include that requirement in its quality management system. The organization records the justification as indicated in 4.2.2 for any clause that is considered to be inapplicable.

Who can apply and Get ISO 13485 Certification?

The requirements of ISO 13485:2016 apply to all companies, regardless of their size or kind, those who are in to the business of medical devices, either Manufacturing, services, supply etc. Wherever criteria are stated to apply to medical equipment, the rules also apply to the organization’s connected services. Also, those who have specific regulatory requirements.

What are documents required for ISO 13485 Certification?

As such there is no any limitation of documentation and record required to be maintained the in the organization to maintain the compliance for ISO 13485 Certification, which is all depends on the nature, size and activities of the organization. But Few are the documents, which are important in nature, the organization must maintain in the organization prior to apply for ISO 13485 Certification, such as

  • Quality Manual
  • Procedures
  • Record of applicable Medical Device Legal & regulatory requirements
  • Internal Audit
  • Management Review meeting
  • Monitoring and Measurement Record
  • Training Record
  • Corrective & preventive action records

What are the Steps of ISO 13485 Certification?

The steps of ISO 13485 Certification are given below

  • Implementation of ISO 13485 requirements
  • Apply for ISO 13485 Certification
  • Stage-1 Audit
  • Stage-2 Audit
  • Award of ISO 13485 Certification

What are benefits of ISO 13485 Certification to the organization?

The key benefits of ISO 13485 Certification are

  • Enhancement of Process performance and overall productivity of the organization
  • Improve the Compliance of Regulatory requirement of Medical Device
  • Enhancement of Customer Satisfaction
  • Enhancement of Credibility of the organization

Certification Process

  • Application
    2. Contract Review
    3. Initial Certification (Stage 1 & 2 Audit)
    4. Surveillance Audit
    5. Recertification


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