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ISO 13485: 2016 Medical Devices

What is ISO 13485:2016 Medical Devices?

ISO 13485:2016 specifies requirements for a quality management system for organizations involved in one or more life cycle stages of medical devices. It is a quality management system for medical devices and includes requirements for regulatory purposes.

ISO 13485 Medical Devices

ISO 13485:2016 is structured similarly to ISO 9001:2008 and does not follow Annex SL.

  • ISO 13485 standard does not apply to pharmaceuticals.
  • ISO 31485:2016 does not include the requirements specific to other management systems such as environmental, occupational health and safety, or financial management.
  • Several jurisdictions have regulatory requirements for applying quality management systems by organizations with various roles in the supply chain for medical devices.
  • Consequently, ISO 13485 expects that the organization.
  • Identifies its role under the applicable regulatory requirement.
  • Identifies the regulatory requirements that apply to its activities under these roles.
  • Incorporates these applicable regulatory requirements within its quality management system.
  • It is emphasized that the quality management system requirements specified in ISO 13485 standard are complementary to technical requirements for products necessary to meet customer and applicable regulatory requirements for safety and performance.
  • Adopting a quality management system is an organization’s strategic decision.
  • It is not the intent of ISO 13485 to imply the need for uniformity in the structure of different quality management systems, documentation uniformity, or documentation alignment to this standard’s clause structure. Read More…

Overview – Regulatory

  • Multiple jurisdictions have regulatory requirements for the supply chain of medical devices.
  • Identify the organization’s role under the applicable regulatory requirements.
  • Identify the regulatory requirements that apply to its activities under these roles.
  • Incorporate these applicable regulatory requirements within the QMS.

Overview – as Appropriate

  • If your organization deems that section of the standard does not apply, there must be justifications for why it doesn’t apply.
  • I am only valid in sections 6, 7, and 8; clauses in sections 4 and 5 must be implemented.
  • If the organization is design responsible, it must have a method to report to regulatory authorities.

Overview – Risk

  • The term “risk” in ISO 13485 pertains to the safety or performance or the regulatory requirements of the medical device.
  • Not ISO 18001 / 45001 or OSHAS.

Overview – Process Approach

  • Understanding and meeting requirements
  • Consider processes in terms of the value they add
  • Look at the result of the process performance and effectiveness
  • Improve the process based on objective measurement.

What Are the Benefits of Certifying to ISO 13485?

  • Enhances the ability of the organization to meet customer and regulatory requirements.
  • It helps the organization to address product safety and effectiveness.
  • Allows the organization to obtain external recognition of conformity of the quality management system to accepted requirements (Certification).
  • Determine the needs and expectations of customers.
  • Determine the capability of the process for customers, as per basic processes for this standard.
  • Establish policies, objectives, and standardized systems for medical devices.
  • Necessary to motivate people to satisfy these needs.
  • Design, Implement and manage a Medical Devices organizational system of inter-related processes to implement the policy and attain the objectives.
  • Pursue the continual improvement of the system from an objective evaluation of its performance.

ISO 13485:2016 Section 4 “Quality Management Systems”

  • The “Plan” step in the deeming ” Plan-Do-Check-Act” cycle.
  • The QMS is planned, organized, documented, and assigned responsibilities and authorities.

Planning in these sections is about managing in QMS rather than planning Production.

  • Scope.
  • Roles.
  • Documentation.
  • Define the process and Subprocess.
  • Identify the risks and the criteria to determine when a risk requires action.
  • Determine the measure of the effectiveness of the QMS.
  • Ensure the availability of resources and Information.
  • Implement actions to achieve the results the QMS is supposed to produce.
  • Establish and maintain records to demonstrate conformance to the standard.
  • Control your supplies.
  • Procedures to document the validation of software used in the QMS.

ISO 13485:2016 Section 4 “Quality Management Systems” Medical Device File

  • A description of the device, including its intended use, labeling, and instructions for use.
  • Product specifications.
  • Specifications or procedures for manufacturing, packaging, storage, handling, and distribution.
  • Procedures for measuring and monitoring.
  • If appropriate, installation requirements and any servicing procedures.
  • Usually audited annually.

ISO 13485:2016 Section 4 “Quality Management systems” Control of Documents

  • How are documents reviewed and approved before use?
  • How are revised documents re-approved?
  • How the current revision status and changes are identified?
  • How is only the current document available for use, and how are ancient documents identified and prevented from use?
  • How are documents kept legible and readily identifiable?
  • How are documents stored to prevent deterioration or loss?
  • How are long-obsolete documents kept?

ISO 13485:2016 Section 4 “Quality Management systems” Control of Records

  • Procedure.
  • Identification.
  • Storage.
  • Security and integrity.
  • Retrieval.
  • Retention time and disposition – at least the life of the device but not less than 2 years.
  • Protect confidential health information contained in records.

ISO 13485 Certification: Recent Improvements That You Need to Know

Key improvements that the ISO 13485 Standard has undergone in its last revision are as follows:

  • More comprehensive emphasis on manufacturing infrastructure, specifically in inputting sterile equipment or devices for surgical purposes. In other words, the standard has many additional requirements for validating sterile items.
  • Need for increased accuracy in fulfilling regulatory requirements, including documentation.
  • Easier harmonization of validation requirements for quality assurance and other software applications used by medical device manufacturers.
  • It encompasses other organizations or processes that are indirectly related to the manufacturing of medical devices. They include raw materials suppliers, parts or subassemblies, sub-contractors, logistics collaborators, repairing and maintenance agencies, and distributors.
  • Additional regulations for designing and developing medical devices or equipment include robust planning, verification at each stage, and records maintenance of all development processes.
  • Inclusion of certain guidelines for post-delivery and marketing activities such as complaints handling, risk reporting, etc.

Benefits of ISO 13485

While ISO 13485 Certification is a stand-alone quality certification for the medical device sector, its scope and approach are similar to a general quality management certification, i.e., ISO 9001.

ISO 13485 goes through major and minor revisions after certain periods. Therefore, it is a requirement for organizations to update their management system to acknowledge the changes in the standard.

Implementation of ISO 13485

Each element of an ISO 13485 QMS: Quality Management System helps meet customer and organization requirements. Quality Management Systems should address an organization’s unique needs; however, the elements all systems have in common include:

  • Organization’s model devices quality policy and quality objectives.
  • Medical devices-based quality manual.
  • ISO 13485-based procedures, instructions, and records.
  • Data management, Risk management & Internal Processes.
  • Customer satisfaction from product quality.
  • Improvement opportunities.
  • Quality analysis for medical devices.

Why Choose Us?

TUV Austria Bureau of Inspection & Certification is an expert company for ISO Certification Services, which helps organizations in diverse industries achieve compliance with management standards. Furthermore, we have ISO specialists to guide an organization throughout the entire process of ISO Certification, From start to finish.

In Addition, to ISO ISO 13485 Audits, we also offer a range of complimentary services:


Who Can Use ISO 13485?

  • Raw Materials.
  • Components and subassemblies.
  • Medical Devices.
  • Sterilization Services.
  • Calibration Services.
  • Distribution Services.
  • Maintenance Services.

What is the Difference Between ISO 9001: 2015 and ISO 13485:2016?

  • Numbered Differently.
  • ISO 13485 requires procedures; there are no required procedures in ISO 9001.
  • ISO 9001 used the term “Documented Information,” ISO 13485 used “Documents” and “Records”.
  • ISO 13485 includes a medical device file requirement, and ISO 9001 does not.
  • ISO 9001 no longer has “preventive action,” and ISO 13485 still has preventive action.

What are the Similarities between ISO 13485:2016 and ISO 9001:2015?

  • Must consider risk.
  • Require a process approach.
  • Management Review.
  • There is no conflict between ISO 9001:2015 and ISO 13485:2016.

What are the key features of ISO 13485?

Key features 

  • Medical devices-based Documentation.
  • Process Definition / System Improvements.
  • Credibility & Risk Management.
  • Procedure Management.
  • Better Planning and Budgeting.
  • ISO 13485-based gaps learning.

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