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Medical Devices Manufacture           ISO13485

ISO 13485 is based on the ISO 9001 format with additional requirements relating

to design, special processes, environmental control, traceability, documentation records,

and regulatory actions.


This is an outcome of the primary objective for the creation of ISO 13485, which was to

facilitate standardized medical device regulatory requirements for quality management systems.


As a result, it includes some particular requirements for medical devices but excludes some of the requirements of ISO 9001 that are not appropriate in a regulated environment.


Registration against the standard from an appropriately approved body is now a direct requirement for some markets (e.g., Australia and Taiwan), an indirect requirement for others (e.g., Europe), or it can form the basis of good manufacturing practice (GMP) compliance in the United States.


The standard is also an important part of maintaining the quality of the supply chain.


ISO 13485: 2012 is based upon ISO 9001: 2008, but the exacting requirements for medical applications require the quality standard to be enhanced to include concerns of the industry. The main differences are in 5 key areas:


  • ISO 13485 sees the promotion and awareness of regulatory requirements as a management responsibility.

  • ISO 13485 expects controls in the work environment to ensure product safety.

  • ISO 13485 expects a focus on risk management activities and design transfer activities during product development.

  • ISO 13485 contains specific requirements for inspection and traceability for implantable devices and specific requirements for documentation and validation of processes for sterile medical devices.

  • ISO 13485 states that the company needs to maintain effective processes, namely the processes specific to the safe design, manufacture, and distribution of medical devices.

  • ISO 13485 has specific requirements for verification of the effectiveness of corrective and preventive actions.


Product Specific

The medical device industry has rigorous and stringent concerns due to its application. These are incorporated in the ISO 13485: 2012 standard:


  • Medical device terminology

  • Training and supervision of staff working in special conditions,

  • Prevention of contamination

  • Risk management has to be in place for all stages of product realization

  • Communication of advisory notes

  • Clinical evaluation, in design and development validation,

  • Cleanliness of products and contamination control

  • Status of product with respect to monitoring and measurement

  • Confidential health information

  • Regulatory statistical technique requirements,

  • NC Product dispositioning authorization

  • Concessions must meet regulatory requirements,


Regulatory requirements:

The intent of the standard is to facilitate the harmonization of quality management system regulations with other management standards on a global basis so a key element of this standard is to develop safe products that have an effective performance.


Reference to regulatory requirements is mentioned throughout ISO13485:2012 and a register of current regulations must be maintained, both national and international, to make sure that these regulations are up to date and changes are communicated to all staff.



Prescriptive requirements for documents, procedures and records are apparent and far more onerous These requirements include:


  • Product file for each type/model of medical device which states:

    • Product specification

    • QMS requirements

  • manufacturing, installation and servicing processes

  • Quality manual – this must show the structure of documentation within the QMS

  • Retention of obsolete controlled documents and records for lifetime of product
    (min. 2 years or as specified by regulatory requirements)

  • Responsibilities and authorities defined, documented and communicated

  • Maintenance activities documented if they affect product quality

  • Health, cleanliness, clothing and contamination work instructions

  • Purchased product configurations (traceability of purchased product to documents and records)

  • Installation activity verification

  • Servicing activities validations

  • Validation of computer software impact

  • Validation of sterilization

  • Product identification including returns

  • Active and implantable medical device traceability

  • Records traceable to product and personnel performing inspection

  • Preserving conformity of product including constituent parts with a limited shelf life

  • Preserving product requiring special storage conditions

  • Control of monitoring and measuring devices

  • Feedback system of early warning of quality problems

  • Analysis of medical-related data

  • Advisory notes issue and implementation

  • Notification of adverse events to regulatory authorities


Customer Satisfaction and Perception

ISO 9001: 2008 requires customer satisfaction and customer perceptions to be monitored and measured however in the regulatory environment of medical devices, customer perception is felt to be too subjective. ISO13485:2912 requirement is therefore to monitor information to demonstrate customer requirements have been met or exceeded.


Continual Improvement

Continual improvement of the QMS is not a requirement of ISO 13485. The requirement is to maintain the continued suitability and effectiveness of the QMS because, in the field of medical products, devices, and components, regulatory requirements and customer expectations are demanding.


Throughout the world, manufacturers and their suppliers are expected to comply with the highest standards and regulations and although being registered does not fulfill the requirements of the various industry regulators, such as the U.S. Food and Drug Administration (FDA), ISO 13485 is now commonly used as the basis of regulatory requirements.


The standard is an essential consideration not only for exporters but for the local market, global suppliers, and subcontractors to prove that their products are of the highest quality. The standard is intended to be used by an organization that needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.


Advice from Q-Share for any organization is strongly recommended before considering the implementation of the Medical Device Manufactures quality system.

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