Critical Difference between ISO 9001 And ISO 13485

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What Is ISO 13485?

An ISO standard that has been specifically made for medical service industries’ Quality Management System (QMS) and is known worldwide as ISO 13485. This has successfully provided the rock solid foundation to all the manufacturers of Medical Device industries for reliability, trust and unbreakable commitment to human safety and the quality of medical devices being manufactured.

What ISO 9001 Implies?

ISO 9001 is one of the international standards that has vividly specified the guidelines to establish a Quality Management System (QMS).

ISO 13485 & ISO 9001 in Contrast

There are few areas in which ISO 13485 and ISO 9001 get differentiated from one another. These areas are:

The type of Product or Services

Stringent controls are in place for the specification of the products and the raw materials used. This is the point where ISO 13485 differs from ISO 9001. The specific clauses of ISO 13485 where it overshadows ISO 9001 are in terminology of medical device industry, Training of staff members, work environment protection by prevention and control of contamination, risk management control, Advisory notes communication, and performance evaluation as per design and product validation, monitoring and recording of product performance and non-conforming product.

Regulatory Requirements

For medical industries, the regulatory requirements are stricter as compared to generic industries. ISO 9001 does not specify requirements for the medical industry but ISO 13485 standard requirements to meet the regulatory requirement for the medical devices manufacturers ,distributors and importers.

Documentation and its effective control

A medical device manufacturing industry must have an effective document control system which should have the documents including General description, Specification of the product in detail, Manufacturing processes, Installation processes and servicing processes. Quality manual should be there with the QMS (Quality Management System).

Job responsibilities must be defined and communicated. All maintenance activities that are carried out daily, weekly, monthly and annually documented. Health and cleanliness of the workers must be specified, records should be maintained of every product’s batch sterilization, product conformity in medical master records, close communication channel with the customers must be established. All complaints are recorded and resolution must be timely having corrective and preventive actions specified for each complaint. Thorough traceability of medical device product must be ensured by documents and records.

Customer Satisfaction

ISO 9001 revolves around customer satisfaction no matter which type of the business or products or services you offer to the customers in the market.

Continual Improvement Cycle

ISO 9001 owns a continual improvement cycle and its effective implementation while ISO 13485 requirements indicate to maintain the effectiveness of continuous improvement in the management system. The difference in approach between the two ISO standards will definitely make the organizational structure slightly changed from each other.

Scope of both ISO standards

ISO 9001 is a way more different than ISO 13485 as ISO 9001 defines the quality requirement for generic industries while ISO 13485 specifies the requirements for the medical device industries. Being a medical devices manufacturing industry, it is not only important to accomplish customers’ satisfaction but it is equally important to meet legal requirements and quality requirements are more stressed upon in ISO 13485 specifically in medical device files, history recording, customer complaint handling, reporting, product compliance, waste handling and regulating quality control.


The primary difference between ISO 9001 and ISO 13485 is their primary factor to focus on. ISO 9001 is customer oriented and to make every effort to minimize or eliminate the risks that can negatively effect on customer satisfaction. The focus of ISO 13485 is majorly on laws and regulations that are enforced on medical devices industries ensuring human safety.

Product Realization

ISO 13485 puts stress on the design and development of new and existing products within product realization. ISO 9001 puts a strong emphasis on operational cycles through which final product gets developed aiming to develop peerless, unmatched and flawless quality product that pleases and satisfies the customers and customers’ requirements making it easy to achieve customers’ retention. Hence making the organizational goals and targets accomplishment pathway slight different to achieve.

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Few Key Additional Requirements of ISO 13485

Following are the key additional requirements of ISO 13485:

  • Prevention of Contaminants: ISO 13485 magnifies the importance of proper cleanliness during the machinery assembling process and packaging of the final product. The overview of product cleanliness includes a few important factors which are Listing of all the devices that should be cleaned before and after use, Listing of all the devices that cannot be cleaned before use, list of devices that have to be cleaned during their usage and listing of all the elements that must be eliminated during the manufacturing of final product or that can hurt the quality of the final product that would be used by the end-consumers.
  • Training Supervision of Management, peers and shop floor level: Although training has been made an integral part of all ISO standards but as far as ISO 13485 is concerned it out more emphasis on training so that safe handling of medical devices can be ensured at all levels.
  • Multiple documentation control: Like any other ISO standard, ISO 13485 also put stress on proper documentation control even for a batch to batch sterilization records are mandatory to maintain in order to meet the requirements of ISO 13485.
  • Continued sustainability of effective QMS striving to achieve customers’ satisfaction at all levels
  • Traceability of the Materials that are Purchased
  • Labeling and Packaging of the Final Product
  • Human Health, Workplace Cleanliness and Products’ Batch Sterilization

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