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ISO 13485 Documentation Requirements

ISO 13485:2016 for medical device quality management requires extensive documentation as evidence of the safety of the products and effectiveness of their quality processes. These documents comply with both the standard and all applicable regulatory requirements.

Aside from the documents you will need for your individual jurisdiction, ISO requires you to document elements like:

Quality policy and objectives

Quality manual

Computer software validation procedure

Quality procedures and records

Medical device file

  1. Quality Manual
  2. Quality Policy
  3. Quality Objectives
  4. Quality Records
  5. Six Procedures
    1. Control of Documents (4.2.4)
    2. Control of Records (4.2.5)
    3. Internal Audit (8.2.2)
    4. Control of Nonconforming Product (8.3)
    5. Corrective Action (8.5.2)
    6. Preventive Action (8.5.3)

How Much Documentation Do You Need?

Much depends on the size and complexity of your organization. You should have enough procedures to cover each section of the standard that applies to your business. The following ISO 13485 clauses require documented procedures to define and control the requirements and practices:

  • 7.3.1 Design & Development-to ensure a controlled, consistent design and development process
  • 7.4.1 Purchasing Process–to ensure the purchased product conforms to specified purchase requirements
  • Particular Requirements for Sterile Medical Devices-to ensure validation of sterilization processes.
  • Identification-to ensure that devices returned are identified and distinguished from conforming product
  • Traceability-to define the extent of product traceability and the records that must be kept
  • 7.5.5 Preservation of Product-to ensure the conformity of product during internal processing and delivery to the intended destination
  • 7.6 Control of Monitoring and Measuring Devices-to ensure that monitoring and measurement can be and is carried out consistently with the monitoring and measurement requirements
  • 8.2.1 Feedback-to ensure an adequate system to provide early warning of quality problems and for input into the CAR/PAR processes
  • 8.4 Analysis of Data-to ensure that data demonstrating the suitability and effectiveness of the quality management system is determined, collected and analyzed and to evaluate any improvements to QMS effectiveness
  • 8.5.1 Improvement, General-to address the issuance and implementation of advisory notices and notification to regulatory authorities, as required. Such procedures must be capable of implementation at any time.

Also, some clauses require documented procedures for specific conditions as well as requirements that require documentation, but not necessarily a ‘documented procedure’. These are:

  • 6.3 Infrastructure-When maintenance activities, or their lack, may affect product quality, documented requirement for such activities will be defined
  • 6.4 Work Environment-
    • When contact between personnel and the product or work environment may adversely affect product quality documented requirements for health, cleanliness, and clothing of personnel will be defined
    • If work environment conditions may adversely affect product quality
      • documented requirements for work environment conditions – and –
      • documented procedures/work instructions to monitor and control work environment conditions
    • Document any special arrangements to control contaminated or potentially contaminated product so that other product, personnel or the work environment are not contaminated.
  • 7.1 Planning of Product Realization-Requirements for risk management throughout product realization will be documented.
  • 7.2.2 Review of Requirements Related to the Product-Customer product requirements are defined and documented
  • Control of Production & Service Provision-The documented procedures, requirements, work instructions and reference materials required to complete production and service activities in a controlled manner must be identified.
  • Cleanliness of Product and Contamination Control-Documented requirements for cleanliness of product, under the conditions defined in the standard. Please review for applicability.
  • Installation Activities-Compare your product requirements to standard for applicability. For example, the application of a bandage would not be considered installation; however, if its application must be effected in a particular fashion in order to work properly, documented requirements may be needed.
  • Validation of processes for Production and Service Provision-Is computer software used that might affect product conformance to specified requirements? If so, documented procedures for software validation are required


How do I set up my Documentation?

If you look at this pyramid, the lower the items are – the more specific they are to your business. The higher levels (QM, Proc) are dictated by the standard.

  • The Quality Manual describes the quality management system
  • Procedure describe a process (Purchasing)
  • Work instructions describe an activity within a process (Creating a Purchase Order)
  • Forms record the actions of an activity or process
    • NOTE: A record is a completed form/Table/etc. that prove the action took place.

Do I need Procedures and Flow Diagrams?


No. Written procedures are more informative and much easier to edit than flows. Sometimes editing flowcharts can be tedious – you’re often better off creating them yourself.

You are required to have a diagram of your overall processes, and we recommend using software like Lucidchart to create them.


Our All-in-One Certification Package is a proven, efficient system. It gives you all you need to prepare for registration – in one simple to use package.

Customer Review:

"I have just passed my ISO Audit with zero non-conformances for the second year in a row using your ISO products to write my entire QMS. Thank you for producing documents of this quality"

Bettye Patrick

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