ISO 13485:2016 – Mandatory Documents List

The new ISO 13485 is revised on the structure of ISO 9001:2008, which concludes that the requirements for documentation are founded on the needs of the earlier version of ISO 9001, with the inclusion of additional documents related to the medical and surgical devices industry.

So, let’s have the list below which are the mandatory documents, but you should also be aware that the Medical device manufacturers’ or Suppliers’ Quality Management System documentation comprises not only the necessary documents listed here but also additional documents required by relevant regulatory requirements and from their specific processes needs.

ISO 13485:2016 Mandatory documents, procedures, and records

Here are the documents’ list required for conformance with ISO 13485:2016:

• Roles played by the organization under relevant regulatory requirements – clause 4.1.1
• Procedure & records for the validation of the implementation of computer software – clause 4.1.6
• Quality Management System Manual – clause 4.2.2
• Records of Medical device file – clause 4.2.3
• Documented Procedure for document and data control – clause 4.2.4
• Documented Procedure for record control – clause 4.2.5
• Documented and communicated Quality Policy – clause 5.3
• Quality objectives (SMART) – clause 5.4.1
• Documented Roles, Responsibilities & authorities – clause 5.5.1
• Documented Procedure and records of management review – clause 5.6.1
• Documented Procedure and records of training – clause 6.2
• Documented Requirements for infrastructure and records of maintenance activities – clause 6.3
• Documented Requirements for the work environment – clause 6.4.1
• Documented requirements for control of contaminated or potentially contaminated product – clause 6.4.2
• Documented Process for risk management in product realization – clause 7.1
• Documented Outputs of product realization and records of product meeting realization requirements – clause 7.1
• Results of the customer requirements review and  records of actions arising from it – clause 7.2.2
• Documented arrangements for communication with customers – clause 7.2.3
• Documented Procedure for design & development – clause 7.3.1

• Design & development planning documents – clause 7.3.2
• Design and development inputs records – clause 7.3.3
• Design and development outputs records – clause 7.3.4
• Design and development review records – clause 7.3.5
• Design verification plans, results, and conclusions records – clause 7.3.6
• Design validation plans, results, and conclusions records – clause 7.3.6
• Documented Procedure for transfer of design and development outputs to manufacturing – clause 7.3.8
• Documented Procedure and control of design and development changes records – clause 7.3.9
• Design and development file for each medical device type – clause 7.3.10
• Documented Procedure for purchasing – clause 7.4.1
• Establish Criteria and maintain evaluation and selection of suppliers records – clause 7.4.1
• Verification record of procured product – clause 7.4.3
• Medical device each batch traceability records – clause 7.5.1
• Documented Requirements for cleanliness of product – clause 7.5.2
• Documented Requirements for medical device installation & establish acceptance criteria for verification of installation – clause 7.5.3
• Medical device installation records & Records of verification of installation – clause 7.5.3
• Documented Procedure for servicing of the medical device and its records – clause 7.5.4
• Sterilization process records – clause 7.5.5
• Documented Procedure of production and service provision process validation and its records – clause 7.5.6
• Documented Procedure of validation of a process for sterilization & sterile barriers systems and its records – clause 7.5.7
• Documented Procedure for product identification – clause 7.5.8
• Documented Procedure for traceability – clause 7.5.9.1
• Traceability, name, the address of the shipping package consignee records- clause 7.5.9.2
• Records on changes on customer property and its reporting to the customer – clause 7.5.10
• Documented Procedure for preserving the conformity of product – clause 7.5.11
• Documented Procedure for monitoring & measuring – clause 7.6
• Calibration records – clause 7.6
• Documented Procedure for validation of the application of computer software and its records – clause 7.6
• Documented Procedure for customer feedback and its records – clause 8.2.1
• Documented Procedure for complaint handling and its records – clause 8.2.2
• Regulatory authorities reporting records – clause 8.2.3
• Documented Procedure for internal audit – clause 8.2.4
• Audits records with its results – clause 8.2.4
• Record of the identity of the individual authorizing the release of the product – clause 8.2.6
• Documented Procedure of control of the nonconforming product and its records – clause 8.3.1
• Rework records – clause 8.3.4
• Documented Procedure of data analysis and its records – clause 8.4
• Documented Procedure of corrective action and its records – clause 8.5.2
• Documented Procedure of preventive action and its records – clause 8.5.3

Note: Some documents will not be necessary if the company does not have applicable processes. Therefore under the pretext of exclusion such documents are not needed.

The benefit of simple documentation