Process for risk management in product realization (clause 7.1).Arrangements for control of contaminated or potentially contaminated products (clause 6.4.2).
Requirements for work environment (clause 6.4.1).Requirements for infrastructure and maintenance activities (clause 6.3).Procedure and records for management review (clause 5.6.1).Responsibilities and authorities (clause 5.5.1).Procedure for record control (clause 4.2.5).Procedure for document control (clause 4.2.4).Procedure and records for the validation of the application of computer software (clause 4.1.6).Roles undertaken by the organization under applicable regulatory requirements (clause 4.1.1).(Please note that some of the documents will not be mandatory if the company does not perform relevant processes related to ISO 13485 documentation requirements): Here are the required ISO 13485 documents, categorized according to the clauses of the standard.
