GLOSSARYGlobal
ISO 13485
The international quality management system standard for medical device organizations. Part 820 incorporates by reference its third edition, dated March 1, 2016.
Avoid This Mistake
Where a clause of ISO 13485 conflicts with the Federal Food, Drug, and Cosmetic Act, the Act controls. The Act's regulations control too.
Clause Groups
- ISO 13485 Clause 4General requirements for documenting and maintaining the quality management system: its processes, outsourced processes, software validation, and the documentation it needs, including the quality manual and records.
- ISO 13485 Clause 5What top management must do for the quality management system: commitment, customer and regulatory requirements, the quality policy and objectives, responsibilities and authorities, and management review.
- ISO 13485 Clause 6The resources the quality management system needs: providing resources, personnel competence, infrastructure, and the work environment.
- ISO 13485 Clause 7Planning and performing product realization, from planning and customer requirements through design and development, purchasing, and production and service provision, to controlling monitoring and measuring equipment.
- ISO 13485 Clause 8Measurement, analysis, and improvement: feedback, complaints, internal audits, nonconforming product, data analysis, and corrective and preventive action.