Certification key areas

9001 certification key areas

The goal of 9001 is to achieve continuous improvement and customer satisfaction. The requirements are divided between seven areas.

Context of the organization

  • Identification of all factors which may affect the quality of provided services
  • Identification of all relevant stakeholders
  • Understanding about customers and their needs


  • Establishment of the quality management system
  • Establishment of relevant quality policies and objectives
  • Communication of all all policies to relevant personnel which are responsible for the quality of products, processes and services
  • Yearly management reviews


  • Documentation and classification all relevant risks
  • Plan for corrective and preventive actions
  • Plan for measures to increase positive development


  • Infrastructure
  • Working environments
  • Human Resource management


  • Quality objectives related to products and services
  • Process guides, documentation and resources for personnel
  • Quality confirmation through monitoring, inspecting and testing
  • Rules for record storing

Performance evaluation

  • Demonstration of compliance with the ISO 9001 standard
  • Verification that all aspects of the quality management system are covered
  • Continuous improvement of quality management across the organization


  • Improvement of services and products
  • Customer need match-up and improvement
  • Identification of processes which do not achieve their goals and their updates

13485 certification key areas

The goal of 13485 is to ensure the commitment for the quality of medical devices.


  • Importance of process approach
  • Need for including all relevant regulatory requirements
  • Processes for continual improvement

Normative reference

  • Reference to ISO 9000:2015

Terms and definitions

  • Definitions used in the standard

General requirements

  • Quality manual
  • Procedures
  • Forms & records
  • Control of documents
  • Control of forms

Management responsibility

  • Management responsibility
  • Quality policy & objectives
  • Customer focus & customer satisfaction
  • Management review

Resource management

  • Personnel & training
  • Resource management

Product realization

  • Production
  • Planning
  • Customer related processes
  • Customer feedback
  • Design
  • Purchasing
  • Process control
  • Identification and traceability
  • Customer property

Measurement, analysis and improvement

  • Customer satisfaction
  • Internal audits
  • Control of non-conforming product
  • Corrective and preventive actions