How to Build the ISO 9001 Documentation System

How to Build the ISO 9001 Documentation System

Before covering how to build the ISO 9001 documentation system, some background on ISO 9001. ISO 9001 is the most widely applied quality management system standard in the world. It covers every part of the production cycle, from R&D and input materials through to the final product, so it has applications in almost every sector.

Sistem Patent Kalite, the certification and testing consultancy, describes the build process below.

• Preparation of the strategic management documents
• Review of the document control procedure, analysis of changes, and conversion into documents
• Review of the nonconformity and corrective action procedure, analysis of changes, and conversion into documents
• Review of the internal audit procedure, analysis of changes, and conversion into documents
• Record-keeping for the procedures that cover the analysis of opportunities and threats
• Identification of the record fields, forms, and similar items tied to the activities that ISO 9001:2015 requires, and closing of gaps
• Review of the monitoring and measurement, operations, and traceability instructions across the stages, and closing of gaps
• Identification of the external legal and regulatory requirements and the monitoring records that support them
• Defining the retention and storage rules for records and putting them into operation
• Review of the archive area and of the records tied to activities
• Review or creation of the records tied to the delegation network
• Defining supplier performance measurement requirements and creating the records of those measurements
• Creation of the records defined in the procedures and processes across every function
• For measurement equipment requiring calibration, records of the calibration activity and its results
• Analysis of customer satisfaction results and implementation of the corrective and preventive actions that follow
• Employee surveys and collection of staff requests and suggestions
• Definition and operation of the methods for evaluating training activities
• Definition of the employee performance measurement requirements and the activities that produce the required information
• Data evaluation and statistical analysis, and the corrective and preventive actions that follow from the results
• Controls on nonconforming service along the defined methods
• Planning and implementation of effective nonconformity and corrective action for the other processes
• Review of the effectiveness of every corrective action taken

Sistem Patent Kalite supports ISO 9001 projects across Turkey. The offices we operate in Istanbul, Izmir, and Ankara are the primary sites for the certification and testing consultancy, with further offices in Konya, Kayseri, Eskisehir, Bursa, Adana, and Antalya. Clients can also reach us online to start an ISO 9001 project.