A: Documentation and document review
Collect and review all applicable standards and guidelines
This service includes identifying and collecting all standard requirements that the manufacturing unit is required to comply with, including national (ISIRI), international (ISO, IEC) and regional standards. The company's internal guidelines are also collected.
Reviewing quality system documentation and implementation methods
In this service, quality management system documentation, including standard operating procedures (SOPs), forms, work instructions, and records, are reviewed to ensure their adequacy to cover the requirements of the standards.
Assessing the adequacy and up-to-dateness of documentation
This service includes assessing whether existing documentation is sufficiently comprehensive and clear, and whether it is up-to-date with the latest standards and process changes. Any gaps or out-of-dateness are identified.
B: Assessing the adequacy and up-to-dateness of documentation
Observe production and quality control processes
This service involves direct and objective observation of production, laboratory and quality control processes to compare actual performance with that defined in documentation. This allows for the identification of operational deviations from written procedures.
Interviewing personnel about awareness and implementation of guidelines
In this service, various personnel, from operators to middle managers, are interviewed to assess their level of awareness and understanding of the relevant guidelines and how they are implemented in practice.
Sampling and testing to assess product compliance
This service includes sampling the finished product or raw materials and testing them in accordance with standard-compliant methods to ensure that the product's characteristics comply with the declared technical specifications.