Ensuring Compliance with ISO 9001 Standard

What is ISO 9001?

ISO 9001 is an international standard laying down the requirements for a Quality Management System (QMS). The ISO 9001 certification allows companies to demonstrate that they are dedicated to providing quality services and goods by setting up mechanisms aimed at eliminating non-conformities and facilitating continual improvement of internal processes.

The standard obligates companies to maintain documentation of their processes, whereby each process must have an “owner” or a person responsible for activities necessary for its successful execution.

The key parts of the QMS include CAPA (corrective and preventive actions), root cause analysis and control of documents and records. Also, running client satisfaction surveys on a regular basis is required to measure the efficiency of processes and to identify areas for improvement.

An ISO 9001-compliant company is subject to regular audits by an independent auditing body to ensure that all standard requirements are fulfilled.

CAPA

CAPA are improvements to internal processes that result in the elimination of the causes of non-conformities. A non-conformity can be a client complaint, a defective product or service, or an element of the QMS that fails to meet a certain set of requirements. Each non-conformity has to be documented and its root causes must be investigated. The analysis results in a report specifying the corrective and preventive actions that need to be taken in order to remove the deviation. The non-conformity report is further used as a basis for implementing necessary changes and is kept as a record for both internal and external audit purposes.

Documentation Requirements

Under ISO 9001, companies are also required to keep records of all their activities as objective evidence of compliance. In terms of the product or service sold to clients, it means that the whole production or service delivery process needs to be documented so that each step can be easily traced back to the person responsible or the owner. Detailed records help to identify non-conformity points in the processes and expedite improvement.

Client Satisfaction Survey

Assessing customer satisfaction is another key metric that has to be measured according to the ISO 9001 standard. The main objective is to evaluate how well a company meets client expectations, what the potential areas for improvement are and what aspects of cooperation are failing. The feedback obtained from clients can be used to demonstrate that the products or services satisfy their requirements and/or enhance the client’s level of satisfaction.

CAPA and Root Cause Analysis in XTRF

XTRF has been designed with the ISO 9001 standard in mind. The Feedback functionality available at the level of every single project in XTRF provides a record of identified non-conformities, both internal ones as well as client complaints. Using a single-page view, a system user can quickly and easily fill in all the necessary details of the deviation detected, specify the root cause of the issue, record the corrective and preventive actions taken as well as identify the people responsible for their implementation and the users or vendors behind the non-conformity.

Once the report is completed, it can be printed out and sent to the client. The report is accessible both at the level of the relevant project as well as in the Client Feedback section of the Reports module. It can be used for tracing CAPA implementation and presented to the auditing body upon request.

Control of documents and records in XTRF

An equally important XTRF functionality from the perspective of standard conformity is keeping records. Every piece of information entered in the system (e.g. vendor evaluation) and every process executed by a translation company as part of running their business is clearly documented. It is also easy to track each action performed by a PM, vendor or any other system user thanks to the History module. Historical information is available for all the main system areas, i.e. clients, vendors, quotes and projects. As an example, the screenshot below shows an overview of all actions performed as part of a project’s management.

Measuring Client Satisfaction in XTRF

The third functionality of the system, the Client Satisfaction Survey, facilitates the process of gathering client feedback on the quality of services or products delivered. The form can be sent to a client from the level of every closed project. It comes with a set of predefined questions that can be customized as per individual specification. It is a quick and easy tool for reviewing a client’s satisfaction with the services provided and for continuous improvement.

The above-mentioned data and records stored in XTRF can be readily used for audit purposes. Using a single system has a pronounced advantage of eliminating the unnecessary and cumbersome distribution of data over multiple devices or tools. The records maintained in the system can be used to demonstrate ISO 9001 compliance evidence to auditors — be it the CAPA report, process documentation and records or client satisfaction survey results.

Monika Kucharczyk
Implementation Specialist
Implementation Specialist at XTRF, formerly Linguistic Department Manager at Argos Multilingual, a major translation agency in Poland.
Monika was working in the localization industry for over 12 years.
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