The International Standards Organization (ISO) is currently reviewing ISO 9001, its standard for quality management systems. A draft version of the new standard is already available; publication of the final version is scheduled for September 2015. The new draft is designed to increase the attractiveness of the standard and its applicability in the service industry. Companies are advised to upgrade to the new standard from autumn 2015 in periodic recertification audits. The experts at TÜV SÜD explain the changes that will result and how to deal with them.
The review of ISO 9001 follows the “high level structure” designed to serve as a uniform basis for all standards and thus improve compatibility with other management systems. While this will initially involve adjustments by many stakeholders in the certification landscape, it will prove to have significant benefits over the medium term. Key new passages and focal areas of the revised ISO 9001 involve application of the process approach, risk-based strategy, management responsibility and flexibility of documentation.
The draft revision of the standard supports implementation of a process-focused management approach for the development, implementation and improvement of the effectiveness of quality management systems (QMS). The revised ISO 9001 requires the input and output of every process to be defined and contains clearer specifications for measurement of performance parameters and definition of roles and responsibilities. “Companies must address the extent to which process orientation is embedded in their existing management system in practice”, explains Ulrich Wegner, head of the Certification Body at TÜV SÜD Management Service GmbH. “Which processes require assessment, which have already been evaluated and which offer potential for more systematic definition? These issues are designed to encourage companies to address the topic of process focus and examine whether they have useful and effective monitoring systems in place.”
A further change involves the topic of risk analysis. The new risk-based approach in the standard requires risks in corporate processes to be identified and appropriate action to be taken, as well as identifying and taking up opportunities – a new addition. This process will enhance the benefits of certification for the users. Under the new procedure, companies will have to identify the factors in each process that could have a negative impact on the desired result, and develop counter-measures for them, taking criteria such as shortage of resources, process instability and other influencing factors into consideration. Ideally, then, companies should therefore analyse their processes to evaluate the extent to which risk factors have previously been addressed.
A further objective of the standard revision is to enhance flexibility for the users. This also applies to process documentation. Companies can select the depth of detail they wish to use in their written documentation, which may depend on factors such as the complexity of their processes or the expertise of their staff. The standard operating procedures formerly demanded by the standard will no longer be necessary. “The procedure now offers the opportunity to avoid creating additional or even unnecessary documents” explains Ulrich Wegner. “Documentation can be aligned far more closely to the company’s individual needs and risks. However, companies with existing systems in place should carefully consider exactly which areas are suitable for a reduction of documentation.”
The revised ISO 9001 will also increase management responsibility; management teams are required to expand their responsibility in some areas and provide clearer support of the QMS. The duties previously performed by quality management officers (QMO) will now be transferred to top-level corporate management and will include integration of the QMS into the company’s business processes and promoting awareness of the process-based approach among staff. In addition, the management team must ensure that the QMS achieves its defined objectives and provide support for staff with relevant tasks.
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