As we can see the opposing competition in a global business market, building a distinguishing competitive advantage comes from having effective quality management systems. If your organization is aiming to acquire robust business performance, being certificated in any of the ISO standards conducted by global leaders and innovators in inspection, verification, testing and certification services would be a great investment. External quality auditors do conduct training and on-site auditing to assess the performance of the organization and generate business solution. In a wide array of international standards that includes ISO 9001 for Quality Management System, OHSAS 18001 for Health and Safety, SA 8000 for Social Accountability, ISO/TS 16949 for Automotive, ISO 14001 and IECQ-HSPM for Environment, ISO 22000, GMP, HACCP, Eurep Gap, BRC, Organic for Food Management, ISO 13485 for Medical and ISO 27001/20000 for Information Technology – brings the specific needs of the organization to improve operational performance.
Praxiom Research Group Limited has made their efforts to distinguish differences between the old and the 2008 version of ISO 9001 that include the essential elements of the overall business process like outsourced processes, documentation, management responsibility, competence, infrastructure, work environment, customer requirements, design and development planning and output, monitoring and measurement equipments, customer satisfaction, internal audit records, process monitoring and measurements and release of products. The Outsourced processes in old version are commonly controlled by a party which is external to the organization and it remains part of the quality management system. The new version stressed out the responsibility of the organization for ensuring that it meets all customer, regulatory, and statutory requirements in outsourced processes. There is the need to specify the extent of control whether or not process control will be mutual with the process supplier, and whether or not sufficient controls can be contractually launched using the process of purchasing.
Documentation, on the other hand, includes the records required by the standard like quality policy and objectives, quality manual and other documented procedures. However, gave the impression that all external documents needed have to be identified and controlled. In the new version, it includes the records that your organization needs to have in order to be able to plan, operate, and control its quality management system processes. A document may contain several procedures or vice versa. This shows that only relevant external quality documents need to be controlled, not all of them.
In the old version of ISO 9001:2000 clause 5, suggest appointment of any member of management to oversee the organization’s quality management system but did not explicitly say that the management representative must be a member of the organization’s own management, outsiders were sometimes appointed instead. In the new edition, the management representative must be a member of the organization’s own management. Outsiders may no longer perform this important function. Competence as significant factor in the organization, has deliberately explained in the old version too, however, it wasn’t very clear who they were talking about. The 2008 publication has revealed that all quality management system personnel must be competent since any task within the QMS may directly or indirectly affect the organization’s ability and willingness to meet product requirements.
Another essential consideration a management should check is the infrastructure. The term infrastructure includes buildings, workspaces, equipment, software, utilities, and support services like transportation and communications has been communicated in the previous publication. Except In the new version, has now added information systems to the previous list of support services. Both old and new standards expect the organization to provide the infrastructure (including information systems) to ensure that product requirements are being met. Also, Work environment in the organization as suggested by the late version, has to ensure that all product requirements are being met. However, it was not clear what they were specifically talking about. Now, it is defined in the newer edition that work environment refers to working conditions. These working conditions include physical and environmental conditions, as well as things like noise, temperature, humidity, lighting, and weather. All of these conditions must be properly managed.
In Clause 7.2.1 of the late regulation, suggested to identify customers’ specific delivery and post delivery requirements. But, some people weren’t sure about what post delivery meant, it wasn’t clarified. This pave way to the newer version to define post delivery requirements include things like warranty provisions, contractual obligations (such as maintenance), and supplementary services (such as recycling and final disposal). These are the considerations that must be identified explicitly. It is also expected to organizations to plan and perform product design and development review, verification, and validation activities. It becomes clear from the newer standard that product development review, verification and validation can be carried out and recorded part by part or in any combination as long as it makes sense for the product and the organization. In addition to that, design and development process generates information (outputs) that the organization’s purchasing, production, and service provision processes need to have. When the latest provision emerged, it explicitly stated that the design and development outputs could contain information that explains how products can be preserved during production and service provision.
Under the monitoring and measuring equipments which have been disseminated from the old publication, mentioned about controlling devices. Since the term device can refer to almost anything from a literary contrivance to a machine, its meaning wasn’t exactly clear. The 2008 version however, refers to the need to control, monitoring and measuring equipment. This shows confirmation that monitoring and measuring software is capable of doing the job and that configuration management and well established verification methods can be used to ensure the ongoing suitability of monitoring and measuring software.
Another issue that has been raised was about customer satisfaction. The old version suggested the need to monitor and measure customer satisfaction (perceptions). However, didn’t clearly stated how to conduct it. In 2008 publication of ISO 9001, it explains that there are many ways to monitor and measure customer satisfaction. Monitoring customer perception can include obtaining input from sources as customer satisfaction and opinion surveys, lost business analysis, compliments, warranty claims and dealer reports.
Moreover, clause 8.2.2 stated that there is the need to establish a procedure to define how internal audits should be planned, performed, reported, and recorded. However, the old standard did not explicitly state that audit records must actually be maintained. In the newer standard, it explicitly says that internal audit activities and results must be recorded and maintained. As for the process monitoring and measurement, the need to demonstrate the ability of the processes to achieve planned results has been communicated to the late publication. But, in the latest version of ISO 9001 clause 8, it considers the impact each process has on the overall effectiveness of QMS and on the ability to meet product requirements when generating decisions about what kinds of process monitoring and measurement methods should be used. According to Clause 8.2.4, product monitoring and measuring records should indicate who was responsible for authorizing the release of products. However, the old standard did not specify who must be on the receiving end. In the new version, it made apparent that products are released for delivery to customers. Records must now indicate who releases products for delivery to customers.
ISO 9001:2000, Quality Management Systems – Requirements, International Organization for Standardization, Geneva, 2000.
ISO 9000:2000, Quality Management Systems Auditor / Lead Auditor Training Course, SGS Philippines Inc., Course Manual Issued 2008.