Document Review FDIS ISO 9001:2008 against ISO 9001:1994
By Dan Nelson
The new ISO 9000:2008 standard is complete, the deadline is set for implementation, and conversion to the new standard is causing some degree of uneasiness in many companies. The process of becoming certified in the first place was difficult enough, but to change what has already been implemented already is daunting, to say the least. In order to ease some of your doubts, we have gone through the new standard and compared it to the old version. The following is a detailed and technical evaluation of new requirements. This will allow you to understand how your system will have to change to achieve compliance in the future.
If you have any more questions, we would be happy to answer them. If you need a little more help, we can upgrade your system to meet the new requirements for a nominal, fixed fee.
Section 4: Quality Management Systems
- 4.1 (General requirements) requires that the organization continually improve the effectiveness of the quality management system; 4.1 b) requires that the sequence and interaction of quality management system processes be determined; e) requires that the organization measure, monitor, and analyze quality management system processes; and f) requires the organization to implement action necessary to achieve planned results and continual improvement of those processes. 4.1 also requires that the organization control and identify within the quality management system any outsourced processes that affect product quality.
- 4.2.2 (Quality Manual) a) requires that the quality manual include not only the scope of the quality management system, but also details of and justification for any exclusions; c) requires the manual to include a description of the interaction between the processes of the quality management system.
Section 5: Management responsibility
- 5.1 (Management Commitment) requires that the evidence provided by top management to demonstrate commitment to the quality management system includes evidence of continually improving its effectiveness; a) requires that top management communicates to the organization the importance of meeting customer as well as statutory and regulatory requirements.
- 5.2 (Customer Focus) requires that top management ensure that customer requirements are determined and fulfilled with the aim of enhancing customer satisfaction.
- 5.3 (Quality Policy) b) requires that the quality policy include a commitment to comply with requirements and continually improve the effectiveness of the quality management system; c) requires that the quality policy provides a framework for establishing and reviewing quality objectives.
- 5.4.1 (Quality Objectives) requires that quality objectives br established at relevant functions and levels within the organization. (Quality objectives must include those needed to meet requirements for product.) Such objectives must be measurable and consistent with the quality policy.
- 5.5.2 (Management Representative) c) requires that the Management Representative ensure the promotion of awareness of customer requirements throughout the organization.
- 5.5.3 (Internal Communication) requires that top management ensures appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system.
- 5.6.2 (Review Input) requires that management review include current performance and improvement opportunities related to: a) results of audits, b) customer feedback, c) process performance and product conformance, d) status of preventive and corrective actions, e) follow-up actions from earlier management reviews, f) changes that could affect the quality system and g) recommendations for improvement.
- 5.6.3 (Review Output) requires that management review outputs include: a) improvement of the effectiveness of the quality management system and its processes, b) improvement of product related to customer requirements, and c) resource needs.
Section 6: Resource management
- 6.1(Provision of Resources) requires that the organization determine and provide the resources needed to a) implement and maintain the quality management system and continually improve its effectiveness, and b) enhance customer satisfaction by meeting customer requirements.
- 6.2.2 (Competence, Awareness and Training) c) requires that the effectiveness of any training provided is evaluated and d) requires assurance that personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives.
- 6.3 (Infrastructure) requires that the organization determine, provide, and maintain the infrastructure needed to achieve the conformity of product to requirements (including, for example, buildings, work space, process equipment, and supporting services).
- 6.4 (Work Environment) requires that the organization determine and manage the work environment needed to achieve conformity of product.
Section 7: Product Realization
- 7.2.1 (Identification of Customer Requirements) requires that the organization determine: a) requirements specified by the customer including delivery and post-delivery requirements, b) product requirements not specified by the customer but necessary for intended or specified use, c) statutory and regulatory requirements related to the product, and d) any additional requirements determined by the organization.
- 7.2.3 (Customer Communication) requires that the organization determine and implement effective arrangements for communicating with customers in relation to a) product information, b) inquiries, contracts, or order handling, including amendments, and c) customer feedback, including complaints.
- 7.4.1 (Purchasing Control) requires that the criteria for selection, evaluation, and re-evaluation of suppliers be established. Records of the results of evaluations and any necessary actions arising from the evaluation must be maintained.
Section 8: Measurement, Analysis and Improvement
- 8.1 (General) requires that the organization plan and implement the monitoring, measurement, analysis and improvement processes needed to: a) demonstrate conformity of the product, b) ensure conformity of the quality management system, and c) continually improve the effectiveness of the quality management system. This must include the determination of applicable methods, including statistical techniques, and the extent of their use.
- 8.2.1 (Customer Satisfaction) requires that, as one of the measurements of the performance of the quality management system, the organization must monitor information relating to customer perception as to whether the organization has fulfilled customer requirements. The methods for obtaining and using this information must be determined.
- 8.2.3 (Monitoring and Measurement of Process) requires that the organization apply suitable methods for monitoring, and where applicable, measuring of the quality management system processes. These methods must demonstrate the ability of the process to achieve planned results. When planned results are not achieved, correction and corrective action must be taken, as appropriate, to ensure conformity of the product.
- 8.4 (Analysis of Data) requires the organization to determine, collect, and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement can be made. This must include data generated as a result of monitoring and measurement and other relevant sources. This analysis of data must provide information relating to: a) customer satisfaction, b) conformance to product requirements, c) characteristics and trends of processes and products including preventive action, and d) suppliers.
- 8.5.1 (Continual Improvement) requires that the organization must continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions, and management review.