ISO 9001: Clauses 4 through 6 Section 4: Quality Management System The company must define its processes and

and show the sequence and interaction of these processes. (This can be done using process mapping or process flow charts.) Determine the testing and documentation needed Documentation is less restrictive and the company can determine most of the documentation they require. Six procedures are required by the standard and about 19 records. You decide the additional documentation and records needed fro your organization.

Section 5: Management Responsibility Top management must provide evidence of its commitment to the development and improvement of the quality management system. Top management is responsible to ensure that customer needs and expectations are determined, converted into requirements, and fulfilled with the aim of achieving customer satisfaction. A quality policy must be established to meet the standard requirements and communicated to all employees. The quality objectives must be established, measurable and consistent with the quality policy and include a commitment to continual improvement. Responsibilities and authorities must be defined and communicated. A management representative must be appointed. The leadership must communicate about the quality management system processes and effectiveness. Management review meetings are required with specific inputs and outputs. Section 6: Resource Management The organization must determine basic competence for employees, hire to meet the competencies, provide training, and determine effectiveness of training. The organization must identify, provide and maintain the facilities it needs to achieve conformity of product including: workspace and associated facilities; equipment, hardware and software; and supporting services. The organization must identify and manage the work environment with consideration of the human and physical factors needed to achieve conformity of product. Section 7: Product Realization Planning The organization needs to plan the activities leading to your product.

Customer The organization must determine customer requirements including those product requirements not specified by the customer but necessary for intended product use and regulatory and legal requirements. You must determine and keep records of the review of contracts or orders. The organization must plan and implement customer communications processes including product information, inquiries, order handling/contracts and amendments and customer feedback. Design and Development There are very specific requirements and records required for design and development planning, inputs, outputs, review, verification, validation and changes. Purchasing The organization must determine criteria for evaluation, selection and reevaluation of suppliers. There are requirements for purchasing information and requirements for verification of purchased product. Production and Service Provision Determine the controls necessary to provide your product including any process validation, identification and traceability, customer property, and preservation of product. Control of measuring devices Determine measuring devices and calibrate according to the standard requirements. Section 8: Measurement, Analysis and Improvement Collect data to provide information on customer satisfaction and dissatisfaction and conformance to customer requirements. These methods shall confirm the continuing ability of each process to satisfy its intended purpose. Audit your quality management system according to the requirements. Monitor your processes to ensure they are operating effectively. At appropriate stages of the product realization process, the organization must measure and monitor the characteristics of the product to verify that requirements are met. Control your nonconforming product, the bad stuff. Collect and analyze data in order to provide a consistent product and improve the effectiveness of your quality management system. The organization must facilitate the continuous improvement of the quality management system through the use of the quality policies, objectives, audit

results, data analysis, corrective and preventive actions, and management review. Fix your problems. Establish corrective and preventive action processes to determine and fix problems and potential problems. Determine root cause, fix the problem and check that the fix was appropriate and successful.

ISO Implementation Keys to implementing a successful management system Start with a solid plan. Know what you already have in place. Know what you need to add in order to meet the standard. Know the best way to add the needed components. Involve employees who understand the ISO standard and the management system goals. The implementation process Teams determine new processes to meet the standard. A Steering Team, composed of key members of the point teams, will meet to coordinate efforts of the point teams. Point Teams work on designated point(s) of the ISO standard. The teams document the new process, and develop required records, forms, and work instructions. The teams train staff members on how the new process works. When the new processes are complete, Internal Audits and Management Review meetings begin. The system is used for 3 to 6 months before your registration audit. At least one cycle of internal audits and management reviews are completed. Now its time for registration!