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ISO 9001 Procedures

ISO 9001 Procedures

Ready to customize, fully written procedures to be used as an example, a foundation and a template for you quality system. MS Word format for ease of customization.

There are 3 ways to purchase the procedures.

423- Document Control Procedure
Describe your method of approving, controlling and distributing documents. Our procedure gives a straightforward process for controlling quality system documents based on using Microsoft Word and Excel to organize and control the documents. add to cart

424-Control of Quality Records Procedure 0
Describe the process for controlling records generated by the quality system. Address what records are maintained, how, where, how long and how they are organized. Our procedure uses a table to list the records, responsibilities and retention requirements. add to cart
500- Management Responsibility Procedure 0
Describe Management Responsibilities for the Quality Management System including: identifying processes to include in the QMS and monitoring and measuring of those processes, determining quality goals and objectives, establishing the quality policy, communicating the quality policy and importance of meeting customer requirements, and holding Management Review. add to cart
622- Competence, Awareness and Training Procedure
Describe the process for ensuring that each employee is competent for the job they are performing. Include identifying what training is required, providing that training, following up on the effectiveness of the training and maintaining training records. Address different ways of training such as outside courses, on the job training and group training. add to cart
630-Infrastructure Procedure
Describe the process for determining, providing and maintaining the infrastructure needed to achieve conformity to product requirements. This includes buildings, workspace, utilities, process equipment and supporting services. We include preventive maintenance in this procedure. add to cart
710-Planning of Product Realization Procedure
Describe the planning of for all product realization processes. When you add a new process or product, how do you identify quality objectives, product requirements, process characteristics, and determine control of the process? Identify responsibility for deciding what work instructions are and records are required. add to cart
720-Customer Related Processes Procedure
Document the process used for communicating with customers and reviewing information from the customer. Include how you determine customer requirements, what information you need to gather from the customer, and how you get customer feedback. We include the customer communication process in this procedure. add to cart
730-Design and Development Procedure 0
Describe the process for controlling the design and development of product or services. We handle this procedure by outlining the responsibilities and the records that drive each segment of the design and development process. Clearly identify what inputs are required or suggested, what outputs may be, and so on. Specify who is responsible for the various steps in the process. The responsibilities may be different for different projects, if this is the case then identify them in the design plan. add to cart

740-Purchasing Procedure
Describe the process for controlling the purchasing process to ensure that purchased product conforms to requirements. Cover how you select suppliers; what are different ways your organization will use to approve them? What data will you track to monitor their performance? add to cart
750-Control of Production and Service Provision Procedure
Describe the process used to provide controlled conditions for product realization processes. Our procedure references the planning procedure and the design procedure as identifying the controls for the process and then goes on to state how product specifications, quality control measures, and approvals are identified. Also covered in this procedure is the need for validation of processes, and how product release criteria are documented and followed. add to cart

753-Identification and Traceability Procedure
Describe the process for identifying materials and product throughout production, service and delivery. You may use paperwork such as a traveler to identify product, or a label fixed to the product. Outline how your process works. Make it clear what identification is required. Do the same for the measuring and monitoring status and traceability. add to cart
754-Customer Property Procedure
Describe the process used to identify, verify, protect and safeguard customer property. You may be able to keep this procedure simple by using identification, traceability and handling processes that are the same as for your products and referring to those procedures. You will also want to include a process for reporting any loss or damage to the customer. add to cart

755-Preservation of Product Procedure
Describe the process for handling, packaging, storage and protection of materials, parts and products. This includes handling requirements such as ESD protection, Clean Rooms, and Temperature Controls. You may want to have the detail in the work instructions you write for process control and state: “…requirements are documented in the work instructions”. We take a similar approach for Packaging and Storage. Handling, Packaging and Storage are all covered in the Preservation of Product procedure. add to cart

760-Control of Monitoring and Measuring Devices Procedure
Describe the requirements and process for control of measuring and monitoring devices. Our procedure references a Calibration list that includes the required information. We detail the responsibilities and process for scheduling, conducting and recording calibration for the equipment. We also address action to be taken when equipment is found to be out of calibration. add to cart

821-Monitoring, Measuring and Analysis of Customer Satisfaction Procedure
Describe the process of collecting customer feedback with several example approaches and the process for analysis of information. Webuild the analysis into the Management Review process. add to cart

822-Internal Audits Procedure

Describe the process of scheduling, planning and conducting internal audits and the reporting and follow up steps for each audit. Our procedure assigns responsibilities to Management, an Audit Coordinator and Trained Internal Auditors. add to cart
824-Monitoring and Measuring of Product and Realization Processes Procedure
Describe the monitoring and measuring of product and the monitoring and measuring of product realization processes. We refer to the Planning of Product Realization Procedure and Design and Development procedure, because that is where we have built in the determination of measuring and monitoring requirements. We then describe a process for collecting and recording the information and reporting it to management in a form that can be analyzed during Management Review. add to cart
830-Control of Nonconforming Product Procedure 0
Describe the process used to ensure that product that does not conform to product requirements is identified and controlled to prevent unintended use or delivery. add to cart
840 - Statistical Techniques 0 add to cart
841 - Root Cause Analysis 0 add to cart

852-Corrective Action Procedure
Describe the process for eliminating the cause of nonconformances through the use of a corrective action system. Include the process for initiating a corrective action request (CAR). (Any employee should be able to initiate a CAR.) Follow the process for tracking, investigating, implementing corrective action, following up and closing corrective actions. We also include a step of reporting to Management Review.

853-Preventive Action Procedure
We use a separate procedure here instead of combining it with Corrective Action because we have found that auditors interpret the standard to mean that separate, individual procedures are required. Describe the process for eliminating the potential causes of nonconformances through the use of a preventive action system. However, the Corrective Action and Preventive Action Procedures are sold as a set. add to cart