ISO 9001 Required Procedures:

What do I need? What should they include?

Although the standard tells you that you must have six specific procedures, you are also expected to have quality processes in place to address the other requirements of the standard. These quality processes must be controlled, and one effective method of control is documenting the process. That means that most organizations will have other documented procedures in addition to the six mentioned in the standard.

The standard allows you flexibility in how you document the processes. You may not end up with a procedure to address each clause or section of the standard, but find that some clauses may overlap, and be covered in one procedure. You are able to design the system to suit the way your organization does business.

As an example of the procedures that can be used to make up an ISO 9001:2008 QMS, we have listed and described the procedures that our Lead Auditors and Consultants used the to build the system offered by The 9000 Store. You can use this as a guide to build your own system.

Save time and purchase any or all of these procedures written in Microsoft Word and ready to edit at The 9000 Store. Procedures cost from $11 to $38.50; when you compare that to the cost of having your employees develop the procedure from scratch you will see that it is a smart, cost effective way to start your procedures. Save even more by purchasing the whole set, along with a Quality Manual and Forms. More information on the Quality Manual and Procedures Package

Procedure Number/Name Required? Description and Purpose
423
Document Control
Yes 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.
424
Control of Quality Records
Yes 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.
500
Management Responsibility
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.
622
Competence, Awareness and Training
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.
630
Infrastructure
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.
710
Planning of Product Realization
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.
720
Customer Related Processes
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.
730
Design and Development
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.
740
Purchasing
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? What action will you take when there is a problem with a supplier? The ISO 9000 Store procedure gives examples of approaches to meet these requirements of the standard, and to meet the requirements for purchasing data.
750
Control of Production and Service Provision
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.
753
Identification and Traceability
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.
754
Customer Property
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.
755
Preservation of Product
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.
760
Control of Monitoring and Measuring Equipment
Describe the requirements and process for control of measuring and monitoring equipment. 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.
821
Monitoring, Measuring and Analysis of Customer Satisfaction
Describe the process of collecting customer feedback with several example approaches and the process for analysis of information. We build the analysis into the Management Review process.
822
Internal Audits
Yes 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.
824
Monitoring and Measuring of Product and Realization Processes
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.
830
Control of Nonconforming Product
Yes 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.
852
Corrective Action
Yes 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
Yes 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.

ISO 9001 All in One Package

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