ISO 9001 Procedures
» A proven, efficient system with all the necessary elements in place.
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Testimonials
"We found the documents very useful considering we were starting from nothing. We have the tools and knowledge now to go back and develop these procedures and forms to better suit our business. "
-Hydraulic Power Technology Texas.
Features
Our ISO 9001 procedures are designed for you to use with your ISO 9001 Quality Management System, as required by the ISO 9001 Standard. Our easy-to-customize procedures relate directly to a section of the standard with the following features:
- All documents are written in MS Word or Excel format for ease of editing
- Blue text highlights areas that require your input
- Procedures list any required forms
- Directly referenced by our ISO 9001 Quality Manual
- Valuable in your ISO 9000 training efforts
- Meets your need to attain ISO 9000 certification
Contents
The procedures are available:
- As a complete QMS in our Quality Manual, Procedures & Forms Package
- As a complete set of procedures only (complete list below)
- Individually (a la carte) WITH included forms (complete list below)
- Includes Technical Support
- Quick email support
- Professional phone support
- 24/7 Online Support - our website provides free and helpful information 24/7
You do the project yourself, but that doesn't mean you do it alone.
Although our products are easy to use, we still offer World Class Support for your project - for FREE!
Our products are so user friendly - we rarely hear from people!
Our products have been proven over 10 years - longer than anyone else - and have helped companies around the world become certified. We don't flood our packages with unnecessary forms and other "fluff" to make them look complete. Ours ARE complete, and get the job done.
But if you need help, we support our products throughout your project!
Experienced ISO professionals are available to answer questions and help you develop and implement your QMS.
How many (and what) procedures do I need? ISO 9001:2008 Documentation Requirements
- Quality Manual
- Quality Policy
- Quality Objectives
- Quality Records
- Six Procedures
- Control of Documents (4.2.3)
- Control of Records (4.2.4)
- Internal Audit (8.2.2)
- Control of Nonconforming Product (8.3)
- Corrective Action (8.5.2)
- Preventive Action (8.5.3)
How Much Documentation Do You Need For Your ISO 9000 process?
Much depends on the size and complexity of your organization. You should have enough procedures to cover each section of the standard that applies to your business.
The ISO/IAF Guidelines says: "The auditee/auditor considers that each clause or sub-clause of ISO 9001 must be defined as a separate process". Do you purchase anything that could have an impact on meeting the customers' requirements? Then you'll need a Purchasing Procedure to describe section 7.4 - yet that isn't "required".
There are actually 20 different related (ISO 9000) processes called out in the standard. The 9000 Store has designed clearly written procedures to describe each section of the standard. That is why our QMS process is better than the rest - we cover the entire standard. Don't think you can only provide a few procedures and call it an ISO 9000 QMS. The result can be a very poor ISO 9000 process. Is it worth the savings?
Compare Products
| Procedures/Forms Package | Price |
|---|---|
| Complete Procedure Package (The 22 individual procedures listed below are included, forms sold separately) | Add to Cart |
| Complete Forms Package (38) | Add to Cart |
| Flow charts (27) | Add to Cart |
| Complete QMS Includes Quality Manual, All Procedures, All Forms, All Flow Charts & Flow Chart Software | Add to Cart |
Procedures are also available individually:
We give you more! These individual Procedures Packs also include any forms referenced in the procedures. To see which forms are included with specific procedures, please view the procedures-forms matrix.
| Procedure | Forms | Price |
|---|---|---|
P-423 Document Control - 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. Includes forms: F-423-001 Master Document List F-423-002 Software Inventory Spreadsheet F-423-003 Document Change Request Form F-423-004 Document Revision Checklist |
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P-424 Control of Quality Records - 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. Includes form: F-424-001 Quality Records Table |
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P-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.Includes forms:
F-500-02 Key Process Master List F-824-001 Product realization Monitoring, Measuring and Analysis Table A-500-001 Quality Policy A-550-001 Organization Chart F560-001 Management Review Agenda F560-002 Management Review Checklist |
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P-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. Includes forms: F-622-001 Action Plan F-622-002 Group Training Record F-622-003 Job Description Form |
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P-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. Includes form: F-630-001 Equipment Problem Report |
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P-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.00-005 Clause 7 Inclusion-Exclusion Worksheet
F-710-001 Quality Planning Table |
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P-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. Includes form: F-720-001 Client Assessment Memo |
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P-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. Includes form: F-730-001 Design Plan F-730-002 Design Review Record F-730-003 Design Change F-824-001 Product realization Monitoring, Measuring and Analysis Table |
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P-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. Includes forms: F-740-001 Supplier Quality Reports F-740-002 Supplier Corrective Action Request F-740-003 Approved Supplier List F-824-001 Product Realization Monitoring, Measuring and Analysis Table |
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P-750 Control of Production & Service - 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. Includes forms: F-750-001 Process Routing - Summary F-750-002 Process Routing - Detail F-752-001 Process Validation Worksheet |
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P-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. Includes form: F-753-001 Traceability Serial Number Log |
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P-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. Includes form: F-754-001 Customer Property Control Log |
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P-755 Preservation of Product - View details & list of included forms 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. Includes form: F-755-001 Storage Inspection Report |
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P-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. Includes form: F-760-001 Calibration List |
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P-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. Includes form: F-821-001 Customer Satisfaction Survey |
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P-822
Internal Audits - 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. Includes forms: F-822-001 Internal Audit Plan F-822-002 Internal Audit Report F-822-003 Applicable Procedures by Work Area F-822-004 Audit Checklist |
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P-830 Control of Nonconforming Product - 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. Includes forms: F-830-001 Rejected Material/Disposition Report - NCR F-740-002 Supplier Corrective Action Request F-852-001 Corrective Action Request |
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P-824 Monitoring & Measurement of Product & Realization - 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. Includes form: F-824-001 Product Realization Monitoring, Measuring and Analysis Table |
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P-840 Statistical Techniques - Statistical Techniques Online Training Both the Statistical Techniques Procedure and the Root Cause Analysis Procedure are used to address the requirements for 8.4. This procedure is used to analyze data and make improvements. The Root Cause Analysis Procedure is used to look into nonconformances. |
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P-841 Root Cause Analysis - Both the Statistical Techniques Procedure and the Root Cause Analysis Procedure are used to address the requirements for 8.4. This procedure is used to analyze data and make improvements. The Root Cause Analysis Procedure is used to look into nonconformances. Includes form: F-841-001 Root Cause Analysis and Action Plan |
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P-852 Corrective Action - 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. Includes form: F-852-001 Corrective/Preventive Action Reques |
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P-853 Preventive Action - View details & list of included forms 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. Includes form: F-853-001 Corrective/Preventive Action Request |
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| VALUE | $605 | |
| Complete QMS Package | Price | |
| If you need all of the procedures, purchase the Quality Manual and Procedures Package | Add to Cart |