Our ISO 9001:2015 procedures are designed for you to use with your ISO 9001:2015 Quality Management System, as required by the ISO 9001:2015 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 9001:2015 Quality Manual
Valuable in your ISO 9001:2015 training efforts
Meets your need to attain ISO 9001:2015 Certification
We give you more for your ISO 9001 process! The individual ISO 9001 Procedures Pack also includes any forms and flowcharts referenced in the procedures. To see which forms are included with specific quality control procedures, please view the procedures-forms matrix
Procedure ISO 9001:2015
P-400 Organizational Context
This procedure applies to the external and internal issues that can affect the Quality Management System. The purpose is to ensure that the context of your company and the needs and expectations of interested parties are understood.
F-440-001 QMS-Process identification worksheet
This procedure describes how to establish and maintain the leadership responsibilities and authority necessary to ensure top management is committed to supporting the requirements of the Quality Management System (QMS).
A-520-001 Quality Policy
P-600 Planning - QMS
This procedure applies to the planning activities and resources required to meet the objectives of the Quality Management System (QMS) and establishes the process for the planning of the QMS.
F-610-001 Risk Opportunity
F-620-001 Quality Objectives Planning
A-600-001 PDCA Guidelines
P-710 Resource Management
This procedure describes the process for determining and providing the resources needed to establish, implement, maintain and continually improve the QMS at Your Company.
F-710-001 Equipment Problem Report
F-710-002 Resource Maintenance Record
P-715 Control of Monitoring and Measuring Equipment
The purpose of this procedure is to outline the requirements for control of measuring and monitoring equipment at your company.
F-715-001 Equipment Calibration List
P-720 Competence and Awareness
This procedure describes the process for ensuring that employees have the training, are aware and are competent for the work that affects quality at your company.
F-720-001 Training Action Plan
F-720-002 Group Training record
F-720-003 Job Description
F-720-004 Employee Training Summary
This procedure describes the process for internal and external communication regarding quality at your company.
F-740-001 Comment Suggestion Record
P-750 Control of Documented Information
This procedure describes the quality management system (QMS) processes for ensuring control of the initial release and changes to the documented information essential for the production or services provided by your company.
F-750-001 Documented Info-Sect-04
F-750-002 Records Matric-Sect-20
F-750-003 Master Documentation Lists
F-750-004 Quality Records Table
F-750-005 Document Change Request
F-750-006 Document Revision Checklist
F-750-007 Software Inventory
P-810 Operational Planning and Control
The purpose of this procedure is to establish the method for the planning of the processes required for the QMS at your company.
F-810-002 Project Planning
P-820 Customer Related Processes
The purpose of this procedure is to describe the process for communicating with customers and determining and reviewing requirements related to products and services provided by your company.
F-820-001 Client Assessment
F-820-002 Production Order
P-830 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.
F-830-001 Design Plan
F-830-002 Design Review
F-830-003 Design Change
P-840 Controlling of External Providers
This procedure describes the process for controlling the procurement process at your company to ensure that purchased products and services, and outsourced processes conform to requirements.
F-840-001 Provider Assessment Report
F-840-002 List of Acceptable Sources
F-840-003 Provider Corrective Action
F-840-004 Purchase Requisition
F-840-005 Purchase Order
F-840-006 Business Agreement-Contract
P-851 Control of Production and Service Provision
The purpose of this procedure is to describe the system that provides controlled conditions under which the key product realization processes are performed at your company. The procedure also applies to the release of products and services, the post-delivery activities, the control of customer or external provider property, and the control of changes.
F-851-001/2 Process Routing Sheet
F-851-003 Process Validation Worksheet
F-851-004 Packing Slip
F-851-005 Service Projects Log
F-851-006 External Property Control Log
F-851-007 Project Inspection Complete Report
P-852 Identification and Traceability
The purpose of this procedure is to provide for a system of identification and status of outputs at your company.
F-852-001 Identification Tag
F-852-002 Traceability Serial Number
F-852-003 Traceability Label
This procedure describes the process used at your company for the handling, packaging, storage, and protection of process outputs in order to preserve the conformity of product through delivery to its intended destination.
F-854-001 Storage Inspection Report
P-870 Control of Nonconforming Outputs
This procedure describes the process used at your company to ensure that outputs that do not conform to product requirements are identified and controlled to prevent its unintended use or delivery.
F-870-001 Nonconformance Report
P-910 Monitoring, Measurement, Analysis and Evaluation
The purpose of this procedure is to establish the process for the monitoring, measurement, analysis, and evaluation of product realization processes and the QMS processes at your company.
F-910-001 Product Monitor Measure Analyze Table
F-910-002 QMS Monitor Measure Analyze Table
F-910-004 Inspection Report
P-912 Customer Satisfaction
This procedure describes the process for the monitoring of customer satisfaction at your company. It applies to products or services where customer satisfaction or dissatisfaction is evaluated.
F-912-001 Customer Survey-Analysis
P-920 Internal Audits
The procedure applies to internal audits that are conducted to ensure that the QMS conforms to the requirements, is effectively implemented and maintained, and continues to be suitable, adequate and effective.
F-920-001 Procedure-Work Area
F-920-002 Audit Checklist
F-920-003 Audit Plan
F-920-004 Internal Audit Report
P-930 Management Review
The purpose of this procedure is to provide for a system for scheduling, conducting and recording management review of the Quality Management System at your company.
F-930-001 Management Review Agenda
F-930-002 Management Review Output
The purpose of this procedure is to establish a process for improvement and continual improvement at your company. The procedure applies to the QMS processes where improvement actions are required to meet customer requirements and enhance customer satisfaction.
F-1010-001 Data Analysis Worksheet
P-1020 Nonconformity and Corrective Action
This procedure describes the process at your company for dealing with nonconformity through the use of a system for corrective action.