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procedures iso 9001

ISO 9001 Procedures

Written by quality management experts, proven to work, our ISO 9001 procedures are available to buy for individual standards, integrated together, or in bundles.

Includes all process maps, turtle diagrams, reports and forms associated with each procedure.


ISO 9001

Analysis & Evaluation Procedure

This procedure aims to establish and define the roles and responsibilities for analyzing and reporting quality management system process performance data to drive continual improvement and to facilitate a factual approach to the decision-making process.

Analysis & Evaluation Procedure explained

Process MapsProcess Maps

  • Analysis & Evaluation Process Overview (turtle diagram)
  • Analysis & Evaluation Process Map

Reports & FormsReports & Forms

  • Monthly Performance Report

Calibrated Test Equipment Procedure

This procedure defines your organization’s responsibilities and activities to ensure that all inspection and test equipment used for product, service, and process monitoring and verification is controlled and calibrated against nationally traceable standards at specified intervals and that such devices are available to ensure continuity of measurement capability.

Calibrated Equipment Procedure explained

Process MapsProcess Maps

  • Calibrated Test Equipment Process Overview (turtle diagram)

Reports & FormsReports & Forms

  • Controlled Equipment Log
  • Calibration Log
  • Software Validation Log

Change Management ProcedureChange Management Procedure

The purpose of this procedure is to establish a standard approach to applying changes to production.

Changes require thorough planning, careful monitoring, and follow‐up evaluation to reduce the negative impact on the user community and to increase the value of vital information resources. This is done through a formal process of recording, assessment, authorization, scheduling, and comprehensive communication around all changes.

Learn about Change Management

Process MapsProcess Maps

  • Change Management Process Overview (turtle diagram)
  • Change Management Process Map

Reports & FormsReports & Forms

  • Request for Change Form
  • Request for Change Status Log

Communication ProcedureCommunication Procedure

This procedure outlines your organization’s guidelines and instructions for managing internal and external communication related to our quality management system.

It also provides specific requirements for the internal and external communication of quality-related issues and the establishment of lines of communication with various parties.

Learn about the Communication Procedure

Process MapsProcess Maps

  • Communication Process Overview (turtle diagram)

Reports & FormsReports & Forms

  • Communication Matrix
  • Register of Objectives & KPIs
  • Objectives Management Programme

Competence & Awareness ProcedureCompetence & Awareness Procedure

This procedure defines your organization’s process for employing and empowering human resources by identifying roles, responsibilities, and authorities, identifying training needs, providing opportunities for attaining competencies, assessing the effectiveness of training, and planning, reporting, and retaining associated training files and records.

Learn about Competence & Awareness Procedure

Process MapsProcess Maps

  • Competence & Awareness Process Overview (turtle diagram)
  • Competence & Awareness Process Map

Reports & FormsReports & Forms

  • Training Needs Analysis
  • Departmental Competency Matrix
  • Competency Assessment
  • Attendance List
  • Training Evaluation

ChecklistsChecklists

  • Employee Induction Checklist

Context Analysis ProcedureContext Analysis Procedure

This procedure outlines your organization’s process for identifying and determining internal and external issues, interested party requirements, management system scope, and processes related to our quality management system that influence our strategic direction (where we’re going) and our operational purpose (what we make and do).

Learn about Context of the Organization

Process MapsProcess Maps

  • Context Analysis Process Activity Map

Reports & FormsReports & Forms

  • Context Analysis
  • SWOT Analysis
  • PESTLE Analysis
  • Competitor Analysis

Corrective Action ProcedureCorrective Action Procedure

This procedure aims to establish the process for identifying, documenting, and analyzing nonconformities and mitigating their impacts by implementing appropriate corrective actions.

Your organization’s quality management system is geared toward proactively eliminating actual and potential deficiencies. Repeated nonconformities in processes are investigated, and action is implemented to prevent occurrence.

Learn about Corrective Action

Process MapsProcess Maps

  • Nonconformity & Corrective Action Process Overview (turtle diagram)
  • Nonconformity & Corrective Action Process Map

Reports & FormsReports & Forms

  • Corrective Action Report
  • 5-Whys Worksheet
  • 8D Worksheet
  • Action Items Log

Contract Review ProcedureCustomer Satisfaction Procedure

This procedure describes the methods for measuring, monitoring, and interpreting customer perception information to determine whether your organization meets customer requirements.

Your organization recognizes that the customer feedback process has essential links and interfaces between other management system processes, including, but not limited to, customer communication, design and development validation, design and development changes, and process validation.

Customer Satisfaction Procedure explained

Process MapsProcess Maps

  • Customer Satisfaction Process Overview (turtle diagram)
  • Customer Satisfaction Process Map

Reports & FormsReports & Forms

  • Customer Satisfaction Survey
  • Customer Feedback Record
  • Customer Complaint & Concern Record
  • Customer Feedback Log
  • Return Material Authorization

Defective Products ProcedureDefective Products Procedure

This procedure aims to establish the process for identifying, documenting and correcting product outputs that do not conform to requirements and to prevent reoccurrence where necessary.

The document also lists the specific steps required for defining product defects, evaluating root causes, and developing particular corrective actions as needed.

Nonconforming Products & Services explained

Process MapsProcess Maps

  • Nonconforming Product Outputs Process Overview (turtle diagram)
  • Nonconforming Product Outputs Process Map

Reports & FormsReports & Forms

  • Nonconforming Product Report
  • Concession Request
  • Concession Request Log
  • Nonconforming Outputs Log

Defective Services ProcedureDefective Services Procedure

This procedure aims to establish the process for identifying and documenting service outputs that do not conform to requirements and ensuring they are controlled to prevent reoccurrence.

It also lists the steps required to document service deficiencies, evaluate root causes, and assign corrective action as needed.

Nonconforming Products & Services explained

Process MapsProcess Maps

  • Nonconforming Service Outputs Process Overview (turtle diagram)
  • Nonconforming Service Outputs Process Map

Reports & FormsReports & Forms

  • Nonconforming Service Report
  • Concession Request
  • Concession Request Log
  • Nonconforming Outputs Log

Design Management ProcedureDesign Management Procedure

This procedure aims to ensure that all product and service design and development activities are coordinated between different organizational functions and that interfaces between stakeholder groups are defined to ensure effective communication and clear assignment of responsibility.

This procedure also ensures that good assurance practices are used during the design process and are consistent with quality management system requirements.

Design & Development of Products & Services Procedure explained

Process MapsProcess Maps

  • Design Management Process Overview (turtle diagram)
  • Design Management Process Map

Reports & FormsReports & Forms

  • Design Requirements Register
  • Design Assumption Register
  • Master Design Documents List
  • Design Review Meeting Minutes
  • Design Document Review
  • FMEA Template
  • Design Issues Log
  • Design Change Request
  • Design Change Request Log

ChecklistsChecklists

  • Requirements Review Checklist

Documented Information ProcedureDocumented Information Procedure

This procedure aims to ensure that all relevant documented information and organizational knowledge that forms an integral part of our quality management system is managed under controlled conditions and that all documented information is reviewed and approved by authorized personnel before issue. 

Documented Information Procedure explained

- View sample

Process MapsProcess Maps

  • Documented Information Process Overview (turtle diagram)
  • Documented Information Process Map

Reports & FormsReports & Forms

  • Master Document List
  • Document Issue Sheet
  • Document Review Sheet
  • Document Change Request

Facilities & Infrastructure ProcedureFacilities & Infrastructure Procedure

This procedure defines your organization’s process for ensuring that suitable facilities, infrastructure, and working environments are provided and maintained as required to ensure product conformity.

This includes planning, providing, and maintaining employee facilities, workspaces, equipment, software, and associated services.

Learn about 7.1.3 Infrastructure

Process MapsProcess Maps

  • Facilities & Infrastructure Process Overview (turtle diagram)

Reports & FormsReports & Forms

  • Equipment Maintenance & Service Log
  • First Aid Treatment Form
  • List of First Aiders
  • Maintenance & Service Record

ChecklistsChecklists

  • Fire Equipment Checklist

Improvement ProcedureImprovement Procedure

This procedure aims to define your organization’s process for establishing a philosophy of continual improvement throughout our business. This philosophy is driven by goals documented in the corporate objectives and policies.

Opportunities for improvement are identified and translated into improvement projects.

Learn about Continual Improvement

Process MapsProcess Maps

  • Improvement Process Overview (turtle diagram)

Reports & FormsReports & Forms

  • Improvement Activity Form
  • Process Effectiveness Assessment Form

Inspection & Testing ProcedureInspection & Testing Procedure

This procedure aims to establish and define the process for testing and inspection activities that verify product, material and service conformance and verify that process inputs and outputs conform to specified requirements.

Documented records and information on inspection and testing include evidence of conformity with the acceptance criteria and traceability to the authorized person. Records of inspections and tests are maintained.

Understanding Testing & Inspection

Process MapsProcess Maps

  • Inspection & Testing Process Overview (turtle diagram)
  • Inspection & Testing Process Map

Reports & FormsReports & Forms

  • Receiving Inspection Log
  • Inspection & Test Data Sheet
  • Final Inspection & Test Report
  • Inspection & Test Log
  • Nonconforming Product Report

Interested Party Analysis ProcedureInterested Party Analysis Procedure

This procedure outlines your organization’s process for identifying and determining interested party requirements related to our quality management system, which influence our strategic direction (where we’re going) and our operational purpose (what we make and do).

Learn about Relevant Interested Parties

Process MapsProcess Maps

  • Interested Party Analysis Process Overview (turtle diagram)

Reports & FormsReports & Forms

  • Interested Party Analysis

Internal Audits ProcedureInternal Audits Procedure

This procedure defines your organization’s process for undertaking internal audits, process audits, and supplier and legislation audits to assess the effectiveness of applying our quality management system and its compliance with ISO 9001.

It also defines the responsibilities for planning and conducting audits, reporting results, and retaining associated records.

Learn How To Conduct an ISO 9001 Internal Audit

Process MapsProcess Maps

  • Internal Auditing Process Overview (turtle diagram)
  • Internal Auditing Process Map

Reports & FormsReports & Forms

  • Internal Audit Plan
  • Internal Audit Report

Management Reviews ProcedureManagement Reviews Procedure

This procedure aims to define your organization’s process for undertaking management reviews to assess the effectiveness of applying our quality management system and its ongoing compliance with ISO 9001.

This procedure also defines the responsibilities for planning, conducting, reporting results, and retaining associated records.

Management Review Procedure explained

Process MapsProcess Maps

  • Management Review Process Overview (turtle diagram)
  • Management Review Process Map

Reports & FormsReports & Forms

  • Authority Matrix
  • Management Review Minutes

ToolkitsToolkits

  • Management Review Tool (Programme, agenda, and action tracker)

PresentationsPresentations

  • Management Review Presentation

Operational Control ProcedureOperational Control Procedure

The purpose of this procedure is to reduce the risk that our organization will not achieve its quality objectives without certain controls in place and to implement the actions determined in ISO 9001 Clause 6, e.g. risk and opportunities, quality objectives, and changes.

These activities are planned and suitably prepared to cover all aspects of your organization’s operations including normal operation, maintenance and emergency situations.

Process MapsProcess Maps

  • Operational Control Process Overview (turtle diagram)

Reports & FormsReports & Forms

  • Production Traveler
  • Work Instruction Template
  • Assembly Parts List
  • Engineering Drawing Sheet
  • Quality Control Plan

Order & Contract Review ProcedureOrder & Contract Review Procedure

The purpose of this procedure is to ensure that all requirements for quotes, orders and contracts, together with additional requirements that are not specified but are necessary for fitness for use as per applicable legislation, regulations and requirements for availability, delivery and support, are adequately defined and that the company is capable of meeting its clients' requirements.

Process MapsProcess Maps

  • Order & Contract Review Process Overview (turtle diagram)

ChecklistChecklist

  • Requirements Review Checklist

Product & Service Provision ProcedureProduct & Service Provision Procedure

This procedure aims to define the activities required to ensure that all elements of the production and service provision process are planned and conducted under control conditions further to ensure conformity to Customer or other specified requirements. 

Learn more about 8.5 Product and Service Provision

Process MapsProcess Maps

  • Product & Service Provision Process Overview (turtle diagram)

Reports & FormsReports & Forms

  • Production Control Plan
  • Traceability Log
  • Customer Property Log

Purchasing ProcedurePurchasing Procedure

This procedure defines the activities required to ensure that purchased products conform to the specified purchase requirements by detailing the combination of supplier controls, purchasing requirements, and purchased product inspection, taking into account the potential consequences of a non-conforming product being delivered.

Purchasing & Procurement Procedure explained

Process MapsProcess Maps

  • Purchasing Process Overview (turtle diagram)
  • Purchasing Process Map

Reports & FormsReports & Forms

  • Approved Supplier List
  • Purchase Requisition
  • Purchase Order Form
  • Receiving Inspection Log

QMS Scope & Processes ProcedureQMS Scope & Processes Procedure

This procedure outlines your organization’s process for identifying and determining management system scope, as well as processes related to our quality management system that influence our strategic direction (where we’re going) and our operational purpose (what we make and do).

4.3 Determining the Scope of the Quality Management System explained

Process MapsProcess Maps

  • QMS Scope & Processes Process Overview (turtle diagram)
  • QMS Scope & Processes Process Map

Reports & FormsReports & Forms

  • Process Matrix & Application

Quality Objectives ProcedureQuality Objectives Procedure

The purpose of this procedure is to establish how your organization implements and maintains quality objectives, targets, and programmes that are consistent with our quality policy.

The ultimate goal is to demonstrate continual improvement of our quality management system.

For each significant risk, your organization establishes an appropriate objective and target.

Learn about Quality Objectives

Process MapsProcess Maps

  • Management System Objectives Process Overview (turtle diagram)

Reports & FormsReports & Forms

  • Register of Objectives & KPIs
  • Objectives Management Programme
  • Risk & Opportunity Register
  • SWOT Analysis
  • PESTLE Analysis

Risks & Opportunities ProcedureRisks & Opportunities Procedure

The purpose of this procedure is to outline your organization’s risk and opportunity management framework and the activities within it.

The risk and opportunity management framework defines our current risk management process, which includes defining risk criteria, identifying, assessing, evaluating prioritization, and communicating actions to mitigate risks or leverage opportunities.

Learn about Risks & Opportunities

Process MapsProcess Maps

  • Risks & Opportunities Process Overview (turtle diagram)

Reports & FormsReports & Forms

  • Risk & Opportunity Register
  • Opportunity Evaluation
  • Context Analysis
  • SWOT Template
  • PESTLE Template
  • Interested Party Analysis
  • Process Responsibility Matrix

Roles & Responsibilities ProcedureRoles & Responsibilities Procedure

This procedure outlines your organization’s approach to defining and documenting the roles and responsibilities (e.g., tasks allocated to a role) of those involved in the quality management system, including the necessary authorities (e.g., permissions allocated within the role) that may be associated with the role or responsibility.

Learn about Organizational Roles, Responsibilities and Authorities

Process MapsProcess Maps

  • Roles, Responsibilities & Authorities Process Overview (turtle diagram)

Reports & FormsReports & Forms

  • Job Description
  • Authority Matrix

Supplier Corrective Action ProcedureSupplier Corrective Action Procedure

Suppliers are responsible for providing defect-free products, components, and assemblies.

This procedure defines and establishes the specific requirements for suppliers of purchased products, components, assemblies, and services.

The intent is to resolve defects and non-conformities in the supply chain and prevent their recurrence by eliminating the root cause of the problem. 

Learn about 10.2 Corrective Action

Process MapsProcess Maps

  • Supplier Corrective Action Process Overview (turtle diagram)
  • Supplier Corrective Action Process Map

Reports & FormsReports & Forms

  • Supplier Corrective Action Request

ToolkitsToolkits

  • Supplier Corrective Action Tracker

Supplier Evaluation ProcedureSupplier Evaluation Procedure

The purpose of this procedure is to define non-critical and critical materials or services and describe the methods for selecting, evaluating, approving and re-evaluating suppliers and subcontractors.

It details the combination of supplier controls, purchasing requirements and purchased product inspection, taking into account the potential consequences of a nonconforming product being delivered.

Learn about 8.4 Control of Externally Provided Processes, Products and Services

Process MapsProcess Maps

  • Supplier Evaluation Process Overview (turtle diagram)

Reports & FormsReports & Forms

  • Initial Supplier Assessment
  • Supplier Evaluation Report
  • Approved Supplier List

iso 9001
ISO 9001

ISO 9001, 16 Procedures - Bundle16 ISO 9001 Procedures - Bundle

Includes all process maps, turtle diagrams, reports and forms associated with each procedure.

These procedures are also included in our Quality Manual Template (16 procedures).

Who is this for? Services, Finance, IT, Retail, Education

  1. Analysis & Evaluation
  2. Calibrated Test Equipment
  3. Competence and Awareness
  4. Context Analysis
  5. Corrective Action
  6. Customer Satisfaction
  7. Documented Information - view sample
  8. Improvement
  9. Interested Party Analysis
  10. Internal Auditing - view sample
  11. Management Reviews - view sample
  12. Purchasing
  13. QMS Scope & Processes
  14. Quality Objectives
  15. Risks & Opportunities
  16. Roles & Responsibilities

Download free example procedure

ISO 9001, 18 QMS Procedures - Bundle28 ISO 9001 Procedures - Bundle

Includes all process maps, turtle diagrams, reports and forms associated with each procedure.

These procedures are also included in our Quality Manual Template (28 procedures).

Who is this for? Engineering, Manufacturing, Construction

  1. Analysis & Evaluation
  2. Calibrated Test Equipment
  3. Change Management
  4. Communication
  5. Competence & Awareness
  6. Context Analysis
  7. Corrective Action
  8. Customer Satisfaction
  9. Defective Products
  10. Defective Services
  11. Design Management
  12. Documented Information
  13. Facilities & Infrastructure
  14. Improvement
  15. Interested Party Analysis
  16. Internal Auditing
  17. Management Review
  18. Operational Control
  19. Order & Contract Review
  20. Product & Service Provision
  21. Purchasing
  22. QMS Scope & Processes
  23. Quality Objectives
  24. Risks & Opportunities
  25. Roles & Responsibilities
  26. Supplier Corrective Action
  27. Supplier Evaluation
  28. Testing & Inspection
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