 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 Maps
- Analysis & Evaluation Process Overview (turtle diagram)
- Analysis & Evaluation Process Map
 Reports & 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 Maps
- Calibrated Test Equipment Process Overview (turtle diagram)
Reports & Forms
- Controlled Equipment Log
- Calibration Log
- Software Validation Log
|
|
Change 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 Maps
- Change Management Process Overview (turtle diagram)
- Change Management Process Map
Reports & Forms
- Request for Change Form
- Request for Change Status Log
|
|
Communication 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 Maps
- Communication Process Overview (turtle diagram)
Reports & Forms
- Communication Matrix
- Register of Objectives & KPIs
- Objectives Management Programme
|
|
Competence & 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 Maps
- Competence & Awareness Process Overview (turtle diagram)
- Competence & Awareness Process Map
Reports & Forms
- Training Needs Analysis
- Departmental Competency Matrix
- Competency Assessment
- Attendance List
- Training Evaluation
 Checklists
- Employee Induction Checklist
|
|
Context 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 Maps
- Context Analysis Process Activity Map
Reports & Forms
- Context Analysis
- SWOT Analysis
- PESTLE Analysis
- Competitor Analysis
|
|
Corrective 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 Maps
- Nonconformity & Corrective Action Process Overview (turtle diagram)
- Nonconformity & Corrective Action Process Map
Reports & Forms
- Corrective Action Report
- 5-Whys Worksheet
- 8D Worksheet
- Action Items Log
|
|
Customer 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 Maps
- Customer Satisfaction Process Overview (turtle diagram)
- Customer Satisfaction Process Map
Reports & Forms
- Customer Satisfaction Survey
- Customer Feedback Record
- Customer Complaint & Concern Record
- Customer Feedback Log
- Return Material Authorization
|
|
Defective 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 Maps
- Nonconforming Product Outputs Process Overview (turtle diagram)
- Nonconforming Product Outputs Process Map
Reports & Forms
- Nonconforming Product Report
- Concession Request
- Concession Request Log
- Nonconforming Outputs Log
|
|
Defective 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 Maps
- Nonconforming Service Outputs Process Overview (turtle diagram)
- Nonconforming Service Outputs Process Map
Reports & Forms
- Nonconforming Service Report
- Concession Request
- Concession Request Log
- Nonconforming Outputs Log
|
|
Design 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 Maps
- Design Management Process Overview (turtle diagram)
- Design Management Process Map
Reports & 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
Checklists
- Requirements Review Checklist
|
|
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 Maps
- Documented Information Process Overview (turtle diagram)
- Documented Information Process Map
Reports & Forms
- Master Document List
- Document Issue Sheet
- Document Review Sheet
- Document Change Request
|
|
Facilities & 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 Maps
- Facilities & Infrastructure Process Overview (turtle diagram)
Reports & Forms
- Equipment Maintenance & Service Log
- First Aid Treatment Form
- List of First Aiders
- Maintenance & Service Record
Checklists
|
|
Improvement 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 Maps
- Improvement Process Overview (turtle diagram)
Reports & Forms
- Improvement Activity Form
- Process Effectiveness Assessment Form
|
|
Inspection & Testing ProcedureThis 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 Maps- Inspection & Testing Process Overview (turtle diagram)
- Inspection & Testing Process Map
Reports & Forms- Receiving Inspection Log
- Inspection & Test Data Sheet
- Final Inspection & Test Report
- Inspection & Test Log
- Nonconforming Product Report
|
|
Interested 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 Maps
- Interested Party Analysis Process Overview (turtle diagram)
Reports & Forms
- Interested Party Analysis
|
|
Internal 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 Maps
- Internal Auditing Process Overview (turtle diagram)
- Internal Auditing Process Map
Reports & Forms
- Internal Audit Plan
- Internal Audit Report
|
|
Management 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 Maps
- Management Review Process Overview (turtle diagram)
- Management Review Process Map
Reports & Forms
- Authority Matrix
- Management Review Minutes
 Toolkits
- Management Review Tool (Programme, agenda, and action tracker)
 Presentations
- Management Review Presentation
|
|
Operational 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 Maps
- Operational Control Process Overview (turtle diagram)
Reports & Forms
- Production Traveler
- Work Instruction Template
- Assembly Parts List
- Engineering Drawing Sheet
- Quality Control Plan
|
|
Order & 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 Maps
- Order & Contract Review Process Overview (turtle diagram)
Checklist
- Requirements Review Checklist
|
|
Product & 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 Maps
- Product & Service Provision Process Overview (turtle diagram)
Reports & Forms
- Production Control Plan
- Traceability Log
- Customer Property Log
|
|
Purchasing 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 Maps
- Purchasing Process Overview (turtle diagram)
- Purchasing Process Map
Reports & Forms
- Approved Supplier List
- Purchase Requisition
- Purchase Order Form
- Receiving Inspection Log
|
|
QMS 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 Maps
- QMS Scope & Processes Process Overview (turtle diagram)
- QMS Scope & Processes Process Map
Reports & Forms
- Process Matrix & Application
|
|
Quality 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 Maps
- Management System Objectives Process Overview (turtle diagram)
Reports & Forms
- Register of Objectives & KPIs
- Objectives Management Programme
- Risk & Opportunity Register
- SWOT Analysis
- PESTLE Analysis
|
|
Risks & 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 Maps
- Risks & Opportunities Process Overview (turtle diagram)
Reports & Forms
- Risk & Opportunity Register
- Opportunity Evaluation
- Context Analysis
- SWOT Template
- PESTLE Template
- Interested Party Analysis
- Process Responsibility Matrix
|
|
Roles & 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 Maps
- Roles, Responsibilities & Authorities Process Overview (turtle diagram)
Reports & Forms
- Job Description
- Authority Matrix
|
|
Supplier 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 Maps
- Supplier Corrective Action Process Overview (turtle diagram)
- Supplier Corrective Action Process Map
Reports & Forms
- Supplier Corrective Action Request
Toolkits
- Supplier Corrective Action Tracker
|
|
Supplier 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 Maps
- Supplier Evaluation Process Overview (turtle diagram)
Reports & Forms
- Initial Supplier Assessment
- Supplier Evaluation Report
- Approved Supplier List
|
|
16 ISO 9001 Procedures - Bundle
