Guidance

Plan your management system

The ISO Navigator™ database hyperlinks the ISO 9000:2005 principles and the ISO 9001:2008 requirements; and explains them in plain English with practical guidance.

This guidance has been superseded by ISO 9001:2015 Clause 7.5 Documented Information. If you want to see a comparison matrix that correlates the requirements of ISO 9001:2008 to the revised requirements of ISO 9001:2015, please click here to begin comparing.

Our range of ISO 9001:2015 quality manuals and integrated manual templates cover the requirements of ISO 14001:2015 and ISO 45001:2018, and offer an easy way to implement and document your organization's quality management system or integrated management system.

ISO 9001:2008: Documentation requirements 4.2 (superseded)

Documents and records are an important organizational asset. They provide the primary route for evidence based verification and traceability in order to demonstrate compliance with customer requirements.

There is an urban myth that procedures must spell out everything in minute detail in case someone falls under a bus. This is a hangover from the Defence standards and has NEVER been a requirement of ISO 9001. 

The answers to these questions will influence the amount of documentation required. The modern way of documenting a quality system this is to have lightweight procedures balanced by heavy training records, which demonstrate competence.

Also, think about having flow-charts instead of text. You can draw adequate flow-charts using Word ‘s auto-shapes. Whether you use text or flow-charts, generally aim (in artistic terms) for an impressionist painting, rather than a detailed engineering blue-print.

  1. General requirements 4.2.1
  2. Quality manual 4.2.2
  3. Control of documents 4.2.3
  4. Control of records 4.2.4

Looking for help with your quality documentation? Our quality manual template provides a great foundation for establishing, implementing and documenting the six mandatory procedures that are required by the standard.

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Free PDCA guidance

ISO Navigator™ is our FREE online training tool that shows you how to apply the principles of PDCA to your operations. We also offer many helpful templates that get you on the road to documenting your management system, please visit the download page.

Planning

ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
4.1 Organizational Context 4.1 Organizational Context 4.1 Organizational Context
4.2 Relevant Interested Parties 4.2 Relevant Interested Parties 4.2 Relevant Interested Parties
4.3 Management System Scope 4.3 Management System Scope 4.3 Management System Scope
4.4 QMS Processes 4.4 EMS Processes 4.4 OH&S Management System
 
ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
5.1 Leadership & Commitment 5.1 Leadership & Commitment 5.1 Leadership & Commitment
5.2 Quality Policy 5.2 Environmental Policy 5.2 OH&S Policy
5.3 Roles, Responsibilities/Authorities 5.3 Roles, Responsibilities/Authorities 5.3 Roles, Responsibilities/Authorities
    5.4 Consultation & Participation
 
ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
6.1.1 Address Risks & Opportunities 6.1.1 Address Risks & Opportunities 6.1.1 Address Risks & Opportunities
6.2.1 Quality Objectives 6.1.2 Environmental Aspects 6.1.2 Hazard Identifcation
6.2.2 Planning to Achieve Objectives 6.1.3 Compliance Obligations 6.1.3 Legal & Other Requirements
6.3 Planning for Change 6.1.4 Planning Action 6.1.4 Planning Action
  6.2.1 Environmental Objectives 6.2.1 OH&S Objectives
  6.2.2 Planning to Achieve Objectives 6.2.2 Planning to Achieve Objectives
 

Doing

ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
7.1.1 Resources - General
7.1 Resources 7.1 Resources
7.1.2 People 7.2 Competence 7.2 Competence
7.1.3 Infrastructure
7.3 Awareness 7.3 Awareness
7.1.4 Operational Environment 7.4.1 Communcation - General 7.4.1 Communcation - General
7.1.5 Monitoring & Measuring 7.4.2 Internal Communcation 7.4.2 Internal Communcation
7.1.6 Organizational Knowledge 7.4.3 External Communcation 7.4.3 External Communcation
7.2 Competence 7.5 Documented Information 7.5 Documented Information
7.3 Awareness    
7.4 Communcation    
7.5 Documented Information    
 
ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
8.1 Operational Planning & Control
8.1 Operational Planning & Control 8.1.1 General
8.2.1 Customer Communication 8.2 Emergency Preparedness 8.1.2 Eliminating Hazards
8.2.2 Determining Requirements
  8.1.3 Management of Change
8.2.3 Reviewing Requirements   8.1.4 Outsourcing
8.2.4 Changes in Requirements
  8.2 Emergency Preparedness
8.3.1 Design Development - General    
8.3.2 Design Development - Planning
   
8.3.3 Design Development - Inputs    
8.3.4 Design Development - Controls    
8.3.5 Design Development - Outputs    
8.3.6 Design Development - Changes    
8.4.1 External Processes - General    
8.4.2 Purchasing Controls    
8.4.3 Purchasing Information    
8.5.1 Production & Service Provision    
8.5.2 Identification & Traceability    
8.5.3 3rd Party Property    
8.5.4 Preservation    
8.5.5 Post-delivery Activities    
8.5.6 Control of Changes    
8.6 Release of Products & Services    
8.7 Nonconforming Outputs    
 

Checking

ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
9.1.1 Performance Evaluation 9.1.1 Performance Evaluation 9.1.1 Performance Evaluation
9.1.2 Customer Satisfaction 9.1.2 Evaluation of Compliance 9.1.2 Evaluation of Compliance
9.1.3 Analysis & Evaluation 9.2 Internal Audit 9.2 Internal Audit
9.2 Internal Audit 9.3 Management Review 9.3 Management Review
9.3 Management Review    
 

Acting

ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
10.1 Improvement - General 10.1 Improvement - General 10.1 Improvement - General
10.2 Nonconformity & Corrective Action 10.2 Nonconformity & Corrective Action 10.2 Incident, Nonconformity & Corrective Action
10.3 Continual Improvement 10.3 Continual Improvement 10.3 Continual Improvement