ISO 9000:2005

Fundamentals and vocabulary

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This guidance has been superseded by ISO 9000:2015. You can learn to apply the latest quality management principles in the context of your business's own particular operations by reviewing and documenting its activities in the context of each quality management principle. 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ISO 9000:2005 – fundamentals and vocabulary (superseded)

ISO 9000:2005 only introduces clarifications to the existing requirements of ISO 9001:2008 and some changes intended to improve consistency with ISO 14001:2004. There are no new requirements.

ISO 9000:2005 Quality management systems – Fundamentals and vocabulary makes no changes to the basic principles of quality management stated in ISO 9000:2005.

For example: both ISO 9000:2005 and ISO 9001:2008 define a procedure as a specified way to carry out a task which does not necessarily have to be documented and that generating documentation should not be an end in itself.

ISO 9001:2008 - What's New?

ISO 9001:2008 is essentially a tidying-up exercise to ensure consistency within ISO Standards. 15 definitions and explanatory notes have been added or expanded to align ISO 9000 with more recent ISO Standards:

ISO 9001:2008 adds “business environment” to the list of factors that influence the design and implementation of a quality management system. The other changes to this text are minor revisions to the other factors, as well as, the use of a bulleted list.

The design and implementation of an organization's quality management system is influenced by - its business environment, changes in that environment, or risks associated with that environment, - its varying needs, - its particular objectives, - the products it provides provided, - the processes it employs employed, and - its the size and organizational structure of the organization.

Later in section 0.1, ISO 9001:2008 changes "regulatory" to "statutory and regulatory” and clarifies that the customer, statutory, and regulatory requirements are those applicable to the product. This International Standard can be used by internal and external parties, including certification bodies, to assess the organization's ability to meet customer, statutory, and regulatory requirements applicable to the product, and the organization's own requirements.

What Do I Need To Do?

This is a relatively minor revision. It will probably have little, or no real impact on your quality system.

If your documentation refers to any ISO 9000:2005 or ISO 9001:2008 terminology you should revise as necessary on ensure consistency with the new 2008 terminology.

Terminology

ISO 9000:2005 Basic QMS Terminology

  1. The product - the thing that your company provides to the customer
  2. The organization - your company
  3. The customer - the people you supply product to
  4. The supplier - the people who supply you something that contributes to your product
  5. Top management - the company directors, executive management
  6. Shall - means "you must" - you will be audited to ensure you comply with the "shalls"
  7. Effectiveness - means that the QMS works and achieves its objectives.
  8. Efficient - means that the QMS uses minimum resources
  9. Quality - there are many incomprehensible, official definitions. Think of quality as "we keep our promises".

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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