Management system guidance

8.5 Product and service provision

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8.5.1 Control of product and service provision

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This requirement is comparable to the requirements from ISO 9001:2008 Clause 7.5.1 - Control of Production and Service Provision and Clause 7.5.2 Validation of Processes from Production and Service Provision. If you need a procedure and forms to help control your business's product and service provision process, click here.

Clause 8.5.1 Control of Product and Service Provision requires your organization to control the manner in which products are produced and the services provided. You should seek and record evidence that your organization has controlled the conditions by which products or services are provided, ensuring that:

  1. Documented information that defines the characteristics of the product or service is available;
  2. Documented information that defines the activities that need to be performed to produce the product or deliver the service is available, and that this specifies the results that are to be achieved;
  3. Monitoring and measurement takes place at appropriate points in the production process to ensure that both the processes themselves and the process outputs meet the organization’s acceptance criteria;
  4. The process environment and infrastructure are suitable;
  5. Suitable monitoring and measurement resources are made available;
  6. Personnel are competent and, where necessary, appropriately qualified;
  7. For processes where the results cannot be verified by subsequent monitoring or measurement,
  8. The process itself is initially validated and then periodically re-evaluated;
  9. Up-to-date work instructions;
  10. Product and service release, delivery and post-delivery activities are implemented.

Businesses should develop, conduct, control and monitor production processes to ensure parts manufactured conform to specifications. This includes documented instructions that define the production activities, approval of processes and equipment and any changes to those processes and equipment, monitoring and control of process parameters, and component characteristics during production.

Making use of documented procedures, work instructions, specifications, drawings, reference materials, suitable equipment and specific monitoring and measurement devices; where the absence of such could affect quality, your organization should employ process controls, which are consistent and appropriate for the operations being conducted.

Your organization should ensure adequate equipment is available and adequate for the manufacture of products to meet specifications. This includes ensuring equipment is maintained periodically, documenting activities performed and by whom and when the activites are performed.

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More information on PDCA

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
 

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