Management system guidance

8.5 Product and service provision

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8.5.2 Identification and traceability

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This requirement is comparable to the requirements from ISO 9001:2008 Clause 7.5.3 - Identification and traceability. You should seek and record evidence that product is identified (as appropriate) and its status with regards to monitoring and measuring (conforming or not) is identified throughout the manufacturing processes.

Where traceability is a requirement, you should expect to see that your organization is controlling and recording the unique identity of the product throughout the production process to ensure that only products that have passed the required inspections and tests are utilised.

Your organization must have a process in place for the identification and traceability of outputs, in terms of the monitoring and measurement requirements at all stages of production, to enable the demonstration of conformity to requirements, e.g. physical part marking, labeling, tags, bar codes, signage, visual indicators, part segregation, lay down areas, storage racks.

There are several ways of identifying products to prevent them becoming mixed with other parts, components, or orders. The most obvious is using tags or stickers with a unique traceability identifier, such as a lot or batch number included on the product labels. The identification may be engraved in the product itself, or the product may simply be marked by a colour.

Establish and implement a procedure to identify the product through the design, development, manufacture and delivery stages. The established a traceability system should track components from raw material through inspection, test, and final release operations, including rework:

  1. Establish the identity and status of products;
  2. Maintain the identity and status of products;
  3. Maintain records of serial or batch numbers.

The auditor will expect to see that product is identified (as appropriate) and its status with regards to monitoring and measuring (conforming or not) is identified throughout the product realization processes.

Where traceability is a requirement, the auditor will expect to see that the organization is controlling and recording the unique identification of the product. If you need a procedure and forms to help control your business's product and service provision process, click here.

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More information on PDCA

Planning

Context

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

Planning

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

Support

ISO 9001:2015
ISO 14001:2015
ISO 45001:2018
6.1 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

Support

ISO 9001:2015
ISO 14001:2015
ISO 45001:2018
7.1 Resources 7.1 Resources 7.1 Resources
7.2 Competence 7.2 Competence 7.2 Competence
7.3 Awareness 7.3 Awareness 7.3 Awareness
7.4 Communcation 7.4.1 Communcation - General 7.4.1 Communcation - General
7.5 Documented Information 7.4.2 Internal Communcation 7.4.2 Internal Communcation
  7.4.3 External Communcation 7.4.3 External Communcation
  7.5 Documented Information 7.5 Documented Information

Operations

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 Customer Requirements 8.2 Emergency Preparedness 8.1.2 Eliminating Hazards
8.3 Design & Development   8.1.3 Management of Change
8.4 Purchasing   8.1.4 Outsourcing
8.5 Product & Service Provision   8.2 Emergency Preparedness
8.6 Release of Products & Services    
8.7 Nonconforming Outputs    
 

Checking

Monitoring, measurement, analysis and evaluation

ISO 9001:2015
ISO 14001:2015
ISO 45001:2018
9.1 Monitoring & Measurement 9.1.1 Performance Evaluation 9.1.1 Performance Evaluation
9.2 Internal Audit 9.1.2 Evaluation of Compliance 9.1.2 Evaluation of Compliance
9.3 Management Review 9.2 Internal Audit 9.2 Internal Audit
  9.3 Management Review 9.3 Management Review
 

Acting

Improvement

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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