Management system guidance

8.0 Operation

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8.1 Operational Planning and Control

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Operational planning is about controlling the design and development process. The organization must ensure that all related activities take place under controlled conditions. Operational planning and control requirements (ISO 9001:2015) are comparable to the requirements from ISO 9001:2008 Clause 7.1 – Product Realization Planning, but it has been extended to include implementation and control, as well planning.

Your organization needs to plan in advance for how they will manufacture their product or deliver their service. The plans need to take into account the product requirements and any quality objectives that might be appropriate, resources and documents that may be necessary, what type of monitoring and/or inspection activities should be put in place to ensure the product or service will meet the requirements, and what types of records should be kept.

There should be a process for developing work instructions that detail standard practice for performing tasks that comply with all management system requirements, as well as a process for identifying hazards and controlling tasks for all non-routine tasks and ensuring all safety and environmental requirements are met.

You should seek and record evidence that your organization has determined the design and the processes to meet the requirements of your customers and the requirements of your management system. Evidence that the processes, including all inputs, outputs, resources, controls, criteria, and process measurement and performance indicators being planned should be sought. Operational planning includes the following elements:

  1. Developing process plans that include clear, concise and detailed work instructions;
  2. Defining quality objectives and requirements (tolerances, surface finish, workmanship standards, etc.) for the product or service;
  3. Defining how quality objectives and requirements are documented; e.g. drawings, specifications, models, etc., and communicated, e.g. instructions, pre-production samples, operator training, etc.
  4. Ensuring that product and service inspection and testing methods and procedures are defined and documented, along with their respective acceptance criteria;
  5. Ensuring that each specified inspection, test and monitoring activity is recorded through work orders, tags, tickets, forms, electronic data collection systems, etc.;
  6. Undertaking risk analysis studies of key manufacturing processes and ensuring mitigations arising from risk management are incorporated into key product and or process designs;
  7. Developing the capabilities, training, qualifications, procedures and work instructions necessary to execute the requirements to ensure product compliance to contract/customer requirements;
  8. Developing training and procedures to ensure general workmanship, safety, equipment maintenance and qualification, material handling and environmental standards are maintained in a manner consistent with contract/customer requirements and sound business practices;
  9. Designating and maintaining an adequate number of personnel trained and qualified to support both new product development and continuous process improvement;
  10. Implementing a production and purchasing control systems capable of managing all phases of manufacturing and service delivery, from scheduling of customer needs, to the delivery of finished goods. The system employed should account for every part entered into the manufacturing process and provide for lot/batch tracking, traceability and integrity of process, including documentation of delays and interruptions;
  11. Ensuring suitable production facilities, equipment, inspection and servicing capabilities are available to achieve contract/customer requirements.
  12. Ensuring that environmental factors such as lighting, housekeeping, contamination, handling equipment, temperature compensation and process licencing are managed in such a way as to comply with contract/customer and regulatory agency requirements.
  13. Controlling conditions such as utilities and supplies including water, compressed air, electricity and chemical products to the extent they affect product quality.

Department Managers must ensure that work practices and instructions are developed as necessary to support the execution of process and production plans, while supervisors at every level must ensure that training is implemented and that qualifications are maintained to support the requirements of process and production plans.

Operational personnel must carry out the process and production plans as per instructions and in the sequence presented to them. When required, they must stop work if they identify any discrepancies in product, planning or instructions to their immediate supervisor, and make input into process improvement or corrective action.

Process and production plan verification

All other customer defined criteria for control or monitoring of quality must have been established (e.g. process mapping, statistical process control, third party verification, etc.) and customer approval must have been obtained as necessary. A new process is deemed qualified for release to production when the following criteria are met:

  1. An approved First Article is produced to the Process Plan to verify that all dimensions, features, and product attributes meet specified requirements;
  2. Key/Critical features are identified for in-process monitoring of machined product through pre-control or other specified means;
  3. All machine set-up, operating instructions and operator qualifications are in place and operating;
  4. Inspection plans are in place for quality control verification at both In-Process and Final Inspection steps;
  5. Special processes have been verified through the approved supplier list or other specified means;
  6. Product and/or component purchases have been verified through the approved supplier list and end item Quality Control or specified functional test.

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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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