8.0 Operation

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ISO Navigator Pro™ is a free tool that provides practical, expert guidance for businesses wishing to interpret the fundamentals of ISO 9000:2015 to help understand, and better implement the requirements of ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018. The ISO Navigator Pro™ database divides the requirements into four sequential stages; Plan, Do, Check and Act.

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8.1 Operational Planning and Control

Operational planning and contro 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. You should seek and record evidence that your organization has determined the design and its 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.

For those risks and opportunities that your organization has identified, you should seek evidence that these actions have been integrated into the management system; as such, these actions should be verifiable at process level – for example, evidence of controls, acceptance criteria and resources to address the risks and opportunities. Review the acceptability criteria; this may include targets, measures, values, KPIs, specifications and other criteria as relevant to the output.

You should ensure that the implemented processes are controlled as planned and that there is evidence that your organization has evaluated the effectiveness of actions taken when addressing risks and opportunities. Evaluate and record any evidence pertaining to planned and unintended changes.

Operational planning is about controlling the design and development process. The organization must ensure that all related activities take place under controlled conditions. The final product or service is the culmination of events that transfer customer requirements and expectations into a tangible product or effective service that conforms to specified requirements and expectations. Control product realization planning by:

  1. Determining quality, environmental and safety objectives for the product;
  2. Determining requirements for the product;
  3. Identifying processes required to achieve conformance;
  4. Establishing processes required to achieve conformance;
  5. Identifying documents to demonstrate conformance;
  6. Identifying resources required to achieve conformance;
  7. Maintaining and retaining documented information.

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.

ISO 9001:2015 and ISO 14001:2015 both introduce the concept of controlling change, whether it is a ‘planned change to be controlled’ or an ‘unintended change to be reviewed for their consequences’. Controls can include engineering controls, procedures, documented procedure, etc. They can be implemented following a hierarchy (e.g. elimination, substitution, administrative) and can be used singly or in combination.

Considering that some of your organization’s environmental impacts can occur once the products and services have been delivered to the customers, organizations need to provide information to those that will transport, use, treat or dispose of the products and services in order to prevent adverse environmental impacts. The Life cycle perspective means that your organization must also:

  1. Design and develop products and services taking into account the environmental impact throughout their life cycle;
  2. Include environmental requirements in the purchasing specifications of products and services;
  3. Communicate these environmental requirements to external providers;
  4. When necessary, provide information on potential environmental impacts related to the transportation, use, end of life treatment and final disposal of its products and services.

Ensure that those with responsibility for each stage of the lifecycle, for example; procurement, design, logistics, operations, sales, and after sales, are represented in environmental aspects identification and evaluation. Again, a workshop scenario works well. Where significant aspects relate to other stages of the lifecycle, these can be managed or coordinated through the EHQMS, for example by operational control and environmental objectives.

Certification Auditors will not expect to see a fully developed life cycle analysis. This is not a requirement of the new standard. Operating procedures should also be developed for processes, plant, and equipment should include:

  1. Specification;
  2. Relevant legislation;
  3. Hazards;
  4. Operating criteria;
  5. Maintenance strategies;
  6. Inspection and testing;
  7. Material safety information.

All operational factors must be determined and risks associated with health, safety and the environment must be managed in a way that conforms to the management system's policy. 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.

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Planning

4.1 Understanding Context 5.1 Leadership and Commitment 6.1 Address Risk and Opportunity
4.2 Interested Parties 5.2 Policies 6.2 System Objectives and Planning
4.3 Determining Scope 5.3 Roles, Responsibility and Authority 6.3 Planning for Change
4.4 Management System Processes    
 

Doing

7.1 Resources 8.1 Operational Planning and Control 8.6 Release of Products and Services
7.2 Competence 8.2 Requirements for Products and Services 8.7 Non-conforming Outputs
7.3 Awareness 8.3 Design & Development of Products and Services 8.8 Emergency Preparedness and Response
7.4 Communication 8.4 Control of Externally Provided Products and Services 8.9 Accident and Incident Investigation
7.5 Documented Information 8.5 Product and Service Provision  
 

Checking and acting

9.1 Monitor, Measure, Analyse and Evaluate 10.1 General
9.2 Internal Audit 10.2 Non-Conformity and Corrective Action
9.3 Management Review 10.3 Continual Improvement

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