Process approach

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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.

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.

Key benefits of the process approach

The process approach and the iterative, four-step PDCA cycle are central themes in management system standards like ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018. ISO standards can be purchased and downloaded from their on-line store.

Use the process approach, coupled with the PDCA cycle and risk-based thinking, to align and integrate your management system with the requirements of the standards. The plan, do, check, act (PDCA) cycle provides a methodology to develop and implement process orientated management systems. The PDCA cycle should be applied to all functions, processes and levels within your organization.

For any organization to function effectively, it has to identify and manage a number of linked activities. All activities use resources (e.g. people, plant, equipment) to transform a process inputs into a process outputs (products). The output of one process is often the input of the next process.

The quality management system (QMS) should be regarded as an inclusive system that describes your business and provides you with useful information (e.g. data analysis), rather than some strange, set of books that the Quality Manager runs exclusively for the benefit of the Certification Body.

ISO 9001:2015 includes specific requirements necessary for the adoption of processes when developing, implementing and improving a management system. This requires your organization to systematically define and manage processes and their interactions so as to achieve the intended results in accordance with both the policy and strategic direction. Certification Auditors will want to determine:

  1. How well is the ‘process approach’ understood in your organization?
  2. Is the quality management system in line with your organization’s context, and requirements of interested parties?
  3. Is it likely the established management system will achieve its intended outcomes and enhance quality performance?
  4. Does it include the enhancement of quality management system performance?
  5. Does it include the desire to fulfil of compliance obligations and objectives?

Some documented information can be used to verify that your organization has implemented all required management system processes. If these are working well for your organization then there is no need to replace them. Existing operational procedures, work instructions and flow charts are valid examples of documented information and can be used to evidence the requirement for ‘documented information to support the operation of processes is being met’.

Check that process inputs and outputs are defined and review how each of the processes are sequenced and how they interact. Look for evidence that your organization has:

  1. Assigned duties/process owners; (Clause 5.3)
  2. Assessed risks and opportunities; (Clause 6.1)
  3. Provided resources; (Clause 7.1)
  4. Maintained and retained documented information. (Clause 7.5.1)
  5. Implemented measurement criteria; (Clause 9.0)
  6. Improved the management system and its processes; (Clause 10.3)

Your organization should begin using quality performance indicators to control and monitor issues, and associated risks and opportunities. These types of objective evidence will indicate that your organization has successfully integrated the quality processes into its business processes.

Evidence may include management reviewing KPI’s as part of regular business reviews, awareness of contractors and employees of QMS goals and expectations, etc.

More information on quality management principles

Customer focus Meeting customer requirements and exceeding expectations
Leadership Establishing strategic direction and operational purpose
Engagement of people Training, knowledge, competence, and empowerment
Improvement Innovation, opportunities, root cause analysis, and ability to react to change
Evidence‐based decision making Data analysis, process performance assessment, and risk-based thinking
Relationship management Maintaining relationships with intertested and providers in the supply chain
 

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