Guidance

Plan your management system

The ISO Navigator™ database hyperlinks the ISO 9000:2005 principles and the ISO 9001:2008 requirements; and explains them in plain English with practical guidance.

If you're looking for more up-to-date guidance on ISO 9001:2015, ISO 14001:2015, and ISO 45001:2018, click here.

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.

ISO 9001: Process approach

For an 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.