Check that process inputs and outputs are defined, and review how each of the processes are sequenced and how they interact.
ISO 9001:2015 includes specific requirements necessary for the adoption of the processes approach when developing, implementing and improving a management system.
This requires your organisation 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. Although ISO 14001 and ISO 45001 do not ‘specifically’ require the adoption of the process approach, both standards do infer its use.
A process model explains the key processes of the business and how each relates and links to the others. The depth of process explanation may be as detailed as the company chooses but should be based on its customer and applicable regulations or statutory requirements, the nature of its activities and its overall corporate strategy.
I suggest that you map out which departments and functions are responsible for executing each element (from Section 4.0 to Section 10.0) of the standard as it applies to each process. You are trying to determine:
​
How well the ‘process approach’ is understood and deployed within the organisation;
How well the management system aligns with the organisational context and the requirements of interested parties;
How likely it is the management system will achieve its intended outcomes and enhance environmental, safety & quality performance;
Identification of the processes needed for the management system (e.g. process models, process grouping, process flow diagram, etc);
Management system processes and their sequence and interaction (e.g. process mapping, turtle diagrams, etc);
What information exists to ensure effective operation and control of the processes (e.g. defined process requirements, defined roles, required competencies, associated training, guidance material, etc);
How the expected inputs and outputs from each of the identified processes, together with assignment of responsibilities and authorities, are aligned;
The necessary criteria and methods to ensure effective operation and control of the processes (e.g. process monitoring indicators, performance indicators, target setting, data collection, trend analysis, audit results, etc);
The arrangements for governing the processes (e.g. process reviews, dashboards, risks and opportunities relating to the process, resource needs, user training and competency, continual improvement initiatives, frequency of reviews, agenda, minutes, actions, etc);
The organisational approach towards continual improvement and the type of action taken when process performance is not meeting intended results;
How the capture of customer, statutory and regulatory requirements is achieved, and the method used to build these into the Management System (e.g. requirements capture, gap analysis, requirements embedded into the process definition, assigned contract assurance instructions, formal links to information, use of specified documentation, etc).
Existing operational procedures, quality manuals, 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.
Your organisation should begin using quality, health and safety, and environmental performance indicators to control and monitor issues, and associated risks and opportunities. These types of objective evidence will indicate that your organisation has successfully integrated your management system processes into your business processes.
​
If you would like to look at how to implement an ISO 9001 quality management system, then simply contact us.
Or, if you want to see what's involved in more detail, then get a completely free, no obligation, totally tailored ISO Gap Analysis for your business (only available to UK businesses).
Article originated on The Ideas Distillery blog
ISO News is an aggregator of global media. All the content is available free on the internet, we have just arranged it in one platform for educational purposes only. In each article, the hyperlink to the primary source is included. All trademarks belong to their rightful owners, all materials to their authors. If you are the owner of the content and do not want us to publish your materials on our website, please contact us by email – ISOnews713@gmail.com and the content will be deleted within 24 hours.
