You may have already heard that changes are being made to the ISO 9001 Quality Management Standard, and that these changes will come to force sometime in 2015. With these changes come the 'buzz' words: "process based management"; "process based auditing" What do they mean? What will we need to do? How will it help us? Let Certex decode it for you.
What is a process approach?
Exactly what it sounds like: a sequence of activities that produce a result. A process can be delivering a service or building a product, preparing an invoice, training staff, or ordering and receiving supplies. A process usually includes an input, an activity and an output. Example 1: Process for recruitment staff - Inputs: a role to be filled as defined by a position description and potential candidates for the role. Activity: review and assess candidate suitability for the role. Output: suitable candidate selected for the role. Example 2: Process for building a fence - Inputs: fencing materials, fence building equipment, plans. Activity: build the fence. Output: a suitable fence built in the right place A process can be an operational activity, as shown by these examples, or it can be a management process such as dealing with and resolving a complaint, or a supporting process such as training the fencer and the recruiter to conduct the activity properly. A process approach focuses on the processes within your business. Often, we employ this without even realising it: processes are just what businesses do. That is, your business can often be described by the processes that you undertake. Consider, for example, about what you teach someone when they are starting a new job or new responsibility in your business. You are teaching them about the process that they will be following.
Quality and the Process Approach- Why the ISO9001 Was Created
The process approach is fundamental to quality management. Quality management seeks to implement quality into each of your business processes, by focusing on accuracy, consistency and reliability. Common quality objectives include minimising or eliminating wastage, reducing errors and rework, as well as enhancing customer satisfaction and retention. Over time, we realised that there were some processes that were common features of good quality processes. These included:
- Defining the processes so that they can be delivered accurately, consistently and reliably.
- Having the right equipment in good working order
- Having suitably competent staff
- A proactive business that is ordered about the way it analyses problems so that it can implement improvements more effectively compared to a business that makes changes in an ad-hoc or random manner.
Auditors were asked to provide an independent assessment of these and other examples of the level of quality in processes, so that businesses could confirm to its customers that their products and services were built using good quality processes. The ISO9001 Quality Management Systems standard was designed as a way of assessing the level of quality built into processes. It is a set of quality principles that auditors can refer to so their assessments are consistent and fair.
Rationale for the Upcoming Changes
Over the years, the intent behind the 9001 standard became misunderstood: it became the set of clauses that businesses used to describe their quality management system and businesses developed their Quality Manual based on the clauses in the 9001 standard. They'd often even apply the same clause numbering of the standard. Sure, this made life easier for the auditor, but a business could not be run according to these clauses because they were not the processes of a business. This is perhaps where we started to see the classic situation where the Quality Manual would be brought out when the auditor arrived, then put away again in the bottom drawer to gather dust until the next visit. Worse still, a Quality Manual that has been based on the clauses of the 9001 standard has the potential to distract a business from understanding its real processes. It may not see the need to define and manage its real-life operational processes because it may believe the Quality Manual already does so.
9001:2015 and the (new) Process Approach
This problem was recognised, but despite addressing it in recent versions of the 9001 standard, the situation was not being fully understood by businesses or auditors. The current version of the 9001 standard- 9001:2008- describes a process-based quality management system approach as one which links the various processes in a business and which delivers products and services that meet the needs of customers. It refers to the Plan-Do-Check-Act methodology which continually supports improving process performance. Despite this focus on business processes, the confusion over the clause-based approach and the process-approach to a Quality Manual has continued. Next year, a new version of the 9001 Quality Management System standard will be released. Although we don't yet know all of the details, we do know that this new standard will reinforce the process based approach to quality management. We expect it will also confirm the standard cannot be taken to be a model for documentation of a business's processes. We understand that the structure of the standard will be quite different, and is likely to emphasise the activities of the business instead of the criteria for a quality audit. At this stage, these sections include:
- Leadership, Planning - policy, management commitment, objectives and planning.
- Support - resources, competencies and documentation.
- Operation - producing goods and services, customer interaction, managing non-conformances.
- Performance, Improvement - monitoring, internal audits, corrective action and improvements
What does this mean for you?
If your Quality Manual and supporting documentation is already not process-based ,then you're probably going to have a bit of work to do. If your management, operational and support processes are not already well defined, then you'll likely need to fix this. You may need to identify then define your processes and ensure they are aligned and consistent. This exercise may also include documenting and ensuring your staff understand this new approach. The upside to this is that you should then have a quality management system which truly sets out what you do, how you should do it, and checks that you do it the right way. The process based approach brings even more changes for external auditors. If we have ever fallen into the bad habit of matching the clauses in your Quality Manual against the standard, then the new changes will put a stop that straightaway. We will need to understand businesses and processes, we will need to assess how well a company's processes are designed and aligned, how well they are planned and controlled, and how well the outputs meet customer requirements. If both of us - you, the business, and we, the auditors - have already been working to a processes management and process audit approach then the changes will not be so significant. There will be a three year transition period during which businesses can shift their quality management system from the 9001:2008 to 9001:2015 requirements. Between now and there will be much public discussion and many seminars and training courses offered. As your accredited certification body, Certex will keep you fully informed of the new requirements as they are made public. We are also planning a series of training sessions and webinars designed for businesses and for consultants and auditors. If you would like to register your interest for these please click here. There is no obligation, but we will be sure to advise you of the sessions.