By now everyone who is certified to ISO9001:2008 knows they have to transition to ISO9001:2015. But it’s all OK, it’s the quality manager who has to make it happen right? And we have time too, there is a long time to changeover.
Actually no, there isn’t that much time and the quality manager can’t do it alone. ISO9001:2008 will cease to be a viable standard in September 2018, that is less than two years. If your company has a lot of cultural adjustment that is not much time at all.
The new standard places much greater emphasis on top management involvement, placing greater responsibility for the quality management system on top management. this means that although top management can delegate authority for certain tasks, responsibility for making those things happen can’t be delegated.
One example is responsibility for the QMS, the standard says top management is responsible for demonstrating leadership and commitment by ensuring the integration of the quality management system requirements into the business processes. This means that authority for ensuring that the business processes meet the needs of the QMS rest with the individual process owners, not simply the quality manager. If your production manager isn’t committed to the QMS and has a habit of regarding the QMS as the quality managers job there will be a problem during audit. Also, the previous quick tidy up just before an audit will be unacceptable. There must be a consistent approach to the QMS evidenced all year round. The requirement is for integration of QMS requirements into the business processes – if the business processes operate every day, but the QMS activity all happens in the month prior to an audit, there is a clear dysfunction.
The new standard also does not require any mandatory procedures. I hear you cheering, but before you make a bonfire out of your manuals there is a catch (isn’t there always!). If there is no documentation the auditor has to interview top management and the staff operating the process to check that there is a common view of what is to be done, roles and responsibilities and a consistent methodology to carry out the process. Interviews take time and it has been reported that some certification bodies are adding between half a day and a day to the audit requirements where documentation is minimal. Consider as well how easy it will be to ensure that all of your staff from managers to shopfloor not only operate the process in the same way, but describe it similarly enough to be recognisable as the same process.
Bear in mind these are only two aspects of twenty-two specific responsibilities placed on top management in clause 5 – Leadership.
Another new clause is 7.1.6 Organisational Knowledge. This mandates that an organisation will determine the knowledge necessary for operation of its processes not only now, but also in the future. This includes identifying what new knowledge and skills will be required to address the changing needs and trends of its business environment. Further changes addressing the need to consider products and services and ensure that key performance indicators are identified and where deemed appropriate, monitored and measured mean that this version of the standard really does have to integrate into the business operation.
Another addition is included in the way businesses think about their processes. In addition to arranging the processes in order and linking them logically, it is also necessary to identify the process inputs and outputs. In order to do this the process owners have to understand how the processes link together. If it isn’t done, don’t blame the quality manager; the responsibility for making it happens lies with top management, which means that the process owners have to be involved.
This is not a thorough review of the implications of ISO9001:2015, it is only intended to give a flavour of the challenges ahead. If this sounds like a task you would appreciate some help with, contact me at Tamarind Tree Consulting – I can help. Head over to my website where you can see my experience and contact me through the website, or message me on LinkedIn to discuss how I can help you meet the September 2018 deadline for transition.