ISO 9001:2015 – Preparation & implementation under the new structure.
Read this blog to learn more about one of the most important changes in ISO 9001:2015 - taking a process approach to a quality management systems.
In September this year a new version of ISO 9001 was released. This update is not only the first since ISO 9001:2008, it is also the first major revision since the year 2000 when the three previous standards - ISO 9001, ISO 9002 and ISO 9003, were consolidated.
ISO 9001:2015 was created because significant changes in technology, business diversity and global commerce have occurred since the last version of ISO 9001 was released. These include:
- Increasingly complex, demanding and dynamic environments in which organisations must operate.
- Changes in technology which have changed how we work.
- The rapid growth of the service sector.
- A greater focus on controlling business risk outside the traditional financial arena.
- Increasingly complex global supply chains in which suppliers are more physically distant from their customers.
- An increase in the adoption of work, health & safety (WHS) and environmental management systems and the concurrent need to integrate these with quality systems, and indeed business management systems, in line with the strategic objectives of organisations.
The key changes.
To ensure that ISO 9001 continues to serve the business community and maintain its relevance in today’s market place, the key changes include:
- An increased emphasis on designing a management system that meets the particular needs of your organisation.
- Greater involvement by the leadership team to ensure alignment between the quality management system and business strategy, and greater accountability.
- An increased focus on risk based thinking as a means of identifying business strengths, weaknesses, opportunities and threats that contribute to bottom line improvements.
- The recognition that knowledge has become the key to the success of any organisation. Knowledge is the energy fueling businesses and this is increasingly the case as complexity and the rate of change increases.
- A much greater emphasis on process as a powerful way of organizing and managing activities to create value for the customer - removing departmental barriers.
- A new common structure and core text that makes it easier to integrate multiple management systems.
The most important change.
We don’t have time to go through all the key changes in ISO 9001:2015 in this blog, so I’m going to focus on the most important one – process.
It’s the most important change because it will have the biggest impact on the profitability of businesses. I have witnessed, and been a part of, organisational change that enabled staff to see who their internal or external customers are, their needs, how to best meet their needs, to measure how well their processes perform, and how efficiently. This has been achieved through the development of a process based quality management system.
The process approach to quality management systems.
So what is a process based quality management system? To know that, we need to clarify what a process is. There are many definitions out there, and they are all fairly similar, but the one I like best defines a process as a "Set of activities that interact with one another. Processes use resources to transform inputs into outputs. They are interconnected because the output from one process often becomes the input for another process."1
Organisations have, for example:
- Marketing processes.
- Design processes.
- Sales processes.
- Purchasing processes.
- Service delivery processes.
- Manufacturing processes.
- Complaint handling processes.
- Communication processes.
- Training processes.
The list goes on and on, especially when you consider that these processes can be broken down into smaller processes.
The requirements for this process approach to quality management systems were not clearly spelled out in either the 2000 or 2008 versions of ISO 9001. The new standard changes this. Clause 4 clearly specifies what is expected. For example it says you must identify:
- Your business processes, the responsibilities for the activities within these processes, and who is to be held accountable for each process.
- The inputs the processes need and the outputs they will provide.
- The resources the processes require in order to thrive.
- How process performance will be measured and monitored.
- The risks to product, service and customer satisfaction if the process doesn’t work.
- How you can improve your processes (and then do so).
The list is quite extensive. While most of these requirements could be inferred from various parts of the previous standards, the clearly articulated concentration of them in a single clause means that they cannot be overlooked.
So what is a processed based quality management system? It uses a systematic approach to manage and control how its quality policy is implemented and how its quality objectives are achieved. A process based management system is a network of interrelated and interconnected processes. Each process uses resources to transform inputs into outputs. Since the output of one process becomes the input of another process, processes are interrelated. Together, these process interactions create a process based quality management system.
ISO2 summarizes the benefits of the process approach as:
- Integration and alignment of processes to enable achievement of desired outcomes.
- Ability to focus effort on process effectiveness and efficiency.
- Provision of confidence to customers, and other interested parties, about the consistent performance of the organization.
- Transparency of operations within the organization.
- Lower costs and creation of shorter cycle times, through the effective use of resources.
- Improved, consistent and predictable results.
- Provision of opportunities for focused and prioritized improvement initiatives.
- Encouragement of the involvement of people and the clarification of their responsibilities.
Effective process management.
Now that you know what a process approach to a quality management system means, how do you actually create one? Well that’s a whole other blog, but firstly, we need to recognize that a quality management system is not about procedures and policies. It’s about people, and our people are inundated with data and information. We need to make knowledge simple.
Too many people in my industry are stuck in the 90’s (or even the 80’s). Your staff deserve to find and access relevant and readable process guidance when they need it, it needs to be easy, and it needs to be in a central repository – a single source of truth. Talk to me or the team at Nintex Promapp about how you can create a process based management system.
Looking for more insights into how to prepare for certification under ISO 9001:2015? Watch the webinar!
About the author.
Liz Murphy is the Managing Director of Grow EQ, managing a team of over 7 highly experienced consultants providing high quality, simple to understand solutions for organisations to reduce risk, improve performance and grow.
With over 20 years of operational experience from supervisory to senior management levels, Liz has a strong reputation for her ability to work effectively with personnel from the CEO to front line operational staff. As an expert in her field, she provides high quality solutions that are simple to understand and delivered on-time and within budget. Liz keenly promotes knowledge transfer to those she works with thus empowering your staff and making them self-sufficient.