ISO 9001 and Growth: Everything You Need to Know

ISO 9001 is a system and process management model, and it’s embedded into industry and business. The principles are hard to argue against and fight it as you will, it’s not going to go away.

There are many impacts of organizational growth on the management system.  There are also some impacts of ISO 9001 on growth.

ISO 9001 on Organizational Growth

If you are going to grow as an organization, then the best way to do it is under defined and controlled conditions. Know and plan for what will get bigger – and know and plan for how it happens. When you bring new people into the organization, you will train them, coach them, and build them into your organization to perform the activities needed to be successful. If the activities and processes are defined by controls such as templates, forms, and data structures, that will cause them to follow a consistent approach, then come into your organization and get on with it. Growth is in each. You don’t need to manage every single individual. You don’t need to lead, inspire and encourage because the solution is defined.

New people always ask about what is expected of them. They always want to impress, show they are better than the status quo, and deliver more than what currently exists. Given the opportunity, they will depart from “normal” with their version of better. Sometimes it is. Often it’s just different. Two new people and you get two new ideas or five. Growth brings variety and differences – lacks consistency and reliability.

The easiest way to grow is to do so with clear, defined, and consistent processes and activities. ISO 9001 delivers this for you.

Organizational Growth on ISO 9001

Organizations grow. Its usually wished for, although not always planned. Timing is rarely in accordance with a schedule. It’s traditionally welcomed and desirable. Often different groups and responsibilities in an organization don’t communicate growth and expectations very well. Companies may not discuss the plans or hopes for change beyond the Sales department, and budgeting may not reflect new successes.

Growth can bring change, and more often, that change is undertaken quickly, cutting as many corners as necessary. People are overworked and busy – they don’t have time to deal with the details. It’s hard to argue with the need to focus on the outcome. One typical victim of all this growth is the management system. Procedures are changed to accommodate new products or services, quicker ways of working. Documents and controls are often never updated, and success can depend on the inspiration of leadership rather than the discipline of controls. As the dust settles – work subsides, or the dust settles in a more extensive business configuration, the lack of discipline and management will continue to have its impact. Some people will escape the extra effort, and that inspiring leadership will disappear. The problems of lack of discipline, consistency, and reliability will expand.

Having disciplines in place before the growth and then sticking to them, following them, maintaining them will allow development to take place. Maybe it won’t be as quick – perhaps it won’t be as free-spirited, but slow,won’t, and steady wins the race. Growth without discipline can be in the wrong direction.

ISO 9001 requires a formal approach to growth (any kind of change). It requires that the impacts, opportunities, and risks that growth brings be considered, and rational controls are put in place to best address the uncertainty. It “expects” those controls and actions to be systemic to accommodate growth, so the growth itself doesn’t negate the processes and controls that exist to support it. Any organization that has 9001 is required to review, plan, communicate and ensure change is effective. Deliberately. Growth is not an excuse.

It’s not always as clear-cut as this, and ISO 9001 is not the “everything” for growth and development in organizations. However, but the principles behind ISO are solid, and discipline brings more reliably known outcomes.

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Upgrading to ISO 13485 from ISO 9001