There are 5 basic steps to becoming ISO 9001 certified and each step presents their own challenges. Every organization that wishes to be certified is required to first prepare themselves by understanding all aspects of ISO 9001. Knowledge of the differences between the current standards and what is needed to achieve ISO 9001 certification. The assignment of an ISO management representative, typically a senior manager who has sufficient authority to change the procedures currently in place can be used. These management representatives will require some training to understand and be able to fulfill their roles. This is why many organizations choose to outsource the process to a consultant who knows the procedures and can make the journey smoother, including the challenges involved.

Once a business has prepared for the certification process, the documentation step begins. ISO 9001 has numerous technical requirements that the documentation should adhere to. Therefore, writing the manuals and policies can be drawn out process with numerous drafts until all requirements to.

The ISO 9001 standard requires the following documents:

•    Quality Policy
•    Procedures
•    Scope of Quality Management System
•    Process Map (Flowchart)
•    Quality Objectives
•    Work Instructions
•    Forms

Work instructions describe specific details on how to fulfill each task within the business. While forms are either records (filled in documents) or work instructions (before they are filled in) and specific to the business so ISO 9001 does not provide explicit requirements.

It is in this second step and the third step – implementation – that the hardest challenge presents itself.  

The certification process requires the involvement of every member within an organization. ISO 9001 states that communication needs to be transparent and visible to all. From directors to employees, all members are required to be involved in the documenting process, as well as the implementation of the new procedures. It is the responsibility of the directors and managers to let everyone in the organization know what is involved in the process. They are required to communicate goals and the milestones then listen to feedback from the employees involved. Senior management is not always hands on so they will mainly rely on their employees to provide the necessary information to complete documentation, if not have employees complete the documentation themselves.

However, sometimes members of an organization can be resistant to change. If an organization has not been through a certification process previously the change in procedures and training can be overwhelming. If management is not open in discussing the process and making clear the organization’s intentions then the workforce may not be understanding as to why the need to change what is common day practice.

On-going support is required to keep the workforce on track and to avoid slipping into old habits. For management, this can be an additional workload that they may not wish to take on, and therefore not fully be engaged themselves. Implementing the new procedures may require additional training, which can affect workloads, and cause frustration amongst members of the workforce.  

Documentation and implementation can be a long process and involves a lot of input, therefore the engagement of all members of the organization is essential. Without complete engagement, there are risks of mistakes and can be detrimental to the organization as a whole. An engaged workforce brings forth any issues that management may not be aware of, reduces mistakes and the need to re-work documentation or procedures. Employees in return feel respected, motivated and more likely to stay with the organization. With everyone on board with the certification process, it can go a lot smoother and quicker, and the continued engagement and open communications can also improve the operating standard of the organization long term.