In order to ensure that an organization meets quality, health & safety, environmental and information security etc. requirements many national and international standards have been formulated against which the organization can certify itself. Developing the documentation is the major requirement which consists of Quality Manual, Standard Operating Procedures (SOPs), Job Instructions, Work Instructions, Forms for recording business activity and Business Process Flow Charts. The organization has to ensure that the SOPs are being followed, the forms are being filled meaning quality activities are being performed and the staff is trained in its work. The ISO Consultant plays a very major role in preparing the documentation for the organization. Without the Consultant the project would run by experimentation and would most likely fail.

Difficulties in getting certified

Documentation development is a time consuming and difficult job and is usually done by the ISO Consultant by taking on the job interviews and discussions with line managers in how they do their jobs and understanding the business processes at the shop floor level. The Consultant or the Management Representative (MR) or ISO Implementer has to understand the requirements of the international or national standard and apply it on the processes of the organization and mould the processes according to the requirements of the standard.  Translating the requirements of the standard into Standard Operating procedures is a difficult task and requires considerable experience and training. The Management Representative has to have a technical mind and have good language skills so as to understand the legal requirements in the standard. If the MR has prior experience in the same business field and with the same standard then many difficulties will be solved easily. If the MR has Lead Auditor training in the standard being implemented then that will also solve problems in implementation.

Change in the knowledge and attitudes of the workers and managers is another difficult aspect of bringing them around to the new way of doing things. For this purpose the Consultant or the MR should conduct training sessions in the standard being implemented. The training can be conducted either in-house or outside the organization like the Consultants office or in any hotel meeting room.

Cultural change has to be brought about in the organization. Efforts have to be made to make the employees accept the new procedures and ways of doing things. The labour and the managers may be comfortable with the old way of doing things. So making a change to a new way will be difficult for them. The MR and the top management have to sell the new system to the employees and the top management has to support the MR in raising awareness and in resolving blockages by employees.

If quality circles are to be created then teamwork is required. The quality circle has to meet and find ways of improving the processes. The quality circles are made of cross functional employees who are concerned with the process. The quality circles have to be supported by the top management and given powers to make changes. They have to be given time off from their daily schedule for the meetings.

Simple statistical techniques and graphical representations have to be made to understand the frequency and behavior of defects. They are used to find out the areas with most defects which are then targeted for improvement. The 80/20 rule or Pareto Charts helps focus on the maximum problems occurring in few areas. Training in statistical techniques have to be provided to the production supervisors so that they can develop process control charts on their own so as to monitor processes.

Filling in the forms during the implementation of Standard Operating Procedures is a time consuming and laborious job and sometimes leads to excessive documentation. The MR has to push the employees to fill in the forms for recording business activities so that data can be collected about the performance of the processes. The Management Representative has to check the implementation of SOPs in each department and further explain the SOPs to the concerned personnel.

As changes are made in the documentation, it is the job of the Management Representative to provide new copies of the updated documents at all locations where the document is kept in the departments and follow the Procedure for the Control of Documents and Records.

The Management Representative and selected staff have to be trained in Internal Audit by the ISO Consultant or other training organizations. After the training they have to carry out internal audit of the implementation of the ISO standard in the organization to find out the level of implementation and understanding. First they have to develop an Audit questionnaire based on the standard and the SOPs. They have to find out the level of implementation of the standard as well as the level of implementation of SOPs developed from the standard based on the organizations business processes. They have to visit each targeted department and ask questions and examine records. Then they have to prepare an audit report for presentation to the top management. Based on the findings of the internal audit, if the organization feels confident then it goes for the external third party audit and certification.

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