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implementing iso 9001 system

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Developing an ISO 9001 Implementation Plan - ISO Update

Once companies have made the decision to implement a Quality Management System (QMS) like ISO 9001:2015, they are usually faced with a multitude of new considerations and issues to sort through. If you are currently running a successful business, chances are you are complying with a large percentage of the standard, it’s only a matter of being able to prove this to an auditor and document your processes effectively. By developing an implementation plan, you will give yourself goals and action points that will help you and your team efficiently tackle the objective of achieving certification. Working on a thorough implementation plan will not only help break the process down but will also give you a rough idea of the resources and time needed to start implementing the standard.

A bit of preplanning is also required. You will need to determine what your timeline and end goals are and whether they can reasonably be attained. Aim for realistic and practical goals and estimates and consider using generic checklists and “Gap Assessments” that will help you move in the right direction.

Team Approach

A supremely effective method of implementation of ISO 9001 for most companies, regardless of size or nature, happens to be the “Team Approach.” The sizes of these teams can vary from organization to organization, usually 1-2 people per team for smaller organizations vs 5-7 people per team for larger companies. The technique essentially utilizes the concepts of allocation of responsibility to more efficiently utilize resources like time and energy.

Amongst these teams there will be one Steering Team, this is the team chosen to lead the project. The make-up should consist of managers of relevant departments to ensure that the members have the appropriate knowledge and power to allocate further responsibilities within their respected departments. The steering team will be expected to meet regularly and discuss updates and plans. The steering team leader will be the project manager for the implementation and their responsibility will include scheduling meetings and preparing agendas etc.

The steering team will also be tasked with reviewing processes and monitoring the work of task teams. These task teams are expected to document required procedures, modify pre-existing processes and develop new ones according to the framework provided in the ISO standard. There is usually a task team for each system procedure that needs to be created and documented so that the work is efficiently allocated. If you are using a Gap Assessment checklist, it would be wise to indicate the responsible parties for each task on or beside each clause of the standard that they are responsible for. The steering team is also expected to choose a Certification Body for external audit purposes.

You can create any suitable number of task teams; just be sure they are well acquainted with already existing QMS procedures within the company and those outlined in ISO 9001. If this is not the case, consider looking into training courses specifically designed to give participants awareness into the specific standard you are looking to become certified to. Many organizations offer the option to bring their trainer into your office to have a whole team seminar or company-wide seminar to help your organization familiarize themselves with the standard and its purpose within your organization. It is important for your task teams to understand the standard because filling in any possible gaps and updating any outdated processes is a large part of their work. Some company processes will need to be tweaked or drastically changed in order to meet standard requirements; in addition to this, the task team will also be responsible for documenting these changes or any newly added procedures for the purpose of auditing for compliance.

Ideally, a task team will discuss any possible additions and changes during the first few meetings alongside the QMS procedure, any decisions will need to be recorded and sent for approval to the Steering Team.

Planning your ISO 9001 Planning Meetings

Overall, there are a few prime factors to consider before you start your meetings. The most important being to decide on desired procedure implementation according to project goals and setting time constraints for the entire process. Recall that the key to any effective meeting is preparation, this must be handled at both an individual and group level if you aim to see productive results.

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Even if you have an informal quality management system within your business it is often difficult to implement the requirements of ISO 9001:2015. Depending on the size of your business this could be a task that may take six to twelve months to complete depending on the established current systems. It is vital that your staff are fully trained and engaged to make any implementation a success. The following 10 tips are vital to smoothly and effectively implementing an ISO 9001 management system:

  1. Get senior management commitment; while this may sound a little cliché, without the full commitment of your management team throughout the business it is going to be very difficult to drive home the changes and improvements that are required.
  1. Provide training at all levels in the business. Your staff needs to understand not only about the requirements of ISO 9001 but also the different quality principles that they should strive to implement within their every day work. Training should be provided on an ongoing basis according to perceived needs.
  1. Ensure that you have effective internal communication. Without this you are not going to be able to maintain the constancy of purpose that is required.
  1. Establish an implementation team with the authority to make things happen. You cannot just implement an ISO 9001 management system by assigning a management representative and expecting them to do everything in isolation. You need to identify the staff that will be required at all levels throughout the business to craft your system.
  1. Conduct a Gap Analysis; you need to fully understand where your current system meets or fails to meet the expectations of ISO 9001:2015 so that you can allocate resources accordingly.
  1. Involve customers and suppliers in analyzing your current systems. It is important to understand how others view the effectiveness of what you currently do and what they expect from you to improve things.
  1. Plan your implementation fully; responsibilities, roles and schedule. As with any project, the better that you plan it the more likely you are to have success.
  1. Create clear and concise policies and objectives for quality to provide the company with a common direction. Well communicated and understood these will help your company to move forward together.
  1. Encourage everyone to question and improve. It is not enough to only have auditors looking for issues with the systems; everyone should continually seek better ways to do things.
  1. Conduct regular reviews of your ISO 9001 management system through your auditing process to ensure that you are continually improving how your systems function.

In addition to the above, foster a good relationship with your certification body. Your auditor is not there to catch you out. They will want to help you to develop and grow a system that will significantly benefit your business, so use them fully.