Developing an Implementation Plan for your New ISO 9001 QMS
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.
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.
ISO Terms Explained
To the novice quality manager, ISO jargon can be extremely overwhelming. What is an NCR? What do you mean by OFI? Are we certified or accredited? But before you go and pull out your hair, let’s take a moment to go over some of the most frequently used terms and their definitions with regards to ISO and Management System Certification.