ISO 9001:2015 Gap Analysis Tool
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1 ISO 9: Gap Analysis Tool Supplemental information for conducting a ½ day workshop to complete the Gap Tool. 43 companies saved and counting as of June 6!
2 Overview The Gap Tool provides your organization with a framework for completing an initial evaluation to determine the level of complexity of transitioning your QMS to ISO 9:. The tool is intended to be completed in a workshop environment. The workshop is carried out using a multidisciplinary approach where every process of the QMS is represented, including a representative of top management is required. The published standard for both ISO 9:8 and ISO 9: will be available during ½ day workshop. It will be most beneficial if all participants read both standards before the workshop. The output of this ½ day workshop will become the input for an implementation project planning process. Activities Westart with an analysis of Annex A of ISO 9:, which provides context and an understanding of the new features of ISO 9:. A discussion will take place to ensure a common understanding is achieved by all participants. 43 companies saved and counting as of June 6!
3 The next activity will be focused on understanding the fundamentals of a QMS by reviewing Section of ISO 9:. Special attention will be given to the new Quality Management Principles. There will be a discussion regarding the comparison of the guidance provided in Section against the current status of your QMS based on ISO 9:8. When we are completing the Gap Tool during the ½ workshop, the first activity will be to review the Introduction of ISO 9:. We will complete the Gap Tool by clause (i.e. complete all of clause 4, then complete the following clauses). Completing the Gap Tool Column One: Clauses of ISO 9: are listed. Column Two: Indicate whether the clause is a new requirement. Column Three: List applicable processes. Each process owner should indicate if the requirements are applicable to her/his process. This is a very important part of the Gap Tool and requires that every process owner carefully review the requirements in each clause. Column Four: Each process owner is to assess the current level of implementation of the affected 43 companies saved and counting as of June 6!
4 process on a scale of - with representing fully implemented and representing nothing in place. Not every process will have the same values. Column Five: Indicate the rationale behind the assigned value in the previous column, level of current implementation. Column Six: Each process owner is to assess the level of difficulty associated with implementation of the affected process on a scale of - with representing not difficult and representing very difficult. Again, not every process will have the same values. Column Seven: Indicate the rationale behind the assigned value in the previous column, level of difficulty to implement. Column Eight: Indicates the level of complexity to implement each process. The value for the level of complexity is the result of multiplying the values listed in the fourth and sixth columns. Level of complexity can range from - with being the lowest level of complexity to implement and being the highest level of complexity to implement. Green, yellow and red colors are used to provide a visual understanding of the level of complexity. This value can be used to identify in which processes the implementation project should focus and will also assist in the determination of the resources needed. Example of Gap Tool - (next page) 43 companies saved and counting as of June 6!
5 Claus e Is this a new requirement? Yes/No/Partiall y Process(s) Affected 8..3 Partially Incoming Level of current Implementatio n 3 Justification Customer property is already controlled but suppliers' property is not controlled. Level of difficulty to implement = Not Justification The current controls can be used for property belonging to the suppliers. Level of complexit y to implemen t 6 Shipping Customer property is already controlled and there is not any suppliers' property. A review of the current controls will be required to ensure conformity. Purchasin g No consideration is given to suppliers' property in the process. 3 A thorough review is needed for all activities in the process, including the current policies. 43 companies saved and counting as of June 6!
6 Level of Implementation Example of Complexity Matrix Level of Difficulty 43 companies saved and counting as of June 6!
7 Conclusion The Company Doctors Gap Tool allows your organization to identify the differences that need to be addressed between your organization s current QMS and the new ISO 9: standard. As well, the Gap Tool can be utilized as a key input in the planning process for the implementation of ISO 9:. By completing the Gap Tool & workshop you will learn how processes are interrelated through all the requirements of ISO 9:. The Gap Tool can be utilized by organizations currently certified to ISO 9:8 and organizations seeking new ISO 9 certification. 43 companies saved and counting as of June 6!
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