In clause 6.3, the standard specifies when your organisation sees a need to make changes to the QMS, the changes must be carried out in a ‘planned manner’.
How to carry out changes in a planned manner
When doing so the organisation must consider:
- The purpose of the changes and the potential consequences;
- The integrity of the QMS;
- The availability of resources;
- The allocation or reallocation of responsibilities and authorities.
Changes must be planned out properly and then acted upon. The standard has a consistent theme across all of the clauses, planning is important! Jumping ahead can lead to simple mistakes that could have been easily avoided with a little extra planning.
Even though this clause doesn’t require documented information, Auditors will look for signs that your organisation has considered the details in clause 6.3 when planning and implementing changes to the QMS. 4.4.1g and 5.3e both refer to changes made to the QMS.
You must evaluate the need for the changes and a person or team must be assigned the role to ensure the integrity of your QMS is maintained when changes are planned and implemented.