B
1) Strategic Direction (SD) does not have to be published to the employees of the organization because top management may have a SD to sell the company so it could be just information maintained by the company president. Within my organization it’s just part of management review records.
2) Don’t overthink the requirement because TC 176 didn’t, they just through the term into the standard without even the courtesy to explain it. Your management review record could just simply say that the quality policy and objectives where reviewed and found to align with the context of the organization and its strategic direction. If they did not, then report that a change to the quality policy, objective or strategic direction was made for better alignment.
3) For my organization we created a “Context of the Organization” top level procedure which states that the items previsions identified are linked to SD and will be reviewed during the regularly scheduled management review meeting. The ISO 9001:2015 requirement is part of 9.3.1
4) Questions that may be asked during an audit could be:
5.5.1- Has the organization established and maintain the quality policy and objectives aligned to the strategic direction, e.g. context of the organization, external/issues (see 4.1).
5.2.1- Has top management provided the provisions for establishing the quality policy that aligns with the context of the organization (see 4.1), e.g. purpose, strategic direction etc.?
[FONT="]6.2.1 – Does the organization maintain documented information to demonstrate that the quality objectives are consistent with the quality policy (see 5.2.1) to ensure that they underpin the strategic direction of the organization?[/FONT]
9.3.3 – Does the documented information of the management review indicated that the QSM is suitable, adequate and effective in its alignment with the organizations strategic direction?
2) Don’t overthink the requirement because TC 176 didn’t, they just through the term into the standard without even the courtesy to explain it. Your management review record could just simply say that the quality policy and objectives where reviewed and found to align with the context of the organization and its strategic direction. If they did not, then report that a change to the quality policy, objective or strategic direction was made for better alignment.
3) For my organization we created a “Context of the Organization” top level procedure which states that the items previsions identified are linked to SD and will be reviewed during the regularly scheduled management review meeting. The ISO 9001:2015 requirement is part of 9.3.1
4) Questions that may be asked during an audit could be:
5.5.1- Has the organization established and maintain the quality policy and objectives aligned to the strategic direction, e.g. context of the organization, external/issues (see 4.1).
5.2.1- Has top management provided the provisions for establishing the quality policy that aligns with the context of the organization (see 4.1), e.g. purpose, strategic direction etc.?
[FONT="]6.2.1 – Does the organization maintain documented information to demonstrate that the quality objectives are consistent with the quality policy (see 5.2.1) to ensure that they underpin the strategic direction of the organization?[/FONT]
9.3.3 – Does the documented information of the management review indicated that the QSM is suitable, adequate and effective in its alignment with the organizations strategic direction?
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