Measurable quality objectives have long been a part of ISO 9001. What is new is the requirement to plan actions to make them happen. The plans are intended to be specific and actionable, addressing actions, resources, responsibilities, timeframes, and evaluation of results. Auditors should closely examine how the plans have been implemented throughout the organization, and who has knowledge of them. Just as employees should be aware of how they contribute to objectives, they should be familiar with the action plans.

Dear Nizar Raissi,

The quality assurance model on which ISO 9001 is based is PDCA:

Plan (to do somethings) - Do it - Check (the obtained result(s)) - Act (plan and take some corrective actions if you not achieve the quality objectives)

The new approach underlying in the ISO 9001-2015 is to make preventive risk assessment of the possible hazards (in Plan-phase), which can arise during to Do-phase and lead to failure to achieve the planed Q-objectives. So, if the management make such analysis previously (before spending resources, not once they have spent them), they can foresee in the Q-plan(s) some preventive actions to avoid (or to minimize) the risk of occurrence of these hazards. This would increase the degree of confidence that the Q-objectives will be achieved. All other activities in the preparation of Q-plans remains the same as previous versions of ISO 9001.

With regard to most used risk assessment methods and techniques, you can review ISO 31000 and ISO 31010 standards.

Best regards,

S. Slavov

Dear Nizar,

I am an ISO Consultant and Practitioner for more than 20 years and my experience on ISO Quality Objectives are as follows:

1. Quality objectives are nothing but KPIs for the organization as a whole and or departments or sections.

2. It is the responsibility of the management to establish the Quality Objectives to all the departments and for the organization as a whole as well.

3. In order to be more effective, Quality Objectives (KPIs) should be discussed with relevant HOD and shall be established to ensure accountability and responsibility.

4. Once the HODs agree to their Quality Objectives, then they need to plan, how are they going to achieve these objectives. The planning sheet may contain as many colums depending on the size and complexity of the qaulity objectives. A simple planning sheet may have the following:

a. Sl. no.

b. Description of the Quality Objective.

c. Target date to achieve.

d. Responsible person(s).

e. Plans / action to be taken to achieve the Quality Objective.

f. Remarks.

You can have one or more columns for your periodic review and status updating.

5. What is important is along with the above planning sheet, the evidence of actions taken to accomplish the quality objectives. You need to attach all the relevant reports pertaining to the actions taken.

Following the above protocol will satisfy the Management Representative for the management review meeting as well as the external auditors during the external audit.

Hope this helps and should in case you need further assistance, please write to me to [email protected]

Regards.

Dr. Sekar Gopal.