#ISO 9001: 2015 Deliverables and Processes

Under the revised ISO 9001 2015 standard, what do you see as the key deliverables and processes owned by the Quality manager or QA department?

A project or process is made up of primary components aimed toward successful completion of the project/process objectives.  Those individual components are the deliverables.

In other words; you have Inputs and Outputs. An Output is a deliverable resulting from the process (Input).

The old aphorism Everyone is responsible for quality is strongly encouraged throughout ISO 9001:2015. Therefore, with the adage of Risk Based Thinking to the new standard, the Quality manager and the QA department would be responsible for the deliverables of their department and its processes. They would also be responsible for discerning any risks to the company s goals and objectives.

Bud Salsbury

ASQ Senior Member, CQT, CQI

Takco Manufacturing

Phillips, WI

ISO 9001: 2015 Design and Development Clause

We are service providers in NDT and inspection field. I want to know how to implement the design and development clause from ISO 9001-2015.

There are two ways to approach this:

One is to use the process developed in ISO 9001:2008, 7.1 where you probably have a “quality plan” for the execution of the service delivery (ISO 9001:2015, 8.1).

The second approach is to design the process itself (ISO 9001:2015, 8.3).  That involves these activities:

INPUT

• Development of a design plan

Who will do what when with what?

Necessary control points

• Identification of customer requirements as inputs, along with inputs from similar previous service offerings

• Identify any special service characteristics, such as safety issues, regulatory compliance

Consequences of failure

• Identify products/services to be purchased/outsourced

THROUGHPUT

• Preparation of an output in a format appropriate to the organization