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.
ASQ Senior Member, CQT, CQI
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:
• 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
• Documentation of these inputs
• Preparation of an output in a format appropriate to the organization
• A comparison of the outputs with the input requirements and an approval, if required
Outputs should include process monitoring and measuring requirements
• Outputs can include verification, design review and validation*
• A mechanism to handle process design changes
Voting member of the U.S. TAG to ISO/TC 176 – Quality Management and Quality Assurance
Our company currently holds dual certifications to API Q1 and ISO 9001:2008 that are not set to expire until November 2017. When making the transition to ISO 9001:2015 and re-certifying in November 2017, will we be able to do dual certifications or will we have to do API Q1 separate from ISO 9001:2015?
Thank you for contacting ASQ’s Ask the Experts program. In response to your inquiry, the timing for transitioning your existing QMS from ISO 9001:2008 to ISO 9001:2015 is dependent upon your Registrar’s timeline to begin issuing ISO 9001:2015 certifications. I highly recommend that you discuss this subject with your Registrar to determine how and when this transition will take place. In my professional opinion, this transition process may be similar to the recent move from API Q1, 8th edition to API Q1, 9th edition.
Since your current certification expires November 2017, transitioning sooner rather than later is recommended. Especially since unlike API Q1, the ISO 9001 certification expiration date cannot be extended.
I hope this helps.
Bill Aston, Managing Director
Aston Technical Consulting Services, LLC
800 Rockmead, Suite 170, Kingwood, TX 77339
Office: (281) 359-2827