Setting quality in a service that an institute provides

Let us apply ISO 9001:2015 clauses 4.2, 4.4, 4.1, and 6.1 to help me in developing the answer.

4.2 - What is the institute’s purpose? Why does it exist in the first place? Whom does it serve? What are their needs and expectations? An institute, like any other organization, has to serve its “customers” (even if they are not the ones who pay) and its patrons (the ones that pay, maybe the government and private donors, for example). These groups also have needs and expectations. And the service may have to be provided under a set of regulations that act as constraints. So, list the more relevant needs and expectations. You see, after all the noise and bells and whistles, the institute exists to provide, to answer, to deliver on those needs and expectations.

From here you can define and characterize the set of services that are provided by the institute, and their outcomes, their service specifications.

4.4 – What kind of processes are needed to systematically provide the desired outcomes according to specifications? Develop the model of your organization based on the process approach.

4.1 – Is it easy to deliver on those needs and expectations? While answering this question reality sets in. The institute is placed in a certain context with internal and external issues. Perhaps there is not enough money, perhaps there is a lack of staff, perhaps “customers” don’t collaborate, perhaps there are voluntaries that can be called to help, …

6.1 – when you confront the relevant needs and expectations of the relevant interested parties with the internal and external issues from the context you can determine risks and opportunities. What can help you or hinder you in meeting the desired outcomes according to specifications? You can use the most relevant risks to develop a Quality Plan – what needs to be controlled, what needs to have work instructions, what needs to be recorded, what kind of training is needed, … this way you are starting to design your quality management system not based on mambo jambo, but in what really matters to the purpose of the institute and its interested parties.

You can find more information below:

• About context and interested parties you can see this free webinar on-demand - ISO 9001:2015 clause 4 - Context of the organization, interested parties, and scope - - where I present examples of internal and external issues and how to determine them, and examples of interested parties and their requirements and expectations.
• About mapping and risks, you can see this free webinar on-demand - The Process Approach - What it is, why it is important, and how to do it - https://advisera.com/9001academy/webinar/iso-9001-process-approach-free-webinar-on-demand/
• About risks, you can see this free webinar on-demand - How to implement risk management in ISO 9001:2015 - https://advisera.com/9001academy/webinar/how-to-implement-risk-management-in-iso-90012015-free-webinar/
• How to determine interested parties and their requirements according to ISO 9001:2015 - https://advisera.com/9001academy/blog/2015/11/10/how-to-determine-interested-parties-and-their-requirements-according-to-iso-90012015/
• How to address risks and opportunities in ISO 9001: https://advisera.com/9001academy/blog/2016/06/21/how-to-address-risks-and-opportunities-in-iso-9001/
• Enroll for the free course - ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
• Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ (I use the approach of this answer in this book)