Clauses 8 & 10

I think it will be easier when you start mapping processes and drawing flowcharts about what happens in your organization around patients.

Some weeks ago, I went to the doctor to see my eyes. I as a patient followed a process like this:

Your organization draws a flowchart representing a process and can ask: What can go wrong? What needs to be improved? With this, you apply the risk-based approach and can determine week points that need to be handled. Please check slide “Risks and processes” in the 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/ way your organization determine the need for process or service control, determine the need for work instructions, determine the need for changes.

Now, let us see section 8:

8.1 – is a general clause

8.2 – is about understanding what the needs and requirements of patients are and reaching an agreement on conditions to perform the service

8.3 – is about developing a new service

8.4 – is about purchasing products, services or processes – it may be cleaning services, administrative services, analysis services, other doctors specialized in particular conditions. It may be buying chemicals or consumables for equipment or tests

8.5.1 – is about having procedures, having specifications for the process, having qualifications for the job, having specifications for the service

8.5.2 – is about identification of the patient, doctor, and lots of consumables used

8.5.3 – is about patient property that may be lost or damaged while he/she is at the facilities

8.5.4 – is about preservation of chemicals or consumables while stored

8.5.5 – is about any guarantees or scheduled calls from organization to follow-up patient condition

8.5.6 – is about changes that need to be done when an equipment is malfunctioning, or a consumable is missing, and the usual procedure cannot be performed

8.6 – is about quality control to ensure that what can go wrong is not wrong

8.7 – is about dealing with nonconformities – when what can go wrong go wrong – giving the wrong prescription, for example

Section 10 is about developing corrective actions (clause 10.2) when a nonconformity occurs or when a relevant process indicator has a bad performance. For example, patients are waiting too much to be seen by a doctor. Clause 10.3 is about deciding to improve even when there are no no-conformities.

You can find more information below:

• Understanding Product & Service Provision in ISO 9001 - https://advisera.com/9001academy/blog/2014/10/07/understanding-product-service-provision-iso-9001/
• Enroll for 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 a lot of examples based on the risk-based approach)