Applicability of ISO-9001 in Healthcare Services - “design and development of products and services”

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When it comes to healthcare, a lot of articles are published on the role of NABH; whereas ISO-9001 (QMS) which forms the core of a good Quality Management System, is hardly written about, even though quite a good number of Hospitals and Clinics are ISO-9001 certified

This article outlines the importance of incorporating design and development of products and services in the healthcare sector (Clause 8.3 of ISO-9001:2015)

The earlier version of ISO-9001 (Clause 7.3 of ISO-9001:2008) mentioned design and development only in terms of products
Whereas the new version of ISO-9001 (Clause 8.3 of ISO-9001:2015) has mentioned design and development in terms of both products and services. Thus, making the design and development Clause more compliant with service industries

Earlier this factor was being excluded by the service sector because the older version of ISO-9001 allowed for exclusions from the Design and Development Clause - refer Clause 1.2 of ISO-9001:2008
But the new version of ISO-9001 does not provide any scope for exclusion of design and development - refer Clause 4.3 and Annex A.5 of ISO-9001:2015 - an organisation can decide a requirement as not applicable (exclusion) ONLY if it does not negatively affect the organisation’s ability to ensure conformity of its products and services and enhancement of customer satisfaction

Since the functions / processes of all the departments and units are interlinked to each other, therefore:-
One - The healthcare organisation needs to justify the “exclusion” very emphatically
Two - Review the customer complaints thoroughly to ensure that they have not arisen from design and development errors
Three - Do a thorough Root Cause Analysis of all errors in processes / services to ensure that they have not arisen from design and development errors

What types of healthcare services can be considered as design and development of services?
Here are some examples:-
One - Treatment modules and methods designed for successful recovery of patients - when Doctors / Surgeons come together to decide upon the line of treatment of a critical or rare case
Two - Designing and developing methods to prevent wrong treatment of patients - implementing strong controls to prevent medication error, transfusion error, wrong site wrong surgery, wrong identification of patient, wrong diet served
Three - Designing and developing new training modules to increase the effectiveness of the training process
Four - Designing newer and better care pathways, in keeping with the requirements of the hospital’s service delivery processes

In design and development, remember these basic requirements
One - Clearly outline the responsibilities and authorities, and the review process
Two - Ensure that legal and other requirements are complied with mandatorily
Three - Maintain and retain documented information as per requirement

NOTE
Maintain documented information means preparing documents like SOPs, Manuals, Work Instructions, etc. and maintaining them properly
Retain documented information means retaining records of the work done (registers, forms, check lists and other methods which have been used to document the work done and actions taken)
Records are the evidences of the work done

This guideline should enable a healthcare center to design and develop newer and better services to enhance patient safety and customer satisfaction