Orientation Program for IVD Manufacturers about Various Quality Systems Programs implemented by their User Industry – Hospitals, Med Labs , Other Healthcare Organisations
Supply Chain is showing interest to learn about various Quality Systems implemented by their Customers
Customers Quality Systems – Supply Chain getting Trained
Got a call from an IVD Manufacturer last week expressing interest to get his team trained on various Quality Management Systems followed by healthcare organisations.
I first thought I heard it wrong, I thought he was seeking training for his team on Med Dev QMS. When I asked the question, he said NO and his question is about getting his team members understand a little about various QMS Programs implemented by their customers like NABL, NABH , CAP, QAI Programs.
I was a little surprised and asked him for the reason for choosing a topic like this, though I could quickly guess where he would be heading to. He has mentioned that they are supplying their products to multiple categories of healthcare organisations . Each one comes up with some Certification, Accreditation program that they are implementing. Having implemented Med Dev QMS & Product Certification Programs in house, he felt that its appropriate for his team to acquire some basic knowledge about their Customers Quality Systems Programs and ensuring that as Vendors to the respective healthcare orgns, they would prefer to provide necessary inputs, information that are needed by these Healthcare Organisations (HCOs) during their Quality journey.
This is what is emerging across the globe. Many businesses / sectors are ensuring that their Supply Chain is also in sync with their Quality Systems Journey. When a Mfrer or a Service Provider delivers a Product or a Service to end user / customer, as a finished good, he/she has to doubly ensure that his supply chain also maintains high Quality Standards. It becomes imperative for the Vendors, Suppliers , Stakeholders who are part of the supply chain to be in sync, in alignment with the Quality Systems adopted by their customers.
Similarly, businesses that are seeking support from suppliers, should also make an effort to understand the Quality Systems – be it Product or Systems Certifications, implemented by the Suppliers in their respective organisations. This is the fundamental requirement of Vendor Evaluation in any business. Understanding the Suppliers Quality Systems Programs Matters for Businesses too ! Many Regulated Business Sectors, across the globe, have initiated this exercise of bringing the Supply Chain under some Quality Standards, Systems Programs. Automotive Sector was the 1st sector to introduce this almost 2 decades ago. Many other sectors which are under Regulatory Control are slowly introducing this concept.
This manufacturers/suppliers, being the suppliers to many healthcare organisations, come under the supplier category to these businesses. Healthcare Sector being regulated (be it Products or Services) in the country now, Supplier Quality Compliance will become a norm sooner or later.
We have customised a 3 day program for the IVD Mfrer’s team comprising of :
– Technical Team
– Sales Team
– Customer Support Team
– Management Team
The program was designed in such a manner to provide them a bird’s eye view on various Healthcare Certification, Accreditation Programs that are currently available in India for healthcare businesses to choose.
We have also designed a session on Minimum Standards that are adopted in the country as Regulatory spec which addresses basic QMS to be implemented by Med Labs in the country.
It was interesting session fielding questions from IVD Mfrers about Quality Systems Programs in HCOs.
- Some interesting questions posed by them :
- For a start up lab, Is there a bare minimum period required to get the accreditation, if all the criteria is met?
- Is there any minimal number of parameters in scope of testing for applying certification ?
- What is the difference betn Certification & Accreditation Program when most of the quality mgmt systems clauses are similar ?
- Is it compulsory to do ILC ? Frequency ?
- When there are multiple Certification , Accreditation Programs available for Med Labs, how to differentiate and choose a relevant, appropriate program for HCO
Matured Participants and the Quality of the interactions was highly invigorating .
Were actually surprised when they were asking questions related to :
– Voluntary withdrawal from Accreditations :
– Suspensions criteria
– Eligibility of the HCOs to reapply
– Normal scenarios , reasons for such actions taken by Accreditation Bodies
– Any penalties , punishments for non compliances
Some screen shots from the session :
3 days of orientation program came to a close today. Bird’s eye view of all National , International Certification, Accreditation Programs , Minimum Standards – Regulatory requirements were covered. Program was well received and appreciated by the participants.
Informative, customised content, pretty detailed, well explained, looking forward to detailed sessions
Some feedback received by the end of the session.
Moving forward, Quality Systems Implementation Programs become more inclusive in nature in near future. Businesses will ensure Quality of their Supply Chain and Suppliers will show more interest to learn about their Customers Quality Systems Implementation Programs. More inclusive it becomes, supply chain gets strengthened and end users will be assured of better Quality & Safe Products and Services.
Session was handled by :
Dr Srivatsan , Expert – Healthcare Quality Management Systems
A A Srinivasan – Principal Consultant
Chithambaranathan – Associate Consultant
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