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Definition of ISO:

ISO means “all sides being equal”. To date, more than ? a million organizations in 149 countries have implemented the ISO Standards.
ISO 9001:2000 is a fundamental quality management system standar

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

d that requires an organization to identify, define, document, implement (follow), monitor/measure, and continually improve the effectiveness of its processes. It is a self-directed system that requires the organization to identify and address a

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ll imposed requirements; as well as improve its organizational performance by modifying systemic issues (e.g. those traditionally associated with the “hand-offs”).

Application of ISO in Healthcare:

Using the ISO Family of Stan

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

dards, the organization can establish a comprehensive Quality / Business Management System which:

Provides a solid basis for compliance with all imposed requirements (e.g., JCAHO, AABB, Federal & State regulations). Makes all other

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

certification & accreditation processes easier and less costly.

Facilitates improved understanding of roles & responsibilities among employees; and enhanced communication/coordination between departments.

Requires the establ

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ishment of measurable improvement objectives and accountability to those objectives through monitoring/measuring and reporting.

Results in improved systems, processes, and outcomes.

Structure of the ISO 9001:2000 Standa

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

rd:

The ISO:9001 2000 Standard is comprised of 8 Clauses. The 1st 3 are introductory in nature. The subsequent 5 clauses include the requirements the organization must address. They are:

Clause 4 – Quality Management System

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

Process Management, Documentation Requirements, Records Control

Clause 5 – Management Responsibility

Customer/Patient Focus, Policy, Objectives, Planning, Responsibility & Authority

Clause 6 – Resource Manage

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ment

Human Resources, Infrastructure, Work Environment

Clause 7 – Product / Service Realization

Planning of New Products & Services, Customer Interface/ Communication, Design, Purchasing/Supplier Management, Produc

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

tion/ Service Operations, Calibration

Clause 8 – Measurement, Analysis, and Improvement

Internal Audits, Customer/Patient Satisfaction, Monitoring/Measurement of Products/Services and Processes, Handling Nonconformances, Corrective &

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

Preventive Action, Continual Improvement

Process / Methodology

While the standard does not prescribe the approach or methodology to be utilized by an organization, the following is recommended.

Obtain Management c

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ommitment to support, understanding, involvement, provision of resources

Educate Management & Staff about the ISO 9001:2000 Standard, Scope of Work, Organizational impact

Define Key Improvement Objectives

Identif

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

y and Map Organizational Processes, key as well as support. Address all imposed requirements.

Develop the organization’s Quality Policy and Quality Manual

Establish approach to document control and access.

Develop

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

, review/revise, and incorporate all required support documentation (e.g. Department Policies/Procedures, forms).

Educate Staff on QMS documentation

Establish and implement monitoring/measurement for each process

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

>Train internal auditors. Implement an Internal Audit Process.

Conduct a Management Review of the QMS.

Undergo a Pre-Assessment or “Mock Survey” to assess system implementation, readiness

Make required correction

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

Submit Document Review to Registrar (Quality Manual, Processes)

Undergo the Certification Audit

Sample Key Improvement Objectives

Improve Patient Satisfaction

Goal: Improve to 70th

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

Percentile

Department Goal: Reduce Wait time for Outpatient Registration to < 4 minutes

Improve Patient Safety

Goal: Reduce Medication Error Rate to < .3%

Goal: Reduce fall rate to < 2.6 per 1,000 patie

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

nt days Note: Organizational/Hospital-wide objectives are then translated to related departmental, process, individual goals/objectives

Sample Process Interaction Diagram
See =>.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

onsulting.net/applications-of-iso9001-to-healthcare.html">http://www.iqsconsulting.net/applications-of-iso9001-to-healthcare.html

Sample Quality Policy

We will strive to be the leading provider of healthcare services in Southern Ohi

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

o. We will accomplish this through

Consistent compliance with all imposed requirements;
Our focus on Patient Safety and Satisfaction; and
Continual improvement of our products, services, and processes.

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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