ISO 9001’s Process Approach to Quality Management

ISO 9001 came into being exclusively as a means of incorporating a process approach to quality management systems. Both ISO 9000 and ISO 9004 underwent an amendment in 2000 to put this approach into place.

It is all about process

Where this approach differs from the previous standard is that it improves upon it by offering an appreciably more generic structure that is readily adaptable, acceptable and applicable across virtually all sectors of the economy and sizes of organizations. Another area where it has made life easier is that it explains the requirements in plain and uncomplicated language that is shorn of Quality waffle and is relatable to people for whom it is meant –organizations’ line managers.

The customer is the focal point

The primary focus of ISO 9001:2000 is on improving the effectiveness of a QMS in order to heighten customer satisfaction by meeting customer requirements. It finds its complement in ISO 9004:2000, whose aim is improvement of the effectiveness and efficiency of a QMS by meeting interested party requirements.

Broadly, these are the steps in this methodology:

  • Step 1: Establish the responsibilities for managing the process;
  • Step 2: Define the process;
  • Step 3: Identify customer requirements;
  • Step 4: Establish measures of process performance;
  • Step 5: Compare process performance with customer requirements;
  • Step 6: Identify process improvement opportunities;
  • Step 7: Improve process performance

How is a QMS built?

  • A QMS comprises of four categories of interrelated processes, which make up the process approach:
  • Management responsibility
  • Resource management
  • Product realization
  • Measurement, analysis and improvement

References:

http://www.iso.org/iso/home/standards/management-standards/iso_9000.htm

http://asq.org/quality-progress/2001/12/standards-outlook/the-process-approach-to-qms-in-iso-9001-and.html

The ISO 13485:2003 Standard has quality management systems at its heart

The ISO 13485:2003 Standard has quality management systems at its heart.

The ISO 13485:2003 Standard relates to quality management systems in the field of Medical Devices. Its requirements ISO 13485:2003 specifically relate to organizations that are in the business of medical devices, no matter what its size or type. At its core, ISO 13485:2003 is all about quality management systems in medical devices.

This standard specifies requirements for a quality management system. Accordingly, it requires an organization to demonstrate the ability to produce medical devices and related services that have to consistently meet both –a) customer requirements and b) regulatory requirements –that are applicable to the file of medical devices and related services.

Harmonization at the core

It thus becomes clear that quality management systems, which are the means to ensuring these requirements, constitute the heart of ISO 13485:2003. This Standard’s essential objective is to foster and bring about harmonization among medical device regulatory requirements for meeting quality management systems. This Standard superseded the earlier version, the ISO 9001. It did away with some of the requirements of that Standard.

When a medical device company deals with medical devices it may not manufacture; it is its responsibility to ensure that processes applicable to the medical device(s) required by ISO 13485:2003, are accounted for in the organization’s quality management system.

In a nutshell, these are some of the requirements set out from Part 4 of ISO 13485:2003 onwards, the Part at which quality requirements begin:

4.1: Establish a quality system for medical devices;

4.2: Document your medical device quality system;

5.1: Support Quality;

5.2: Focus on customers;

5.3: Establish a Quality Policy;

5.4: Perform Quality Planning;

5.5: Control your Quality Management System;

5.6: Carry out management reviews;

6.1: Provide quality resources;

6.2: Provide Quality personnel;

6.3: Provide quality infrastructure;

6.4: Provide quality environment

8.2: Monitor and measure quality;

8.3: Control your nonconforming products;

8.5: Take required remedial actions


References:
http://www.iso.org/iso/catalogue_detail?csnumber=36786
http://www.praxiom.com/iso-13485.htm

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John Robinson
GlobalCompliancePanel
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ISO 13485 vs. ISO 9001

ISO 13485 vs. ISO 9001

One of the most commonly countered questions in the medical device industry is: ISO 13485 vs. ISO 9001. They are often confused for each other. But they are never the same, although they have many common requirements.

ISO 13485 is part of ISO 9001 family of regulations

When understanding ISO 13485 vs. ISO 9001, we have to understand that both standards are part of the ISO QMS, and must meet general requirements. These general requirements merely state that “the organization shall establish, document, implement and maintain a quality management system and maintain its effectiveness in accordance with the requirements of this International Standard”.

ISO 13485 flows from ISO 9001. While ISO 9001 is a general standard for third party assessment, ISO 13485 is that part of this standard that is specific to the medical devices industry.

Critical differences

The crux of ISO 13485 vs. ISO 9001 lies in the application. ISO 13485 includes some specific requirements for medical devices and excludes those requirements of ISO 9001 that are not appropriate for regulatory requirements. So, although similar on the surface, these two standards work in tandem, but are yet exclusive to each other in many respects.  Organizations which claim that their medical devices meet ISO 13485 requirements cannot claim that their organization automatically meet ISO 9001 as well.

The ISO wanted to make the 13485 specific to the medical devices industry. It wanted to remove the complexity associated with the 9001 and make a standard that was usable by organizations of varying sizes, was easily comprehended, was compatible with management systems such as ISO 14001, and had a direct relationship with the activities that went into running a business. The ISO 13485 standard has achieved all this, and thus is a continuum of the ISO 9001 standard with the necessary refinements.

Difference in terms of operation

ISO 13485 must define document retention times based on organizational and regulatory requirements, while 9001 must record retention times based on organizational and regulatory requirements.

Reference:

http://www.slideshare.net/riteshreddych/differences-between-iso-13485-and-iso-9001

 

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