Is your organization a part of the food chain?

The exploding and irreversible pace of globalization has brought in its wake changes in almost all areas of human activity. Goods and commodities that were once confined to one’s local area have now started reaching out to the unlikeliest corners of the world. One of the most active and important of such items to undergo a sea change in the way it is produced and consumed is food.

What we need every few hours, and was available and restricted to local use has now smashed boundaries. Finding a Mexican restaurant in Japan or a Chinese one in Canada is common. At the base of such drastic change in the food supply chain is the need for hygiene standards.

 

A single standard for global food?

In the last couple of decades or so since the phenomenal and hitherto unseen way in which the countries and markets of the world are getting closer to each other; the need for a uniform, global standard that regulates food standards has become a critical need. Again, this is a little problematic, because food, as we know, is very varied. It is as heterogeneous as mankind. So, is having a single Standard going to make sense?

It may not, but this does not obviate the need for a pan-food supply chain, global Standard for food safety. In fact, its need is greater than ever before now, with the changed times, when the boundaries of food movement have thinned down like never before. It is with the intention of standardizing standards across the food supply chain that ISO 22000 was born.

Certification

ISO left it to The Foundation for Food Safety Certification to establish strict systems for the effective implementation and rigorous auditing and maintenance of the standard combination. It is supported by the Confederation of the Food and Drink Industries of the European Union.

Being a certification scheme, The Food Safety System Certification 22000 or FSSC 22000 comprises ISO 22000 and ISO/TS 22002-1. It sets out a number of impartial Standards for manufacturers and others in the food supply chain to ensure quality standards. At its core, it insists on the PDCA (Plan, Do, Check, Act) methodology for the food supply chain. ISO 22000:2005 sets out the requirements for a food safety management system where any organization that is part of the food chain has to demonstrate its ability to control food safety hazards. This is to make sure that food is safe at the time it is being consumed by humans.  It applies to primary producers, processors, manufacturers, food and related service providers, and product suppliers.

References:

http://www.iso.org/iso/catalogue_detail?csnumber=35466

http://www.praxiom.com/iso-22000-intro.htm

http://arcms.ie/home/health-and-safety-systems/iso-22000-food-safety-management-system/

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

Thanks & Best Regards,
John Robinson
GlobalCompliancePanel
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.
Web: www.globalcompliancepanel.com
Email: john.robinson@globalcompliancepanel.com