A Quarterly International Service Newsletter

 The  Moorhill  Monitor
 * Volume 14 / Issue 2 / Date 2nd Quarter 2005 *
 
QMS + EMS + OHSMS + ITMS = ISMS

In this Issue:
[National Day of Prayer] [WWII Facts] [Executive Summary - ISO 13485:2003]

[Your Life May Resemble an Eagle's] [The Eight Quality Management Principles of ISO 9001:2000]

Moorhill International Group, Inc.
Fostering International Relations Through Commerce

1. National Day of Prayer - Thursday, May 5th, 2005!

You'll love this from Col. D.G. Swinford, USMC, Ret. and history buff. You would really have to dig to get this kind of ringside seat to history:

1. The first German serviceman killed in WW2 was killed by the Japanese (China, 1937), the first American serviceman killed was killed by the Russians (Finland 1940), the highest ranking American killed was Lt. Gen. Lesley McNair, killed by the US Army Air Corps. . . . So much for allies.

2. The youngest US serviceman was 12 year old Calvin Graham, USN. He was wounded and given a Dishonorable Discharge for lying about his age. (His benefits were later restored by act of Congress).

3. At the time of Pearl Harbor the top US Navy command was Called CINCUS (pronounced "sink us"), the shoulder patch of the US Army's 45th Infantry division was the Swastika, and Hitler's private train was named "Amerika." All three were soon changed for PR purposes.

4. More US servicemen died in the Air Corps than the Marine Corps. While completing the required 30 missions your chance of being killed was 71%.

5. Generally speaking there was no such thing as an average fighter pilot.  You were either an ace or a target. For instance Japanese ace Hiroyoshi Nishizawa shot down over 80 planes. He died while a passenger on a cargo plane.

6. It was a common practice on fighter planes to load every 5th round with a tracer round to aid in aiming. This was a mistake. Tracers had different ballistics so (at long range) if your tracers were hitting the target 80% of your rounds were missing. Worse yet tracers instantly told your enemy he was under fire and from which direction. Worst of all was the practice of loading a string of tracers at the end of the belt to tell you that you were out of ammo. This was definitely not something you wanted to tell the enemy. Units that stopped using tracers saw their success rate nearly double and their loss rate go down.

YOU'VE GOT TO LOVE THIS ONE....

7. When allied armies reached the Rhine the first thing men did was pee in it. This was pretty universal from the lowest private to Winston Churchill (who made a big show of it) and Gen. Patton (who had himself photographed in the act).

8. German Me-264 bombers were capable of bombing New York City but it wasn't worth the effort. 

9. German submarine U-120 was sunk by a malfunctioning toilet.

10. Among the first "Germans" captured at Normandy were several Koreans. They had been forced to fight for the Japanese Army until they were captured by the Russians and forced to fight for the Russian Army until they were captured by the Germans and forced to fight for the German Army until they were captured by the US Army.

AND I SAVED THE BEST FOR LAST....

11. Following a massive naval bombardment 35,000 US and Canadian troops stormed ashore at Kiska, in the Aleutian Islands. 21 troops were killed in the firefight. It would have been worse if there had been any Japanese on the island..

Source: Colonel Swinford, 2005

The certification of a quality management system, specifically for medical devices, to ISO 9001/ISO 13485/EN 46001 proves advantageous, and in many cases essential, for medical companies which export their products to the global market.

In the European Union, the fulfillment of EU Directives (e.g., Active Implantable Medical Devices Directive, Medical Devices Directive and In Vitro Diagnostic Directive) allows the free trade of medical devices. A significant portion of demonstrating compliance with the EU directive requirements is the establishment and independent assessment of the quality system.

The European harmonized medical device quality system standards are EN ISO 13485:2000 and EN ISO 13488:2000. These two standards will replace current harmonized standards EN 46001 and EN 46002 (transition period until March 2004), as published in the Official Journal (OJ) of the European Community on July 31, 2002.

When manufacturers are active in the world market, the focus on global or international standards (e.g., ISO) is not only advantageous - it may be stipulated by certain countries. For example, Canada requires that medical device manufacturers marketing their products in Canada must have a quality system certified to ISO 13485 or ISO 13488 after January 2003. Existing license holders have until November 2003 to demonstrate compliance.

In the U.S., the revised Quality System Regulation (21 CFR 820, Oct. 7, 1996) was based on the ISO 9001 and ISO 13485 quality system standards. US manufacturers in compliance with the FDA Quality System Regulations can assume that their quality system is close to meeting the requirements of the ISO 9001/ISO 13485 standards.

What does each standard mean?
ISO 9001 are generic quality system standards applicable to many industries. EN 46001/46002 and ISO 13485/13488 are standards specific to medical device quality systems that supplement the ISO 9001 and 9002 standards. Some of the additional requirements relate to design controls, process controls (including environmental controls), special processes, traceability, record retention, and regulatory actions, which are more critical for the medical device industry. ISO 13485/13488 is very similar to the European Standards EN 46001/46002, but do contain some additional requirements.

ISO 9001 / EN 46001 / ISO 13485 -- Who is certified to these standards?

• Companies who currently manufacture private label medical devices, but want to eventually place these devices under their name on the market in the European Union.
• Companies, such as consulting shops, which design, manufacture, and assemble medical and in vitro diagnostic medical devices, and medical component manufacturers.
• Manufacturers of In Vitro Diagnostic Medical Devices that want to distinguish themselves, and prepare for future IVD regulatory obligations to enter the EU.

Accreditations
There are several well qualified companies in the United States offering registration services.

ISO 13485:2003
Quality systems - Medical devices - Particular requirements for the application of ISO 9001

ISO 13488:1996
Quality systems - Medical devices - Particular requirements for the application of ISO 9002

What is the difference between ISO 13485 and ISO 13488?

• ISO 9001, ISO 13485 and EN 46001 are applicable to manufacturers and service providers that perform their own design activities.

• ISO 9002, ISO 13488 and EN 46002 are for manufacturers and service providers without design activities.

Is the ISO 13485 and ISO 13488 document being updated to ISO 9001:2000?
Internationally, the ISO 13485:2003 document, is currently released.

Is ISO 13485 applicable for European Requirements?
Yes. The European harmonized medical device quality system standards are EN ISO 13485:2000 and EN ISO 13488:2000. These two standards will replace current harmonized standards EN 46001 and EN 46002 (transition period until March 2004), as published in the Official Journal (OJ) of the European Community on July 31, 2002.

Source: QSU - TUV, 2003

4. Your Life May Resemble An Eagle's!

Eagles Love to Play with the Wind – They ride thermal updrafts to an altitude of 14,000 feet.  The Golden Eagle can reach a speed of 180 miles an hour in a dive. “Those who hope in the Lord will renew their strength.  They will soar on wings like eagles; they will run and not grow weary, they will walk and not be faint.”  (Isa. 40:31)

Eagles Travel Light - Their bones are hollow and filled with air: The 7,000 feathers on a Bald Eagle weigh only 21 ounces.  “…Let us strip off anything that slows us down or holds us back, and especially those sins that wrap themselves so tightly around our feet and trip us up; and let us run with patience the particular race that God has set before us.”  (Heb. 12:1 – Living)

Eagles have Keen Eyesight – They see eight times better than human beings.  They can spot a mouse in the grass a mile away. "The eye is the lamp of the body. If your eyes are good, your whole body will be full of light.  But if your eyes are bad, your whole body will be full of darkness. If then the light within you is darkness, how great is that darkness!”  (Matt. 6:22, 23)

Eagles are Focused – Once an eagle has spotted its prey, it does not take its eyes off the creature until it strikes. “…This one thing I do, forgetting those things which are behind, and reaching forth unto those things which are before, I press toward the mark for the prize of the high calling of God in Christ Jesus.”   (Phil. 3:13b,14)

Eagles Prefer Peace and Quiet when Raising a Family – They build their nests in high hard-to-reach areas.  “Make it your ambition to lead a quiet life...”  (I Thess. 4:11a)

Eagles, Male and Female, Work Together Building their Nest or Eyrie – The arduous task takes several weeks to several months. “Two are better than one, because they have a good return for their work: If one falls down, his friend can help him up. But pity the man who falls and has no one to help him up!”  (Ecc. 4:9,10)

Eagles Keep Improving their Home – They continue to bring fresh green sprigs through the nesting period.  Some think the sprigs are simply for decoration. “Blessed are those whose strength is in you, who have set their hearts on pilgrimage. As they pass through the Valley of Baca, they make it a place of springs; the autumn rains also cover it with pools.”  (Psa. 84:5,6)++

Eagles Fiercely Defend their Nesting – They stand up against any animal that might be a threat to their young. "I am the good shepherd. The good shepherd lays down his life for the sheep…Be shepherds of God's flock that is under your care, serving as overseers--not because you must, but because you are willing, as God wants you to be…Jesus said, ‘Simon son of John, do you truly love me?’ He answered, ‘Yes, Lord, you know that I love you.’  Jesus said, ‘Take care of my sheep.’"  (Jn. 10:11; 1 Pet 5:2a; Jn. 21:16b)

Submitted: The Navigators, 2005

5. The Eight Quality Management Principles of ISO 9001:2000!

Principle 1 - Customer-Focused Organization

Organizations depend on their customers and therefore should understand current and future customer needs, meet customer requirements and strive to exceed customer expectations.

Key Benefits:

· Increased revenues and market shares obtained through flexible and fast responses to market opportunities.

· Improved customer loyalty leading to repeat business and referrals

Principle 2 - Leadership

Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives.

Key Benefits:

· People will understand and be motivated towards the organization’s goals and objectives

· Activities are evaluated, aligned and implemented in a unified way

· Leading by example thereby enabling continual improvement

Principle 3 - Involvement of People

People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organizations benefit.

Key Benefits:

· Motivated, committed and involved people

· People feel accountable for their own performance

· People eager to participate and contribute to continual improvement

Principle 4 - Process Approach

A desired result is achieved more efficiently when related resources and activities are managed as a process.

Key Benefits:

· Ability to lower costs and shorten cycle times through effective use of resources

· Improved, consistent and predictable results

· Allows improvement opportunities to be focused and prioritized.

Principle 5 — System Approach to Management

Identifying, understanding and managing a system of interrelated processes for a given objective improves the organization’s effectiveness and efficiency.

Key Benefits:

· Alignment of the processes which will best achieve the desired results

· The ability to focus effort on the processes that matter

· Provides confidence to key interested parties of the effectiveness and efficiency of the organization

Principle 6 — Continual Improvement

Continual improvement should be a permanent objective of the organization.

Key Benefits:

· Increased competitive advantage through improved organizational capabilities

· Flexibility to react quickly to opportunities

Principle 7 - Factual approach to decision making

Effective decisions are based on the analysis of data and information

Key Benefits:

· Informed decisions

· An ability to demonstrate the effectiveness of past decisions through reference to factual histories

· Ability to review, challenge and change opinions and decisions.

Principle 8 - Mutually beneficial supplier relationships

An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value

Key Benefits:

· Increased ability to create value for both parties

· Flexibility and speed of agreed joint responses to changing markets

· Optimization of costs and resources.

 Source: ISO, Geneva, CH, 2002~2005

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