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Advice Pool - ISO 9001 Okay Now You Have It How Do You Market It?
Marketing ISO 9001 2000.
Lately we've been seeing a lot of press releases from wineries and suppliers touting their ISO certifications. "We've obtained ISO 9001: 2000," they trumpet. Great! But what exactly does that mean?
In simple terms, ISO certification verifies a company's compliance to a set of globally accepted s tandards for quality management and operational systems. The name ISO refers to both the Greek word for equal
Lately we've been seeing a lot of press releases from wineries and suppliers touting their ISO certifications. "We've obtained ISO 9001: 2000," they trumpet. Great! But what exactly does that mean?
In simple terms, ISO certification verifies a company's compliance to a set of globally accepted s tandards for quality management and operational systems. The name ISO refers to both the Greek word for equal
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
, and the International Organization for Standardization, a worldwide federation established in 1947 with a mission to facilitate the international exchange of goods and services. More than 90 countries use the ISO standard.
According to Anke Varcin, head of public relations for ISO, the organization's function is to develop the standards that auditors use to evaluate companies seeking certification. "ISO ... does not audit orga
According to Anke Varcin, head of public relations for ISO, the organization's function is to develop the standards that auditors use to evaluate companies seeking certification. "ISO ... does not audit orga
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
izations and does not issue certificates attesting to the fact that they conform to ISO standards," Varcin explained. "Certification is carried out independently of ISO by some 750 certification bodies around the world. ISO does not control their activities."
How does ISO determine its standards? "What happens is that the need for a standard is felt by an industry or business sector which communicates the requirement to one of I
How does ISO determine its standards? "What happens is that the need for a standard is felt by an industry or business sector which communicates the requirement to one of I
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
O's national members," Varcin said. "The latter then proposes the new work item to ISO as a whole. If accepted, the work item is assigned to an existing technical committee. Proposals may also be made to set up technical committees to cover new scopes of technological activity. In order to use resources most efficiently, ISO only launches the development of new standards for which there is clearly a market requirement."
There ar
There ar
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
many different types of certification, depending on the company's function and the year in which certification was issued. "Previously, 'ISO 9000-certified' organizations were actually certified to one of the three standards in the 1994 version of the ISO 9000 series: ISO 9001, ISO 9002 and ISO 9003," Varcin said. "The scope of these standards differed, but they were of equal rank." (For more information about the various certif
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
cations, visit the ISO Web site: iso.org.)
In 2000, the revised and improved ISO 9001:2000 standard was introduced to replace the 1994 versions. Organizations certified to the 1994 versions were given until Dec. 15, 2003, to upgrade to ISO 9001:2000. Both ISO 9000 and ISO 14000 concern the way a company goes about its work--but not directly the result of this work. However, the way in which a company manages its processes will o
In 2000, the revised and improved ISO 9001:2000 standard was introduced to replace the 1994 versions. Organizations certified to the 1994 versions were given until Dec. 15, 2003, to upgrade to ISO 9001:2000. Both ISO 9000 and ISO 14000 concern the way a company goes about its work--but not directly the result of this work. However, the way in which a company manages its processes will o
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
viously affect its final product.
So why seek ISO certification? "Deciding to have an independent audit of a management system ... is a decision to be taken on business grounds," Varcin said. Companies may decide to seek ISO certification for any number of reasons, including market requirements, customer preferences or staff motivation. Companies that adhere to ISO standards may benefit from increased demand for their products,
So why seek ISO certification? "Deciding to have an independent audit of a management system ... is a decision to be taken on business grounds," Varcin said. Companies may decide to seek ISO certification for any number of reasons, including market requirements, customer preferences or staff motivation. Companies that adhere to ISO standards may benefit from increased demand for their products,
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
ore positive customer feedback and a reduction in costs.
On the subject of cost, there is no set price for certification. According to Varcin, it varies depending on such factors as the company's current quality management system, the size and complexity of the organization and the attitude and commitment of the top management.
Setting An Example
If anyone knows how the ISO certification process works, it's Lisa Farrell, direc
On the subject of cost, there is no set price for certification. According to Varcin, it varies depending on such factors as the company's current quality management system, the size and complexity of the organization and the attitude and commitment of the top management.
Setting An Example
If anyone knows how the ISO certification process works, it's Lisa Farrell, direc
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
or of communications for New York's Canandaigua Wine Company. Two of Canandaigua's wineries--Mission Bell, in Madera, Calif., and New York's Widmer's Wine Cellars--have obtained ISO 9001:2000, and several more of the company's California, New York and Washington wineries are scheduled to follow.
"Canandaigua Wine is making a concerted effort toward standardizing its processes throughout the production environment to gain discipl
"Canandaigua Wine is making a concerted effort toward standardizing its processes throughout the production environment to gain discipl
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
ne and sustainability," Farrell explained. "The ISO certification provides us with standard operating procedures, which include valuable communication and system feedback loops among Canandaigua Wine and its customers, employees and managers. It helps us document and control our manufacturing processes to help exceed customer expectations and ensure quality processes within our production environment."
To get the process rolling
To get the process rolling
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
Canandaigua worked with Dr. Judy Luchsinger, who consulted with Fetzer during its ISO certification in 1994. With Luchsinger's help, Mission Bell and Widmer's completed the following steps leading to their ISO 9001:2000 certifications.
Applied to approved ISO-certifying bodies and selected Lloyd's Register Quality Assurance for auditing toward certification
Formation of ISO leadership teams at both wineries
Kick-off meetings
Applied to approved ISO-certifying bodies and selected Lloyd's Register Quality Assurance for auditing toward certification
Formation of ISO leadership teams at both wineries
Kick-off meetings
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
eld with employees at both wineries
Quality manuals created at both wineries
Employee training at both wineries
Audit and certification process, including all areas of production, bottling and distribution, including internal and external audits conducted by an assessor representing Lloyd's Register Quality Assurance.
"After the external audit, the assessor then makes a recommendation for or against certification, which is re
Quality manuals created at both wineries
Employee training at both wineries
Audit and certification process, including all areas of production, bottling and distribution, including internal and external audits conducted by an assessor representing Lloyd's Register Quality Assurance.
"After the external audit, the assessor then makes a recommendation for or against certification, which is re
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
iewed by the management team of (the certifying body)," Farrell said. Both Mission Bell and Widmer's were approved after about a year.
"The (certification) standards are challenging to meet," Farrell said. "To pursue them, you must follow standard operating procedures as outlined in your quality manual and have the discipline and focus needed to follow these consistently and in a highly efficient manner. This process demands str
"The (certification) standards are challenging to meet," Farrell said. "To pursue them, you must follow standard operating procedures as outlined in your quality manual and have the discipline and focus needed to follow these consistently and in a highly efficient manner. This process demands str
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ng leadership from senior management and a sense of commitment and teamwork among employees at all levels."
Is Getting Certified Worth The Effort?
To get the inside scoop, we asked wine industry suppliers (listed in the W & V Buyer's Guide/Directory) to tell us why their companies took the plunge, and whether or not they're happy with the results. This partial list represents a random sampling.
Supreme Corq, Inc. Kent, Wash.
Is Getting Certified Worth The Effort?
To get the inside scoop, we asked wine industry suppliers (listed in the W & V Buyer's Guide/Directory) to tell us why their companies took the plunge, and whether or not they're happy with the results. This partial list represents a random sampling.
Supreme Corq, Inc. Kent, Wash.
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ccording to marketing manager Joyce Steers-Greget, Supreme Corq decided to pursue ISO certification "to ensure a consistent, quality product ... to ensure continuing customer satisfaction and effective process controls ... and to receive a globally recognized quality process certification." The company earned ISO 9001:2000 in July of 2002. "Our customers are pleased that we have taken this proactive step ... Some larger wineries
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
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
r grocers require compliance to quality and food standards to be an approved supplier. As the wine industry becomes more global, ISO certification will likely be necessary to compete in this international arena."
M.A. Silva Corks, USA Santa Rosa, Calif.
"Our supplier in Portugal felt that the market was looking for companies that had that certification, that (it would give them) some sort of competitive advantage. They also fel
M.A. Silva Corks, USA Santa Rosa, Calif.
"Our supplier in Portugal felt that the market was looking for companies that had that certification, that (it would give them) some sort of competitive advantage. They also fel
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
that it would greatly improve the company's performance and (help it to) operate at a better standard," said company representative Neil Foster. After meeting the requirements for ISO 9001, Foster said, the company's product improved and business increased. "And also new markets opened up for us...and we noticed that we saw increasing business from (existing) customers. It's a positive thing, without a doubt."
Novembal San Fran
Novembal San Fran
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
isco, Calif.
Though Novembal itself is not ISO certified, its supplier--TetraPak Plastics in Mexico--obtained ISO 9001:2000 in Nov., 2002. "We (felt) that is was important for our company to adopt a quality system like ISO, because this system permits us to integrate all of the company's processes--human resources, maintenance and management," said TetraPak ISO coordinator Adriana Flores. Since adopting ISO standards, Flores sai
Though Novembal itself is not ISO certified, its supplier--TetraPak Plastics in Mexico--obtained ISO 9001:2000 in Nov., 2002. "We (felt) that is was important for our company to adopt a quality system like ISO, because this system permits us to integrate all of the company's processes--human resources, maintenance and management," said TetraPak ISO coordinator Adriana Flores. Since adopting ISO standards, Flores sai
.
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
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
, her company's clients feel more secure and the company's processes run more smoothly. "The most important improvement is the process standardization."
Scott Laboratories, Inc. Petaluma, Calif.
"In order for our growing company to continually improve we needed a good documented quality management system," said ISO lead auditor Mary Ann Changnon. "Also some of our customers were requiring ISO certification from their vendors."
Scott Laboratories, Inc. Petaluma, Calif.
"In order for our growing company to continually improve we needed a good documented quality management system," said ISO lead auditor Mary Ann Changnon. "Also some of our customers were requiring ISO certification from their vendors."
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
he company's cork and laboratory sectors were awarded ISO 9000:1994 in July of 1999, and all company sectors obtained ISO 9001:2000 in August of 2001. "We use ISO certification as a sales tool. We open our quality system to our customers so they can see our commitment to continually improve both our products and services. We have noticed improvements in many of our products due to improved processes as a result of customer input.
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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