Business Strategies for New Year

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Our newsletters provide information on business management systems and process improvement methods. These systems include ISO 9001 QMS, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, ISO 14001 Environmental Management Standard, and others. Subjects include performance improvement methods such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

Do You have a Subject of Interest for a future 2016 Newsletter, please let us know!

Business Strategies for the New Year




Welcome to 2016! At this time of year it is natural to reflect on your company annual performance and set personal and business goals for the new year. The question is what kind of results do you want to create for yourself and your business? Do you have customers coming back for more of your product or service? Do you have a set of ideal customers you want to cultivate? Are your business processes in control and capable of producing what you and your customers require on a continuous basis?


Times change, your business may need to consider some new, and tried and true strategies:


1.  Understand what your customers really care about.

Business people often assume that how great your service is, or how low your prices are makes all the difference to your current or potential future customers. Customer loyalty runs thin today, and old business thinking is not going to scale your business growth.

What customers do care about is how smart you are about their business, asking probing questions and identifying what you can do for them; how you can lower their risk; or how well your reputation is with other people they may know. Continuous communication focused on their wants and needs will establish a long term mutual relationship.

2.  Every business today needs to get their message out.
Original Content Creation and Social Selling continues to grow through websites, LinkedIn, Facebook and other channels.

Here are some survey findings one social selling company recently assembled on activity in the sector:


  • 79% of salespeople who use social media outsell those who don’t.
  • 53% of buyers said they listen to peer recommendations before they make a purchase.
  • 65% of buyers feel the vendor’s content had an impact on their final purchase decision.

These trends will continue to grow. Thought content-from blog posts to videos-that create a sense of excitement among consumers will only become more crucial. Businesses with the most compelling, original voices will rise above the noise.

3.  Collect the right information to strengthen your customer knowledge.

Would you go to a job interview without researching the company? Then why not take the time to understand your customer’s business and the company current picture, realize  that people change roles and jobs. Keep an eye on these changes through the company website pages – announcements, news, blogs, webinars, industry and association meetings. Pay attention to these changes to find new leads and to exceed the customer relationship experience.

4.  Establish a stable sales and operational management system.

How efficient and effective was your business system in prior years? When sales began to slow, did you jump from activity to activity to test the waters, see what sticks, neglecting to follow any kind of sales and operational stability?

A documented and well-defined system tells everyone what needs to happen to be successful. When you go to a hospital, they don’t use multiple check-in methods or leave process control to chance. The hospital would be chaos, procedures and orderly steps need to happen in order to treat patients, and your customers effectively.

5.  Keep Customer Prospecting.

If you only pay attention to current customers, you will suffer long-term opportunities, to your competition’s delight.  When businesses grow to a certain size, employees can get into a mode of not needing to prospect all the time. Few people like to prospect for new customers, but you have to do it continuously.

It’s important not to neglect existing customers, and with the many peaks and valleys in today’s dynamic business environments, new customers must never be overlooked.

ISO 13485:201X Medical Devices Standard


A standard for quality management systems specific to the medical devices industry is under review and has just moved a step closer to completion.

Welcome ISO 13485:2016! The publication of the next version of ISO 13485 is scheduled in the first quarter of 2016.

ISO 13485 Medical Devices – Quality Management Systems – Requirements for regulatory purposes, enables manufacturers to demonstrate their compliance to quality and regulatory requirements, providing confidence to consumers and professionals worldwide. The standard is intended for use by organizations involved in the design, production, installation and servicing of medical devices, as well as in the design, development and provision of related services.

The Final Draft International Standard (FDIS) has been released for review and comments.

The new ISO 13485 is applicable across the whole supply chain and seeks to address the entire lifecycle of a medical device.

Some of the key changes include:


  • Harmonization of regulatory requirements
  • Inclusion of risk management throughout the QMS
  • Additional clarity with regard to validation, verification, and design activities
  • Strengthening of supplier control processes
  • Increased focus regarding feedback mechanisms

Proposed Structure of ISO 13485:2016

The content of this revision continues to be structured around the requirements detailed in the Design Specification. This includes the format, which, will be based on ISO 9001:2008. There is no plan, as part of this current revision, to align with the High Level Structure contained in Annex SL as applied in the new ISO 9001:2015.


This may create a bit of a nuisance for ISO 13485 Medical Device companies (and our certified clients) that are operating under two or more QMS standards.  A transition period of 3 years will apply. The revised Standard has been drafted to recognize not only of existing European Medical Devices Directives, but also the proposed European Medical Device Regulations when they are published.
We will keep you informed of any new information. Contact us with questions and for further information on how we can support your future ISO 13485:2016 Medical Devices Management System Transition Needs.


Environmental Management System


In our last newsletter, we announced that ISO 14001:2015 EMS Standard had been published. This standard along with all major ISO-QMS Standards have been revised, or in transition with the ISO 9001:2015 new requirements.

Depending on your business application and customer requirements, many certified organizations will be addressing further requirements beyond ISO 9001, and utilizing extended support and guidance documents to meet these requirements.

An example of a new guidance documents aligned with the ISO 14001:2015 is the complementary standard ISO 14004 which has reached final draft stage.

Helping an organization integrate an environmental management system (EMS) such as ISO 14001 effectively into their business management is the key focus of the revised ISO 14004, as reflected in its new title “Environmental management systems – General guidelines on implementation”.

The future ISO 14004:2016 aims to provide guidance on the establishment, implementation, maintenance and improvement of an effective EMS. It is intended to help organizations manage their environmental responsibilities in a systematic manner, thereby contributing to sustainability.


In September 2015, the International Organization for Standardization published its much-anticipated updated ISO 14001. More than 300,000 organizations globally use the environmental management standard and have achieved ISO 14001 certification – and it’s saving them millions of dollars.

The majority of these savings were delivered through energy efficiency measures (71 percent of those surveyed) and improved waste management (64 percent of those surveyed). Wider benefits include improved environmental performance (38 percent), meeting legislative requirements (39 percent), enhancing stakeholder relations, and generating new business opportunities (22 percent).

ISO 14004:2016 is due to be published in March 2016.


Methods to Avoid Counterfeit Issues


Counterfeiting is a lucrative business. When for example, scrapped electronic components, parts from recycled electronic products, or inexpensive components can be re-labeled and sold as new, higher quality and more expensive versions.

Due to this high profitability and low risk of being caught – especially in the developing markets – counterfeiting activity has proliferated in recent years. Additionally, disposal of electronic waste by the western world in poorer countries has made the problem worse.

Counterfeiting is not limited to only the U.S. defense industry.  Industry Week reported “consumer and industrial businesses are losing approximately $250 billion each year because of counterfeit components.” The automotive industry is also losing $3 billion in sales, and the semiconductor business is taking a $75 billion hit due to counterfeit parts.

How Manufacturers and Distributors Can Avoid Counterfeit Issues

While there are various channels that produce counterfeit items, there are several preemptive steps that companies can take to reduce the risk of your parts being counterfeited.

Incoming product inspection is a must to ensure no counterfeits enter your company’s supply chain. Counterfeit electronic components are generally refurbished and re-labeled before being resold as a new product. Various screening methods can help detect marks made from various counterfeiting methods like sanding and re-labeling, blacktopping and more.


  • Visual inspection
  • X-ray inspection
  • Decapsulation methods
  • Scanning Electron Microscopy (SEM) or X-Ray Fluorescence (XRF)
Beyond specific techniques, detailed inspection protocols should be applied when inspecting your incoming products. Aim to create systems and processes in your operations to identify and proactively mitigate risks from counterfeit parts.

If you don’t have the people, processes, tools and knowledge about best-in-class inspection processes, engage with industry groups or reputable technical services companies. Some of these companies can not only perform inspections for you, but they can also help develop processes and systems to identify and prevent the fraudulent product in your supply chain.

For more detailed information, see the entire article on the NTS Website.



In the News

U.S. Is Now the Preferred Location for New Factory Capacity to Serve U.S.
Of manufacturers planning to add production capacity over the next five years for goods consumed in the U.S., more plan to add that capacity in the U.S. than in any other country-a sharp reversal since as recently as two years ago. And a rising percentage of U.S.-based executives at the manufacturers say they are already in the process of reshoring production work from China. These are among the findings of new research released today by The Boston Consulting Group (BCG).

Thirty-one percent of respondents to BCG’s fourth annual survey of senior U.S.-based manufacturing executives at companies with at least $1 billion in annual revenues said that their companies are most likely to add production capacity in the U.S. within five years for goods sold in the U.S., while 20% said they are most likely to add capacity in China. Asked the same question in 2013, 30% of respondents said that China was the most likely destination for new capacity devoted to serving the U.S. market, while only 26% said capacity would be added in the U.S.

If Japan Can…Why Can’t We          

Inaccessible for 35 years, this documentary can now be viewed free of charge.

In June 1993, I had the privilege of attending Dr. Edwards Deming three-day seminar.  At 93 years old, I was amazed this quality giant was still presenting his message of quality. Being a Deming Disciple (you seasoned quality people understand) I am excited to announce this documentary opportunity.

On June 24, 1980, Americans widely viewed a NBC documentary called “If Japan Can… Why Can’t We.” The program, part of NBC’s white paper series, prominently featured W. Edwards Deming. Produced by Clare Crawford-Mason and narrated by Lloyd Dobyns.

This compelling documentary, about the ever-increasing industrial competition between the United States and Japan, introduced Deming to Americans. For the first time, they learned of the then 80-year old American who was widely credited with the Japanese industrial resurgence after World War II.  Soon the icons of American industry, such as Ford Motor Co., General Motors, Dow Chemical Co., Xerox, and Hughes Aircraft were asking for his help.


To view the entire NBC documentary video that started it all, visit the Deming Institute Website.


A Winning Hand?  

What makes you happy at work? Of course, compensation can play a huge role. But what are some other influencers of job and salary satisfaction? In this year’s ASQ Salary Survey, the variables that can affect quality professionals’ outlooks about their jobs, and how an employer’s culture of quality (or lack thereof) intertwines into the satisfaction equation.

To view the December 2015 Salary Survey Issue through open access, or if an ASQ member download the entire report, visit the Quality Progress Magazine Website.  

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With the new year starting, now is the right time to revisit and reduce manual workarounds caused by ineffective business processes. The processes that were put in place when the business started, or even grew may not be effective or even relevant anymore.

This does not always mean there is a need to take on costly process re-engineering. When a process review is complete, you may need to make only minor modifications to a process to achieve improvements in cost and time savings.

It makes no sense to continue using a process or partial process if the only reason it is in place is because “it has always been done this way here.” This is an area where past performance should not necessarily be considered an indicator of acceptable future performance.

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Best Regards,

Walter Tighe and SES Team
Sustaining Edge Solutions, Inc.
Toll Free 888-572-9642


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