Archive for the ‘Article’ Category

A New Year Business Approach

Thursday, November 8th, 2018

With the New Year approaching, many of us are thinking of what is the best way to shape our company’s economic future and growth into the most profitable form possible.

The answer is to deliver more than your share of customer value! Keep in mind your competition won’t be standing idle while you innovate and grow. To stay ahead of your competition, you should keep a strategic focus on what sets your company apart within your industry.

You could have a number of marketable differences from your competition. Spending more on R&D, or sales efforts? Acquiring capital equipment beyond your current capacities? Is what you’re doing focused on internal needs, or are you implementing your customer’s ideas?

1. Conduct face-to-face interviews.

Of all the ways to learn about customer needs-telephone, e-mail survey, Internet, nothing comes close in effectiveness to face-to-face customer interviews. Many of us use customer surveys to determine satisfaction levels. We use a Likert Scale method (1-5) based on questions we have determined are important. The reality, though, is that most questions asked are actually customer-reactive, not market-customer proactive interviews. Should we be asking our customers “Please rate the quality of our products?”, or “How can we provide a better quality product to you?” Get out and visit your customers and find out what’s important to them!

2. Develop a Voice of the Customer mentality.

Voice of the Customer studies typically consist of both qualitative and quantitative steps. They are generally conducted at the start or finish of a new product, process, or service design in order to better understand the customer’s wants and needs. That e-mail survey with the 3-5% average return, is it handing you a report of “what the customer wants?” This is a flawed model. Train your people to be VOC experts!

Best of all, you’ll develop a reputation among customers as “that supplier who really does listen to us.”

3. Become a quantitative organization.

After you conduct good qualitative customer interviews, you can target specific customer ideas you could work on. Which ideas do you target in your product design? Which ideas do you target in your product realization processes? At this point get quantitative. Being quantitative helps you to understand which customer outcomes are most important and least satisfied.

The key to taking advantage of the future is in changing the way your company approaches your current and future customers. Start now, with a new approach and you’ll shape a sustainable organization for Year 2019 and beyond!

Service Management System Life Cycle

Friday, October 5th, 2018

According to a Forbes report, IT service management is highly important to most executives and a lack of a service management approach hurts competitiveness due to too much time and money spent on ongoing maintenance and management rather than new initiatives.

A service management system (SMS) supports the management of the service cycle, from planning to delivery and improvement, offering better value for customers as well as those delivering the service. It gives ongoing visibility, allowing for continual improvement in effectiveness and efficiency.

ISO has updated two standards in its service management series, with new features, topics and tips from the top.

ISO/IEC 20000-1:2018, Information technology – Service management – Part 1: Service management system requirements, specifies the requirements for an organization to establish, implement, maintain and continually improve an SMS,

ISO/IEC 20000-10:2018, Information technology – Service management – Part 10: Concepts and vocabulary, describes the core concepts and terminology for the whole ISO/IEC 20000 series.

The ISO/IEC 20000 series can be of benefit to anyone that provides services to customers, whether it be a whole company or an individual department, not only improving their service but ensuring that service management activities meet business needs and objectives.

The revised versions take into account changes in market trends, including the services and the management of multiple suppliers by an internal or external service integrator. It also incorporates new features such as requirements about knowledge and service planning, as well as updated terminology and definitions.

You can purchase these service management system standards at the ANSI Webstore.

FDA To Use ISO 13485 for Medical Devices Regulation

Wednesday, August 29th, 2018

The US Food and Drug Administration (FDA), the government department that regulates the medical devices sector, announced its intention to use ISO 13485 as the basis for its quality system legislation.

ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes, is the International Standard for quality management systems for the medical devices sector. Published in 2016, it is designed to work with other management systems in a way that is efficient and transparent. The standard, which is now in its third edition, received strong support from the FDA, in line with its drive for global convergence of medical device regulatory processes.

The announcement by the FDA that it will use ISO 13485 in replacing its current quality system regulation, is an important next step in the recognition this standard has already gained globally.  The committee Chair, Peter Linders, added that “this bold step by the FDA seems logical, considering the role of ISO 13485 as the foundation for the Medical Devices Single Audit Program (MDSAP), currently operated by Australia, Brazil, Canada, Japan and the USA”.

Auditing Management Systems Standard Updated

Monday, July 16th, 2018

Management system standards are growing in popularity as organizations see how they can be applied to manage interrelated processes to achieve their objectives. From quality or energy management to food or traffic safety, the list of standards aimed at helping organizations put in place effective management systems is getting long.  In order to get the best out of a management system and ensure continuous improvement, regular auditing needs to take place.

 

ISO 19011:2018, Guidelines for Auditing Management Systems offers a uniform, harmonized approach, enabling effective auditing across multiple systems at the same time.  Key changes in the 2018 version include the addition of a risk-based approach to the principles of auditing to reflect the enhanced focus on risk in both management standards and the business application.  In addition, guidance has been expanded in a number of areas such as managing an audit program, and conducting an audit.  We highly recommend purchasing this document. You can purchase ISO 19011:2018, Guidelines for Auditing Management Systems from the Techstreet Store .

 

New AIAG Regulatory Updates Page

Tuesday, May 22nd, 2018

In partnership with Compliance & Risks, AIAG now offers a New Free Regulatory Updates webpage that automatically populates with relevant content as regulations are updated and customer requirements change.

This RSS feed driven page is geared toward individuals involved with corporate responsibility and sustainability (CR/S), and those performing quality functions that require reporting into IMDS, and all others dealing with global substances of concern and waste regulation. The page’s simple and straightforward format allows users to quickly skim through content if desired, but also makes it easy to find more information. Clicking on any particular update’s title takes the user to the source page, where more detail is available.

Resources like this help support proactive and reactive measures within automotive industry organizations in response to changes in global regulations. Since the page populates with fresh content as regulations are updated and customer requirements change, the process of staying informed is made stress-free – checking back often will help individuals stay up to date on the latest need-to-know regulations and requirements, and better prepared for compliance challenges. Additionally, although new content appearing at the top of the page will displace older updates, the latter will still be readily available simply by scrolling down.

To view the Regulatory Updates page, simply visit this link, or navigate to the Corporate Responsibility tab at www.aiag.org to explore related topics.

Avoiding Supply Chain Counterfeit Components

Saturday, April 14th, 2018

The global trade in counterfeit electronics and equipment currently stands at $121 billion, but counterfeit products don’t just cost companies money, they ruin reputations, they’re dangerous and what’s worse, they can become harder to identify.  In March 2018, the Anti-Counterfeiting Forum, held at BAE System headquarters brought together a range of speakers who explained the steps that should be taken to prevent and combat counterfeit products.   A key topic proved to be the importance of ‘knowing your supply chain’.

A key speaker stated the U.S. Department of Defense has identified upwards of a million counterfeit components in its military supply chain, caused by poor supplier control and weak buying practices.  When sourcing parts, tell the subcontractors the full manufacturer’s part number and the current name, and if relevant, any previous names. He also said to avoid only identifying a component by using a distributor’s part number.  The problem of counterfeiting isn’t new, so existing stock should also be checked. Visual inspection alone is not sufficient, so the best course of action is to send suspicious products to a testing company.  He went on to explain that obsolete products are one of the main opportunities for counterfeiters. To combat this, he suggested better anticipating the demand for products and stocking up on them.

 

ISO 45001:2018 Published Today!

Monday, March 12th, 2018

ISO 45001 is an ISO standard for management systems of occupational safety and health. It follows the management system standard structure guideline Annex SL. The standard requirements aim to allow an organization to provide a safe and healthy workplace(s), by preventing work-related injury and/or ill health, as well as by proactively improving its OH&S performance.

ISO 45001:2018 is applicable to any organization that wishes to establish, implement and maintain an OH&S management system to improve occupational health and safety, eliminate hazards and minimize OH&S risks (including system deficiencies), take advantage of OH&S opportunities, and address OH&S management system nonconformances associated with its activities.

ISO 45001:2018 helps an organization to achieve the intended outcomes of its OH&S management system. Consistent with the organization’s OH&S policy, the intended outcomes of an OH&S management system include:

a) continual improvement of OH&S performance;

b) fulfillment of legal requirements and other requirements;

c) achievement of OH&S objectives.

To purchase ISO 45001:2018 OH&S Management System visit the ANSI Standards Store.

ISO 9001 and 14001 Certification Audits

Saturday, January 13th, 2018

A notice from the International Accreditation Forum (IAF) that an official resolution has been reached regarding audits performed to ISO 9001:2008 and ISO 14001:2004.

A key aspect of this resolution was the following mandate:

“Effective March 15, 2018, all audits performed to ISO 9001 or ISO 14001 must be performed to the 2015 year revision.”

As the three-year transition for ISO 9001 and ISO 14001 moves into its final year, IAF (the global association for developing the principles and practices for the conduct of conformity assessment) has passed a resolution that as of 15 March 2018, conformity assessment bodies must conduct all ISO 9001 and ISO 14001 initial, surveillance and recertification audits to the new versions – ISO 9001:2015 and ISO 14001:2015.

Any organizations who need to move to the new version of ISO 9001 and ISO 14001 should contact their conformity assessment body as soon as possible to make arrangements for their audit.  Note that failure to achieve certification to the 2015 standard by the deadline means that your certification is no longer valid and this may affect your ability to supply to all markets.   A copy of this resolution can be obtained from the IAF Here.

ISO Management System Standards Certifications Continue to Rise

Sunday, November 5th, 2017

Use of ISO management system standards continues to rise.  The number of valid certificates to ISO management system standards (MSS) rose 8 % in 2016 compared to 2015, according to latest figures of the ISO Survey.  The ISO Survey is an annual survey of valid certifications to ISO management system standards issued by accredited certification bodies worldwide. It is the most comprehensive overview of certifications to these standards currently available.

The ever-popular ISO 9001, Quality management systems – Requirements, and ISO 14001, Environmental management systems – Requirements with guidance for use, were up 7 % and 8 % respectively, with 1,106,356 and 346,189 certificates issued, while more recent additions to the survey, such as ISO 50001 for energy management and ISO/IEC 27001 for information security, rose by 69 % and 21 % respectively, amassing 20,216 and 33,290 certificates worldwide.

As ISO does not perform certification, the figures in the ISO Survey represent the number of valid certificates reported to ISO by accredited certification bodies as at 31 December 2016.  View the executive summary and full results on the ISO Survey page.

ISO/IEC 17025 moves to final stage of revision

Tuesday, September 19th, 2017

Calibration as well as testing and analyzing a sample is the daily practice of more than 60,000 laboratories worldwide, but how can they reassure customers about the reliability of their results?  Over the years, ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories, has become the international reference for testing and calibration laboratories wanting to demonstrate their capacity to deliver trusted results.

However, the laboratory environment has changed dramatically since ISO/IEC 17025 was last published in year 2005.  After 15 years with all the significant changes and market conditions worldwide, it is time for a revised standard. Developed jointly by ISO and IEC in the Committee on conformity assessment (CASCO), the new version of ISO/IEC 17025 will replace the 2005 version and is scheduled for publication at the end of 2017.

For more information on the main changes to the standard, see the article on the ISO Website.