International Certification Database

 
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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!

International Certification Database

A recent vote was taken among 78 nations with accreditation bodies that are part of the International Accreditation Forum (IAF). From the vote it was determined that a new international database for quality management system (QMS) certifications should be created.

 

According to an article in Quality Digest, the intent of the database is to allow anyone with access to the internet to simply look up whether or not a QMS certificate was issued by an accredited conformity assessment body (CAB), sometimes referred to as a “registrar.” Although companies do pay money to be certified for conformance to a standard, in the past it has been difficult to distinguish the certificates issued by accredited CABs from the certificates issued by non-accredited CABs. Appearances are often deceiving.

 In short, a QMS database of accredited certifications provides a single spot for purchasers or others who need to verify the source of a company’s accreditation.

 

Why the IAF?

According to the last published ISO Survey of Management System Standard Certifications, there are more than 1.6 million accredited QMS certificates in circulation worldwide. The survey reports on certificates to ISO management system standards, which include those covering quality, food safety, medical devices, and information security, among others. Important to note, the survey only counts certificates issued by CABs that have been accredited by members of the IAF.

What will the database look like?

The approved proposal suggests using the English language along with as many other languages as possible, for the database is intended to serve all inquiries worldwide. The IAF proposal suggests having .pdf copies of the actual certificates, which will allow visual confirmation in addition to access to specific information considered most relevant to industry as well as certain types of regulators (who are the most likely users).

What will the database look like?

The approved proposal suggests using the English language along with as many other languages as possible, for the database is intended to serve all inquiries worldwide. The IAF proposal suggests having .pdf copies of the actual certificates, which will allow visual confirmation in addition to access to specific information considered most relevant to industry as well as certain types of regulators (who are the most likely users).
Monitoring the supply chain will be easier

Making 1.6 million certificates accessible will make it possible to rapidly screen ISO certifications from one location. On occasion in the past, regulators have nearly approved medical devices for use in the public health system, based on faked certificates that were later deemed illegitimate. The new IAF database will allow manufacturers and regulators to quickly check those certificates without the inconvenience of going to multiple websites,

The supply chain will be held accountable as never before. Legitimate audits will become even more valuable as the rest fade from existence.

 

The database particulars are still being worked on and there is no scheduled release date as yet.  Stay tuned for further details as to when this database will be made available to the public.

 

ISO 9001:2015 Guidelines for Application

A new standard, ISO/TS 9002, Guidelines for the application of ISO 9001:2015, is being developed to assist users in implementing an ISO 9001-based quality management system.

The Technical Specification (TS) is intended to be informative and provide guidance on the requirements in ISO 9001, with a clause by clause correlation to clauses 4-10 in ISO 9001.

 

ISO/TS 9002 will not add new requirements to ISO 9001. However, it will give examples of what an organization can do. These examples will not be definitive and only represent possibilities, not all of which are necessarily suitable for every organization.

ISO 9001 contains requirements that can be objectively audited or assessed. ISO/TS 9002 will include examples, descriptions, and options to help implement a quality management system and to strengthen its relation to the overall management of an organization.

While the guidelines in ISO/TS 9002 will be consistent with the ISO 9001 quality management system model, they are not intended to provide interpretations of the requirements in ISO 9001 or be used for audit purposes.

 

ISO/TS 9002 is currently at the Committee Draft level.

We will keep you informed of the publication timeline. Contact us with questions and for further information on how we can support your future ISO 9001:2015 Management System Transition Needs.

 

Cleanroom Standards for Contamination

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Controlling contamination is essential in many manufacturing and research activities. The use of cleanrooms, along with strict and stringent processes, makes this possible. The recently revised ISO standards for cleanrooms can help.

Food production, pharmaceuticals, aerospace and automotive manufacturing are just some of the many areas where controlled and classified cleanrooms are essential. Cleanrooms are zones where contaminants in the air are highly controlled. Without effective control, contamination can wreak havoc on products and processes.

ISO has a series of standards dedicated to cleanrooms, outlining the practices and procedures required to manage the risk of contamination. The first two in the series have just been updated to take into account the latest technological developments and market requirements.

ISO 14644-1:2015, Cleanrooms and associated controlled environments – Part 1: Classification of air cleanliness by particle concentration, and ISO 14644-2:2015, Cleanrooms and associated controlled environments – Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration, provide the framework for classifying and monitoring the cleanliness of the air in cleanrooms.

 

The ISO 14644 series is available for purchase through the ANSI Website.

 

Methods to Avoid Counterfeit Issues

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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.

Many of our AS9100 clients are finding that a documented Counterfeit Control Procedure as an aerospace supplier has become a critical requirement.   Some of the standards you should be aware of include:
  • Aerospace Standard (AS) 5553 If you purchase electric parts for integration into aerospace equipment or assemblies, you should implement the AS 5553 standard. This standard was created to tackle the substantial increase of counterfeit electronic components entering the aerospace supply chain posing significant reliability and safety risks.
  • Aerospace Standard (AS) 6081 – AS 6081 is specifically intended for distributors to help keep counterfeit electronic components out of the supply chain. This standard was created to provide consistent requirements, practices and processes to alleviate the risks of purchasing and supplying counterfeit components.

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

 

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In the News
Congratulations to our Client, Anokiwave for achieving ISO 9001 Certification!

Anokiwave is a fabless semiconductor company providing highly integrated SiGe core chips and III/V front ends for mmW markets. Our team is dedicated to providing the world’s best integrated circuit solutions for next generation mmW applications.

We are comprised of a unified and accomplished group of professionals who are able to provide solutions to your most challenging mmW applications. Anokiwave is adaptable, persistent, and dedicated to superior quality – customer satisfaction is our number one priority.

SES worked with the Anokiwave Team at their sites in Boston, MA., and San Diego, CA. for a highly successful certification process. Anokiwave was certified by NQA, one of the largest and most respected certification bodies in the world, with over 35,000 certifications in over 70 countries.

For more information about Anokiwave products, please visit the company website.
 
ISO 9001:2015 Internal Auditor Course          
 

SES is conducting an ISO 9001:2015 Internal Auditor Course on March 15-16, 2016 in the Phoenix area (east valley location.) The course description and student registration can be found on our website training page. Students will receive a comprehensive workbook and certificate of training completion. Group discounts are available. Please Contact Us with any questions.

 

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Want more Business…

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Best Regards,

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

 

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