TG Manufacturing De Mexico

Written by ASR Editor on . Posted in Client News

Apodaca, Monterrey, Nuevo Leon MX
ISO 9001:2015 Registration
Certification: 6494

Manufacture of Metal parts, Robotic and Manual Welding, Roll forming, Metal Stampings and Machined Products

Refurbish and Sale of Medical Equipment

Northern Gear and Machining, LLC

Written by ASR Editor on . Posted in Client News

Muskego WI 53150
ISO 9001:2008 Transfer
Certification: 6495

Manufacture of Machined Components and Assemblies made from Forged and Cast Metal Products for Engines, Off Road and Agricultural Equipment and Hydraulic Systems

Refurbish and Sale of Medical Equipment

Sensor Technology Systems

Written by ASR Editor on . Posted in Client News

Beavercreek OH 45440
ISO 9001:2008 Transfer
Certification: 6496

Design and Manufacture of Electro Optic Solutions

Refurbish and Sale of Medical Equipment

Roylco Industrial

Written by ASR Editor on . Posted in Client News

Anderson SC 29624
ISO 9001:2015 Registration
Certification: 6478

Manufacturer Providing Custom Die Cutting, CAD Services, Excluding Design Processes

Refurbish and Sale of Medical Equipment

Plasma-Tec, Inc.

Written by ASR Editor on . Posted in Client News

Wayland MI 49348
ISO 9001:2008 Registration
Certification: 6479

Precision Machined and Coated Products which Meet Industry and/or Customer Requirements

Refurbish and Sale of Medical Equipment

Techni-Car Inc.

Written by ASR Editor on . Posted in Client News

Oldsmar FL 34677
ISO 9001:2008 Registration
Certification: 6504

Electronic Service Center for the Refurbishment, Distribution and Sales of Automotive Electronic Devices including Audio Systems, Multimedia and Instrument Clusters

Refurbish and Sale of Medical Equipment

Coating Technology, Inc.

Written by ASR Editor on . Posted in Client News

Rochester NY 14605
AS9100C Registration
Certification: 6498

Metal Finishing, including Electroless-Nickel, Anodizing, Zinc Plating, Passivation, Conversion Coatings and Powder Coating for the Aerospace, Defense and Commercial Industries
Refurbish and Sale of Medical Equipment

Precious Metal Sales, Inc.

Written by ASR Editor on . Posted in Client News

Watertown CT 06795
ISO 9001:2015 Registration
Certification: 6499

Sourcing and Distribution of Industrial Precious Metals for Surface Finishing Applications
Refurbish and Sale of Medical Equipment

TapeCase, Ltd.

Written by ASR Editor on . Posted in Client News

Wheeling IL 60090
ISO 9001:2008 Transfer
Certification: 6500

Sale, Purchasing, Distribution and Converting of Pressure Sensitive Tape, Adhesives and Industrial Products
Refurbish and Sale of Medical Equipment

June 2016 Newsletter

Written by ASR Editor on . Posted in Newsletters

Clarification to the FMEA Risk Article


FMEA (Failure Modes Effects Analysis) can be a successful risk reduction tool to assist in meeting the risk planning (design and manufacturing process) requirements mandated by ISO 9001:2015.

As an analytical tool, ISO 9001 organizations can use the FMEA to review steps in a process to determine how much risk there is in each specific process step. This documented criteria score (1 – 10) identifies, among other issues, how often the failure occurs and can the issue be detected prior to the product leaving the facility? A completed FMEA highlights the greatest risks requiring an action plan for process improvement to mitigate the risk.

There are other tools to use for risk planning, but the FMEA (Design or Process) is a strong and valuable method to evaluate risk and is regularly used by many aerospace, automotive, and medical device manufactures.

It is also important to mention that ISO 9001:2015 (8.5.1g) requires “implementation of actions to prevent human error.” How an organization addresses this requirement is left to their discretion. However, one of the common tools used is error proofing or mistake proofing - installing a device to help the operator perform a task without making an error. This could be a tool to use after completing a design or process FMEA. Error proofing can be very useful in high volume production where it is difficult to catch 100% of the problems.

Evaluating risk is a new concept for ISO 9001 organizations and standard writers made it very clear that planning for risk (6.1.2 b) 1) shall be performed throughout the quality management system. However, organizations need to apply good judgment when implementing a program that is proportionate to the potential impact on the conformity (6.1.2 b) to products and services.
 
 

Online Training


Click here to register for the ISO 9001:2015 Risk Requirements course.

Click here to register for the ISO 14001:2015 Internal Auditor Training course.

Click here to register for the ISO 9001:2015 Internal Auditor Training course.


Use promo code:
 

 
Use this code for a 40% discount.  Note: it can be used only 12 more times, so act soon.

3 or more employees? Contact us for additional discounts!
 

May 2016 Newsletter

Written by ASR Editor on . Posted in Newsletters

Ideas for ISO 9001:2015 Internal Auditing


As ISO 9001 organizations adjust their systems to meet 2015 requirements, it opens an opportunity to add two new processes to the internal auditing requirements to capture effective implementation.

Audit program managers might want to consider Context of the Organization and Strategic Direction as separate audits inside of the organization’s audit program.  Adding these topics to the internal audit process based format requires inputs/outputs to these processes as well as measurement activities to demonstrate effective implementation.

Internal auditors should begin with top management.  Auditors should be looking for available documented information that determines what the Strategic Direction is.   This would cover many of the segments of the Context of the Organization that have been established.  Some of the segments include internal and external issues, and the organization’s interested parties.

Once auditors have gathered this information, the next step is verifying top management’s commitment.

Questions for Management:
  1. Tell me about your company’s strategic direction?
  2. Who are the senior managers leading this effort?
  3. What activity is ongoing and how is progress reviewed?
  4. Let’s review the management review records? Is the QMS aligned with the Strategic Direction?

Go to our website and read the full article.



 

New 2016 Automotive and Aerospace Standards Set for 4th Q 2016 Release


ISO/TS 16949 – IAOB announced in a recent meeting with Certification Bodies (registrars) that the new standard should be available this October instead of December.  The October release will add a couple extra months to the automotive community’s implementation timeline.

ASR is advising its TS 16949 clients to acquire a copy of the standard just as soon as it is available to ensure there is sufficient time for a system upgrade.  ASR is hopeful of conducting upgrade audits by early April 2017.
 
AS9100:2016 Series - International Aerospace Quality Group (IAQG) has agreed to align transition to the forthcoming revised 9100:2016 series standards with the International Accreditation Forum's (IAF) requirement to transition to the ISO 9001:2015 quality management system (QMS) standard no later than September 15, 2018.  AS9100:2016 is based on ISO 9001:2015.


 

Long Time Auditor Passes


ASR has lost a valued colleague and dear friend, James McDonald.  James passed away on May 8, 2016.   James worked with ASR for 10 years conducting ISO 9001, ISO/TS 16949 and ISO 14001 audits. 

He was an integral part of ASR’s audit team and will be dearly missed.   

Memorial Services to celebrate James’s life will be held Saturday, May 28, 2016 at 10:00am at The Inn at St. John’s, 44045 Five Mile Road, Plymouth, Michigan  48170. 

In lieu of flowers the family asks that you consider a donation in James’s memory to the American Heart Association which can be done on their website, www.heart.org.  Share a memory at www.eltonblackandsonewhitelake.com
 

ASR Releases ISO 9001:2015 Risk Requirements Training Course


This course covers Risk Based Thinking in the new ISO 9001 2015 standard.  The instructor covers what the standard requires and what should be included for effective risk management.   The course is intended for:
  • Companies that have a current ISO 9001 QMS
  • Organizations new to ISO 9001; those looking for first time certification
  • Executive Staff involved in your QMS
  • Quality Managers
  • Internal Auditors
Use the ASR client promo code below:

            


The first 20 clients will receive a 40% discount.

This is an Individual Course and not part of the corporate account package.

Click here to register for the ISO 9001:2015 Risk Requirements course.

Click here to register for the ISO 14001:2015 Internal Auditor Training course.

Click here to register for the ISO 9001:2015 Internal Auditor Training course.


If you have 3 or more employees that need to take this course, please contact us for additional discounts!
 

Sampson Light Industry

Written by ASR Editor on . Posted in Client News

Cincinnati, OH 45246
AS9100 Registration
Certification #: 6460

Advanced Manufacturing & Engineering Consulting

Refurbish and Sale of Medical Equipment

BRITECH

Written by ASR Editor on . Posted in Client News

Allentown PA 18109
ISO 9001:2008 Registration
Certification #: 6461

Contract Manufacturing of Wire and Cable Assemblies, Control Panels, PCB Assemblies, and Powder Coating

Refurbish and Sale of Medical Equipment

Midway Rotary Die Solutions

Written by ASR Editor on . Posted in Client News

Williamston MI 48895
ISO 9001:2008 Transfer
Certification #: 6470

Design, Manufacture and Service Rotary Tool Steel Dies and Accessories for the Converting Industry

Refurbish and Sale of Medical Equipment

Velentium

Written by ASR Editor on . Posted in Client News

Katy TX 77494
ISO 13485:2003 Registration
Certification #: 6474

Manufacture of and Provision of Services for Medical Devices and Manufacture of Systems and Medical Device Components; Inclusive of Customer Approved Design Support

Refurbish and Sale of Medical Equipment

West Pak Avocado, Inc.

Written by ASR Editor on . Posted in Client News

Murrieta CA 92563
ISO 9001:2008 Transfer
Certification #: 6475

Packaging, Pre-Conditioning and Wholesale of Avocados

Refurbish and Sale of Medical Equipment

Custom Tool Inc.

Written by ASR Editor on . Posted in Client News

Cookville TN 38506
ISO 9001:2015 Transfer
Certification #: 6478

Precision Machining and Assembly of Primarily Metal Component Parts per customer-Supplied Design

Refurbish and Sale of Medical Equipment

April 2016 Newsletter

Written by ASR Editor on . Posted in Newsletters

Standards Certification Professionals - Worldwide

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You are receiving this newsletter because you are an ASR client or want to stay current with the latest international standards.


Please forward this email to a collegue or associate so they may benefit from this information.





  ISO 9001:2015 Documentation - What is Really Necessary?

Organizations are beginning to transition their QMS to the 2015 version of ISO 9001 prompting some clients to ask how much documentation is necessary. The answer is your choice as 2015 is very open regarding documentation.

ISO 9001:2015 splits documentation into a category called "maintain documented information" and a second category called "retain documented information."

Click Here to Download the guide to Required Documentation.

Maintain Documented Information - refers to procedures, work instructions, forms and other items that were controlled in Clause 4.2.3 of ISO 9001:2008. Therefore, your existing documented procedures, forms and work instructions are probably acceptable and can be used in most cases without changes. However, ISO 9001:2015 adds to the "maintain documented information" requirement. See the attached list for the specific sections regarding maintain document information.

Retain Documented Information - refers to records, and documented performance, either hard copy or electronic. Section 4.2.4 of ISO 9001:2008 that addressed control of records is similar to ISO 9001:2015. See the attached list for the specific sections addressing retain documented information.

Mandatory Procedures – are NOT listed in ISO 9001:2015. Each organization must evaluate what written procedures are necessary for the day to day success of their operation.

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ASR Releases Internal Auditor Training for:
ISO 14001:2015 &
ISO 9001:2015


Use the ASR client promo code below:

ixxxra

You will receive an 30% discount.

This is an Individual Course and not part of the corporate account package.


Click here to register for the ISO 14001:2015 Internal Auditor Training coursecourse.

Click here to register for the ISO 9001:2015 Internal Auditor Training course.


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ASR Referral Program

ASR has a customer referral program that pays our clients $200.00 for any referral where the organization becomes an ASR registered client.
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Risk and ISO 9001:2015

With the release of the 2015 revision, it is important to revisit one of the major changes to the standard – developing risk based thinking.

ISO 9001:2015 moves risk based thinking from a "should" or a good idea to enhance a QMS to a "shall" requirement.

Both ISO 13485:2003 and AS9100 require users to address risk in Section 7 of their respective standards.

A good way to look at risk and to address risk is by utilizing the PDCA cycle - Plan, Do, Check and Act.



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Auditor Transition Tools


ASR is making available tools developed for use by ASR's ISO 9001 and ISO 14001 auditors.

Take a look at them.

ISO 14001:2015:

ISO 9001:2015:


Click here to see all our downloadable documents and presentations.




Welcome Aboard

We want to welcome these new clients.

Prime Janitorial Service Corporation
ESW CleanTech, Inc.
Prestige Extreme Machining and Manufacturing
South Bend Modern Molding (SBMM)
BAE Industries
Stryver Manufacturing, Inc.
E.A. Patten Company
Identification Products Corp.
Kerf Waterjet, Ltd.
AttainX
Vetronix Research Corporation
Stratasys, Inc.
Oshkosh Coil Spring, Inc.
Tower Optical Corporation
General Control Systems, Inc.
Weldaloy Products Company
Monroe, LLC
Anwo Machine & Tool Company
Sequoia Tool
Frank Roth Company, Inc.
LAB Security Systems, Inc.

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Prime Janitorial Service Corporation

Written by ASR Editor on . Posted in Client News

Based in Ponce PR 00716
ISO 9001:2008 Registration
Certification #: 6448

Provision of Cleaning Services
Refurbish and Sale of Medical Equipment

ESW CleanTech, Inc.

Written by ASR Editor on . Posted in Client News

San Diego CA 92121
ISO 9001:2008 Registration
Certificate # 6452

Design, Manufacturing and Distribution of Diesel Emissions Control Devices
Refurbish and Sale of Medical Equipment

South Bend Modern Molding (SBMM)

Written by ASR Editor on . Posted in Client News

Mishawaka IN 46544
ISO/TS 16949:2009 Transfer
Certificate # 6454

Manufacture and Inspection of Custom Rubber Parts and Assemblies
Refurbish and Sale of Medical Equipment

BAE Industries

Written by ASR Editor on . Posted in Client News

Auburn Hills MI 48326 & Warren MI 48091
ISO/TS 16949:2009 Transfer
Certificates 6455-1 6455-2

Auburn Hills:
Design and Manufacture of Stampings and Assembly of Latching Mechanisms

Warren:
Design and Manufacture of High Volume Small to Medium Stampings with Automated Resistance Welding, Robotic MIG Welding and Mechanical Seembly of Latching Mechanisms
Refurbish and Sale of Medical Equipment

Sequoia Tool

Written by ASR Editor on . Posted in Client News

Clinton Township MI 48036
AS9100 Registration
Certification #: 6444

Stampings - Prototype/Short Run/Low Volume Production, Horizontal and Vertical CNC Machining, Spot Welding, Robotic Welding, Mig and Tig Welding for the Aerospace, Automotive, and Commercial Industries

Refurbish and Sale of Medical Equipment

Frank Roth Company, Inc.

Written by ASR Editor on . Posted in Client News

Stratford CT 06615
AS9100 Transfer
Certification #: 6445

Manufacture of Precision Electromechanical Components and Assemblies and Manufacture of Aerospace Sheet Metal parts

Refurbish and Sale of Medical Equipment

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