Medical Device Makers and Component Suppliers Software Validation Reminder

Written by Rand E. Winters - ASR Senior Auditor on . Posted in ASR Quality & Standards Blog


Medical-device-1Medical device manufacturers will want to review their QMS documents to ensure they are addressing software  validation requirements.

ISO 9001:2008 -7.5.2.1 and the FDA requirements in 21 CFR 820.30 and 21 CFR 820.70i spell out validation requirements for software design as well software in the production environment.

If your organization is only a component manufacturer, the FDA requirements will probably not impact you. Your customer may insert software validation as a customer specific requirement in their PO or in their customer requirement manual.

2011 Review

Written by Richelle Kinzie - President on . Posted in ASR News & Press Releases

2011 was a year of growth for ASR! We added over 100 new clients in North America and another 200+ Internationally.
Our North American family has grown to 500+ clients with 600+ certifications. Worldwide we have over 1700 certifications. You can view your certification status at www.iaar.org.

Our talented pool of auditors changed during 2011. Several auditors experienced health issues and reduced their audit
days. Two auditors took positions in industry and one auditor died unexpectedly. We added 5 new auditors in North America and over 10 Internationally. We are continuing to look for competent auditors for all standards and this is one of our top goals as we head into 2012! Kudos to our current staff of auditors for stepping up to the plate to ensure all our clients were taken care of in 2011. Auditors worked Saturdays, gave up vacation days, and are working during Christmas and New Years to make sure the audits get done. We really appreciate all their extra auditing efforts!

Thanks to you, our clients, for all your help and patience in 2011! In the true spirit of partnership, you worked with us to reschedule audits so other clients could be accommodated. You held our feet to the fire when audit schedules were
delayed or audit reports were not timely, but you also told us when we exceeded your expectations! IT'S ALL ABOUT
IMPROVEMENT!

F-3000 Nonconformance Response

Written by ASR Quality Expert on . Posted in ANAB



chart-non-conformanceBelow highlights the changes that have been made to the ASR Nonconformance Report (F-3000).

The changes to the F-3000 are in response to a nonconformance issued to ASR by ANAB. ANAB does not feel as though ASR Auditors are pressing our clients hard enough for good correction, root cause analysis and corrective action(s).

Risk Management—Advanced Product Planning for Industry

Written by Rand E. Winters - ASR Senior Auditor on . Posted in ASR Quality & Standards Blog


Risk analysis and advanced product planningRisk Management is part of ISO 13485:2003 and AS9100 Rev C.

These two standards need to be fully understood before an effectively implemented system can be developed. Some  type of risk management plan might be valuable for all manufacturing and service industries.

Risk Management is a planning process to define the level of risk in a product, and to take appropriate actions to potentially reduce the risk and maintain risk within acceptable levels. The second portion of that statement (maintain  risk) is to proactively address any problems found after the product is shipped.

Creating a Good Management Review System

Written by Rand E. Winters - ASR Senior Auditor on . Posted in ASR Quality & Standards Blog


man-writing-in-plannerISO's series of standards including AS 9100 and ISO/TS 16949 require an annual management review. Results of management reviews should lead to an improving quality management system and key business processes.

Trends in the use of ISO 9001 and the other standards show that organizations are holding management reviews more
frequently than once per year. When this activity is conducted yearly it is more like reviewing history that cannot be changed.

Reviewing an organization's operations several times during a year gives top management an opportunity to look at  operating trends. This periodic look allows for adjustments that can impact a company's operations for the remainder of the year.

CQI-11 and CQI-12 – New Mandates For North American Automotive

Written by Rand E. Winters - ASR Lead Auditor on . Posted in ASR Quality & Standards Blog


These two self-assessments were developed by AIAG to promote improved and uniform quality and processes for plating (CQI-11) and coating (CQI-12) operations. Both self-assessments were effective January 2008 for first tier suppliers to GM, Ford and Chrysler.

CQI-11 and 12 apply to all levels in the GM, Ford & Chrysler supply chain. Your customer is responsible for notifying its suppliers of the need to conduct a self-assessment.

ISO 14001 – Foundation for Becoming Green

Written by Rand E. Winters - ASR Lead Auditor on . Posted in ISO 14001


going green helps bottom line

Green Living for Dummies states that becoming "green" means taking action now to stop using the Earth's resources faster than the Earth can replace them.


Organizations seeking to improve their environmental performance and promote a "green" image should look at ISO 14001 as a starting point.

First, let's define environment-friendly performance by an organization or being "green." A "green" company is an organization that has a plan, led by top management allocating resources to continually improve its environmental performance, measuring the improvement and publishing its improvements to assist other organizations in the community to do the same.

Root Cause and Corrective Action Tool

Written by ASR News Editor on . Posted in ASR Quality & Standards Blog


Root Cause Analysis


root-cause-analysisHere is the beginning process on how to approach the corrective action process from properly identifying the problem statement to implementing irreversible corrective action.

These questions are great tools as you work through the root cause and corrective action process. They ask a series of questions and help guide you in the right direction. The content provided is as follows. If you would like some of the original laminated versions, please call us and we will send them to you.

Problem Statement

Opportunity for Improvement - A Benefit

Written by Rand E. Winters - ASR Lead Auditor on . Posted in ASR Quality & Standards Blog


Opportunity-for-improvement-in-quality-managementAn Opportunity for Improvement (OFI) is a pretty neat idea! It allows your ASR auditor to share with you valuable ideas that may be helpful as your organization pushes its quality management system for continual improvement.

In fact, a well-thought out Opportunity for Improvement in many cases may be of more value than a well-implemented non-conformance.

What is the definition of an OFI as listed in ASR's auditing procedure?

Stahlin Non-Metallic Enclosures Recognized for Excellence by J.D. Power

Written by ASR News Editor on . Posted in ASR News & Press Releases


stahlin-asr-client-gets-awarded-jd-powersASR would like to congratulate Stahlin Non-Metallic Enclosures of Belding, MI for receiving a Call Center  Operation Customer Satisfaction Award for Excellence from J.D. Power.

Ed Atanasoff of Stahlin states that at least 70% of the criteria for the J.D. Power award overlapped with their ISO 9001:2000 Registration. He credits their embracing of ISO 9001:2000 as a contributing factor to
achieving this prestigious award. Stahlin is the only non-automotive company in Michigan to obtain this award and also the only one in their industry.

Waste is Bad

Written by Brad Bukowski, ASR Lead Auditor & Registration Manager on . Posted in ASR Quality & Standards Blog


How do we increase the margin on the parts or services we provide our customer(s)?Cut costs and waste to improve margin

  1. We have three basic options:
  2. Raise the price of our product or service – in a competitive global market this is difficult.
  3. Lower the cost of the raw materials - with the increase of raw material and transportation cost this most likely will also be difficult.
  4. The third option is reduce waste – this is easy to say but difficult to do.

ASR Congratulates Tailored Label Products for Receiving Multiple Industry Awards

Written by ASR News Editor on . Posted in ASR News & Press Releases


tailor-labeled-products-banner2006 was another great year for Tailored Label Products of Menomonee Falls, Wisconsin as evidenced by the multiple industry
awards they were given. They were recognized on the World stage as well as the local level for Manufacturing and Printing Excellence. The awards they received include:
  • Electronic Printing: Excellence in Technical Achievement in Printing (FINAT and various World Label Associations)
  • First Place Winner: Plateless Printing, Household Goods (Tag and Label Manufacturers Institute)
  • Second Place and Honorable Mention: Plateless Printing, Household Goods (Tag and Label Manufacturers Institute)
  • Top 10 Small Businesses of the Year (Waukesha County Chamber of Commerce) 2005 and 2006
  • Wisconsin Manufacturer of the Year
  • Best Workplaces in America 2006
Congratulations to Tailored Label Products and their employees for establishing themselves as an industry benchmark.

ISO/TS 16949:2002 Rules 3rd Edition & ISO/TS 16949:2009

Written by ASR Quality Editor on . Posted in ISO/TS 16949


The International Automotive Task Force (IATF) has released ISO/TS 16949:2002 Rules 3rd Edition. The 3rd Edition Rules went into effect on January 1, 2009. There are numerous changes from Rules 2nd Edition, however, the majority of them are directed towards Certification Bodies. ASR has developed a one page summary which was distributed to all ISO/TS 16949:2002 customers during the month of December 2008. This information sheet details all of the changes that may have an impact to our customers. It is recommended that all ISO/TS 16949:2002 registered customers purchase a copy of Rules 3rd Edition from AIAG (www.aiag.org).

ISO 9001:2008: Implementation and Changes

Written by ASR Quality Editor on . Posted in ISO 9001


ISO 9001:2008 was released and became effective on November 15, 2008. This new version of ISO 9001 contains no new requirements, only minor wording changes, clarifications and notes. ASR expects all ISO 9001 clients to purchase a copy (www.iso.org or www.asq.org) of this new version and be prepared to be audited against it beginning January 1, 2009.

The main changes to the standard occur in the following clauses.

ASR Client Recognized for Excellence in their Industry

Written by ASR News Editor on . Posted in ASR News & Press Releases


Advance turning and Manufacturing-incASR would like to congratulate Advance Turning & Manufacturing of Jackson, MI for being named one of the Top 10 Machine Shops in the United States!

The publication American Machinist conducted a survey of approximately 600 Machine shops ranging from small to large. They looked at a number of indicators for best practices and Advance Turning rose to the top in many categories. Those companies that were recognized had one main thing in common – they run a systematic operation driven by metrics.

The use of metrics to run your business is a key component of ISO 9001:2000 and although you do not need to be ISO  registered to utilize metrics, ASR would like to recognize Advance Turning & Manufacturing's commitment to ISO 9001:2000 as well.


Pridgeon & Clay Receives Quality Award

Written by ASR Quality Editor on . Posted in ASR News & Press Releases



Pridgeon-and-Clay-logoASR would like to recognize Pridgeon & Clay for being awarded the 2009 Parkview Metal Products Excellence in Quality Award by the Precision Metalforming Association (PMA).

This award recognizes companies that achieve excellence in the areas of implementation and maintenance of their quality management system as well as effective use of continual improvement.

Pridgeon & Clay was chosen based on seven key areas of their business including quality system/continuous improvement, executive management commitment, management review of the quality system, statistical data, preventive action, employee training/education and supplier partnerships.

Congratulations Pridgeon & Clay for using your quality management system (ISO/TS 16949:2002) to bring excellence and recognition to your company and employees!

ASR Joins UN Global Compact

Written by ASR Quality Editor on . Posted in ASR News & Press Releases


un-global-impactASR has joined the United Nations Global Compact! This is the world's largest voluntary corporate responsibility initiative. The UN Global Compact is a strategic policy initiative for businesses that are committed to aligning their operations and strategies with ten universally accepted principles in the areas of human rights, labor, environment and anticorruption. By doing so, business, as a primary agent driving globalization, can help ensure that markets, commerce, technology and finance advance in ways that benefit economies and societies everywhere.

As a participant, ASR has made a commitment:
  • to set in motion changes to business operations so that the Global Compact and its ten principles become part of strategy, culture and day-to-day operations;
  • to publicly advocate the Global Compact and its principles via available communications channels; and
  • to communicate annually and publicly on progress made in implementing the Global Compact principles.

For more information regarding the UN Global Compact visit their website at. www.unglobalcompact.org

ASR Customer Recognition

Written by ASR News Editor on . Posted in ASR News & Press Releases


ASR WOULD LIKE TO CONGRATULATE THESE COMPANIES FOR THEIR ACHIEVEMENTS IN THE AREAS OF QUALITY AND PERFORMANCE!

K&M Machine Fabricating of Cassopolis, MI was paid a visit by Michigan Governor, Jennifer Granholm. Ms.  Granholm was touring facilities around the state that are on the forefront doing work with alternative energy. K&M works with numerous companies in the wind power industry. K&M continues to be successful and attributes much of this to their work with alternative energy.

Executive Management, are you Using the Quality Management System to Improve Your BUSINESS?

Written by Bart Solomon, ASR Technical Expert on . Posted in ASR Quality & Standards Blog

Organizations today cannot afford to maintain a quality management system without getting full value from it. So....How do we  get value from our quality management system?

BY USING the management system to:
  • achieve the organizational vision – where we want to be in 5 years
  • reach annual goals and objectives and,
  • improve profitability

ISO 9001:2000, The Process Approach & Surveillance Audit Requirements

Written by Brad Bukowski, ASR Registration Manager on . Posted in ASR Quality & Standards Blog


We all know that at a Registration and/or a Re-Assessment Audit, auditors are required to review all elements of a Quality Management System as defined by the customer's processes and the ISO 9001:2000 Standard, but what truly needs to be audited during a surveillance audit? There is obviously less time involved, so a comprehensive look at the whole system is not  possible. However, as a Registrar, we want to give you a value-added audit that assists you with improving your business!

Process Approach to Auditing and Expectations of Our Customers

Written by Bart Solomon, ASR Technical Expert on . Posted in ASR Quality & Standards Blog


audit-turtle-diagram-smallI am often asked the question "Do I have to do process auditing?" ASR has had many discussions concerning this topic. So I would like to analyze the requirements and try to reach a logical conclusion that adds value to your quality management system and sets out ASR's expectations for your internal audit program.

Let's start by looking at what ISO 9001:2000 requires:

"The organization shall conduct internal audits at planned intervals to determine whether the quality management system

New Food Safety Management System Offers Opportunity to Global Food Supply Chain

Written by Bill Grande on . Posted in ISO 22000


As global markets for food and food products continue to grow the need for harmonization of international food safety  standards is becoming an essential component for facilitating effective and efficient trade agreements and protocols  between trade partners and regulatory bodies alike.

After years of development, the International Organization for Standardization (ISO) issued its new food safety  management system standard, ISO 22000:2005 last October. This new standard, first in the 22000 family, applies to any  participating organization within the food industry; basically from farm inputs through final food product preparation,  packaging and delivery to the ultimate user.

Transfer your certificate to ASR

We make it easy,
and affordable.

  1. Contact Us
  2. ASR Review
  3. Legal Documents / Approval
  4. Transfer
ASR-Referral-Button

News Delivered to Your Inbox

Standards of Interest:

Latest Poll

How do you train your employees?

Shadowing or Mentoring - 50%
Training Manual - 16.7%
Computer Based or Online Training - 33.3%
None - 0%

Automotive

  • IATF 16949
  • Intl. Automotive Task Force
  • BS 25999
  • OHSAS 18001

Medical Devices

  • ISO 13485
  • Product Safety
  • Device Recalls
  • Emergency Situations

Aerospace

  • AS9100
  • AS9110
  • AS9120
  • SAE Technical Standards

Environmental

  • ISO 14001
  • EPA Regulations
  • EMS Tools
  • Emergency Preparedness