Tag: Quality Management

AS 9120 Aerospace Quality Management

AS 9120, titled, “Quality Management Systems — Requirements for Aviation, Space, and Defense Distributors,” has just been updated.  It is one of a number of documents on Quality Management published by SAE International.  The new revision B will replace Revision A, which is now obsolete.  This document is available now from Document Center as a hard copy or for PDF download.

Implementing a Quality Managment System can improve the quality, cost, and timing of delivery of your products.  It also has the added benefit of inspiring confidence in your vendors and customers.  That is precisely why so many different companies scramble to pick up these quality management standards when they come out.    If you’re an aerospace or defense distributor looking to implement a quality system in your company,  AS 9120 may just be the standard for you.

Who needs this document, anyway? AS 9120 was published to be a guide to the ever-so-popular ISO 9001, but it is specifically designed for aerospace and defense distributor needs.  That is, if you are buying and reselling parts in the aerospace industry, this applies to you.

In it, ISO 9001 is included, accompanied by helpful notes and added content on aerospace applications.  Next, the document is divided into a number of sections to ensure that each facet of the quality management system is addressed.  Sections applying specifically to leadership, planning, support,  operation, evaluation, and improvement are included.  Following this are a number of annexes informing the reader of other quality standards that may be of interest.

To ensure the soundness of your quality management system, pick a copy of the AS 9120.  At Document Center, we’ve got it available in a number of formats, including hard copy, PDF, and for site-wide subscription.  Here’s a link to the order page for AS 9120.  Need to pick up some accompanying documents, while you’re at it?  Go to www.document-center.com and browse our standards library.

If you’ve got questions about quality, aerospace, or any other standards, get in contact with us.  We can be reached by phone (650-591-7600) or email (info@document-center.com).  Providing guidance to the world of standards is what we do.  Make us your Standards Experts!

 

New AAMI SW87 provides guidance for Application of Quality Management System concepts to Medical Device Data Systems (MDDS)

The new AAMI SW87, “Application of Quality Management System concepts to Medical Device Data Systems (MDDS),” has been released and is now available from Document Center Inc.

To ensure the safety and effectiveness of medical device data systems (MDDSs), regulators like the U.S. Food and Drug Administration are requiring organizations that develop or provide medical device data systems to implement a quality management system.

This 38-page recommended practice provides information that allows the medical device data system manufacturer to implement a quality management system that matches the risk presented by the device, the complexity of device and manufacturing processes, and the size and complexity of organization.

Right now, the new ANSI/AAMI SW87:2012 is only available in pdf format, but should be released in paper format from the publishers soon.  You can purchase a copy on our website, www.document-center.com.  Or contact us for more information by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We appreciate the chance to help you with your standards requirements and questions.

ISO 50001 2011 Edition tackles the problem of Energy management systems – Requirements with guidance for use

The new ISO 50001:2011 specifies requirements for establishing, implementing, maintaining and improving an energy management system.  The new document, titled “Energy management systems — Requirements with guidance for use,” is expected to be adopted by the European Union as EN-ISO-50001 and will replace EN-16001.

ISO 50001:2011 specifies requirements applicable to energy use and consumption, including measurement, documentation and reporting, design and procurement practices for equipment, systems, processes and personnel that contribute to energy performance.  And Annex A provides informative guidance on its use.

The ISO standard applies to all variables affecting energy performance that can be monitored and influenced by the organization. However, it does not prescribe specific performance criteria with respect to energy.

ISO 50001 has been designed to be used independently, but it can be aligned or integrated with other management systems.

It is applicable to any organization wishing to ensure that it conforms to its stated energy policy and wishing to demonstrate this to others, such conformity being confirmed either by means of self-evaluation and self-declaration of conformity, or by certification of the energy management system by an external organization.

Energy management can reduce energy consumption, leading to:

  • Reduced energy costs
  • Reduced carbon emissions
  • A more secure supply of energy
  • Improved reputation when implemented with certification

    • ISO 50001 enables organizations to take a systematic approach to energy management. It’s goal is to help companies achieve continual improvement of energy performance, energy efficiency and energy conservation.

    Who should buy this standard?

  • Anyone who wants to reduce their energy costs, reduce carbon emissions or improve their organization’s reputation
  • Those who want a better understanding of international best practice energy management
  • Users of ISO 14001 who want to further develop their management of energy and increase their performance and savings
  • Those responsible for planning and implementing an energy management system

    • ISO 50001:2011 is available from Document Center Inc. at our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).   We have been an authorized distributor of ISO standards since the 1990’s.

    The ISO 9000 Compendium – The top quality standards at a low price

    The ISO-9000 Compendium 12th Edition is a real bargain in the world of standards.  You get a real cross-section of the important quality standards at a reasonable price.  Yes, it is only available in CD Rom format (Now in pdf format as well.)  But you will be able to review many more documents than you could otherwise.

    Of course, there is one major problem with ordering any compilation of standards.  The documents may be revised individually while the compilation stays static.  This is certainly the case with the current issue of the ISO 9000 Compendium.  The final draft for the ISO-9004 has been approved and is now available as an authorized edition, rather than the draft included in the compendium.

    So, if you need to be sure you’re meeting the ISO-9001 certification requirements but want to take a look at the balance of the collection just for informational purposes only, you may want to purchase the compendium.  Then, get notification service for the ISO-9001 document.  That way, you’ll find out right away when any changes are made to the document you use for certification.

    Here’s the contents of the current  Twelveth Edition  (along with links to the current edition of each item as a solo purchase):

    • ISO 9000 : 2005 Quality management systems — Fundamentals and vocabulary
    • ISO 9001 : 2008 Quality management systems — Requirements (With Technical Corrigendum)
    • ISO 9004 : 2000 Quality management systems — Guidelines for performance improvements
    • ISO 10001 : 2007 Quality management systems — Customer Satisfaction — Guidelines for codes of conduct for organizations
    • ISO 10002 : 2004 Quality management systems — Customer Satisfaction — Guidelines for complaints handling in organizations
    • ISO 10003: 2007 Quality management systems — Customer Satisfaction — Guidelines for dispute resolution external to organizations
    • ISO 10005 : 2005 Quality management systems — Guidelines for quality plan
    • ISO 10006 : 2003 Quality management — Guidelines for quality management in projects
    • ISO 10007 : 2003 Quality management systems — Guidelines for configuration management
    • ISO 10012 : 2003 Measurement management systems — Requirements for measurement processes and measuring equipment
    • ISO/TR 10013 : 2001 Guidelines for quality management system documentation
    • ISO 10014 : 2006 Quality management — Guidelines for realizing financial and economic benefits (With Technical Corrigendum)
    • ISO 10015 : 1999 Quality management — Guidelines for training
    • ISO/TR 10017 : 2003 Guidance on statistical techniques for ISO 9001:2000
    • ISO 10019 : 2005 Guidelines for the selection of quality management system consultants and use of their services
    • ISO 19011 : 2002 Guidelines for quality and/or environmental management systems auditing
    • ISO/DIS 9004 Managing for the sustained success of an organization — A quality management approach

    ISO 9001:2008 – Are you using the right edition?

    If you’re certified to ISO 9001, Quality Management Systems – Requirements, you’ll want to make sure you’re using the right edition of the document.

    With new changes released in 2009, there’s some confusion over exactly what is the current edition of the ISO-9001:2008.

    The problem stems from having a corrected and reprinted edition released at the same time the Technical Corrigendum was issued (7/15/2009).

    So in fact, you can have your document one of two ways, and you’re going to be just fine:

    1.  You can use the corrected and reprinted 4th Edition from 7/15/2009.  This is a completely reprinted copy with the changes integrated into the text of the standard.

    or

    2.  You can use the original 4th Edition from 11/15/2008 and the Technical Corrigendum from 7/14/2009.  In this case, the changes are contained in the Corrigendum (correction sheet) only.  So you’ll have to manually integrate the 7 pages of changes into the original 11/15/2008 copy of the standard.

    What determines which path you take?  If you get the reprinted and corrected document, you’ll have to pay for the standard again.  If you just get the corrigendum, the costs will be minimal.  But you’ll have to spend the time to get the changes integrated into your original copy.

    In either case, Document Center Inc. can help you with copies available of all 3 components.  Just get in touch with us at info@document-center.com, by phone at 650-591-7600 or on our website at www.document-center.com.