ASQ-Z1.4 Archives - Document Center's Standards Forum

Document Center’s 20 Top Selling Standards of 2012

Yes, it’s time to review Document Center‘s top selling standards of 2012. Do you use any of these popular items?

BS EN ISO 13485, New 2012 Edition, Medical Devices. Quality Management Systems. Requirements for Regulatory Purposes
BS EN ISO 14971, New 2012 Edition, Medical Devices. Application of Risk Management To Medical Devices
ISO 15223-1, New 2nd Edition, Medical Devices – Symbols To Be Used With Medical Device Labels, Labelling and Information To Be Supplied – Part 1: General Requirements
BS EN ISO 15223-1 (paper or CD Rom format), New 2012 Edition (replaces BS EN 980), Medical Devices. Symbols To Be Used With Medical Device Labels, Labelling and Information To Be Supplied. General Requirements
ASTM F2096, 2011 Edition, Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
AMS 2750, New Revision E, Pyrometry
21 CFR Parts 800-1299, 2012 Edition, Code of Federal Regulations – Title 21–Food and Drugs (Parts 800 To 1299)
ISO 19011, 2011 Edition, Guidelines for Auditing Management Systems
SOR/98-282, 2012 Consolidated Edition, Medical Devices Regulations (Canada)
IEC 60601-1, Consolidated Edition 3.1 with Corrigendum, Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance
MEDDEV 2.12/1, New 8th Revision, Guidelines on a Medical Devices Vigilance System
ASTM E1417, 2011 Edition with Editorial Change, Standard Practice for Liquid Penetrant Testing
ASTM E18, 2011 Edition, Standard Test Methods for Rockwell Hardness of Metallic Materials
ASTM A370, 2012A Edition, Standard Test Methods and Definitions for Mechanical Testing of Steel Products
IPC-A-610, Revision E, Acceptability of Electronic Assemblies
ISO 11137-2, 2012 Edition, Sterilization of Health Care Products – Radiation – Part 2: Establishing the Sterilization Dose
ASTM A240/A240M, 2012A Edition, Standard Specification for Chromium and Chromium-Nickel Stainless Steel Plate, Sheet, and Strip for Pressure Vessels and for General Applications
ASQ Z1.4, 2008 Edition, Sampling Procedures and Tables for Inspection by Attributes
ISTA 2A, 2012 Edition, Performance Tests for Packaged-Products, Packaged-Products 150 Lb (68 Kg) or Less
IPC/WHMA-A-620, Revision B, Requirements and Acceptance for Cable and Wire Harness Assemblies — tied with the all time favorite: ISO-9000, 2005 Edition, Quality Management Systems – Fundamentals and Vocabulary

All these standards are available from Document Center Inc. at our webstore, www.document-center.com. Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We’re here to assist you with both your standards purchases and the services you need to maintain your standards collection.

Document Center’s Top 20 Best Selling Standards for 2011

Yes, it’s the end of the year and what better time to highlight our best selling standards of 2011! Here’s what Document Center customers wanted this year:

ISO 14155, 2nd Edition and Technical Corrigendum (correction sheet) from 2011, “Clinical investigation of medical devices for human subjects – Good clinical practice”
ISO 19011, 2nd Edition, 2011, “Guidelines for auditing management systems”
AMS 2700, Revision E, “Passivation of Corrosion Resistant Steels”
21CFR(800-1299), 2011 Edition, “Code of Federal Regulations – Food and Drug Administration Parts 800 through 1299”
BS EN ISO 14971, 2009 Edition with Corrigendum 1 (correction) from 2011, “Medical devices. Application of risk management to medical devices”
ASTM F1980, 2007 R2011 Edition (reapproved in 2011), “Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices”
IPC A 610, Revision E from 2010, “Acceptability of Electronic Assemblies”
AS 9100, Revision C from 2011, “Quality Management Systems – Requirements for Aviation, Space & Defense Organizations”
ASME Y14.5, 2009 Edition, “Dimensioning and Tolerancing”
ASQ Z1.4, 2008 Edition, “Sampling Procedures and Tables for Inspection by Attributes”
ASTM E1417, 2011 Edition, “Standard Practice for Liquid Penetrant Testing”
ISTA 2A, 2011 Edition, “Performance Tests for Packaged-Products, Packaged-Products 150 lb (68 kg) or Less”
ISO 9001, 4th Edition, Corrected and reprinted in 2009, “Quality management systems — Requirements”
SOR/98-282, 2011 Edition, “Canadian Medical Devices Regulation”
ASTM D4169, 2009 Edition, “Standard Practice for Performance Testing of Shipping Containers and Systems”
ASTM E1444, 2011 Edition, “Standard Practice for Magnetic Particle Testing”
BS EN 60601-1, 2006 Edition with Corrigendum 1 (correction sheet) from 2011, “Medical electrical equipment. General requirements for safety”
ISO 10993-1, 4th Edition with Technical Corrigendum 1 (correction sheet) from 2011, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”
ISO 13485, 2nd Edition with Technical Corrigendum 1 (correction sheet) from 2009, “Medical devices – Quality management systems – Requirements for regulatory purposes”
ASTM A240, 2011a Edition, “Standard Specification for Chromium and Chromium-Nickel Stainless Steel Plate, Sheet, and Strip for Pressure Vessels and for General Applications”

These documents are all 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) for more information. We’re happy to help you with all your standards questions and requirements.

Happy New Year!

Whatever happened to MIL-STD-105?

MIL-STD-105, “Sampling Procedures and Tables for Inspection by Attributes,” is another of those popular military standards that got cancelled during Mil Spec reform in the mid-1990’s. The documents referenced in the cancellation notice can cause confusion for users, so some assistance with this can be helpful.

The last revision of the MIL-STD-105 was Revision E from 1989. This last issue was cancelled three times, first in 1995, then in 2001 and finally in 2008. Cancellation Notice 1 from 1995 simply replaced the standard with ASQC-Z1.4 (now ASQ-Z1.4). This ASQ document is actually a reprint of the MIL-STD-105 and an obvious choice to use in lieu of the MIL Standard.

However, Notice 2 from 2001 really put a wrench in the works. It stated “MIL-STD-105E … is hereby canceled without replacement. Current DOD PREFERRED METHODS FOR ACCEPTANCE OF PRODUCTS are described in MIL-STD-1916… and should be considered for future acquisitions.” However, MIL-STD-1916 is an administrative standard.

In fact, MIL-STD-1916 was developed to encourage defense contractors to submit process control (prevention) procedures instead of using prescribed sampling requirements like those detailed in ASQ-Z1.4. In other words, the standard supports the DoD desire to change contractual requirements from a system of acceptable quality levels to one of continuous improvement.

Quality documents referenced by MIL-STD-1916 include ASQ-B1, B2, and B3, ISO-8402, and ISO-9000 (ASQ-Q9000) and ISO-9004 (ASQ-Q9004). They are all quality standards, but do not address the issue of sampling by attributes, with the many tables that ASQ-Z1.4 contains.

Apparently, this approach got some push-back because in 2008, Cancellation Notice 3 again modified the replacement information. It now allows for use of either the MIL-STD-1916 or the ASQ-Z1.4.

And while we’re on the topic of the ASQ-Z1.4, we should also mention the ASQ-Z1.9 standard, “Sampling Procedures and Tables for Inspection by Variables for Percent Non-conforming.” It’s the replacement document for the cancelled MIL-STD-414 (with the same title). The two ASQ documents are often purchased at the same time and can really be considered to be a set.

All the standards above can be purchased from Document Center Inc. You can use our website, www.document-center.com, but if you need any of the obsolete documents, you’ll get a quote before you purchase. That’s because we want to confirm that you understand you’re purchasing a withdrawn document prior to purchase. Or you may prefer to contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We’re able to provide you with many obsolete standards, as well as help you determine what replacement documents are available.

All time best selling Standards on Sampling and Statistical Process Control

It’s said if you can measure it, you can manage it, and Statistical Process Control is the tool to use! So it’s no surprise that there are a wide range of standards on the subject. Here’s our list of the top 10 Standards on Sampling and Statistical Process control.

ASQ-Z1.4, Sampling Procedures and Tables for Inspection by Attributes

ASQ-Z1.9, Sampling Procedures and Tables for Inspection by Variables for Percent Nonconforming

These 2 Standards replace MIL-STD-105 and MIL-STD-414, both of which are now obsolete. Filled with pages of tables for use with a continuous supply, the documents are our current best-selling sampling standards. The Z1.4 covers go/no go data, the Z1.9 covers measurement.

Zero Acceptance Number Sampling Plans is often used as an alternative to the MIL-STD-105/ASQ-Z1.4 Inspection systems. It is based on C=0 concept developed by author Nicholas Squeglia back in 1961. The 5th edition is the current revision of this item.

During the last few years, the ISO standards on this topic have seen greater usage as well. Top sellers include the ISO-2859 series, the ISO-11462 series, the ISO-3534 series, and the ISO-5725 series.

ISO-2859-10, Sampling procedures for inspection by attributes – Part 10: Introduction to the ISO 2859 series of standards for sampling for inspection by attributes, is a good starting point for the ISO-2859 set. It provides a general introduction to acceptance sampling by attributes and provides a brief summary of the attribute sampling schemes and plans used in Parts 1 through 5. The standard also provides guidance on the selection of the appropriate inspection system for use in a particular situation.

ISO-11462-1, Guidelines for implementation of statistical process control (SPC) – Part 1: Elements of SPC, and ISO-11462-2, Guidelines for implementation of statistical process control (SPC) – Part 2: Catalog of Tools and Techniques, are two additional useful standards. They provide concepts, tools and techniques to help an organization in planning, implementation and evaluation of an effective statistical process control (SPC) system.

ISO-5725-1, Accuracy (trueness and precision) of measurement methods and results – Part 1: General principles and definitions, is an introduction to the ISO-5725 series. It outlines the general principles to be understood when assessing accuracy of measurement methods and results. It can also be used to establish practical estimations of the various measures by experiment. The standard may be applied to a very wide range of materials, including liquids, powders and solid objects, manufactured or naturally occurring.

For Statistics – Vocabulary and symbols, the ISO-3534 series covers all the bases:

ISO-3534-1, Part 1: General statistical terms and terms used in probability

ISO-3534-2, Part 2: Applied statistics

ISO-3534-3, Part 3: Design of experiments

ASTM International (formerly the American Society for Testing and Materials) also has a number of standards on the topic of Sampling and Statistical Process Control. We often sell the following:

ASTM-E122, Standard Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot or Process. This standard is intended for use in determining the sample size required to estimate, with specified precision, a measure of quality of a lot or process. The practice applies when quality is expressed as either the lot average for a given property, or as the lot fraction not conforming to prescribed standards.

Should you have any questions about the above standards, or need more suggestions to get the information you need, please contact us at www.document-center.com, info@document-center.com, or phone us at 650-591-7600. We’re always ready to help you out.