ISO 20581 – Workplace Air Quality

ISO 20581, “Workplace air – General requirements for the performance of procedures for the measurement of chemical agents,” has just been released.  This new ISO standard is based on EN 482 (including Amendment 1 from 2015).  It provides you with information on how to measure for chemical agents in the air in workplace breathing zones.  This will facilitate the development of a quantitative exposure assessment protocol for your organization.

The ISO Technical Committee 146 (author of this standard) recognizes the impact of national laws and regulations that require assessment of possible worker exposure to chemical agents.  So there is a need for reliable and valid testing procedures to use over time.  You’ll use these procedures in conjunction with exposure limit values and control strategies to fulfill your requirements.

There are already any number of standards on specific types of air quality measurement devices (sampling pumps, various detectors, and so on).  The ISO 20581 is a general performance requirement document.  You’ll use it to develop procedures for the determination of the concentration of chemical agents in the workplace atmosphere.  The actual testing will occur in laboratory conditions.

What does this mean for the user?  ISO 20581 covers a broad number of screening measurement protocols.  It discusses various types of testing, like screening measurements using time-weighted average concentration, concentration in time and/or space, using occupational exposure limit values, and periodic measurements.  The Section 6 delves into these in greater detail, providing you with performance requirements for each.  Test methods and valication reporting is also covered.

Annex A provides you with the structure of a method description.  Annex B is on the calculation of uncertainty in measurement, with particular emphasis on airborne particles, gases and vapors.  And an 18-item bibliography completes the document.

In order to take advantage of the wealth of information in this standard, you’ll need to purchase a copy and you’ll want to use an authorized ISO distributor like Document Center Inc.  Search for and order ISO standards at our webstore, www.document-center.com.  Here’s a direct link to the order page for ISO 20581.  You can get a copy in either paper format or for pdf download.

Want a company-wide solution instead?  Need to know more about Document Center’s best-in-class notification services?  Check in with our staff by phone (650-591-7600) or email (info@document-center.com).  We’re been working with standards since 1982 and provide you with knowledgeable compliance support services.  Make us your Standards Experts!

 

IATF 16949 Rules is here!

IATF 16949 Rules 5 “Automotive certification scheme for IATF 16949, Rules for achieving IATF recognition” has been released.  You’ll use this new publication to better understand how you’ll meet the IATF 16949 2016 Edition certification requirements.  The Rules include the criteria for certification body recognition, the audit process, auditor qualifications and information on the certificates.

What is the IATF 16949?  This new 2016 Edition provides the requirements for quality management system certification for the automotive industry.  You’ll use this document to find the requirements you must meet in order to get your certification.

What are the IATF 16949 Rules?  These are the criteria that certification bodies must meet in order to provide you with the auditing and other services needed for your certification.  It is used by the IATF and sister organizations (IATF Global Oversight) to qualify companies as “third party” certifiers.  In other words, IATF provides the requirements for quality certification.  It then sets up the criteria for auditing to those requirements in the Rules.  An oversight scheme authorizes 3rd parties to assess whether or not companies like yours meet the quality requirements.

Why purchase a copy of the IATF 16949 Rules?  If you are a part of a third party certification organization, the need is clear.  There is a new edition of the IATF 16949 and of course that means new auditing responsibilities.  But if you are in an organization that gets audited, the need is still there.

Reviewing the IATF 16949 Rules document if you need to get your certification provides you with a clearer understanding of what to expect in your audit and from your third party certification company.  You’ll get a better understanding of contractual issues, like what will be included in the contract, change notices, and so on.  It lays out the certification cycle, which is a 3-year scheme.  It shows how many days you should expect your auditor to be on site.  And it gives you insight into how your auditing team will be established.

A number of other areas are covered as well.  You’ll get a clear view of the reports that are generated in this process.  This includes such things as reporting and correcting nonconformities. There are 4 pages of terms and definitions.  The audit activity flow is spelled out.  And special audits are addressed.  The document ends with a number of samples for audit day calculation, shift verification of audits, audit planning output, and eligibility criteria for the certificate structure.

As you can see, this document is a useful companion to the IATF 16949.  You’ll want to get a copy soon and you’ll want to use an authorized standards distributor like Document Center Inc.  Search for and order standards at our webstore, www.document-center.com.  Here’s a direct link to the order page for the IATF 16949 Rules.

Document Center also has a number of services to help you meet your compliance requirements.  Check in with our staff about notification services and enterprise access solutions.  Our Standards Online service, for example, can provide your organization with 24/7 cloud access to the standards you use in your business.  Find out more by reaching out to us by phone (650-591-7600) or email (info@document-center.com).  We’re your Standards Experts!

New ISO/TS 9002 2016!

ISO/TS 9002, “Quality management systems – Guidelines for the application of ISO 9001:2015,” has just been released.  This new 1st Edition from 2016 revives the document which was cancelled in 2000.  It is a Technical Specification, which means that it is a guidance document.  You’ll use it when you are implementing the requirements of the ISO 9001 5th Edition from 2015.

How is the new ISO/TS 9002 organized?  It walks through the ISO 9001:2015 clauses 4 through 10, subclause by subclause.  Additional information is provided to help you implement each of these subclauses.  You’ll find examples of some possible solutions for each.  Just note that there are certainly more ways to meet the 2015 Quality Management standard than shown in this document.

Why release the ISO/TS 9002 now?   The new ISO 9001:2015 is a significant change from the 2009 Edition.  There is a greater focus on risk management, for example.  The TC 176 quality committee felt that additional guidance would be beneficial to those using the management standard.  So the ISO/TS 9002 provides you with insight into why various subclauses are included in the new 9001.  And it gives you information on what factors should be used when evaluating how to address each clause.  When possible, suggestions for solutions are also included.

The ISO/TS 9002 is a 56-page publication.  So there is a lot more material on Clauses 4 through 10 than in the ISO 9001 itself.  And there is a 31-item bibliography at the end of the document that will be very helpful to those of you going for ISO 9001 certification.

To take advantage of the wealth of information in ISO/TS 9002, you’ll need to purchase a copy from an authorized distributor of ISO standards like Document Center Inc.  Use our webstore, www.document-center.com, to search for and order the standards you need.  Here is a direct link to the order page for ISO/TS 9002.  You can choose to receive it in either paper format or for pdf download.

Perhaps you have additional questions or would like to learn more about our many services.  Just get in touch with our staff by phone (650-591-7600) or email (info@document-center.com).  We can provide you with enterprise access solutions (our Standards Online service) or help you with many of your concerns about using these compliance documents.  We understand how challenging ISO 9001 certification can be.  So make us your Standards Experts!

JESD 31 for Semiconductor Distributors has been updated!

Standard JESD 31 from JEDEC has been updated.  Its full title is “General Requirements for Authorized Distributors of Commercial and Military Semiconductor Devices”. The new Revision E will replace Revision D, which is now obsolete.  It’s available now from Document Center in hard copy format or for PDF download.

Suppliers of semiconductor devices face unique challenges and requirements.  JESD 31 lays out in clear terms all of those requirements.  If quality control is your realm of expertise, this standard is a must.

There are a lot of standards on quality control out there, so having one that applies specifically to your industry sector can be especially helpful.  Standard JESD 31 addresses everything from quality systems, document control and record keeping to inspecting, auditing, packaging, and counterfeit risk mitigation.  All of this is presented as it applies to semiconductor distributors.

Concerned about compliance when it comes to military distributing?  Have no fear!  The writers of JESD 31 have created a section specifically devoted to military distributors.  In it, issues like Certificate of Conformance, packaging procedures, and process control are covered.

For ease of compliance, the writers of the standard JESD 31 have also included an audit checklist template.  Each section of the checklist is devoted to a different requirement.  For example, the document control section lays out every requirement of the distributor’s document control system in plain English.  Finally, the document finishes with an extensive changes section.  This part of the document notes every change made between Revision E and the standard’s previous revisions.

You can pick up this revision of the JESD 31 and many other JEDEC standards from Document Center.  Just go to www.document-center.com and browse our standards library.  We offer this standard in hard copy, PDF, and for site-wide subscription.  We also provide notifications for every document you purchase at no additional charge.  You can go directly to the JESD 31 order page here.

Additional questions or concerns?  Just get in contact with us.  We are available by phone (650-591-7600) and email (info@document-center.com) and are ready to answer any questions you may have.  It’s what we’re here for.  We’ve been working with these standards for years, so you can rely on our advice.  Make us your Standards Experts!

 

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!

 

ASTM F1886 Packaging Standard Update

ASTM F1886, “Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection,” has just been updated.  The new 2016 edition will replace the 2009 edition, which is now obsolete.  This standard will outline basic guidelines you should follow when visually inspecting the seals on your packages.  It’s available now from Document Center as a hard copy or for PDF download.

Inspection of your flexible packaging seals can reveal problems with the packaging itself or the process being used to seal it.  Visual Inspection is the front line of defense in protecting against packaging defects.  With ASTM F1886, you will have clear instructions on the proper way to perform visual inspection of your packaging.

Standard F1886 includes within it the usual scope, references, summary, and significance sections.  This is followed by the actual visual inspection method itself, in clearly numbered steps.

To reassure you of the reliability of the standard, the writers have included several tables.  These present evidence of inspections performed in previous studies. Things like type of material and size of defect are presented with the number of times the inspectors were correct or incorrect.

The last large section of this standard is its one appendix.  In it, you can find descriptions and characteristics of typical defects, along with the meaning of each type of defect.

If visual inspection of packaging is an important part of your production process, then you’ll want to pick this standard up.  You can purchase it from Document Center in either hard copy or PDF.  Browse our vast library of ASTM standards at www.document-center.com.  If you’d like to go directly to the ASTM F1886 order page, you can do so here.

Do you have questions?  Give us a call (650-591-7600) or send us an email (info@document-center.com), and we’ll help you out.  We’ve been selling ASTM standards for over thirty years.  Make us your Standards Experts!

 

AS 6171 Counterfeit Detection and Testing

The new standard AS 6171 has just been released from SAE.  Its full title is, “Test Methods Standard; General Requirements, Suspect/Counterfeit, Electrical, Electronic, and Electromechanical Parts”.  This standard is available now from Document Center.  You can buy it in either hard copy format or for PDF download.  AS 6171 will provide you with a framework for detecting and testing counterfeit parts used in the aerospace industry.

Using counterfeit parts in aerospace manufacturing can pose risks to the quality and safety of your products.  Detecting and testing these parts can cause significant reduction in these risks.  If you’re a buyer and are concerned about parts bought through sources with unknown supply chains, you need to pick this document up.  It will outline for you the steps needed to perform risk assessment, detect counterfeit parts, and test parts of unknown origin.

The AS 6171 standard begins with the usual scope and definitions sections.  Part 3 goes over everything you need to know about counterfeit detection and testing but the tests themselves.  This includes risk assessment, sampling plans, reporting and analysis, safety and training, and many more.  Need specific test descriptions?  That’s what section 4 is all about.  In this section, individual tests are described, as well as their respective benefits and examples of when they may be used.

This brings us to the AS 6171 “slash sheets”.  These are separate, accompanying documents for each test described in the standard.  If you need a specification for radiological inspection of parts, you’ll want to pick up AS 6171/5.  Want to know more about inspection by acoustic microscopy?  You’re looking for AS 6171/6.  These are just a couple of the 10 different examination methods described in the AS 6171 standard.

Finally, where do you get these standards?  You’ll want to purchase from an authorized distributor like Document Center.  We’ve got AS 6171 as well as test methods 1-10 available.  Here’s the order page for AS 6171.  If you’re looking for other standards, go to www.document-center.com and browse our library.

Not sure exactly which standard to buy?  Contact us and we’ll help you figure it out.  You can reach us by phone (650-591-7600) or email (info@document-center.com).  We’ve been working with standards and the aerospace industry since 1982.  Make us your Standards Experts!

New AS 9101 – Quality Management Auditing

SAE’s AS 9101, “Quality Management Systems – Audit Requirements for Aviation, Space, and Defense Organizations” has been updated. The new 2016 Revision F (to replace revision D from 2014) is available now from Document Center as a hard copy or for PDF download.  This document is designed to guide aerospace industry users through the audit process for the requirements laid out by AS 9100.

To ensure the quality of their services, aerospace and defense buyers and suppliers must have a system in place.  The requirements of this system were determined by various Standards-Developing Organizations (SDOs).  These include the International Standards Organization (ISO), the International Electrotechnical Commission (IEC), and the International Aerospace Quality Group (IAQG).

In order to enforce conformity with these standards, various certifying bodies are charged with the task of auditing.  AS 9101 walks the user through the entire auditing process from basic information to specific tips and requirements. This includes a terms and definitions section to help avoid confusion caused by the language used in the document.

Following this is an extensive section describing and outlining every facet of auditing and reporting.  This includes information on audit activities, planning, conducting audits, reports, specific requirements, and nonconformity management.  It also describes a variety of different types of audits. Appendices A and B provide an acronym log and an extensive selection of auditing forms.

If you are interested in picking up a copy of the new AS 9101, contact us at Document Center.  You can visit our webpage (www.document-center.com) to browse for this standard or any other SAE standard you may need.  Here is the order page for the AS 9101.

Questions and concerns can be directed to our friendly staff.  You can contact us by phone (650-591-7600) or email (info@document-center.com).  With our vast knowledge of the world of standards, we’re sure to be able to help you out.  Make us your Standards Experts!

ISO 15223-1 Medical Device Labeling Update!

For the first time since 2012, ISO 15223-1 has been updated.  The full title of this document is “Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1: General Requirements”.  This document will lay out for you all the requirements for a wide variety of medical device label symbols.  As I’m sure many of you current users of ISO 15223-1 already know, this standard is an important one.  If medical devices are your game, you’ll want to pick this one up ASAP.  It’s available now from Document Center as a paper copy or for PDF download.

Certain information must be conveyed when presenting a new medical device.  Much of this information is vitally important to the proper and safe use of the device.  It is also mandated by regulation in the US, EU, Canada, and many more. This can pose a problem when marketing a device that must be presented in various geographic locations and languages.  The solution to this problem?  Create a series of internationally recognized symbols, detailed within ISO 15223-1.  This document was designed to take the confusion out of labeling medical devices in different languages.  In doing so, it helps to ensure the safe use of the products that it applies to.

Detailed within this text you’ll find a discussion of the scope of the document and who it applies to.  Requirements for usage of the medical device labels that are presented are covered.  Following this is an extensive “Symbols” section.  This includes a 16-page series of tables showing the symbols themselves.  It also provides their titles, descriptions, requirements, and informative notes.

The document finishes with two informative annexes.   Annex A gives practical examples of how each symbol is used to convey information.  Some examples are manufacturing location, use-by date, and batch code.  Annex B provides guidance on general prohibition and negation symbols.

Do you need a copy of ISO 15223-1?  Contact us at Document Center.  Here’s a link to the order page for ISO 15223-1. If you need to provide a document for multiple users, make sure to ask about our site-wide subscriptions.  You can also visit our website (www.document-center.com) and browse our standards library.

If you have questions regarding ISO 15223-1 or other standards, just give us a call (650-591-7600) or send us an email (info@document-center.com).  We’ve been an authorized distributor of ISO standards for thirty years.  Make us your Standards Experts!

 

IEC 82304-1 Health Software Safety

A new standard, IEC 82304-1 was recently released.  Titled “Health Software–Part 1: General requirements for product safety”,  this standard will help to guide developers through the process of health software design providing particular emphasis on safety and security.  It’s available now as a hard copy or for pdf download from Document Center, Inc.

Health software development is a complex and many-faceted process.  This standard will help you through the many steps of design.  The earliest stage covered includes guidance on defining your product’s general requirements and performing initial risk assessment.  Other topics in this section include software use requirements and system requirements.  It also provides guidance on the verification and update of said requirements.

The following sections detail life cycle processes for health software development.  Following this is an in-depth look at how to have your software product validated.  Next, guidance on how to identify your product and provide appropriate documentation that will accompany your software.  Finally, there is a section on after-market considerations for your software product.  These include maintenance, re-validation, communication, decommisioning, and disposal.

The last portion of this document is dedicated solely to supplementary material.  This includes an appendix explaining the rationale for health software as well as a number of figures and tables explaining the scope of this document and related documents, health software product processes, and examples of products not within the scope of IEC 82304-1.  Lastly, the document finishes with a 2-page bibliography.

Interested in health software development?  You can buy IEC 82304-1 from Document Center.  We’ve been selling IEC standards since the 1980’s and can provide a wide variety of products and expertise on them.  Browse our webpage at www.document-center.com or, if you’d like to go directly to the order page for IEC 82304-1,  here’s a link.

Need more information?  Have questions?  Get in touch with our friendly and knowledgeable staff at Document Center by phone (650-591-7600) or by email (info@document-center.com) and make us your Standards Experts!