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Software Engineering
Standards Checklists
(Includes
4*
Hours of Consultation)
Prepared by experts to ensure that your organization understands the
requirements of a standard and is compliant. Available now in easy to use format!
The checklists are constructed around a classification scheme of physical evidence
comprised of policies, procedures, plans, records, documents, audits, and reviews.
Checklists
reduce the confusion surrounding what is really required for compliance by providing an
easy-to-use product evidence list that will assist any software organization in
meeting the requirements of the standard. Each checklist comes with 4* hours of consultation
on how to apply the checklist to the particular standard. Order information
listed below. The experts at SEPT
have produced checklists for 15 of
the major software engineering and software related standards.
Note:
The new 12207 and 15288 was just released (March
2008) by ISO, SEPT
will update all its corresponding checklist and templates by July 2008. If
you buy one of our 12207 or 15288 products in the meantime we will give you 50%
off the new price when the product is released. Thank you for your patience
during this transition period.
| Checklists |
Price
|
To order a
checklist from Techstreet, Click on order. |
|
ANSI/AAMI/ISO 13485:2003
Medical Devices - Quality Management
Systems - Requirements for Regulatory Purposes1--Defines
over 300+ required or suggested items of
physical evidence.
(policies,
procedures, plans, records, documents, audits, and reviews)
|
$149 |
Order
|
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ANSI/UL 1998-2004, Software in Programmable Components,
Incorporates revision. 1--Defines
over 350+ required or suggested items of
physical evidence.
(policies,
procedures, plans, records, documents, audits, and reviews)
|
$149 |
Order
|
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FDA,
Electronic Records;
Electronic Signatures; Final Rule-FDA 21CFR Part 11 |
$149 |
Order
|
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FDA,
General Principles of Software Validationï Final Guidance
for Industry and FDA staff.
(Release date
January 11, 2002). --
Over 400 required or suggested items
of physical evidence. |
$149 |
Order
|
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FDA,
Guidance
for the Content of Pre-market Submissions for Software Contained in Medical Devices. |
$149 |
Order
|
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FDA,
Guidance
for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use
in Medical Devices as amended by
Guidance for
Industry, FDA Reviewers and Compliance on
Cyersecurity for
Networked Medical Devices Containing Off-the Shelf (OTS) Software",
January 14, 2005
Defines over 60+ required or
suggested items of
physical evidence.
(policies,
procedures, plans, records, documents, audits, and reviews) |
$149 |
Order
|
|
IEC 60601-1-4
(Edition 1.1 2000-04)
Medical Electrical Equipment Part 1: General Requirements for Safety.
Part 4. Programmable Electrical Medical System. |
$149 |
Order
|
IEC 62304:2006
Medical device software - Software life cycle processes
Defines over 300+ required or suggested items of
physical evidence.
(
procedures, plans, records, documents, audits, and reviews)
|
$149 |
Order
|
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IEEE/EIA 12207.0
1996
Industry
Implementation of International Standard ISO/IEC: 12207:1995
Software life cycle processes.
Defines over 440+ required or
suggested items of
physical evidence.
(policies,
procedures, plans, records, documents, audits, and reviews) |
$149 |
Order
|
|
ISO 9001-2000,
Quality
Management Systems - Requirements.
Defines over
200+ required or suggested items of
physical evidence.
(policies,
procedures, plans, records, documents, audits, and reviews)
|
$149 |
Order
|
| ISO/IEC 12207,
Software Life Cycle Processes,
including Amendment 1
and 2.
Defines over 475+ required or suggested items of
physical evidence.
(policies,
procedures, plans, records, documents, audits, and reviews) |
$149 |
Order
|
|
ISO/IEC 15288,
Systems
Engineering - Systems Life Cycle Processes. Defines over 450+ required or suggested items of
physical evidence.
(policies,
procedures, plans, records, documents, audits, and reviews) |
$149 |
Order
|
New
Standard ISO/IEC 27002:2005
Information technology � Security techniques -- Code of
practice for information security management.
(Including
Technical
Corrigendum 1.)
Defines over 450+ required or suggested items of
physical evidence.
(policies,
procedures, plans, records, documents, audits, and reviews)
|
$149 |
Order
|
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ISO/IEC 90003:2004,
Software
Engineering. Guidelines for the application of ISO
9001:2000 to computer software.
Defines over 550+ required or suggested items of
physical evidence.
(policies,
procedures, plans, records, documents, audits, and reviews) |
$149 |
Order
|
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SUPPLIER
ASSESSMENT CHECKLIST,
for Standard ISO/IEC
90003:2004 Software engineering: Guidelines for the application of ISO
9001:2000 to computer software.
A
checklist to use with your software suppliers to determine if they meet the
requirements of Standard ISO/IEC 90003:2004.
|
$99 |
Order
|
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Medical
Device
Standard Kit:
SEPT is
pleased to announce a kit of 10 key checklists for medical device firms.
Save 50%
or more
off the individual prices when ordering this collection of medical device standards
checklists!
This kit
includes:
|
$725 |
Order
|
Benefits of the Checklist
 | Every Checklist comes with four hours of free
consultation. SEPT will answer any question concerning the standard or checklist for
60 days after purchase. |
| The Checklist clearly defines the standards' expectation
for procedures, plans, records, documents, audits, and reviews. |
| Use of the Checklist may aid in meeting certain governmental
requirements. |
| A quality product at a reasonable price. |
Save time, save money, and
increase compliance! Order now!
For a
"FREE COPY"
of a PowerPoint presentation . on "
Choosing and Improving Your Suppliers Quality by Using A Checklist Approach With
ISO 9001" E- mail:
stanmagee@smartwire.net
Many firms are posting these checklists to
their Intranet for wider access to this important information.
We have a 5 year license
for $1800 for any checklist in word
format.
Contact SEPT
at stanmagee@smartwire.net
for details.
The
4 hours of consultation is conducted by telephone or e-mail for up to 60 days
following
checklist purchase date.*
SEPT
2725 NW Pine Cone Drive
Issaquah, WA. 98027 USA
Telephone: 425-391-2344
Fax: 425-557-9419
Software Engineering Process Technology does not accept unsolicited
advertisements at this facsimile number
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