PDXpert software facilitates compliance with ANSI/ISO/ASQ Q9001:2008,
including earlier versions and related standards of the ISO 9000 series. For
brevity and to respect copyright, the relevant requirements have been
paraphrased; refer to the ISO 9001 standard for actual requirements.
| ISO 9001:2008 requirement |
PDXpert PLM software |
| Clause 4.2.3 Documents must be (a) approved prior to use; ...
(c) identified by revision status; (d) available where needed; (e)
legible and identifiable; (f) managed regardless of source; (g)
withdrawn when obsolete. |
Documents are approved using a flexible change workflow that
ensures proper identification and revision control. All document
revisions are clearly managed as pending, released
or canceled, and changes to this status occur only upon
completion of a change workflow. Document dispositioning tasks, such
as delivery of new releases and destruction of canceled revisions,
can be defined in the implementing change form. |
| Clause 4.2.4 Records must be controlled to ensure they're
identifiable, legible and available. |
Record document types may be created with their
own attributes and file attachments. An expedited change workflow
can be established to ensure records are reviewed, accepted and
locked from further modification to become a permanent history of
actions supporting the QMS process. |
| Clause 5.4.2 Changes to the quality management system (QMS) must
be controlled to ensure continued system integrity. |
Create and manage ISO documentation using PDXpert document
types, revision management and change workflow. A separate
QMS-related change form can reflect the unique approval requirements
of your ISO procedures. |
| Clause 6.3 Provide information systems resources to support the
QMS and meet customer requirements. |
In addition to committing human and other resources for ISO
9001, implementing PDXpert as your QMS information infrastructure
demonstrates your organization's commitment to efficiency through
automation. |
| Clause 7.2.1 Identify customer, regulatory and organizational
requirements for the product. |
PDXpert can manage each approved revision of a requirements
document. In addition to internally-developed requirements, PDXpert
let you identify external sources (e.g., customers
and regulatory agencies) of requirements using those sources' proprietary document
identification. These documents can be linked directly to the affected product,
and revisions are managed using a change control process. |
| Clause 7.2.3 Publish product information to customers. |
PDXpert can identify, manage and link customer-related materials such as
marketing & sales literature; specifications; installation,
operation and maintenance guides; and other information. For highly
customized products, PDXpert can email change notifications to
customers who are specifically affected by product revisions. |
| Clause 7.3.2 Identify requirements for the
product based on functional, performance, regulatory,
historical and other relevant design and development inputs. |
Third party documents such as industry standards and regulatory
requirements may be imported into the file library and managed using
review & control procedures similar to internally-developed
documents. Broadly applicable requirements (e.g., plating specs,
packaging standards, test procedures) can be easily managed as a
single document instance yet related to multiple products. |
| Clause 7.3.3 The design activity outputs must (a) meet the input
requirements; (b) address acquisition, production and service needs;
(c) identify acceptance criteria; and (d) define safe and correct
operation. |
The PDXpert product structure is both a bill of materials and a document
tree. Design outputs, such as product assemblies, can directly
reference functional and performance requirements, purchase
specifications, work instructions, service procedures, test &
inspection procedures, and end-user installation and operation
guides. |
| Clause 7.3.4 Design functions' representatives evaluate
development progress, identify risks to meeting requirements, and
initiate design revisions. |
Flexible approval workflows allow for individuals and design
function groups to participate in the review process. |
| Clause 7.3.7 Design changes must be identified, reviewed, and
approved. The impact of such changes on related items must be
assessed. |
A complete Affected Items list on each change form allows
reviewers to "drill down" into each item, and examine revisions in
terms of production attributes, document and part relations,
electronic file attachments, and other attributes. Impact assessment
may include multiple dispositioning instructions for each affected
item. |
| Clause 7.4.1 Purchased items must have documented requirements,
and suppliers must be qualified to meet those requirements. |
Each item in PDXpert has a (1) Structure list for documenting
its functional and performance requirements; and (2) Source list
that allows one or more qualified supplier items to be identified,
ranked and controlled. Source items include the full set of item
attributes including supplier, item number, revision, lifecycle
phase, materials, cost & ordering attributes, and specification
files. |
| Clause 7.5.1 Production and service tasks must use documented
assembly, inspection and servicing procedures. |
Specialized change forms can be defined with their own with
workflows and approval lists to control production and service
procedures. |
| Clause 8.3 Product nonconformity must be eliminated, authorized,
prevented from use, and/or its effects mitigated. |
New change forms can be defined within PDXpert, including
stop shipment notices, deviations and waivers, each with their own reviews, observers and
workflow. Affected parts listed on change forms can include
disposition instructions (with quantity, cost, current location,
assignee, etc.) for rework, return to vendor, user as-is, and
similar tasks. |
| Clause 8.5.2 Corrective actions for nonconformance must be
recorded and changes approved. |
Problem Sources may be used to classify how the basis for the
corrective action was discovered (customer complaint, service
records, quality audit, etc.). |
| Clause 8.5.3 Preventative actions for potential nonconformance
must be recorded and changes approved. |
Change Reasons may be used to classify why the preventative
action is taken (cost reduction, part availability, interface
compatibility, etc.). |