PDXpert PLM Software
Product Lifecycle Management
PDXpert PLM software features: ISO 9001:2008
PDXpert software assists 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 precise requirements.
Clause 4.2.3 - Document Control
ISO 9001:2008 requirement
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by revision status; (d) available where needed; (e) legible and identifiable; (f) managed regardless of source; (g) withdrawn when obsolete.
PDXpert PLM software
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. Physical 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 Control
ISO 9001:2008 requirement
Records must be controlled to ensure they're identifiable, legible and available.
PDXpert PLM software
Record file attachments may be added to their related items by the item trustee or analyst. Or, a distinct Record document type can have its own attributes, file attachments and approval workflow. An expedited change workflow can 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 - QMS Changes
ISO 9001:2008 requirement
Changes to the quality management system (QMS) must be controlled to ensure continued system integrity.
PDXpert PLM software
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 - Information Systems Resources
ISO 9001:2008 requirement
Provide information systems resources to support the QMS and meet customer requirements.
PDXpert PLM software
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 - Requirements Identification
ISO 9001:2008 requirement
Identify customer, regulatory and organizational requirements for the product.
PDXpert PLM software
PDXpert can manage each approved revision of a requirements document. In addition to internally-developed requirements, PDXpert lets 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 - Customer Communication
ISO 9001:2008 requirement
Publish product information to customers.
PDXpert PLM software
PDXpert can identify and control customer-facing materials such as marketing & sales literature; specifications; installation, operation and maintenance guides; and other information. For very specialized products, customers can receive email notifications as product information is revised.
Clause 7.3.2 - Design Inputs
ISO 9001:2008 requirement
Identify requirements for the product based on functional, performance, regulatory, historical and other relevant design and development inputs.
PDXpert PLM software
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 - Design Outputs
ISO 9001:2008 requirement
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.
PDXpert PLM software
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 Reviews
ISO 9001:2008 requirement
Design functions' representatives evaluate development progress, identify risks to meeting requirements, and initiate design revisions.
PDXpert PLM software
Flexible approval workflows allow for individuals and design function groups to participate in the review process.
Clause 7.3.7 - Design Changes
ISO 9001:2008 requirement
Design changes must be identified, reviewed, and approved. The impact of such changes on related items must be assessed.
PDXpert PLM software
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 - Purchasing Requirements
ISO 9001:2008 requirement
Purchased items must have documented requirements, and suppliers must be qualified to meet those requirements.
PDXpert PLM software
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 Control
ISO 9001:2008 requirement
Production and service tasks must use documented assembly, inspection and servicing procedures.
PDXpert PLM software
Specialized change forms can be defined with their own workflows and approval lists to control production and service procedures.
Clause 8.3 - Nonconforming Product
ISO 9001:2008 requirement
Product nonconformity must be eliminated, authorized, prevented from use, and/or its effects mitigated.
PDXpert PLM software
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, use as-is, and similar tasks.
Clause 8.5.2 - Corrective Actions
ISO 9001:2008 requirement
Corrective actions for nonconformance must be recorded and changes approved.
PDXpert PLM software
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 - Preventive Actions
ISO 9001:2008 requirement
Preventative actions for potential nonconformance must be recorded and changes approved.
PDXpert PLM software
Change Reasons may be used to classify why the preventative action is taken (cost reduction, part availability, interface compatibility, etc.).