Project Management and ISO Compliance
If your company is ISO certified, or if it aspires to be, product development projects should be done in accordance with ISO requirements. ISO compliance supports the implementation of project management disciplines and controls. If you implement good project management practices, you will be naturally ISO compliant, and if you implement ISO requirements you will end up enforcing many sound project management practices. The following is a summary of the ISO requirements as they relate to engineering efforts for new product development. The ISO requires that you have documented processes and procedures in place, that you comply with these, and that you document your compliance. The applicable section of ANSI/ISO/ASQC-1994 is 4.4, Design Control. This following table is a top level summary. In order to ensure your understanding of the requirements, you should obtain a copy of the latest governing document from your organizations ISO compliance administrator or internal auditor..
4.4 Design Control
Section |
Requirement |
Procedures |
Documentation |
| 4.4.1 General (Procedures to control and verify the design) | Maintain documented procedures to control and verify design so requirements are met. | Your organization should have a written procedure to describe this porcess. | Company procedures and business processes that govern the new product development process. |
| 4.4.2 Design and development planning | Prepare plans, define responsibilities, assign adequate resources, and update plan as required. | Ditto. | Initial cost & time estimates Initial project plan Critical path assessment Project approval document Engineering Statement of Work WBS & Milestone plan Test requirements & procedures Project kick-off meeting records |
| 4.4.3 Organizational and technical interfaces | Define interfaces, document them, transmit and regularly review. | Ditto. | Project team organization charts for the engineering team and for the company-wide cross functional 'core team.' |
| 4.4.4 Design input | Product requirements including regulations should be identified, documented, and reviewed, including resolution of ambiguous or conflicting requirements. | Ditto. | Marketing requirements statement. Design requirements specs. (HW & SW) Trip reports from customer visits. Note that your design spec. should state that the project shall be ISO compliant. Design specs should have measurable requirements. |
| 4.4.5 Design output | Should meet and reference acceptance criteria. | Ditto. | Documentation of the design in drawings, BOMs, software releases. |
| 4.4.6 Design review | At stages, hold formal documented design reviews, with key functions represented, and records maintained. | Ditto. | Project office files of completed PDRs & CDRs |
| 4.4.7 Design verification | Shall be performed and documented. | Ditto. | Test procedures with quantified requirements. |
| 4.4.8 Design validation | Shall be performed under operating conditions and documented. | Ditto. | This must be conducted in a customer environment. |
| 4.4.9 Design changes | All design changes identified, documented, reviewed, and approved by authorized personnel before implementation. | Ditto. | Ensure changes to design specifications are signed by those functions approving the original versions. |
Last revised: 10/14/98