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Generic ISO 9001 Procedures
Why Not Engineering (WNE) has researched and developed generic ISO 9001 procedures that implement the process approach described in ISO 9001:2000, paragraph 0.2. These procedures have been designed to comply and be traceable to every ISO 9001:2000 paragraph. The most difficult paragraph of ISO 9001:2000 to comply with is 4.1 parts a), and b). This paragraph requires that all needed processes are identified, and that the sequence of the processes and the interaction of these processes are determined. If your ISO 9001 auditor is not helping you with compliance to this paragraph, you are not receiving the benefits of ISO 9001:2000. The WNE Generic ISO 9001:2000 Procedures instantly provides adequacy to ISO 9001:2000, paragraph 4.1 a), and b). All needed processes are contained in procedures that are sequenced. All procedures have the required inputs and outputs. The procedure inputs and outputs are traceable from the source processes and traceable to the sink processes. In this way, the ISO 9001:2000, paragraph 4.1 requirements are met.

Generic Configuration Management Procedures (Under development)

Generic Quality Assurance Procedures (Under development)

Generic IEC 61508 Procedures (Under research)
Why Not Engineering is researching generic procedures adequate to IEC 61508-1, IEC 61508-2, and IEC 61508-3. Just like the Generic ISO 9001:2000 Procedures already developed by WNE, the IEC 61508 procedures will use the "Process Approach". All procedures will be defined, sequenced, and traceable to the appropriate IEC 61508 requirement.
All procedure inputs and all outputs will trace to their respective source and sink procedures. Also, all Conformity Assessment of Safety-related Systems (CASS) Targets of Evaluation (TOEs) will have traceability to the generic IEC 61508 procedures.

Paul Bodeau has been working on IEC 61508 adequacy and compliance for three years. This is a three year lead on the only attempt to comply with every requirement of IEC 61508. If you find another organization claiming compliance to IEC 61508, ask if all IEC 61508 requirements have been met. Ask how IEC 61508-1, subsection 6.2.1 is complied with. Also, ask if a CASS audit can be performed.


Anything less is not worth risking life, limb, or the liability of your organization for.

The four parts to CASS compliance are:

Part 1, IEC 61508-1, clause 6, Management of functional safety

Part 2, IEC 61508-1, clause 7, Overall safety lifecycle requirements

Part 3, IEC 61508-2, Functional safety of electrical/electronic/programmable electronic safety-related systems

Part 4, IEC 61508-3, Functional safety of electrical/electronic/programmable electronic safety-related systems software requirements

Generic IEC 61511 Procedures (Under research)

Generic RTCA/DO-178B Procedures (Under research)

Generic RTCA/DO-254 Procedures (Under research)

Generic ISO/IEC 12207 Procedures (Under research)

Services

For Specific Standards

Why Not Engineering assists organizations developing programmable electronic systems with adequacy and compliance to safety and quality system standards. Why Not Engineering has system safety engineers knowledgeable in the following standards.

Why Not Engineering besides assisting in development, can provide training on the following standards:

  • IEC 61508
  • ANSI/ISA 84.01
  • IEC 61511
  • SEI-CMMI
  • ISO/IEC 12207
  • RTCA/DO-178B
  • RTCA/DO-254
  • MIL-STD-498
  • MIL-STD-882D
  • FDA 21 CFR
  • ISO 9001:2000

     

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