Internal ISO Audit Preparation and Intellectual Property Procedures Mapping

Overview of Internal Audit for ISO Compliance

• The internal audit serves as preparation for an external audit regarding ISO compliance scheduled for September.

• The primary objective is to evaluate institutional readiness and improve documentation prior to the external visit.

• Honesty in self-assessment is required to provide accurate recommendations for readiness.

• The audit is conducted for the benefit of the institution as it pursues ISO certification.

Intellectual Property Management (MOP $5.01$)

• The audit for Intellectual Property Management utilizes two distinct checklists:

  • A home checklist provided for each office.

  • An intended audit checklist specifically for the Manual of Procedures (MOP) of a particular office.

• There are five main Manual of Procedures ($MOPs$) uploaded, with $5.01$ specifically dedicated to Intellectual Property Management.

• The document structure includes categories from $3.1$ to $3.1.10$ and $3.2$ to $3.2.2$, with actual procedures ranging from $4.0$ to $4.9$.

Specific Policies and Procedure Mapping for IP Management

• Full Disclosure of Intellectual Creations ($3.1.1$ and $3.1.2$):

  • These policies are linked to procedures $4.1.1$, $4.1.2$, and $4.1.3$.

  • Evidence of disclosure is maintained via an Intellectual Property Disclosure Monitoring Sheet.

  • Staff must instruct the code for received disclosures and double-check records as proof of submission.

  • Policy $3.1.2$ involves the submission of proposals for the search process, which maps to procedure $4.1.5$.

  • It is noted that policies and processes must be explicitly connected; if a policy exists for disclosure, the procedures must clearly state how a Lasallian partner should disclose their creation.

• Royalty-Free License and Ownership Identification ($3.1.3$):

  • Maps to procedures $4.2$ and $4.8$.

  • Procedure $4.8$ pertains to Copyright Registration.

  • There are two specific disclosure forms used for records: the Invention Disclosure Form ($ID$) and the Copyright Disclosure Form.

  • Evidence of ownership identification is established through the provision of an assessment code.

• Commercialization Potential ($3.1.4$):

  • This involves evaluating the output submitted to the repository to identify commercial potential.

  • Corresponding procedures include $4.1.6$, $4.1.10$, and $4.1.5$.

• Disclosure Triage and Prior Art Search ($3.1.5$ and $3.1.6$):

  • These policies are integrated into procedure $4.6$.

  • After disclosure, a Prior Art Search is conducted while the disclosure triage committee verifies the search before drafting a patent.

  • Essential evidence includes the Prior Art Search Report and the Patent Monitoring Report.

• Ownership Rights and Registration ($3.1.7$ and $3.1.8$):

  • Ownership rights of disclosed inventions or works ($3.1.7$) map to procedure $4.5$.

  • Evidence for ownership is identified through service forms and works records.

  • Patentable works ($3.1.8$) map to registration procedure $4.6$.

  • Evidence of patent registration is found in the Intellectual Property ($IP$) application records.

• Portfolio Monitoring and Enforcement ($3.1.9$ and $3.1.10$):

  • Portfolio and monitoring of IP rights ($3.1.9$) correspond to patent maintenance procedure $4.7$.

  • Evidence includes intellectual property and creative records.

  • Intellectual property infringement and enforcement ($3.1.10$) link to procedure $4.9$.

  • Required evidence for enforcement includes case reports, cease and desist letters, and trademark infringement complaint forms.

Technology Transfer (MOP $5.02$)

• Policy statements in this module provide a general description of technology transfer and the institutional direction.

• General Procedures ($4.1.1$ to $4.1.5$):

  • These are mapped to policies $3.1.2$, $3.1.3$, and $3.1.4$.

  • They cover the initial disclosure of commercialization.

  • Specific procedural codes used for reference include $RNIP\,201$ through to $RNIP\,208$.

• Committee and Institutional Roles:

  • Policy $3.1.3$ describes the committee involved in the process, which is explicitly mentioned in procedure $4.1.5$.

• Technology Transfer Agreements ($TTA$):

  • Key evidence for these processes includes Technology Transfer Agreement records, monitoring sheets, and the Technology Transfer Agreement template ($4.1.8$).

  • Memorandum of Understanding ($MOU$) documents are cited as evidence for collaborative transfers ($3.1.6$ and $3.1.7$).

• Commercialization and Royalties:

  • Commercialization activities for patented works ($3.1.8$) link to procedure $4.1.11$.

  • Licensing to third parties ($3.1.9$) links to procedure $4.1.16$.

  • Royalty sharing ($3.1.10$) maps to procedures $4.1.13$ through $4.1.17$.

  • Evidence for revenue distribution is the Technology Transfer Revenue Distribution Report.

• Conflict of Interest and Property Disposition ($3.1.11$ and $3.1.12$):

  • Conflict of interest and due diligence map to procedures $4.1.7$, $4.1.8$, and $4.1.9$.

  • Policy $3.1.12$ concerns the disposition and use of tangible property purchased with government funds, which maps to procedure $4.1.12$.

  • A Fairness Opinion is required as evidence for the disposition of such property.

NexSys Facilities and Operations Management (MOP $5.03$ and $5.04$)

• Reservation and Usage ($3.1$ to $3.3$):

  • Reservation and usage of NexSys facilities map to procedures $4.1.1$ through $4.1.11$.

  • Monitoring of these reservations maps to $4.1.12$, $4.1.13$, and $4.1.14$.

  • Evidence produced includes monitoring sheets for facility usage.

• Utilization and Maintenance ($3.4$ to $3.5$):

  • Usage and utilization reports map to procedures $4.2$ and $4.4$.

  • Inspections and maintenance ($3.5$) map to procedure $4.3$.

  • Evidence for maintenance includes the Incident/Equipment Damage Report Form and a semiannual scheduled inspection record.

  • There is a noted need to establish current evidence for inspections since the policy exists but active maintenance records need verification.

• Fabrication and Inventory ($3.6$ to $3.7$):

  • Fabrication service requests map to procedure $4.6$.

  • Annual physical inventory ($3.7$) of NexSys equipment maps to procedure $4.5$.

  • Evidence for inventory is the New Inventory Report.

Partnership, Marketing, and Outreach (MOP $5.05$)

• Agreement Processes ($3.1$ to $3.2$):

  • Partnership agreement processes and MOA signing map to procedures $4.1$ and $4.2$.

• Documentation and Templates ($3.3$ to $3.4$):

  • Policies for specific agreements and partnership documents link to procedures $4.3$ and $4.4$.

  • Templates serve as the primary evidence for these sections.

• Marketing and Communications ($3.5$ to $3.7$):

  • Promotional procedures map to $4.6$.

  • Marketing and outreach activities ($3.6$) map to procedure $4.7$, which includes media and press coordination.

  • Marketing communications ($3.7$) map to procedure $4.5$.

Questions & Discussion

• Question: What are the specific evidences needed to show that a disclosure of an intellectual creation took place?

• Answer: The office maintains an Intellectual Property Disclosure Monitoring Sheet. Upon receiving a disclosure, the staff instructs the specific code for the submission and double-checks the entry to create a record of evidence.

• Question: Is the copyright disclosure form different from the disclosure for general intellectual creation?

• Answer: Yes, there are two distinct forms: the Invention Disclosure Form (ID) for inventions and the Copyright Disclosure Form for creative works.

• Question: How is the ownership identification verified for patentable works?

• Answer: An assessment code is provided for each work to confirm ownership identification as part of the procedure.

• Question: What is the specific evidence required for the enforcement of intellectual property?

• Answer: Required documentation includes case reports, cease and desist letters, and possible trademark infringement complaint forms.

• Question: Regarding the maintenance of NexSys facilities, what proof is necessary to satisfy the audit?

• Answer: The auditor recommends at least a semiannual schedule of inspection. While the policy exists, the actual evidence (like the incident or equipment damage report form) must be consistently generated and presented.

• Question: Is there existing evidence for partnership agreements and MOA signings since April 6th?

• Answer: The staff member noted they started the previous week and would need to check for templates and specific records generated since that date.

• Question: What evidence exists for the marketing and outreach activities listed in procedure 4.7?

• Answer: Specifically for marketing and outreach ($3.6$), the procedures follow media and press coordination, and templates are available to serve as evidence.", "title": "Internal ISO Audit Preparation and Intellectual Property Procedures Mapping"}