ISO 9001: 2000 Quality Management System Design
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11.2 Hub Template
A typical master reference list of a hub document–oriented manual is shown in Table 11.1. Each section of the manual would refer to the appropriate hub document. An alternative method of display would be, for example, by means of a documentation tree (see Figure 11.1).
| ISO 9001:2000 Section | Manual Section | Typical Hub Documents | Typical Document Champions/Authors |
|---|---|---|---|
| 4.0: Quality management system | 4.1, 4.2.1 | Business processes manual Security manual Employee manual | Executive committee Security officer HR manager |
| 4.2.2 | Quality policy manual | CEO ISO management representative ISO management representative | |
| 4.2.3 | Control of documents procedure | ||
| 4.2.4 | Control of records procedure | ||
| 5.0: Management responsibility | 5.1, 5.2, 5.3, 5.4, 5.5, 5.6 | Business plan Quality policy directive Quality objectives directive Organizational chart Management review procedure | Executive committee CEO COO COO ISO management representative |
| 6.0: Resource management | 6.1 | Resource management process | COO |
| 6.2 | Human-resources manual | HR manager | |
| 6.3, 6.4 | Facilities manual | Plant manager | |
| 7.0: Product realization | 7.1 | Product realization process plan | Vice president operations |
| 7.2 | Marketing and sales process manual | Plant manager | |
| 7.3 | Design and development standards | Vice president engineering | |
| 7.4 | Purchasing manual | Purchasing manager | |
| 7.5 | Operations manual Customer service manual | Vice president operations Service manager | |
| 7.6 | Metrology manual | QA/RA manager | |
| 8.0: Measurement, analysis, and improvement | 8.1, 8.2.1, 8.2.2, 8.2.3, 8.2.4 | Monitoring and measurement control plan Auditing manual | Vice president operations QA/RA manager |
| 8.3 | Nonconforming product procedure | QA/RA manager | |
| 8.4, 8.5.1 | Statistical analysis manual | QA/RA manager | |
| 8.5.2, 8.5.3 | Corrective and preventive action procedures with customer complaints | QA/RA manager |
Some key attributes of the hub design are as follows:
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In most cases, there is only one hub document per major clause (e.g., Clause 6.2: Human Resources Process Manual).
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Several hub documents are used within a section when they either represent unique processes or require a summary statement (e.g., the business plan is a partial response to all of Section 5.0 and is a hub document because of its scope and multiple topics).
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An operations manual is used in Section 7.0 as a hub document to contain the various procedural requirements for the production process.
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A service manual is used in Section 7.0 to cover after-sales processes.
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Hub documents are invariably very high level process or standard operating procedural documents, including quality and control plans.
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