Chapter 7: Procedure Design

7.1 Some Procedures Are Mandatory Documents

Par. 4.2.1(c) of the Standard leaves no doubt that there are certain documented procedures that are clearly required as part of the QMS. However, only six are stipulated:

1. Control of documents (Par. 4.2.3);

2. Control of records (Par. 4.2.4);

3. Internal audit (Par. 8.2.2);

4. Control of nonconforming product (Par. 8.3);

5. Corrective action (Par. 8.5.2);

6. Preventive action (Par. 8.5.3).

The rest is up to you if you feel that more procedures are necessary. However, from our analysis to this point, it is clear that more documented procedures are needed just to put the tier II requirements somewhere (e.g., where do we put the plans that define our processes?). In fact, as we have already noted, if we want to use process documents, they can be termed procedures under the broad definition provided in the Standard's vocabulary and guidelines. Table 6.4, discussed earlier, is an example of a "you do this, then you do this" procedural structure that fits our definition of procedure as illustrated in the four-tier taxonomy.

For those writers who are required to include sector-specific requirements (e.g., medical device requirements), be aware that the tendency is in the direction of not only adopting the ISO 9001:2000 process structure but to continue to expand clauses to cover sector-specific mandatory conditions that include more procedures like the 1994 version.