9.6 Special Mandatory Requirements

9.6.1 Customer Complaints As a Mandatory Requirement

In its charge to the accredited registrar, EN 45012, Par. 18 advises us that the registrar is to make sure that the certified sites keep records of all customer complaints and how such complaints are managed and resolved.

In addition, the Standard advises us in 8.5.2: Corrective Action that we are to create a documented procedure to define how we manage customer complaints.

We have generally found that this set of directives is misunderstood. What is called for is a clear statement with regard to how customer complaints are managed and recorded. This could be done by means of corrective action reports, marketing and sales logs and memos, or any combination thereof. For those who work in the medical industry, this directive is simply part of the general FDA/CGMP requirement.

The prescriptive response to customer complaint management belongs as a separate section in the manual as part of Clause 8.5.2: Corrective Action. This process can then be referenced in Clauses 5.2: Customer Focus and 8.2.1: Customer Satisfaction as one of the methods to measure either customer satisfaction or dissatisfaction.

The partial redundancy of Clauses 5.2, 8.2.1, and 8.5.2 are an example of what we refer to as the Standard's concomitant relationships. The redundancy inherent in the Standard does cause some agony when you create the manual because you can easily end up repeating paragraphs. This can be ameliorated somewhat if you use references back to previous text to avoid this trap. Then flesh out the section with any really new requirements over the redundant requirements.

9.6.2 Registrar-Mandated Factored-Items Requirement

We can define a factored item as a product, shipped to your customer with your logo on it, that has not been manufactured under your certified quality management system. The existence of a factored item requires that the supplier alert the customer base to the fact that the product was not manufactured within a certified QMS.

An example of a factored item is a can of some chemical that you might stock and sell to your customers for their convenience. The can is purchased under private label from the manufacturer and then either inventoried in your shop and shipped from stock, or drop-shipped to the customer by the manufacturer. Although you do check the label for accuracy, you do not verify the product's specifications or integrity. The sale of such cans represents a significant percent of your total sales (e.g., 1% or more of total revenue).

As a result, this product must be declared as a factored item and cannot be included under those products that are processed through your ISO 9001:2000 quality management system. Your customers will need to be made aware of such a situation in some manner (e.g., a memorandum or a note in a catalog). Because brochures and catalogs are usually printed in the thousands, it is customary to use stick-on labels to correct the current documents until the next printing run. In such cases, it is best to inform your registrar of the issue and come to a decision on the best course to follow. The registrar will need to make the final decision ^[6].

If you do not wish to have factored items, the remedy could be just a simple sampling plan or could be as serious as a resident QC inspector at the manufacturer's plant. Other methods include: buying the material from an ISO 9000 certified and accredited supplier; periodic vendor audits; and certificates of compliance or analysis.

The declaration of a factored item(s), and a description of the process that is used to inform customers, is usually placed in Section 4.1: General Requirements.

^[6]Although the supplier is ultimately responsible for the choice of exclusion and how that exclusion is justified to their organization, it is essential to keep in close touch with your registrar on interpretation because the registrar has a similar issue (i.e., how the Standard should be interpreted against the requirements of the accreditation board).