| definitions | iso 9000 hit list | iso intro | iso auditor interview |

Most of the following Hit List items are lessons learned at the receiving end of a Nonconformity note. We have either received a formal corrective action from an external ISO auditor or that auditor has specifically pointed out the importance. Of course different auditors will see different things but you can bet that the most particular of those auditors will know and/or live by the content of mental lists similar to this one.

1. There must be an assessment of your training needs. Once completed it will give you a plan of action for a training program. (Clause 6.2.2 a)
2. Job descriptions must be current for everyone in the company. When the ISO Auditor mentions all job descriptions for employees performing a quality function, they mean everyone (Clause 6.2.2 a).
3. Are all employees qualified to perform their function? If so, a document must evidence this fact, and the company must be able to prove it (Clause 6.2.2 e). You might already be doing this with regular performance reviews.
4. In order to prevent regression and to promote continuous improvement, an internal audit program must be established. You must develop an audit plan that is maintained and implemented internally (Clause 8.2.2).
5. When conditions are found to be insufficiently defined or are out of control, they will need to be defined or brought into control (Clause 7.5.1). Individuals that work on these types of processes need to be empowered to make the changes and write corrective action requests (CAR's). (Clause 6.4 & 8.5.2)
6. There are six mandatory procedures identified by the Standard; however, other written procedures may be needed if conditions are found that a process has not been established by other means of communication (i.e., verbal) (4.2.1 d). The Auditor will ask two or three people about a process and if the answer is not identical from each, a nonconformance is likely to result.
7. If a document states a time frame for action, the action must be accomplished within that time or a CAR will be written. For example, when design decision documents by Design Engineers must be kept permanently, you should be able to show all design decision documents. Or, if an action in a CAR must be completed by February 14 and it's still open on March 15 without a written explanation or extension, the Auditor will issue your company a nonconformance. (an internal non-compliance with organization’s procedures) (Clause 4.2.1 d)
8. Management (i.e. the President, CEO or the management representative) must create top-management review records (agenda & minutes) on the effectiveness of the company's quality program system (Clause 5.6). This means each person or department should provide him/her with a report on the status of that department. For example, Order Processing spends an average of 45 minutes per order due to options that need to be clarified by the customer. The CEO will then assign two people to evaluate and make a recommendation within 2 weeks. Wasted time is wasted profits and in today's competitive industry this cannot be allowed.
9. If disposition of nonconformances requires authorization then the authorized person must be identified. (Clause 8.3)
10. Purchase orders (PO's) or equivalent must be reviewed to ensure that purchased product conforms to requirements prior to the supplier getting the order. This means that before the PO is mailed to the supplier it must be reviewed by a cognizant individual to verify drawing revision(s) and any special materiel requirements (i.e. swasey or tests). The PO should then be signed and dated. You must provide evidence that you have control of this process (Clause 7.4.1)
11. You must provide proof (records) that you have evaluated suppliers based on their ability to meet your requirements. You must establish criteria for selecting, evaluating and re-revaluating suppliers. Also these records must be kept according to your record retention requirements (Clause 7.4.1)
12. There must be a program in place that monitors the calibration and maintenance of test equipment by a certified standard or agency. The calibration standards must be traceable to an industry-recognized standard or where a standard does not exist, you will need to establish a basis for calibration and keep records of verification (Clause 7.6 a).
13. Statistical techniques may be included where it is determined applicable for an opportunity for improvement. For example, the time to process an order, rework, or wrong product supplied (options or descriptions) (Clause 8.1 & 8.4).
14. There must be records/evidence of design input (sales, customer, marketing) and design output (engineering) and verification that the criteria were met. Use a form for design release similar to that of design specification - meaning most of the same signatures required (Clause 7.3.1).
15. Required procedures and records must be under control (4.2.3 & 4.2.4).
16. Industry Codes and Standards (i.e. ANSI, NEMA, and ISO) are treated by the Standard as documents of external origin and must be controlled. (Clause 4.2.3 f).
17. There must be evidence that effective processes are in place to collect and analyze customer complaints, customer perception, and satisfaction (Clauses 7.2.3 c, 8.5.2, 8.2.1, 8.4 a, 5.2, and 6.1).
18. When changes are made to customer orders and related documents, it must be recorded (records) (Clause 7.2.2 b).
19. There must be records/evidence of contract review and approval of the customers order before it is sent to Production, Operations, or Manufacturing (Clause 7.2.2).
20. Controlled documents may not exist in an outdated status within any area that uses those documents (Clause 4.2.3 c).
21. Controlled documents may not be altered, even by personal notes, without proper procedural allowances such as being redlined, signed and dated Clause 4.2.3).
22. All materiel subject to quality inspection or test must show evidence of inspection or test (Clause 8.2.4).
23. Materiel that deteriorates or has a limited life must be under shelf-life control. A few examples of this materiel would be labels, adhesives, epoxies, solutions, and o-rings (Clause 7.5.5).
24. All quality management system (QMS) documents must be referenced in the quality manual (4.2.2).
25. Top management must provide evidence/records (quality policy, management review, etc.) of their commitment in developing, implementing and improving the effectiveness of the quality management system (QMS) (Clause 5.1).