FAQs
Please see the links page, I have links provided to some of the officially published FAQs supported by specific industries and certification bodies. You may find your answer there. If not or if you feel your question is unique and specific to your processes, submit a question, that is what I'm here for.
Question listed by clause number of the Standard or just ask a question. There are questions at the bottom of the page that do not fall into the normal catagory of the ISO standard.
Clause
| Clause | Question | ISO |
| 4.1 | What is 4.1 about | The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International standard.
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| b | | |
| 4.2 | | |
| 4.2.2 | | The Organization must document a Quality Manual that meets all of the requirements listed in this section, a, b, c. The Quality Manual may be hard copy or electronic. It must be controlled per the requirements defined in section 4.2.3. The Quality Manual can be as short as one page and still be compliant. The requirement for the Quality Manual is to contian all the required procedures or reference them. It must contain a description of the interaction of the processes |
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| 7.6 | What tools do I need to calibrate? | Tools used to validate product requirements, This could extend to thermocouples in heat treat ovens, and the accuracy of machines used to cut parts, if you rely on them to deliver an attribute or dimension that is not later validated. |
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| 8.2.2 | What is meant by audit planned based on the status and importance of the processes and areas to be audited, as well as the results of previous audits | The intent here is to plan the internal audits based on what are considered important areas of the organization. The best way to plan for internal audits is to review the areas that have problems; What processes are the cause of customer complaints, which areas have been targetted for improvement by Management, what areas had problems in the last audits, etc, Plan to audit that areas that will give you the most return for the time spent. There is nothing in the ISO 9001 or AS9100 standards that require all processes and elements of the standard to be audited every year. TS16949 actually does require all processes to be assessed each year. |
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Question;
We need to self-certify our product with a CE label…do you know what the criteria are? I have found a few places that “sell” the information, but since it is a requirement it should be available somewhere for free? Or, perhaps that’s wishful thinking.
Answer; The CE label indicates compliance to a standard. At the very least you will have to buy the standards to which you are considering compliance. Now that is a lot to say,since the CE compliance in general may involve a series of standards and you need the ones for you product type, There are many such standards that could be applicable. For instance for a battery cabinet it could reference;
EN 62040-1-1 : 2003 (Safety)
EN 50091-2 :1995 (EMC)
EN 61000-3-2 : 2000 (EMC)
Directive 2006/95/EC (Low Voltage)