| Feb 10 | Is it required to have a Lead Internal Auditor on the Internal Audit T.. Hi everyone, We are aiming for an ISO 14001 certification this year and on the process of training our internal audit team. Im not sure if it is required to have a lead internal auditor among the internal audit team but we are identifying someone to.. |
| Feb 9 | Has anyone ever heard of Registrar QSRD-International? Has anyone ever heard of them? They have no direct website and their certs do not have the ANAB stamp/embossment. |
| Feb 9 | GRI (Global Reporting Initiative) KPI Question Good Afternoon, We are looking for some clarification on some KPI\'s for GRI. We will be reporting to Level C. We are a privately held worlwide company with a very few competitors. We do not think our owner would like for the details of the financail.. |
| Feb 9 | Objectives & Targets - Continuous Improvement (ISO14001) In 2010 when we first set up our EMS and were working towards getting ISO14001 certification we had set an objective to reduce electricity and gas usage by 10% in 2011. We did achieve this- infact reduced it by about 15%. So now that we are in 2012 .. |
| Feb 9 | Special Contract Manufacturing or 510k Licensing I understand that this question might sound familiar but what I need is advice on a slightly different variation to the standard OEM/private label relationship. We are interested in producing a class II product for our company. However we already ha.. |
| Feb 9 | Transmission Fluid Test - What is a Coulter Test? What is a Coulter Test? What other tests would produce the same result as the Coulter test? Thank you |
| Feb 9 | New to ISO/TS16949 - Our QS-9000 certification has expired We are a very small job shop of three people that provides metal cleaning services to manufacturers and automotive industries. As we grow, our customers are now asking for us to be TS16949 certified. In the past, we were once 40+ people strong! Sinc.. |
| Feb 9 | New to ISO/TS16949 We are a very small job shop of three people that provides metal cleaning services to manufacturers and automotive industries. As we grow, our customers are now asking for us to be TS16949 certified. In the past, we were once 40+ people strong! Sinc.. |
| Feb 9 | ISO 17025 in lieu of ISO 9001? Our management recently decided to drop our ISO 9001 registration saying that 17025 covers the same material and then some. Now our customers who previously accepted our 9001 registration (but had no requirement for 17025 accredited calibrations) ar.. |
| Feb 9 | Six Sigma Forum - Suggested reference threads Six Sigma discussion are some of the more lively (and interesting) discussions that can be found on the Elsmar Cove. There are many legitimate points of view and different perspectives. Anyone interested in Six Sigma may want to review some of these.. |
| Feb 9 | IVD Veterinary Testing - European Market Regulations Please, I\'d liKe to start a new thread about this kind of products: IVD test for Veterinary Diagnostics, specifically IVD test for Companion animals. All companies producing and distributing human in-vitro-diagnostics in the EU have to comply with t.. |
| Feb 9 | Six Sigma Register - Historical Body of Evidence Hello, With my auditing I use a register offered by the IRCA to prove an update my historical body of evidence. My question is, I have concluded several six sigma projects and I would like a similar top level register that I can use as a body of evi.. |
| Feb 9 | Morning Wakeup Music - Norah Jones - Sunrise (Live - Glastonbury) Norah Jones - Sunrise (Live - Glastonbury - 2010) |
| Feb 9 | Complying with ISO 14001 Clause 4.4.4 \"Document Interaction\" Just had my stage 1 audit and apart from it being painful and lots to do, I had a bit of an issue with somethign that the auditor wanted me to do. They said I had to develop a flow chart or something to demonstrate \"document interaction\" - I was a l.. |
| Feb 9 | Political Advertisements - 2012 - Super PAC Mad Libs I don\'t think the *needs* to be in the Controversial Forum, but I figured I\'d make sure... Mark Fiore |
| Feb 9 | IDE Regulations for Feasibility IDE Study Will FDA accept an IDE feasibility study proposal in which only safety is assessed? The device is approved Class III and the study will be multi-center. There are no known safety issues with the device so no AEs are expected. The study is a user pre.. |
| Feb 9 | Design History File DHF Practices and Contract Manufacturer Looking for others experience regarding DHF practices when using contract manufacturer to create a part to meet a specification. For example a catheter shaft is a specified material, dimensional and physical characteristics. The specification does n.. |
| Feb 9 | GCP for Class III Device Programming (Predecessor Device Program quest.. In an IDE trial of a Class III medical device, the test device needs to be programmed for the patient. The patient has a predecessor device and the programming settings for the predecessor device are stored on the clinic\'s computer. The predecessor .. |
| Feb 8 | Digging Datums - Feature control frame (FCF) applied to a pipe I.D. Hi To All, Searched but unable to find an answer, don\'t have drawing to post but here\'s the question. Given a cylindrical pipe with a mounting flange and a feature control frame (FCF) applied to the pipe I.D. , requiring a tolerance of position of 0.. |
| Feb 8 | Charging a customer who wants to audit our QMS? We are an ISO 13485 certified contract manufacturer. Lately, we have hosted quite a number of customers who have come to perform QMS audits of our facility. I recently had as many as 4 audits in a 10 day span. These audits tie up resources in prepar.. |