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- 18001 – Occupational Health and Safety (2)
- AS9100 – Aerospace (5)
- ASQ Certifications (1)
- Audit by Exception (1)
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- Cost of Quality (1)
- Customer satisfaction (2)
- Design for Six Sigma (DFSS) (2)
- Design of experiments (DOE) (1)
- FDA regulated industries (1)
- ISO 13485 – Medical Devices (4)
- ISO 14001 – Environmental Management Systems (3)
- ISO 17025 – Testing and Calibration Laboratories (10)
- ISO 19011 – Auditing (5)
- ISO 22000 – Food Safety (1)
- ISO 9001 – Quality Management Systems (51)
- Lean Six Sigma (1)
- Measuring (2)
- Metrology (4)
- Other (8)
- Outsourcing (1)
- Process Management (2)
- Professional Development (1)
- Quality Culture (2)
- Quality Manual – Service Industry (1)
- Quality Tools (2)
- Root cause analysis (1)
- Sampling (1)
- SIPOC (1)
- Six Sigma (6)
- Statistics (4)
- Supply Chain Management (2)
- TS16949 – Automobiles (7)
- Voice of the customer (VOC) (1)
- Z1.4 & Z1.9 – Sampling (19)
Popular Posts & Pages
- Root cause analysis samples
- ISO documentation practices; ISO standard difference between record and document
- ISO 9001 clause 7.5.1 work instructions
- Defining Qualification, Verification, and Validation
- ISO 9001 procedure vs. process
- Standard vs. specification and guidance documents
- ISO 2859-3 Skip-lot Sampling 5.1.1 & 5.2.1
- Does ISO 9001 clause 7 apply to processes?
- Six Sigma Standard
- Using the 10:1 ratio rule and the 4:1 ratio rule
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Author Archives: Ask The Experts
ISO 9001 Quality Policy
Question: ISO 9001:2008 clause 5.3 regarding quality policy requires that it should include commitment to continually improve the effectiveness of quality management system. Our Registrar is saying that for compliance these same words should be included in the quality policy. … Continue reading
TS16949 conformance for a non value add company certified to ISO9001/14001
Question: We’re a fabless semiconductor company, Tier 2, who are in the process of designing and developing an automotive product to deliver through our TS16949 certified subcontractor, Tier 3, to an auto supplier Tier 1, for an OEM. We know … Continue reading
Posted in ISO 9001 - Quality Management Systems, TS16949 - Automobiles
Tagged ISO 9001, ts16949
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Gap Analysis vs. Pre-assessment for a standards audit
Question: Can you clarify the difference between a gap analysis and a pre-assessment in relation to an activity that takes place prior to the full compliance audit? It is my understanding that a gap analysis compares something against a set … Continue reading
MSA- Location Variation
Question: Is it acceptable to use traceable standards (VLSI, NIST, etc.) to complete stability, bias and linearity studies if these standards cover the operating range of the gage? For stability and bias, the AIAG MSA 4th edition (p. 85, p. … Continue reading
Pesticide Residues Surveillance Program sampling
Question: I am plant production specialist working in government sector. I am the manager of pesticides residues surveillance program, on this program we targeting local commodities of fresh fruits and vegetables (F&V) by sampling the targeted numbers and types of … Continue reading
ISO/TS 29001:2010 Standard in Oil and Gas Production
Question: We are an Oil & Gas production testing, frac flow back, and trucking company and while in the beginning stages of instituting ISO 9001:2008 standards, we ran across Oil & Gas industry specific standards ISO/TS 29001:2010 and we are … Continue reading
ISO/TS Standards Exclusions
Question: I have a question regarding exclusions from the ISO/TS standards. The majority of our business is the design and manufacture of enclosure hardware. Recently though, a small portion of our business has become the sole North American Distributor for … Continue reading
Posted in ISO 9001 - Quality Management Systems, TS16949 - Automobiles
Tagged exclusions, ISO 9001, Outsourcing, ts16949
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Audit by exception
Question: I would like information regarding the use of the internal auditing method referred to as “audit by exception”. While this method sounds like it may provide a much more efficient use of my time and my Manager’s/employees time, I … Continue reading
ISO 9001:2008 Requirement for Control and Monitoring of Measurement Equipment
Inquiry: I am trying to clearly understand the ISO 9001:2008 requirement for Control and Monitoring of Measurement Equipment. My question: If a measurement equipment like a Karl Fisher Titrator or pH meter which is calibrated by the user with a … Continue reading
Posted in ISO 9001 - Quality Management Systems, Measuring
Tagged ISO 9001:2008, measure, measurement equipment
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Measurement System Analysis
Question: Is there ever an exception to the rule about needing full Measurement System Analysis for any instrument placed in the Evaluation / Measurement Technique column on the Control Plan? If an instrument is listed on the control plan, does … Continue reading
