February, 2013 Newsletter Articles

Required Records

Feb 1, 2013 in Newsletter | Comments Off on Required Records

A record is defined in ISO 9000:2005, 3.7.6, as a “document stating results achieved or providing evidence of activities performed”. According to ISO 9001:2008, 4.2.1.c, the quality management system documentation must include the records required by the standard. Specific records are identified in the standard for: 1. Management review – 5.6.1 2. Education, training, skills, and experience – 6.2.2.e 3. Evidence that realization processes and resulting product meet requirements – 7.1.d 4. Results of review of...

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Required Documents

Feb 1, 2013 in Newsletter | Comments Off on Required Documents

According to ISO 9001:2008, 4.2.1.a, an organization must include documented statements of quality policy and quality objectives in its quality management system. Clause 4.2.1.b states that the documentation must also include a quality manual. Clause 4.2.1.c, adds that the documentation must include the documented procedures and records required by the standard. Therefore, ISO 9001:2008 requires the following documents at a minimum: 1. Statement of quality policy (see 5.3) – 4.2.1.a 2. Statement of quality objectives (see 5.4.1) –...

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Audit Requirements

Feb 1, 2013 in Newsletter | Comments Off on Audit Requirements

If you conduct internal audits of an ISO 9001-based quality management system, what steps are you taking to improve the audit program and its results? In addition to getting feedback from your auditors and the audited areas, you should consider adopting some of the extra audit requirements contained in other management system standards. After reviewing the ISO 9001 internal audit requirements, I will cover the extra requirements that were thought to be necessary beyond the basic audit requirements of ISO 9001. Audit Definition According to ISO...

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Regulation Avalanche

Feb 1, 2013 in Newsletter | Comments Off on Regulation Avalanche

According to an article by Mike Verespej in Industry Week, beyond the budget crisis, tax reform, and spending cuts, the most troubling Capitol Hill issue for manufacturers this year may be an aggressive regulatory program. The author points out that the federal debt is now over $16 trillion, and has topped $1 trillion each of the past four years. As a result, taxes and the budget deficit will be the dominant issues in Congress this year. How the federal government eventually resolves the nation’s fiscal issues will have a huge impact on...

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