December, 2013 Newsletter Articles

TL 9000 R5.5 Requirements Handbook

Dec 1, 2013 in Newsletter | Comments Off on TL 9000 R5.5 Requirements Handbook

The new TL 9000 R5.5 Requirements Handbook may be used for audits conducted on or after January 1, 2014. It must be used for audits conducted on or after January 1, 2015, meaning the R5.0 Requirements Handbook can be used until January 1, 2015. Adder Changes There are two new or split adders in R5.5 (an adder is a unique TL 9000 requirement beyond those included from ISO 9001). Four adders have a changed scope. Seven adders were modified and two adders were deleted.  Four adder clauses were renumbered and seven adders were reworded for...

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Document Reviews

Dec 1, 2013 in Newsletter | Comments Off on Document Reviews

Documents are reviewed before an audit and during an audit. The relevant documents are reviewed before an audit to: Gather information to plan your audit activities and develop work documents Examine the extent of the documentation to detect possible gaps Documents, records, and prior audit reports are included in this review. Auditors should consider the size, nature, and complexity of the organization and system, as well as, the audit objectives and scope. During the audit, the applicable documents are reviewed to: Determine conformity of...

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Certification Scope

Dec 1, 2013 in Newsletter | Comments Off on Certification Scope

The scope of a quality management system defines its geographic locations, product lines (including services), applicable processes, and identifies any excluded ISO 9001 requirements. Sites For example, an organization can define its scope to include a single site, or the scope can include multiple sites if they have a common system and the same top management. Products The scope can include the applicable processes for a single product or service, or include the processes necessary for multiple products and services. Processes The scope...

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Process Owner Duties

Dec 1, 2013 in Newsletter | Comments Off on Process Owner Duties

Some process owners have specific requirements in ISO 9001 that apply to their process, e.g., clause 7.4 provides unique requirements for the purchasing process. However, there are some general ISO 9001 requirements that apply to all processes within the quality management system. Clause 4.2.3 describes document control requirements for all types of process documents, e.g., procedures, instructions, and forms. Clause 4.2.4 describes record control requirements for all types of process records, e.g., those that provide evidence of conformity to...

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Manufacturing Metrics

Dec 1, 2013 in Newsletter | Comments Off on Manufacturing Metrics

Mark Davidson recently posted a blog entry titled, “28 Manufacturing Metrics that Actually Matter (The Ones We Rely On)” at the LNS Research web site. He notes that the Manufacturing Enterprise Solutions Association (MESA) has sponsored research to help the manufacturing marketplace identify the most important metrics, and help decision makers understand metrics improvements and their relationships to metrics programs and the use of software solutions. As part of the most recent metrics survey, 28 manufacturing metrics were...

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