One of my first jobs on a contract is to review documents currently in use in the quality system. Documentation is often the weakest link in the quality system chain and can be a major nonconformance in the certification audit. In my experience the assessors could regard the following as non-conformances: no central record (Master… Read more »
Posts Categorized: ISO9001:2015
LEANING TO LEAN MANAGEMENT?
LEANING TOWARDS LEAN MANAGEMENT? Lean enthusiasts often overlook the difference between perspective and performance. In their zeal to control the traffic (remove bottlenecks) they don’t recognise the imperative connections between traffic point duty (on site observations according to procedures) and control room perspective (overall strategy and implementation). Lean management allows little margin for error… Read more »
ISO9001 and service organisations
Service industries often have a tough time applying the ISO standard to their activities. The Nonconforming product control requirement is an example . I have applied the Qualidoc procedure successfully for telephone service distributors, voice and data communication for a large pharmaceutical company and a research laboratory, I have also worked with many marine… Read more »
A REMINDER: AS9116 NOTICE OF CHANGE (NOC) Requirements issued in October 2014
AS9116 can be a standalone requirement or an additional requirement to AS9100D, AS9110 (Aviation Maintenance Organizations) or AS9120 (Aviation, Space and Defense Distributors). It does not apply to ‘build to print’ contracts. Source Control Drawings, Bills of Material, Manufacturing methods and Key components must be considered for their NOC status, i.e., design characteristics and performance… Read more »
CUSTOMER-IMPLIED SPECIAL REQUIREMENTS
Early identification of customer- implied special requirements or potentially critical items: provides design engineering with valuable information which they can use for design implementation and design history. provides management with acceptance rationale for those requirements or items, identifies the means by which emerging risks can be controlled and mitigated, enables critical design features, tests, inspection… Read more »
ISO9001:2015: DOCUMENTED INFORMATION
The draft ISO9001:2015 changes the former “Documentation requirements” to “Documented information”. Accordingly, this information can refer to: ” the management system (3.04), including related processes (3.12); information created in order for the organization to operate (documentation); evidence of results achieved (records).” So how much documentation can we get rid of? In my… Read more »
ISO9001:2015: NEW CLAUSES
Continuing my review of the new clauses, No. 4 Context of the organization includes “Needs and Requirements”. This is pretty straightforward; you just have to know your customer and your business, and ask the right questions. “Needs and Requirements” will be those “generally implied or obligatory” for the customer and those who need to know in your… Read more »
ISO9001:2015 – documentation requirements
I have seen comments recently via LinkedIn where some contributors to the quality groups seem to be under the impression that no, or little, documentation is required to meet the ISO9001:2015 standard. No such luck; there are specific requirements under “Documented Information” and other clauses of the draft revision. “Documented information” replaces “Documentation Requirements”. It is… Read more »
ISO9001:2015: NEW CLAUSES
ISO NEW CLAUSE STRUCTURE From the latest information available to me, the ISO9001:2015 will carry new clauses from 1 – 10. Clauses 1, 2, 3 will be Scope, Normative references and Terms and Conditions, as before. Clauses 4,5,6,7 will fall within PLAN; Clause 8 under DO; Clause 9 under CHECK; Clause 10… Read more »
ISO9001:2015: LATEST ON PROPOSED TERMINOLOGY CHANGES
Just received – proposed changes to terminology for the 2015 revision which, if implemented in the final issue, mean considerable editing of current quality system documentation. I will be suffering; I have to change the offerings on the QUALIDOC website. At least everyone who watches this blog and my website will not be caught napping…. Read more »
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