CUSTOMER-IMPLIED SPECIAL REQUIREMENTS

Posted by & filed under AS9100, ISO9001:2015.

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

Posted by & filed under AQAP, AS9100, ISO9001:2015.

     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

Posted by & filed under ISO9001:2015.

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

Posted by & filed under ISO9001:2015.

 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

Posted by & filed under ISO9001:2015.

    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

Posted by & filed under ISO9001:2015.

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 »

MORE THOUGHTS ON ISO9001:2015

Posted by & filed under ISO9001:2015.

  The days are gone when expectations between customer and supplier could include a degree of ambiguity.   The global, and yet most immediate, business environment is unforgiving of error which there is often insufficient time to correct before disaster strikes. Casual arrangements such as those expressed by Leonardo da Vinci trying to get work from… Read more »

I.M. HAPPY COMPANY – MANAGEMENT REVIEW AGENDA: DETAILED RESPONSIBILITIES

Posted by & filed under ISO9001:2015.

MANAGEMENT REVIEW AGENDA: ASSOCIATED  RESPONSIBILITIES   REPORTS QUALITY MANAGEMENT REPRESENTATIVE (QMR) Status of Actions from last Management Review Report on quality system development Work in hand on the quality system (Control of Nonconformity procedure introduction) Risk assessment and risk management for unresolved nonconformities (e.g., supplier, effect on delivery of services to customers) Changes which could… Read more »

ISO9001:2015 REVISION

Posted by & filed under ISO9001:2015.

I have it on the latest, highest authority that the revision contains: more emphasis on non-manufacturing sectors a new common ISO format. This is still at committee stage, but so far this is how ISO9001:2015 will look: MAIN SECTIONS 4.   Context of the organization 5.   Leadership 6.   Planning 7.   Support 8…. Read more »