We are breathing a sigh of relief at Qualidoc. The new package is ready for downloading, with samples from updated documents and paid access to the updated version of our popular Internal Audit Checklist, Quality Policy Manual and Quality Assurance Procedures Manual. The policies are critical for establishing the commitment by senior management to the… Read more »
Posts By: Jean White
AS9100:2016 and ISO9001:2015
AS9100:2016 is floating around in draft. I have read it and it doesn’t keep me awake at night. Risk assessment and management are still flavours of the month. Tackling risk assessment and management can be intimidating, but if we can keep our heads when all around are losing theirs we shall not waste time and… Read more »
THE STATISTICAL ROCKY ROAD
How would you like to have an operation by a surgeon who, when you ask him what your chances were, told you that 99 out of 100 people died during the operation, but you were lucky because you were the 100th patient? I wouldn’t give much hope for a healthy recovery, would you?… Read more »
ANAB, OEMs and AS9100 audits
According to recent information which has come my way, prime contractors (OEMs) and standards boards are becoming increasingly concerned about the insufficient depth of AS90XX audit reports, which they are returning to certification boards as unacceptable. Three examples of immediate concern, especially to the aerospace industry, are: DOCUMENT CONTROL (no surprise there) ESPECIALLY CONFIGURATION MANAGEMENT… 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 »
HANDLING, PACKING,PRESERVATION, DELIVERY (SHIPPING)
With all the emphasis on measurement in the ISO9001 standard it is sometimes easy to overlook the importance of the day-to-day production that is just as important. For example, what does “delivery” mean in your business? It could mean delivery to a specific site, or conclusion of system installation, or when the product leaves your… 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 »
INSPECTION, MEASURING and TEST EQUIPMENT: controlled or not?
On one of my contracts I asked to see the Certificate of Compliance from a accredited calibration agency because I concluded that the ‘certificate’ on file was simply a Work Order issued by the technician who had checked the equipment. The WO only referenced the certificate number. I wanted the proper certificate to be on… Read more »
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