ISO9001 and service organisations

Posted by & filed under ISO9001:2015.

  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 »

QUALITY SYSTEM TRAINING: the essentials

Posted by & filed under Uncategorized.

Too often employees believe that the quality system is ‘man­agement business’ and it is a shock when they discover that everyone is involved. I have found also that academic training centres (universities, training colleges) do not give sufficient credibility to quality management, particularly in their engineering and business development studies.   We do not want… Read more »

A REMINDER: AS9116 NOTICE OF CHANGE (NOC) Requirements issued in October 2014

Posted by & filed under AS9100, ISO9001:2015.

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 »

DOCUMENTATION REQUIREMENTS, and the Readers’ needs

Posted by & filed under Uncategorized.

During one of my contracts in marine freight forwarding I worked with a Maintenance Foreman who was responsible for isolating and identifying nonoperational forklifts used to move cargo. His habit was to remove the forklifts to a corner and attach a small (grubby) tag marked ‘DO NOT USE’ to each one. Unfortunately, the night shift… Read more »

QUALITY SYSTEM MANAGEMENT: RISK MANAGEMENT and the danger of CATEGORY ERROR

Posted by & filed under Uncategorized.

  The zeal for “measurement” and “continuous improvement” expressed through numbers has been gaining strength for some years. I have even seen one comment that “nothing in process development was any use unless it was, or could be, measured”. I maintain that measurements can’t be made, or make any sense at all, unless they derive… Read more »

APPRENTICES: our responsibility and obligation to them

Posted by & filed under Uncategorized.

FROM: JEAN WHITE, QUALIDOC WWW.QUAlIDOC.CO.UK   Apprentices are not confined to the “shop floor”. In my recent workshop on quality management for apprentices I had eight PhD university student/apprentices. They are working and studying. This is why we should get rid of the belief that students go to university or college and get a degree… Read more »

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 »

CERTIFICATION BODIES: assessment

Posted by & filed under CERTIFICATION BODIES.

Certification Bodies (CBs) are currently the focus of dissatisfaction in some LinkedIn groups.Many of the comments express disappointment (to put it mildly) at what they consider is the lack of thorough audits by some assessors. It’s worth noting that there is a rigorous review of reports submitted by assessors to their CBs and onward to the… Read more »

QUALITY SYSTEM DEVELOPMENT: management review (risk assessment)

Posted by & filed under ISO9001: RISK ASSESSMENT AND MANAGEMENT.

The demand for risk assessment and risk management in the current quality management standards can immobilise the most dedicated executives, not to mention the quality management representatives. Out of pity for their dilemma and misery I offer the following questions, which are extracted from the Qualidoc Quality System Internal Audit Checklist at www.qualidoc.co.uk. Are the… Read more »