Tag Archives: David Hoyle

#63 – EXPOSING UNCERTAINTY ABOUT RESOURCES IN ISO DIS 9001:2015 – DAVID HOYLE

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David in Office (2)There should be no uncertainty about what resources  are required to be determined and provided in implementing the requirements of ISO 9001. Unfortunately, there is considerable uncertainty on the subject as I reveal  as I examine the clauses of ISO DIS 9001 .

The first mention of resources in the standard is in clause 0.4 where in explaining the P in PDCA, it is suggested we “establish the resources needed to deliver results in accordance with customers’ requirements and the organization’s policies”.  Nothing wrong here except this is not a requirement as the clause simply explains a methodology. Continue reading →

#59 – EXPOSING THE UNCERTAINTY ABOUT RISK IN ISO DIS 9001:2015 (PART 1) – DAVID HOYLE

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David in Office (2)The new edition of ISO 9001 under development will include the concept of risk in the form of definition, guidance and requirements.  Previous editions included a clause on preventive action which aimed to prevent the occurrence of nonconformities and to some extent this was risk mitigation by another name.

Risk has therefore always been addressed in ISO 9001.  In addition if we look at ISO 9001 through a ‘risk tinted’ lens we would see all requirements in ISO 9001 as risk treatments, therefore risk and ISO 9001 is not a new combination.  However, the way in which the term risk is defined, used and explained in the current draft creates some uncertainty as to what the term means and this has implications for users.  In Part I, I look at the differences in meaning between the word ‘risk’ as commonly understood and the word ‘risk’ as defined in ISO 9001. Continue reading →

#24 – AMBIGUITIES IN ISO 9001: 2015 INITIAL OBSERVATIONS PART II – DAVID HOYLE

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David in Office (2)In this second article, I’m looking at areas of possible confusion and ambiguities in ISO 9001 (2015). My first article can be found at ISO 9001: (2015) Initial Observations.

AMBIGUITY OVER THE MEANING OF A QUALITY MANAGEMENT SYSTEM
Among the definitions in section 3 in ISO 9001 (2015) is the definition of a management system which goes like this: “set of interrelated or interacting elements of an organisation to establish policies and objectives and processes to achieve those objectives”.  Hence a quality management system would appear to be a system that establishes quality policies and quality objectives and quality processes to achieve those quality objectives.  But when one reads this closely it reads as though the system only establishes policies, objectives and processes; it does not read as though the system includes the processes and if it doesn’t include the processes, what indeed are its outputs and outcomes?

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#23 – ISO 9001: 2015 INITIAL OBSERVATIONS – DAVID HOYLE

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David in Office (2)David Hoyle, the author of the best selling ISO 9001 Quality Systems Handbook and other management systems books, offers his unique observations on ISO 9001:2015  Committee Draft (CD).  The second part of his observations will be published in the second issue. Continue reading →