Sept. 22, 2018, is the deadline for registration to ISO 9001:2015, and this seems to allow organizations plenty of time to make the transition to the new standard. The good news is that, despite the radical changes to the standard’s structure, the underlying requirements are not particularly different. This means that no extensive overhaul of existing documents and processes is necessary. The bad news is that the transition must be performed well before the deadline, and ISO 9001:2015 is therefore closer than we think.
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ISO 9001:2008 requires internal audits and management reviews of the quality management system, and it therefore comes as no surprise that ISO 9001:2015 also requires them. The catch is that, to qualify for registration to ISO 9001:2015, the internal audit and management review must meet the requirements of the new rather than the old standard.
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Conformity Matrix
Clauses 4.4.1 and 5.1 state in ISO 9001:2015 that the organization must integrate the quality management requirements into the organizations processes. The "process" mentioned in the Conformity Matrix are extracts of some 'requirements' and a few automotive type ones. They are NOT the organizations processes - more so, being procedures.
The Conformity Matrix is okay but not required. I do agree it is helpful to show where such ISO 9001:2015 Requirements have indeed been integrated within the procedures of the selected process.
By way of example - take the 12 Processes of say the APQC PCF into the Y axis of a list of processes and then on the x axis place the Clauses of ISO 9001 (clearly any other ISO MSS or non-ISO MSS can be used) and then place a make where that requirement has been considered and used to control that process. This is not control of clause of a clause.
If I may - this is one extract of a Certification Body perpetuating no real change to a ISO 9001:2008 Clause-by-Clause documented QMS. Just update the Clauses (yes, I agree a Quality Manual is likely to be kept and useful) and add say Risk Based thinking, Context stuff as per "Note 2 and 3' for SWOT and PESTEL, some Risks and Opportunities, say reference the use of PFMEAs and so on, seems that's it, recertification by 2018!
See LRQA extract from their website being atypical of most 3rd Party Bodies:
“If your QMS manual is written around and references the clauses of the current ISO 9001 then, if you decide to keep your quality manual, the numbers will need to be updated to match the new clause numbering.”
So, for these topics, the existing processes within your current QMS may well already address the new requirements since they have largely only been re-arranged to fit in with the Annex SL structure.
In preparation for the changes, LRQA can perform a Gap Analysis on your current system to determine how much work you need to do to bring it into line with the new standard.”
So, what this Conformity Matrix article communicates is contrary to ISO 9001:2015 Clauses 4.4.1 and 5.1 and likewise to all HLS based ISO MSS. The HLS itself is to be ONLY used for ISO MS Standard writers and not for organizations to then document their QMS or other discipline-specific MSS, or integrated management system.
Likewise, nor should PAS 99 or CQI's MSS 1000 be used as a basis to document an Integrated Management System by their respective clauses. Granted they do help consolidate such multidiscipline system requirements and then useful to then embed within the organizations processes. The 'Quality' or IMS Policy Manual contents page should then reflect the Core, Management/Leadership and Systems Support Processes - not the ISO MSS Clauses.
Michael W McLean. Convener - ISO/JTCG/TM/TF5 for the Integrated Use of Management System Standards and ISO WG2 ISO 10005 and QR-008 (ISO 9000/1) Member
use of a Conformity matrix
With due regards to William, the use of conformity matrix as recommended will not add any value to the organization.
To take full advantage of the changes to the standard, the organization should start again on a clean slate. This will make the management and the team unbiased (though partly only) and they may be able to appreciate the changes made specially for top maangement and risk estimation. Everything REPEAT everything must be repeated.
A conformity matrix, on the other hand, may give the result that only 30 % is not complying and the management, may as well tell the previous Management representative to fill up the gaps fast (somehow) and make it ready for an audit.
For an organization with the objective of taking advantage of the QMS, this will be just maintaining the status quo.
Regards
virendra
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