Gunavardhan Digest

14-06-2013
Death of the 1994 Auditor
(Release of an entirely different 9001!)
Gunavardhan Training Institute is
glad to release this issue of Gunavardhan Digest: Year 3 issue 5.
This is a limited edition for friends in the certification business in India.

Just nine months back, I had released an issue of Gunavardhan Digest on the subject of
upcoming revision to ISO 9001. That was based on an article (dated 28 th Aug 2012) by Mr. Nigel
Croft, Chairman of the TC 176. He had mentioned therein that the standards have “stood the
test of times” and “no need to introduce additional requirements”. Therefore, I had projected
that the new version of ISO 9001 will be a lukewarm affair. I was wrong!
The new Committee Draft ISO 9001:2015CD has just arrived. And its’ fragrance is very
exciting. Believe me, it’s an entirely new standard. If the revision from 1994 to 2000 made it
“generic”, this one is “truly more generic” (I quote from the CD). The bias towards
manufacturing has almost vanished. Foreword talks about reducing the prescriptive nature of
the standard. Done remarkably well. Only place where it is prescriptive is in specifying the
details of Process mapping and Process Approach.
Yes, it is written in line with Annexure SL (Clause numbering similar to ISO 14001). Those
of us, who had become used to the clause numbering of 2000 for past 13 years, will be at a loss.
That is just a small matter.
It has done away with words like document and records, manual and procedures; it has
done away with preventive action. [ I remember, in 2002, we had a three page checklist for
documentation. Redundant! Those “six mandatory procedures” can no more be the focus of
auditor now.] Gone with the wind are terms like calibration “with traceability to National or
International standards” and all that! The word ‘Design’ itself is missing, therefore no question
of splitting hair over Design verification and Design validation. No ragging of the auditees over
continual vs. continuous! The all-famous PDCA, so dear to the hearts of trainers, has become
implicit--no reference to Plan-Do-Check-Act in the Foreword, no fancy diagramme.
In turn, it has brought in some heady stuff. Starts with ‘purpose of the organization’ and
‘strategic direction’. Then it goes on with interested parties, Knowledge, innovation & risk (Not
risk management!). Sounds more like 9004:2009.

Quality is never an accident--- Williams A. Foster

 The tone of the document itself has changed. Remember clause no. 7.4.3 “shall
establish and implement inspection---“. Instead, now you have, “shall ensure that externally
provided goods and services conform to specified requirements.” Alternatively, look at the
famous clause of Corrective Actions. Earlier wording “shall take action to eliminate the causes of
NC” is now replaced by “ shall evaluate the need for action & implement if needed”. Left
entirely to the discretion of the organization! Whole thing is now dependent on the sincerity of
the implementer, the spirit and zest with which organization takes up the implementation of
the standard.
Auditing for Conformance?
There is a proverb in Marathi that you can take a horse to water but you cannot make
him drink the water. Auditors cannot dictate anything, cannot show the rulebook to the
auditee. Those auditors, who start the audit by asking for List of records and List of approved
suppliers are going to find it difficult to comprehend the tone of the standard. Control of
documented information is significantly different from Control of documents. Methodology
may still remain same but focus will—should-- shift from revision dates and formats to contents
and results. One auditor had asked a veteran marketing manager from the client’s office, “How
do you address 7.2.2?” This gentleman replied, “ I have been selling appliances for a lifetime
but I do not know what is 7.2.2”. Clause-wise auditing (and more importantly, clause-wise
vetoing) will become outdated. Twelve years after implementing and auditing the process
approach, we still need a department-wise organization chart to prepare an audit schedule.
One Auditor told the client, ”You should revise at least one document in a year so that I can
write something in the report!” And this is not a stray case. There are veto persons who have
rejected the report because left side margin was not conforming to German Procedure.
These auditors are going to find it difficult to discuss “issues related to purpose of the
organization and strategic direction” or “demonstration of leadership”. Or requirements like
“Top Management shall be accountable for the effectiveness of QMS”. The core activities of
development (Design) are left entirely to the discretion of the organization—“ Organization
shall plan and implement processes for development- - -”. Full stop. Auditor will have little scope
while auditing for conformance.
The so-called “value addition” by the auditors and CB, those petty Suggestions for
improvements, are going to appear out-of-place in new era. ISO 19011’s “Collecting
information through interviews and judgmental sampling(?)” itself is going to appear out-of-
place, probably. We may need to borrow a page from Business excellence assessment.
Auditing to 2015 version is going to be a new ball game!
In short, the days of 1994 Auditor are numbered.

Quality is never an accident--- Williams A. Foster

 9001:2015 from the perspective of stakeholders
—CBs, Orgn. & their customers.
What happens to the CBs in India? To the old Auditors? How are they going to tackle
the new standard? Let us have a close look at the type of Auditors in the market today. I can
classify them in three categories.
Cat. A:- Those in the field since 90’s, erstwhile third party inspectors and Quality
Engineers, including Batala-trained veterans. They are away from hands-on management for at
least 10 to 15 years. Management practices have undergone sea-change in last 20 years. This
group keeps learning thro audits, but there is a limitation to the Ring-side view.
Cat. B:- New generation auditors in the age group of 30-35, who switched from
manufacturing/QC to Certification with just 4 to 10 years experience, with little or no
experience of hands-on management. Many of them are equipped with MBA degrees but they
have never worked in middle management; they get bogged down with the idea of auditing Top
Management.
Cat. C:- Experts from other domains, like Environment or Food, compelled to audit QMS
for the convenience of the back-office coordinators of the CB.
What kind of competence development activity goes on in the CBs? Continuous
Professional Development! Same routine discussion on NACE codes, Lean six-sigma(Or flavour
of the day improvement technique), issues in integrating systems, how to minimize reports.
Can the present lot of auditors rise to the need of the hour?
Certainly, it is going to be uphill task for CBs, unless they want to make the whole affair
superficial.
Certified Organizations include broadly two categories. First, those who valued the
process of implementation and certification. They used to eagerly look at the Opportunities for
improvement generated thro the auditing process. This category is already disillusioned with
the performance of the current practices of audits-- the casual approach of Auditors & CB and
the tasteless odourless colourless reports. They will probably find the audits for 2015 version
superficial and irrelevant. Business Excellence Awards are a better vehicle for them for the
purpose of “demonstration of abilities”.
IAF had issued the procedure for ASRP for such clients. However, CBs took a selfish
short-sighted view of ASRP and never implemented it. I believe, it’s not yet late to start it.
Other category is of those companies who were forced to go for certification or those
obtained certification to avail the subsidies extended by govt. Many of them have discontinued
certification after pocketing subsidy. The number of accredited certificates in India has gone
down from 46091 in 2007 to 29574 in 2011. Clearly, they did not see any benefit from
certification.

Quality is never an accident--- Williams A. Foster

 Finally, what impact will this standard have on the main stakeholder of the Certification
process, the customer(s) of the certified organizations? 1987 version talked about providing
“external assurance of quality” (to the Contractor!). Over the years, that assurance had eroded
for both legitimate and illegitimate reasons. 2015 version will not even make a claim of any
such assurance to external customer. Without any mandatory documents, customers can not
even be assured of continuity of the system, not to talk of robustness of the system. Quality
plan was relegated to NOTE way back in 2000. Now, external customers cannot be assured of
an elaborate design process, or of a healthy calibration process.
Will PSUs or MNCs insist that their supplier be certified to ISO 9001? Purchase managers
are already skeptic about it.
There are so many groups, especially in West, who did not approve this “generic”
approach of the standard. I can mention here IATF, API and Medical Devices regulators of EU,
who influenced the release of documents TS 16949, TS 29001 and ISO 13485 respectively. I am
anxious to know how these and other groups will react to “truly generic” version!

Gunavardhan would be accompanying you on this transition.

Contact us at sales@gunavardhan.com

Quality is never an accident--- Williams A. Foster