Every revision of ISO 9001 invites a revision to the sector schemes based on it. For example, the aerospace and defense industries’ AS9100 relies on ISO 9001 as its foundation. So does the auto industry’s ISO/TS 16949. When ISO 9001 changes, sector schemes need to change with it if they are to remain sector schemes. With the upcoming revision of ISO 9001 expected in 2015, we hear grumblings from some sector schemed industries about wanting to part ways with ISO 9001. Maybe they never should have become so intimate in the first place.
Why would industry leadership resist developing updated sector schemes in response to changes in ISO 9001? It’s probably at least partly an effort to avoid undergoing yet another round of re-defining industry requirements and individual management systems.
SOME BAD BETROTHALS WITH ISO 9001
Rather than coupling structure and definition of their management systems with ISO 9001, organizations should have defined their management systems for themselves, based on the structure of their own organizational operations. Similarly, rather than coupling definition of industry-specific requirements with ISO 9001, leadership in each industry should have defined its own industry-specific requirements, complementing ISO 9001 requirements instead of becoming one with them.
Pressing industry-specific requirements into a marriage with ISO 9001 seems akin to the mistake of pressing ISO 9001 requirements into the definition of any QMS.
No QMS is properly defined by adopting a standard intended to assess it as a basis for system structure. A real quality management system (QMS) doesn’t depend on a standard for its existence or its structure. Organizations’ QMSs were operating before ISO 9001 came along. Every organization staying in business had a system for satisfying customers, or they wouldn’t survive long enough to seek ISO 9001 registration in the first place. So QMSs exist independently of ISO 9001. They should be defined as they actually operate, not according to the clauses of ISO 9001.
Standard operating procedures (SOPs) predating ISO 9001 were better descriptions of the processes needed for QMSs than any out-of-the-box procedures based on ISO 9001 clauses. If SOPs were already in place and comprehensive, organizations could simply have reviewed these (documented) planned arrangements against the requirements of ISO 9001. Sure, some updating may have been required to squarely address some requirements, but the basic requirement of having a documented system was largely already being met.
In these cases, there was never a need to adopt a set of procedures based on the requirements of ISO 9001 to establish a QMS. To a large degree, the QMS was already established and documented. Incorporating the requirements of ISO 9001 into their system definitions simply caused trouble. It divorced the definition of management system from daily operations in favor of being married to ISO 9001 requirements.
This is the marriage that should have been saved: the one between QMS definition and actual daily operations (SOPs). A QMS is the system outputting product, it’s not a set of documents pandering to ISO 9001 requirements. When we define a QMS merely as being something responding to ISO 9001 requirements, the real QMS must operate undefined beneath this useless layer of quality bureaucracy.
A real QMS is merely supposed to comply with ISO 9001, it’s not supposed to be defined by it (in its various revisions). So new revisions of ISO 9001 shouldn’t be impactful on the structure and fundamental operations of any QMS. QMSs never should have been married to the clauses of ISO 9001 in the first place.
It’s high time for a divorce.
Likewise, industry-specific requirements never should have been married to ISO 9001. It was never a happy marriage. As we’re hearing from the grumbles, the need to review and reassimilate industry requirements into each new revision of ISO 9001 seems to be more work than it’s worth. Well, it may well be more work than it’s worth. Some premarital counseling might have been a good idea, because this conflict was foreseeable, but it’s a little late for that at this point.
So, how about a separation?
SECTOR SCHEME MADNESS
It seems to me that if ISO 9001 were properly applied in the first place, we wouldn’t have this proliferation of sector schemes today. ISO 9001 is supposed to be applied by auditors with experience in the industry of the audit client. If an industry defines its own industry-specific requirements, these would become (contractually) part of the ISO 9001 audit criteria for suppliers to that industry.
Audit time would be added to accommodate the additional requirements, document review is done as normal, and on-site auditing is done as usual, only with conformity to some extra requirements being assessed as part of the system audit.
Rather than infusing industry-specific requirements into a generic international standard and calling it a sector scheme, industry leadership would have been wise to leave ISO alone and define their own industry requirements however they see fit. That way, industry-specific requirements aren’t muffled by being voiced through the fabric of ISO 9001. Independent of ISO 9001, industry-specific requirements can be changed whenever and however industry leadership wishes. Or not. But at least it wouldn’t depend on ISO 9001’s language, interpretations, and development cycles.
CONSCIOUS UNCOUPLING
Coupling their industry-specific requirements with ISO 9001 wasn’t really a good idea in the first place. It doubled sector scheme leadership’s headaches. Not only did they need to define and express their industry-specific requirements, then they had to assimilate these requirements into the various clauses and sub-clauses of ISO 9001.
They could have simply defined their own industry requirements in their own language and format, published them as industry requirements, and then flowed these industry-specific requirements down the supply chain, referencing them in purchase orders and contracts, making them auditable customer requirements.
At the same time, training on these industry-specific requirements would be required of those auditing in those specific industries. Qualified auditors—experienced and trained with ISO 9001 and any specific industry requirements—would be scheduled to audit clients in their area of qualification.
So, an ISO 9001 audit of a supplier to, say, Boeing would be assessed not only to ISO 9001 requirements, but also to established requirements of the aerospace industry. If supply to the aerospace industry is in the supplier’s QMS scope, aerospace industry-specific requirements apply.
But these requirements don’t need to be infused into a sector scheme of ISO 9001 to be included as audit criteria during an ISO 9001 audit. Being experienced in the aerospace industry and trained in industry-specific requirements, the auditor would incorporate industry-specific requirements into the audit criteria along with the requirements of ISO 9001. Then audit as normal, albeit with industry-specific requirements being included among the audit criteria.
An ISO 9001 certificate resulting from the above scenario would mean that a supplier has a management system in place to satisfy customers within its scope of supply requirements. That seems only right. Meanwhile, the world would be spared the efforts required from committees of people forcing a shot-gun wedding between their beloved industry requirements and ISO 9001. Maybe they were never meant to be married.
Bio:
T. D. (“Dan”) Nelson has been closely involved with ISO 9000 since 1994 as a technical writer, quality manager, management representative, consultant, author, and CB auditor. Holding an MA in Business Administration from the University of Iowa, Dan also has 12 years of experience as an IRCA-certified QMS Lead or Principal Auditor, conducting registration audits and surveillance audits, and training Lead Auditor candidates in accredited courses. Using a process approach, Dan has taken several scores of clients of various shapes and sizes through registration to ISO 9001:1994/2000/2008 and related sector schemes (e.g. QS 9000, AS9100, ISO 13485, and ISO 17025). Dan’s numerous articles about the process approach have also been published by Quality Digest, Inside Quality, ASQ’s Quality Management Division, the Society for Manufacturing Engineers (SME), and the South African Quality Institute (SAQI); Dan has been featured as a guest blogger by RABQSA, and has been featured on Quality Digest Live. Dan is available for management consulting, training, and coaching, as well as auditor training and coaching. Contact: dan@tdnelson.com 720 412 7994