Sector specific standards
Is there really a need for sector specific standards? Leading inspection expert Dedi Dharmadasa argues that such specifications make auditing easier while Ashley McCraight, a pharmaceutical standards expert, says sector specific standards have dragged the industry from the dark ages. General Motors representative Joe Bransky believes they finish what the ISO 9000 started and telecoms forum director Richard Morrow finds out how auditors in this field really feel about them.
When ISO 9001 was launched, it was heralded as an all-encompassing set of standards, which could be applied to any kind of business. But what happens when an industry sector deals with specialised materials, complex processes or creates products for human consumption? The generic specifications of ISO 9001 can only go so far in creating a quality management system (QMS) that effectively addresses niche markets, such as pharmaceuticals and edible products.
The food ISO 22000, pharmaceutical PS 9000, automotive ISO/TS 16949 and telecoms TL 9000 standards have all helped to bridge the gap in the ISO 9001’s ability to adequately address the particular issues of quality management that arise in these industries.
Food
The ISO 22000 standard involves the following elements:
- interactive communication
- system management
- prerequisite programmes
- hazard analysis and critical control points (HACCP) principles
The standard applies to all organizations involved in food operations, from initial production, like fisheries and dairy farms, to final consumption, eg restaurants, as well as the suppliers of utensils, packaging and so on.
Dedi Dharmadasa of training and inspection organization SGS Lanka says: ‘ISO 9001 complements ISO 22000. Food businesses will now have to make an effort to create an integrated management system to address quality and food safety. Single management systems will then emerge for third party certifications. The food industry has an enormous incentive to work towards ISO 22000, as it will mean cutting out many of the second party audits of various other food standards. Since HACCP is the core of the ISO 22000 standard, most of the retailers and regulatory bodies will endorse companies certified by it’.
Pharmaceutical
PS 9000 is based on, and replaces, the two separate pharmaceutical supplier codes of practice for contact and printed packaging materials, first issued in 1990 and 1995.
Ashley McCraight, leader of the codes of practice development project says: ’Long before BS 5750 emerged, supplier quality management was in a dark period. It was down to some pioneering individuals from the pharmaceutical industry to visit their suppliers to evaluate whether they could trust them. Eventually, these individuals developed their own standards, however they were often different and confused suppliers’.
He adds: ‘The introduction of BS 5750 was a godsend as it presented a clear basic framework for both managing and auditing a quality system. But confusion was still there. BS 5750 was not enough and this led to the UK’s Pharmaceutical Quality Group www.pqg.org deciding that something need to done. Ten years ago it published a set of basic good manufacturing practice (GMP) expectations that expanded on the ISO 9002 framework. The code of practice it came up with created a code for each of three sectors: printed packaging materials, contact packaging materials and raw materials.’
However, success was mixed. While the printed materials code was adopted by the print industry very quickly and soon became the de facto standard in the UK, the other two codes were less enthusiastically taken up. McCraight is hopeful about the code of practice’s future, however, saying: ‘The PQG invited the suppliers to join them in redefining these standards, which has been very productive. One team has just created ”The application of ISO 9004 to pharmaceutical packaging material suppliers” and the feedback they have been getting from all over the EU has been very positive.’
Automotive
ISO/TS 16949 was developed by the International Automotive Task Force (IATF) www.smmt.co.uk/home.cfm to advance the supply chain and certification process. As an indication of just how relevant the standard is, almost all major vehicle manufacturers are required to hold this specification certification to do business at all.
The standard supersedes existing US QS 9000, German VDA6.1, French EAQF and Italian ASQ automotive quality system standards. TS 16949 applies to all automotive supply businesses, be they multi-national corporations or small site operators. However, only sites where production or service parts are manufactured are required to adhere to it. Essentially, it specifies the quality system requirements for the design and development, production, installation and servicing of all automotive-related products.
The IATF made the decision to directly manage the oversight of its recognized certification bodies. This approach means that the oversight offices are directly accountable to the IATF. In addition, the IATF oversight offices manage witness auditing, auditor licensing, and general operations including a website with important information related to both the standard and certification scheme. The IATF oversight offices also maintain an extensive data base for monitoring a large array of certification activities.
Joe Bransky, General Motors representative to the IATF, believes that while the ISO 9001 provides an excellent, ‘foundation standard’, some fields require greater specificity. He says: ‘Industries like the automotive, aerospace and telecommunications sectors are typically global and may involve extensive supply chain resources. They involve greater complexity based on the materials, components, interactions, final product and volume. I know of a number of other industry sectors also considering a sector specific approach.’
The problem is not the ISO 9001 standard itself, rather it involves certification credibility. As Bransky points out: ‘The legitimacy of the certificate is the real issue. I see this problem manifesting itself in a number of ways, for example: organizations going through the motions of certification; auditors not auditing but selling and marketing to clients; lack of due diligence on the part of the auditor or certification bodies in the audit or in making the certification decision; lack of accountability of certification bodies to accreditation bodies; and lack of accountability of accreditation bodies to anyone.’
Bransky continues: ‘Ultimately, there are two key components of an effective sector standard. First, the sector standard needs to be robust with the requirements appropriately tailored to meet the industry needs. This requires a collaborative and consensus approach among the industry or sector members. Second, and equally importantly, there needs to be a credible certification scheme that includes meaningful oversight of the recognized certification bodies that is satisfactory to the industry or sector’.
Telecoms
TL 9000 is a QMS standard for the design, development, production, delivery, installation and maintenance of telecoms products and services. Quality Excellence for Suppliers of Telecommunications www.questforum.org/index.htm developed the standard and has been pushing for improved quality in the telecoms industry since its inception in 1998. Richard Morrow, QuEST’s director of TL 9000 administration and forum information systems, says: ‘On the QuEST forums the general consensus appears to be that though ISO 9001 contains requirements applicable to any organization in any industry, a sector-specific standard allows the addition of requirements unique to that industrial sector. In the case of TL 9000, there are 90 additional requirements and a set of product performance measurements specific to the telecoms industry’.
Morrow acknowledges that in order to be applicable to any organization, ISO 9000 must be generic. He explains: ‘It is a baseline system, and the sector-specific standards build on that base. ISO 9001, if truly implemented, is effective, but it only goes so far. The biggest challenge in ISO 9001 and any other third-party audit based compliance verification system is maintaining the effectiveness and integrity of the audits themselves. This is another area where the sector-specific standards have implemented additional requirements and oversight.’
Obviously, a system that is truly effective for those auditing it, as well as those implementing it, it needs to target specific needs and evolve ways to better address them. Strengthening the ISO 9000’s scope, the sector specific standards discussed above enhance the overall structure of quality standards.
For more information about any of the companies mentioned in the article, visit their websites:
SGS Lanka w: www.lk.sgs.com
Pharmaceutical quality group w: www.pqg.org
IATF w: www.smmt.co.uk/home.cfm
QuEST w: www.questforum.org/index.htm
