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Robyn Ruder

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Aug 2, 2024, 9:30:10 PM8/2/24

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ISO/TS 9002:2016 provides guidance on the intent of the requirements in ISO 9001:2015, with examples of possible steps an organization can take to meet the requirements. It does not add to, subtract from, or in any way modify those requirements.

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ISO 9001:2015 is the current edition of the official international standard for quality management system requirements. It allows for any organization to implement a system by which it can demonstrate its ability to consistently provide products and services that meet customer expectations and statutory or regulatory requirements.

However, ISO 9001:2015 was written with generic requirements which can be objectively audited or evaluated. To strengthen these requirements, ISO/TS 9002:2016 is composed of examples, descriptions, and options that aid in fulfilling their stipulations. All additional information addressed in this technical specification (TS) serves as a collection of recommended guidelines, and it is not intended to supersede the content of the quality management standard, but to support it, if applicable.

For example, in the early stages of the implementation of a quality management system, any organization should consider its context, with internal and external issues influencing its need for quality. ISO/TS 9002:2016 identifies many potential issues that an organization could consider.

ISO/TS 9002:2016 also includes information necessary for applying some of the updates made to ISO 9001:2015. The role of top leadership in executing the quality management system was heavily emphasized in the latest revision of the quality management standard, and the technical specification addresses several ways in which this can come to realization, including taking clear accountability, monitoring the current and projected workload and schedules, and engaging and directing individuals in the organization in carrying out tasks relevant to quality management systems.

These three examples are only a slight glimpse into the total options described in ISO/TS 9002:2016. Overall, this technical specification walks the user through the majority of the content in ISO 9001:2015, listing a large breadth of applications for each section of the original quality management document. This allows users of both 9001 and 9002 to adhere to the international standard while tailoring it for their own use.

In my last series of blogs we discussed the importance and benefits of implementing an ISO 9001:2015 based quality management system in your business however neither my blogs nor the standard itself provide the reader with any guidance on practical application and this is where ISO/TS 9002:2016 steps in to hopefully help fill some of those blank spaces in our understanding.

ISO/TS 9002:2016 is comprised of examples, descriptions and possible options that can aid organisations in addressing the requirements of the ISO 9001:2015 standard. The ISO/TS 9002:2016 is set of recommended guidelines only and does not include any additional requirements nor does its content supersede the requirements of ISO 9001:2015.

As an example, one area that causes some debate, during initial implementation of a quality management system, is in understanding and demonstrating the context of an organisation as well as understanding the internal and external factors that may impact on the quality management system. ISO/TS 9002:2016 removes some of the strain associated with this area of the standard by providing many potential issues that an organisation needs to consider as part of its context, such issue can include but are not limited to;

As well as outlining possible internal & external factors, ISO/TS 9002:2016 also then goes a step further by detailing possible sources of information that will aid in an organisations determination of context e.g.

Do you want to learn more about the implementation of the different standards in the Automotive or Medical Device sector? We work remotely with you. Please contact us at in...@lorit-consultancy.com for bespoke consultancy or join one of our upcoming online courses.

The ISO 9000 family is a set of five quality management systems (QMS) standards by the International Organization for Standardization (ISO) that help organizations ensure they meet customer and other stakeholder needs within statutory and regulatory requirements related to a product or service.[1] ISO 9000 deals with the fundamentals and vocabulary of QMS,[2] including the seven quality management principles that underlie the family of standards.[2][3][4] ISO 9001 deals with the requirements that organizations wishing to meet the standard must fulfill.[5] ISO/TS 9002 offers guidelines for the application of ISO 9001.[6] ISO 9004 gives guidance on achieving sustained organizational success.[7]

Third-party certification bodies confirm that organizations meet the requirements of ISO 9001. Over one million organizations worldwide[8] are independently certified, making ISO 9001 one of the most widely used management tools in the world today. [9][10][self-published source?] as being wasteful and not being useful for all organizations.[11][12]

The global adoption of ISO 9001 may be attributable to several factors. In the early days, the ISO 9001 (9002 and 9003) requirements were intended to be used by procuring organizations, such as contractors and design activities, as the basis of contractual arrangements with their suppliers. This helped reduce the need for subcontract supplier quality development by establishing basic requirements for a supplier to assure product quality. The ISO 9001 requirements could be tailored to meet specific contractual situations, depending on the complexity of the product, business type (design responsibility, manufacture only, distribution, servicing, etc.), and risk to the procurer. For example, the food industry combined the ISO 9000 series with HACCP as a single management system. [16] [17] If a chosen supplier was weak in the controls of their measurement equipment (calibration), and hence QC/inspection results, that specific requirement would be invoked in the contract. Adopting a single quality assurance requirement also leads to cost savings throughout the supply chain by reducing the administrative burden of maintaining multiple sets of quality manuals and procedures.

A few years later, the UK Government took steps to improve national competitiveness following the publication of cmd 8621, and Third-Party Certification of Quality Management Systems was born under the auspices of the National Accreditation Council of Certification Bodies (NACCB), which has become the United Kingdom Accreditation Service (UKAS).

In addition to many stakeholders' benefits, several studies have identified significant financial benefits for organizations certified to ISO 9001, with an ISO analysis of 42 studies showing that implementing the standard enhances financial performance.[18] Corbett et al. showed that certified organizations achieved a superior return on assets[19] compared to otherwise similar organizations without certification.[20]

Heras et al. found similarly superior performance[20] and demonstrated that this was statistically significant and not a function of organization size.[21] Naveha and Marcus claimed that implementing ISO 9001 led to superior operational performance in the U.S. automotive industry.[22] Sharma identified similar improvements in operating performance and linked this to superior financial performance.[23] Chow-Chua et al. showed better overall financial performance was achieved for companies in Denmark.[24] Rajan and Tamimi (2003) showed that ISO 9001 certification resulted in superior stock market performance and suggested that shareholders were richly rewarded for the investment in an ISO 9001 system.[25]

While the connection between superior financial performance and ISO 9001 may be seen from the examples cited, there remains no proof of direct causation, though longitudinal studies, such as those of Corbett et al. (2005),[20] may suggest it. Other writers, such as Heras et al. (2002),[21] have indicated that while there is some evidence of this, the improvement is partly driven by the fact that there is a tendency for better-performing companies to seek ISO 9001 certification.

The mechanism for improving results has also been the subject of much research. Lo et al. (2007) identified operational improvements (e.g., cycle time reduction, inventory reductions) as following from certification.[26] Internal process improvements in organizations lead to externally observable improvements.[27][28] The benefit of increased international trade and domestic market share, in addition to the internal benefits such as customer satisfaction, interdepartmental communications, work processes, and customer/supplier partnerships derived, far exceeds any and all initial investment.[29]

Essentially, the layout of the standard is similar to the previous ISO 9001:2008 standard in that it follows the Plan, Do, Check, Act cycle in a process-based approach but is now further encouraging this to have risk-based thinking (section 0.3.3 of the introduction). The purpose of the quality objectives is to determine the conformity of the requirements (customers and organizations), facilitate effective deployment, and improve the quality management system.[38][39]