The new ISO 9001:2015 standard is being described as a game-changer. There have been a number of changes in parameters since the last 9001:2008 version. Pradip V Mehta takes a look at the changes, and points out what these mean for apparel manufacturers.
The ISO 9001 - XXXX Quality Management Systems - Requirements standard sets out the criteria for a quality management system, and can be used to assess an organisation's ability to meet customer and regulatory requirements. It is the standard against which third party registration or certification can be achieved. This standard originally came into existence in 1987. It has been revised four times since then-in 1994, 2000, 2008 and 2015. The 2015 version is the fifth edition of ISO 9001 Quality Management Systems - Requirements. Currently, there are over a million organisations in over 170 countries certified to the requirements of this standard.1
ISO 9001:2015 was published in September 2015. For those organisations which are certified to ISO 9001:2008, there is a three year transition period, starting from September 2015 to get certified to ISO 9001:2015. That means they have time till September 15, 2018 to make the transition. Those who fail to do so, would have to go through an entirely new audit and registration process.
The purpose of this article is to give an overview of the changes in ISO 9001:2015 version compared to 2008, so that apparel manufacturers can start working to meet the new requirements. The International Organization for Standardization (ISO) does not report the number of apparel manufacturers certified worldwide. Apparel manufacturers are lumped in the category 'Textile and Textile Products'.
The 2015 revisions are hailed as "a game changer", "a real improvement that will lead to a more robust QMS", "this is a wonderful opportunity for organisations to refocus their QMS on their business operations", "ISO 9001:2015 will have huge impacts across the world", "it will provide more confidence that quality management systems really work"1. Changes in the ISO 9001:2008 were necessary due to increasingly demanding customers, increased complexity of the supply chains, emergence of new technology, greater awareness for the need to address sustainability, etc.2
While Table 1 shows an overview of the clause of 9001:2015 and 9001:2008, the major differences between the two versions are as follows:
Title of the clauses and their order, and simplified language
A new clause addressing "Context of the Organisation"
Process approach strengthened and made more explicit
Concept of preventive action now addressed throughout the standard by risk identification and mitigation
A clause addressing "Leadership" as opposed to "Management Responsibility"
Fewer prescribed requirements and lesser emphasis on documentation
Title of the clauses and their order
Title of the clauses and their order in the revised 9001 standard are aligned with other ISO management systems standards, such as the one on environmental management. All ISO Management Systems Standards are now required to use a common 10-clause high-level structure. These changes will make it easier for organisations to address the requirements of more than one ISO Management Systems Standards within a single integrated system.
The simplified language of the revision makes it easier for service organisations to use this standard. The term "products and services" is now used throughout the standard to reflect the far greater use of the standard outside of the manufacturing sector, and to emphasise its applicability in service industries.
Apparel manufacturers who are already certified to ISO 9001:2008 and are considering transition to the new standard may want to consider renumbering various quality management systems documents so that it would be easy to cross-reference them with the revised standard.
Context of the Organisation
The "context of the organisation" means the environment in which an organisation functions and various external and internal factors that affect its business. The clause on "context of the organisation" was included so that the organisations can view themselves strategically which will influence their quality management practice. This clause requires organisations to have a high level understanding of various factors that may affect their business-both positive and negative.
These factors are the competitive and regulatory environment, market environment, operational factors such as labour, facilities, utilities, suppliers, logistics, etc. Clear understanding of how these factors affect an organisation will influence quality management system and practices of an organisation. Under this, the management is required to identify the internal and external issues that are relevant to its purpose and strategic direction, and understand needs and expectations of the relevant interested parties.
"Context of the organisation" is the foundation of effective quality management system, because an effective quality management system can be put in place only if an organisation has a clear understanding of the context in which it operates.
What this means for the apparel manufacturers is that they will have to identify their customers and their code of conduct or labour standards, local labour and environmental laws and figure out how to meet their customers' expectations while meeting all regulatory challenges. Thinking about the "context of the organisation" is new to the apparel manufacturers, ISO 9001:2015 just formalises it.
While there is no specific clause requiring an organisation to use a process approach, the language throughout the standard is such that it requires an organisation to identify its key processes for meeting the organisation's objectives as well as customers' needs.
While the concept of the process approach was introduced in ISO 9001:2000, the 2015 revision makes it explicit through PDCA (plan, do, check, act) as a tool to manage processes and systems.
"Plan" involves setting objectives of the processes and systems (what to do, how to do) to deliver results. Clauses 4,5, and 6, that is, context of the organisation, leadership, and planning, respectively address "Plan" part of the PDCA. "Do" involves actually implementing and controlling what was planned (operations). Clause 8, operation, addresses the "Do" part of the PDCA.
"Check" involves monitoring the process through measures and comparing those measures to the requirements. Clause 9, performance and evaluation, addresses the "check" part of the PDCA. For the apparel manufacturers, this means all production processes, including quality inspection at various stages of manufacturing and testing components and final product. "Act" involves taking actions to improve performance of the processes. Clause 10, improvement, addresses the "Act" part. For apparel manufacturers, this would mean any actions taken based on the results of inspection and testing.
Risk identification and mitigation
One of the key changes in the 2015 revision of ISO 9001 is to establish a systematic approach to considering risk, rather than treating "prevention" as a separate component of a quality management system. Identifying and addressing risk in itself is preventive action(s).
The management is expected to identify risks in the processes of the quality management system that may affect the organisation's ability to meet its objectives, i.e. customer requirements, so that those risks can be addressed as appropriate. By systematically identifying and addressing risks an organisation can better meet requirements of its customers. The typical risk that most apparel manufacturers face is not being able to deliver merchandise when promised. The revised 9001 standard requirement would mean that apparel manufacturers must have some plans in place to address such a situation.
There is a change from "Management Responsibility" in ISO 9001:2008. The revised ISO 9001 standard requiring the leadership of an organisation to be "Leadership" is a significant change, and will result in organisations producing much better quality products and services with much improved operations. This change puts quality management system in front of the top management like never before.
The revised ISO 9001 standard requires leadership of an organisation to:
Be accountable for the effectiveness of the quality management system by allocating adequate resources and engaging, directing and supporting personnel to contribute to the effectiveness of the quality management system.
Ensure that the quality policy and quality objectives are compatible with the context and strategic direction of the organisation.
Ensure that the quality policy is communicated, understood and applied in the organisation.
Ensure the integration of quality management system requirements into the organisation's business processes.
Promote the use of process approach and risk-based thinking.
Communicate the importance of effective quality management and of conforming to quality management system's requirements.
Support relevant management roles.
Ensure that the quality management system achieves its intended results.
What the above means is that the top management can no longer be a "supporter" or "observer" of the quality management system, but will have to be a "participant" of the quality management system. This will require a paradigm shift on most top management's part.
It is only after this presentation that other issues are addressed. Conducting a meeting in such a fashion sends out a very clear signal to all plant managers that the top management of this company is committed to quality. Since these plant managers' quality performance is reviewed every month in presence of their peers they have no place to hide. Nobody likes their weaknesses to be exposed in front of their peers. Therefore, everyone of these plant managers is committed to quality in his respective plant and the quality level in each plant keeps improving.
Table 1: Overview of ISO 9001:2008 and ISO 9001:2015
While the prescriptive title of a management representative has been deleted, it is up to the top management to ensure that the roles and responsibilities are assigned for reporting on the performance of the quality management system. Some organisations might find it convenient to have a single person carry out this role, while others may find some other structure(s) depending on their organisational context.
The revised ISO 9001 allows organisation flexibility in the way it chooses to document its quality management system. Specific documented procedures are no longer mentioned. It is the responsibility of the organisation to maintain documented information to support the operation of its processes and to retain the documented information necessary to have the confidence that the processes are being carried out as planned.
Documented information is defined as "information required be controlling and maintaining by an organisation and the medium on which it is contained."4 Documented information can include documents, records, data, and any other information that might be contained in an enterprise resource system (ERP) and computer aided design (CAD) programmes.
A quality manual is no longer specifically required. If an organisation finds it convenient and appropriate to describe its quality management system in a quality manual, then it is perfectly acceptable.
Because of this flexibility, each organisation will be able to determine the amount of documented information needed in order to demonstrate effective planning, operation, and control of its processes as well as implementation of continual improvement of the effectiveness of the quality management system. While the standard does not prescribe which documents to maintain, it would be wise for apparel manufacturers to maintain inspection results, test results, decisions regarding disposition of non-conforming merchandise, standard operating procedures, minutes of the meetings where quality management system performance was addressed/discussed, and the like.