When you're finished changing, you're finished." While Ben Franklin was not a business person by trade, his words echo today more than ever for apparel industry quality professionals who are looking to improve performance and improve efficiency in an increasingly competitive economy.
One change for the positive is the new ISO 9001:2015 standard that sets criteria for a quality management system and can be used to assess an organization's ability to meet customer and regulatory requirements. It's also the standard against which third-party registration or certification can be achieved.
For those organizations already certified to ISO 9001: 2008, there is a three-year transition period — until Sept 2018 — to get certified to ISO 9001:2015. Those who fail to do so will have to go through an entirely new audit and registration to get certified to ISO 9001:2015.
Why go through this process? For the apparel industry, which has a number of operational challenges and heavy expenditures, implementing ISO standards can mean lower operating costs and improving the quality of output, ultimately increasing the level of customer satisfaction. While some apparel manufacturers may view ISO certification as a necessity only for exports, there are other factors to consider. There's a key relationship between quality of materials and quality of final product and ISO standards help ensure quality of raw material input, strengthening the quality of the final product. It can also positively impact leadership, management and supplier relationships.
Changes to ISO 9001-2008 were necessary due to increasingly demanding customers, growing increased complexity of the supply chains, emergence of new technology, and greater awareness for the need to address sustainability.
The following are major differences between the two versions: (see Table 1).
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 organizations to address the requirements of more than one ISO management systems standards within a single integrated system.
Apparel manufacturers that are already certified to ISO 9001-2008 and are considering the 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 organization
The context of the organization refers to the environment in which an organization functions and various external and internal factors that affect its business. This clause was included so that the organizations can view themselves strategically, which will influence their quality management practice. This clause requires organizations to have a high-level understanding of positive and negative factors that may affect their business, including a competitive and regulatory environment, market environment, and operational factors such as labor, facilities, utilities, suppliers and logistics.
Under this clause, 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.
This means apparel manufacturers will have to identify their customers and their code of conduct or labor standards, local labor and environmental laws and figure how to meet their customers' expectations while meeting all regulatory challenges. Thinking about the context of the organization is new to apparel manufacturers and ISO 9001:2015 helps formalize it.
While there is no specific clause requiring an organization to use process approach, the language throughout the standard requires an organization to identify its key processes for meeting its business 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.
Risk identification and mitigation
Plan involves setting objectives of the processes and systems (what to do, how to do) to deliver results.
Do is implementing and controlling what was planned (operations).
Check monitors the process through measures and comparing those measures to the requirements. For the apparel manufacturers this means all production processes including quality inspection at various stages of manufacturing and testing components and final product.
Act takes actions to improve performance of the processes. For the apparel manufacturers, this would mean any actions taken based on the results of inspection and testing.
One of the key changes in ISO 9001:2015 revision is to establish a systematic approach to consider risk, rather than treating "prevention" as a separate component of a quality management system. Identifying and addressing risk in itself is preventive action(s). By systematically identifying and addressing risks, an organization can better meet the requirements of its customers.
A typical risk most apparel manufacturers face is not being able to deliver merchandise when promised. The revised 9001 standard requirement would mean that an apparel manufacturer must have some plans in place to address such a situation.
The shift from "Management Responsibility" to "Leadership" in ISO 9001:2015 is a significant change and will result in organizations producing better quality products and services with improved operations. This change puts quality management systems in front of top management like never before.
The revised ISO 9001:2015 standard requires an organization's leadership to be accountable for the effectiveness of the quality system, ensure objectives are compatible with strategy, promote use of process approach and risk-based thinking and support relevant management roles. The days when quality managers would be thanked for their QMS status presentation and then asked to leave the meeting because "we have business to attend" are over.
The revised ISO 9001 allows organizations flexibility in the way they choose to document their quality management system. Specific documented procedures are no longer mentioned. It is the responsibility of the organization 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 may include records, data and any other information such as might be contained in ERP (enterprise resource system) and CAD (computer aided design) programs.
While the standard does not prescribe which documents to maintain, it would be wise for the apparel manufacturers to maintain inspection results, test results, decisions regarding disposition of non-conforming merchandise, standard operating procedures, and minutes of the meetings where quality management system performance was discussed.
Those organizations that have ISO 9001-2008 certification and are contemplating a transition to ISO 9001:2015 certification should obtain a copy of ISO 9001:2015 standard and perform a thorough gap analysis and then prepare an action plan to close those gaps in order to comply with ISO 9001:2015 requirements.
Overall, ISO 9001:2015 will drive organizations from product and service excellence to business excellence. For more information on ISO, visit ASQ Quality Management Standards.
Clause ISO 9001-2008 ISO 9001-2015
1 Scope Scope
2 Normative References Normative References
3 Terms and Definitions Terms and Definitions
4 Quality Management System Context of the Organization
5 Management Responsibility Leadership
6 Resource Management Planning
7 Product Realization Support
8 Measurement, analysis, improvement Operation
9 Performance Evaluation
Pradip Mehta has more than 32 years of professional experience in quality assurance and is a fellow of the American Society for Quality (ASQ), an author, a teacher and an executive with diverse quality assurance and management experience including as quality assurance director for the Army & Air Force Exchange Service (AAFES). He is author of The Quality Management Handbook for the Apparel Industry (2012) and An Introduction to Quality Assurance for the Retailers (2004) and has taught quality management courses at the National Institute of Fashion Technology in India under United Nations Development Program.