While ISO 9001:2008 focused only on manufacturing, ISO 9001:2015 is a high-level quality management program that has become a significant way to implement improvements within the more general customer-supplier relationship. The final four clauses of ISO 9001:2015, Support, Operation, Performance Evaluation and Improvement, were amended and added to support this high-level supplier quality program and to help ensure that working ISO systems support a company’s financial numbers, whereas ISO 9001:2008 did not.
7.0 Support: Overall, this clause now dictates that a company determine and provide the support necessary for its resources, which include qualified workers, to help establish, implement, maintain and improve the company’s quality management system (QMS). Specifically for mold manufacturers, qualified production personnel are needed to operate lathe equipment, EDMs, direct metal laser sintering machines, grinding equipment, milling machines, metal finishing equipment, metrology equipment, molding machines and more.
|New or Revised Clauses of ISO 9001:2015|
|ISO 9001:2008 Structure||Clause||ISO 9001:2015 Structure|
|Normative References||2.0||Normative References|
|Terms and Definitions||3.0||Terms and Definitions|
|Quality Management Responsibility||4.0||Context of the Organization|
Under ISO 9001:2008, this clause required job descriptions
that were too general and did not define duties and responsibilities, so the necessary supports to improve the QMS were hard to determine. This clause under ISO 9001:2015 requires industry-specific job descriptions with supporting documentation of knowledge, experience, skills, aptitude and attitude to perform the job adequately. Job descriptions must include details of a position’s required technical competence in, for example, strategic planning, financial reporting, project management, marketing, procurement, receiving and shipping, engineering, supplier relations, and more. Supporting documentation must include formal education, degrees, educational certificates, professional certificates and self-study achievements.
8.0 Operation: The bulk of management system requirements lie within this single clause, as it addresses both in-house and outsourced processes used by a company. Prior to this latest revision, a company had to plan, implement and control only manufacturing processes. Now it must include quality, sales and customer service processes as well, and the revision also demands sufficient documentation to demonstrate that these processes have been carried out as planned. This clause under ISO 9001:2008 required only generic internal documentation, whereas ISO 9001:2015 requires industry-specific internal and external communications documentation.
This latest revision also requires that companies provide objective evidence of product quality via certificates of compliance, test reports, statistical records and process control. It also requires that all certifications related to special processes, such as plating, anodizing and heat treatment, state specifications (including revision levels of the specifications) to which the parts were processed. All certifications related to raw materials must now be the original mill certification and must include a record of actual physical and chemical material analysis, and a certificate of conformance to the applicable material specifications. Lastly, personnel performing work on the product must prove qualification for the type of work being performed, such as, for example, welder certification.
9.0 Performance Evaluation: This new clause requires companies to determine what, how and when things are to be monitored, measured, analyzed and evaluated. An internal audit is part of this process to ensure the management system conforms to the requirements of the company as well as to the standard itself. A management review is also required to determine whether the management system is suitable, adequate and effective.
ISO 9001:2015 added this clause with the following requirements:
• Suppliers must notify customers of any significant changes, such as company name, location or senior/top management.
• Suppliers must maintain control of quality records for the number of years specified on the purchase order.
• When indicated on a drawing or purchase order, a supplier must monitor key characteristics using statistical process control (SPC), such as the supplier’s ability to reduce defects, and material handling and manufacturing costs. Improvements will lead to the elimination of late shipments and reduced inventory.
• At all times, the supplier must maintain the integrity and identification of each lot (for example, 10,000 pounds of polymer received in 1,000-pound boxes) received for processing. This clause now requires suppliers to keep track of and record data before, during and after injection molding (including incoming inspection, in-process inspection and final inspection). ISO 9001:2008 did not require all these quality checkpoints.
This clause also requires measureable objectives at relevant functions and levels.
Objectives are something to be attained within a defined timeframe. Functions are departments, such as purchasing, design, human resources, manufacturing and quality control/assurance. Levels are reporting positions, such as president/CEO, vice president, manager, supervisor and technician; and relevant refers to anyone in a company who contributes to its success. Examples of measureable objectives might be: “In 2016, reduce scrap in Dept. A by 20 percent compared to 2015,” or “In 2016, achieve a ‘first-time-through’ success rate of 85 percent for all new designs that are turned over to manufacturing.”
10.0 Improvement: In an ever-changing business world, not everything always goes according to plan, so this new clause was added to dictate how non-conformities and corrective actions should be managed to ensure continuous improvement throughout the company. Such improvements might include, for example, reducing scrap and rework, improving productivity with tighter part quality standards, ramping up for new products, increasing production capacity, reducing costs, improving cycle times, enhancing machine/process flexibility, and integrating ISO 9001:2015 with other management systems and regulatory compliance.