Keeping Up with ISO: A New High-Level Structure

The CEO/owner of a company is responsible for its strategic leadership, ensuring the organization’s future relevance, credibility and viability. Now, as outlined last month, the ISO 9001:2015 standard for quality management requires that leadership steer the compliance process as well. This forces them to also be leaders in their tool and die and injection molding related industries, using their capable workforce and modern technologies to produce quality products. It also requires an understanding that all products and services are the result of a process, and that all processes must be continually improved by the process owners. 

Your organization can be on its way to reducing costs, increasing efficiency, gaining access to new markets and establishing a competitive advantage by examining and complying with the 10 new or revised clauses of ISO 9001:2015, which can be found in this chart. (ISO 9001:2008 has eight clauses.)

New or Revised Clauses of ISO 9001:2015
ISO 9001:2008 Structure	Clause	ISO 9001:2015 Structure
Scope	1.0	Scope
Normative References	2.0	Normative References
Terms and Definitions	3.0	Terms and Definitions
Quality Management Responsibility	4.0	Context of the Organization
Management Responsibility	5.0	Leadership
Resource Management	6.0	Planning
Product Realization	7.0	Support
	8.0	Operation
	9.0	Performance Evaluation
	10.0	Improvement

To provide a clear understanding of each clause, the respective changes and the business impact, we will examine a few each month in this column. This month, we review the first three.

1.0 Scope: ISO 9001:2015 now requires records of transparency and accountability for all employees, including those involved in CNC machining processes, finite element analysis, mold flow analysis and CAD/CAE/CAM analysis. Prior to this revision, keeping of such records was only recommended, not required. Basically, this clause of the quality standard for moldmakers and molders serves to support their business plans. 

2.0 Normative References: ISO 9001:1987 was revised in 1994, 2000, 2008 and 2015. The standard was first introduced in 1987 as a manufacturing processes standard. In 1994, emphasis shifted to producing assurance using preventive actions. Those changes were followed by a large update in 2000 that focused on quality management and further refinement in 2008. The latest evolution of the standard uses the new Annex SL structure, which harmonizes the text, terms and definitions for all management system standards, including ISO 9001; TS 16949, 13485 and 14001; and OHSAS 18001. The revision also adds new contextual requirements such as records of confidentiality and intellectual property protection on businesses. It also emphasizes the importance of understanding the internal and external context of the organizations with which a company has relationships, verifying and validating process/product manufacturing flow, for example.

3.0 Terms and Definitions: The following terms have been added to properly define the supply chain: supplier, organization and customer. Prior to this revision, only the company and customer relationships were recorded and under control. The organization maintained records for customers in sales, accounting and auditing to ensure achievement of the organization’s objectives in operational effectiveness and efficiency. Few suppliers (vendors) were providing help with financial reporting and complying with laws, regulations and policies. Now, supplier performance metrics are required as well. 

A supply chain includes all activities, functions and facilities (directly or indirectly) in the flow and transformation of goods and services from raw material to finished product to end user delivery. These activities include procurement, customer service, distribution, transportation, inventory control with information systems, sales, planning, order entry, receiving, shipping, inspection, purchasing, production scheduling, master scheduling, warehouse management and supplier management. The supply chain also encompasses all interconnected relationships, including the moldmaker, molder, designer, materials, sales channel, distribution, warehousing, manufacturing, transportation and suppliers. 
ISO 9001:2015 now requires an increased emphasis on achieving value across the entire supply chain by offering guidance on reducing total cost of ownership, producing customer surveys, improving suppliers performance report cards, emphasizing risk-based management across all departments, and how to use corrective and preventive actions (CAPA) to identify risk levels (high, moderate or low). CAPAs are improvements to a company’s processes that eliminate causes of non-conformities or other undesirable situations. Examples are putting in place a system that provides notification and escalation of CAPA due dates and building risk into the process to identify the biggest areas of improvement.

Clause 3.0 requires certain documentation to be included in a company’s capability statement. For moldmaking, this might include something along the lines of the following:

• Milling Division: The company uses the most precise CNC milling machinery available, and the milling department is fully equipped to accept a wide range of applications from small to large components with complex surfaces and contouring.
• Lathe Division: The company uses multiple CNC lathes with four-, five- and six-axis and bar-feeding capabilities. Personnel participate in weekly planning meetings to decide how work will be most efficiently distributed to ensure high morale and a high level of competence.
• Grinding Division: Cylindrical grinding (OD, ID and centerless) is an integral part of the mold machining process for this company. From large to small products, grinding is the most cost-effective approach to ensure consistent sizing and a precise finish. 
• Metal Prep Division: Properly preparing metal for tooling is an important step for the moldmaker. Management understands that precision sawing combined with facing and centering are essential steps toward ensuring a quality finished product.
• Projects Division: The company brings engineers and toolmakers together to manage a customer’s job in the most efficient and quality-conscious manner possible. Advanced planning and coordination ensure customer satisfaction. From problem-solving and prototyping to manufacturing and delivery, the company can easily accommodate one, 1,000 or 100,000 pieces.
• Engineering: The company’s goal is to meet customers’ tooling, engineering and production needs. If the CNC program for a job requires geometrical support, engineering may assist the moldmaker with developing the project. The company has developed a unique and diverse approach toward helping customers solve technical problems and industrial challenges.

Examining and complying with these first three revised clauses in ISO 9001:2015 should enable your company to produce metrics on problem areas, track customer feedback and establish a change-management process. (Change management encompasses the people side of the processes, tools and techniques that are necessary to achieve a required business outcome.) 

One of the keys to compliance is benchmarking against metrics. Consider a centralized reporting system to help build reports and analytics related to company processes. Another key is post-market feedback, which is a central area for collecting adverse event data. If you are not collecting and captioning these items, you may miss key compliance issues. Lastly, take event data and automate the process of operational change. All of this will reduce costs, increase efficiency and yield a competitive advantage.