ISO9001: 2015 Certification

ISO9001: 2015 Certification

New revisions in the standard require management to be more “hands on” and develops a universal language between all standards…

By Garrett MacKenzie/ Lewis Yasenchak


The CEO/ Owner of a company is responsible for its strategic leadership, ensuring the organization’s future relevance, credibility and viability. The ISO 9001:2015 standard for quality management requires that leadership maintains direct responsibility in the compliance process as well. As leaders of their injection molding operation, the new standard demands that the leader must maintain a capable workforce and modern technologies to produce quality products. It also requires an understanding that all products and services result from the overall process, and that continuous improvement is primarily driven by the process owners. Management is expected to be “hands on” to ensure that the quality policy and quality objectives are consistent with the overall strategy and context

10 new or revised clauses of ISO 9001:2015 can be found in this chart below. (ISO 9001:2008 has eight clauses.) Reduced costs, increased efficiencies, and access to new markets through compliance to the new standard. The organization establishes a competitive advantage through careful examination and compliance to the newest ISO requirements.


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
 Measurement Improvements 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. 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 design processes, including 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 mold makers and molders serves to support their business plans.

2.0 Normative References: ISO 9001:1987 was revised in 1994, 2000, 2008 and 2015. The 1987 standard was first introduced as a manufacturing control. In 1994, focus shifted to producing assurance through preventative actions. Those changes were followed by a large adjustment in 2000 with a primary focus on quality management. Even further refinements were made in 2008. The latest evolution of the standard uses the new Annex SL structure, which combines the text, terms and definitions for all management system standards, including ISO 9001; TS 16949, 13485 and 14001; and OHSAS 18001. Annex SL is a high-level structure created by ISO to provide a universal upper-tier structure, identical core text, and common terms and definitions for all management system standards. It was designed to make it easier for organizations requiring compliance with more than one management system standard.

The revision now requires new contextual requirements such as confidentiality records, and intellectual property protection on businesses. It also emphasizes the importance of understanding the internal and external contexts of 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. In past standards, only the company and its relationships with customers were recorded and controlled. The organization maintained customer records in sales, accounting and auditing to assure the organization’s objectives for operational effectiveness and efficiency were met. In past ISO requirements, few suppliers (vendors) were providing help with financial reporting and/ or complying with laws, regulations and policies. Now, supplier performance metrics are required as a means of increasing the company’s ability to achieve its system goals.

A supply chain includes all activities, functions and facilities (both direct and indirect) in the flow. It also includes the transformation of goods and services from raw material to finished product, and end user delivery. These activities include procurement, customer service, distribution, transportation, information systems (inventory control), sales, planning, order entry, receiving, shipping, inspection, purchasing, production scheduling, master scheduling, warehouse management and supplier management. The supply chain also includes all internally connected relationships, including the mold maker, molder, designer, materials, sales channel, distribution, warehousing, manufacturing, transportation and suppliers.
ISO 9001:2015 now requires an increased effort to achieve value across the entire supply chain. This is accomplished by mentoring methods for reducing total cost of ownership, producing customer surveys, improving supplier 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) Part of the goal of compliance is the ability to ensure that adverse events are being properly escalated to a Corrective Action Preventive Action (CAPA), and resulting actions are turned into opportunities for improvement. An example of this is 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 mold making and plastic injection, this might include the following:

  • Milling Division: The company uses the latest and most precise CNC milling machinery available. 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 as well as bar-feeding capabilities. Weekly planning meetings determine how work will be most efficiently distributed, which ensures high morale and a high level of competence.
    • Grinding Division: Cylindrical grinding (OD, ID and centerless) is a key part of the mold machining process. From large to small products, grinding is both cost-effective, and ensures consistent sizing and a precise finish.
    • Metal Prep Division: Properly preparing metal for tooling is an important step for the mold maker. Management recognizes that precision sawing, facing and centering are essential steps that assure a quality finished product.
    • Projects Division: The company brings Designers, Tool Makers and the Process Engineers 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 1, 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 mold maker with developing the project. If a customer’s goal is 0 PPM scrap production, great care and time are afforded to develop a strong and repeatable plastic injection process, using tools such as DOE and PPAP. The company has developed a unique and diverse approach toward helping customers solve technical problems and industrial challenges.

Examining and complying to these first three adjusted clauses in ISO 9001:2015 will enable your company to produce measuring capabilities in problem areas, track customer feedback and to develop a change-management process. Change management addresses the human factor within processes. It also helps to define tools and techniques that are necessary to achieve a required business outcome.

One of the keys to compliance is bench marking against metrics. A centralized reporting system can help build reports that provide analytic s related to company processes. Another key means of analysis is post-market feedback, which is a central approach for collecting adverse event data. If you are not collecting and recording this information, you may be missing key non-compliance issues. Lastly, take event data and automate the process of operational change. All of this helps to reduce costs, increase efficiencies and to develop a strong overall yield. In the end, these improved approaches will give your company a strong, competitive advantage.

Garrett MacKenzie is the Owner/ Editor of and also a technical writer for Plastics Today. His 31 year plastic injection career includes engineering and management for the automotive, medical and handgun industries. He currently offers in-plant processor training programs and training-based webinars.

Email: [email protected] for more information or a quote.

Lewis Yasenchak is the founder/owner of P&Y Management Resources, specializing in ISO compliance/certification, quality training, and related management issues for the plastics industry.

His ISO compliance/certification program is industry-specific for Plastics and its Value-Chain Relationships. Not the competitors general off-the-shelf (creating unnecessary paper work with no accountability for operational/financial improvements). Yasenchak can be reached at [email protected] or call Garrett @ 404-793-9834 to  schedule a conference call.


ISO Certification – Outline

Plastics Processors – Materials Suppliers – Machine Shops

ISO certification developed by Plastics Professionals for Plastics Professionals.

Through our “hands-on” business process re-engineering, we help create a better quality supply-chain, eliminate waste and cost reductions. And for you, win more business. Lewis Yasenchak is the Author, ISO 9000 FOR PLASTICS, published by the Society of Plastics Engineers, trained by KPMG & NSF-ISR.


ISO 9001:2015 Quality Management System is $8,500.00 (plus travel expenses)

– Includes all required documentation: ISO manual and procedures

– Lean manufacturing concepts training, coaching, mentoring

– Time Line for implementation & certification: 4 Months

– Already ISO 9001:2008 certified?…contact us for special plant-site assessment and pricing to upgrade to ISO 9001:2015


– ISO 14001:2015 (EMS), add $3,000.00 plus 1 month

– ISO 13485:2016 (Medical), add $2,000.00 plus 1 month

– IATF 16949:2016 (Automotive), add $3,000.00 plus 2 months

– OHSAS 18001 (Safety), add $5,000.00 plus 2 months


Surveillance Audit every 6 months

– $1,500.00…desk audit (includes employee training materials for Continuous Improvements).

– $1,800.00…on-site audit (plus travel expenses).

To start the ISO Program:

Lewis Yasenchak, ISO Expert, performs a thorough one or two-day on-site analysis of a client’s facility. The assessment starts at receiving raw materials and reviews the entire operation through finished goods–including your support functions. It is a complete health check of your operations providing observations and recommendations for improvement. Resulting deliverables include a supplier score card, pareto charts by assessment section, audit results per question, specific improvement recommendations and a complete executive briefing at the end of the assessment.

Cost: $1,800.00 plus travel expenses.

Email: [email protected] for more information, or call 404-793-9834.

Plastic Injection Service and Training

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