What are 3rd party auditors looking for? This is the first of a three part series by Jim Lee, President of simpleQuE
Clause 4 of Annex SL – Context of the Organization
This is the cornerstone of a management system and the business’ strategic direction. An organization needs to identify internal and external issues that can impact its intended outcomes, as well as all interested parties and their requirements. It needs to document its scope and set the boundaries of the management system to line up with business objectives.
The context doesn’t have to be documented, so 3rd party auditors (as well as internal auditors) will be asking questions of various management members, and looking for these as objective evidence that an organization understands its context and considers all the factors and stakeholders affecting the business. The items listed below don’t have to exist, but if they do, you want to take credit for them in understanding the context. Some items may not by themselves demonstrate an understanding of the context, but combined with multiple examples, can provide the evidence an auditor is looking for.
Watching the big game? Here are a few takeaways that apply to any business.
You’re only as strong as your weakest link Football is a team sport, and so is business. A weak link in the supply chain can be detrimental to a business that fails to assess supply chain risk management.. SimpleQuE’s supply chain audits and corrective actions drive supplier development and can identify risks to your company.
Sometimes you have to take the punt to score the touchdown Football is all about taking risks. Going for a field goal is an easy way to score three points, but punting the ball could result in a touchdown for seven points. Just as the coach examines the possible outcomes before making the decision to go for a field goal or a punt, ISO 9001 calls for a manager to use a risk-based thinking cap. Organizations are asked to identify, analyze and prioritize all potential risks as they undergo implementation or upgrading their existing quality management system for certification.
When the plan fails, change the plan Things do not always go as planned on the football field. It’s not an ideal situation, but by quickly adapting to the current circumstances, the most effective teams can often salvage a few yards rather than giving up. Similarly, companies often need to come together, improvise and move forward in the face of adversity.
Always play the long game
Sure, the other team may score a touchdown in the first few minutes of the game. Instead of focusing on what went wrong, the best teams keep a long-term perspective. And in business, try not to get caught up in the day-to-day—rather, focus on long-term quality and excellence.
Training is important Far before the game starts, football players have spent days and weeks practicing and training to ensure they’re ready to play. Consider offering plentiful opportunities for training, such as SimpleQuE’s slate of courses covering internal auditing, root cause analysis and problem solving, and more.
Understand the competition The best coaches understand that beating the other team is often more about understanding their strengths and weaknesses than it is about playing your best. Businesses can employ the same strategy when it comes to their competition. Understand what advantages other companies have while also learning their key weaknesses is essential to your own success.
Always watch the highlight reel In football and in business, it’s essential to learn from your past mistakes as well as to repeat your past successes. Every situation has an upside, and provides opportunities to learn and move forward. As we always emphasize when working with companies on ISO, AS, or IATF implementation, Once plans are implemented, it’s essential for organizations to check the effectiveness of their actions and continually learn from experience.
The automotive quality standard has come a long way since it’s first inception in 1994. Take a look at our infographic to learn about the development of the standard, and it’s new iteration, the IATF 16949.
Quality Excellence is the foundation of our business at simpleQuE, as well as part of our name – (notice the Qu and E). To celebrate National Trivia Day, we gathered some interesting facts from around the world about QualityManagementand its important role in every business we serve. We hope you enjoy this fun trivia and learn something new about ISO and quality.
Happy Trivia Day!
The term ISO (as in ISO standard) derives from the Greek word “isos,” which means equal.
Many quality terms, tools, and methods were popularized in Japan— kaizen, gemba, muda, kanban, etc.
In Germany, 77 percent of organizations provide ISO training and 82 percent provide general quality management training—the highest of any group of organizations.(2)
The Pareto principle, or 80-20 rule, states that 80 percent of problems come from 20 percent of causes, and that management should concentrate on the 20 percent. It was popularized by Joseph M. Juran.
Twenty percent of senior executives rate their quality programs as world class, but only 5 percent of quality professionals do the same. (4)
Philip B. Crosby is perhaps best known for promoting a standard of excellence based on nothing—the concept of zero defects.
The “Big Q” refers to comparing differences between managing for quality in all business processes and products; while the “little q” relates to managing quality in a limited capacity, traditionally in factory products and processes.
One of the world’s best-known standards is ISO 9001.
Plan-do-check-act is not only the name of a popular process improvement method, it’s also the title of a music CD released in 2014 by a New Jersey-based rock trio Recovery Council.
Edwards Deming introduced the 14 points for management, which, he said, “have one aim: to make it possible for people to work with joy.”
Time Magazine, http://content.time.com/time/specials/packages/article/0,28804,1908719_1908717_1908537,00.html
ASQ Global State of Quality research, 2013. www.globalstateofquality.org
The Economic Impacts of Inadequate Infrastructure for Software study, prepared by RTI for the National of Standards and Technology, 2002. http://www.nist.gov/director/planning/upload/report02-3.pdf
Not only is Accutech Mold and Machine (AMM) ISO 9001:2008 certified, but they also achieved their ISO/TS 16949:2008 certification from Eagle Registrations. In January 2016, simpleQuE consultants, Larry Vance and Don Milinkovich began working with AMM to assess their existing processes and formulate an action plan that would address the gaps and fit their very tight timeline. That was followed up by an internal audit and training to prepare for the expansion to the automotive standard.
Why was this so important to AMM’s founders, Kelly and Darrin Geiger? As AMM’s website states, “International Standards are the backbone of our society, ensuring the safety and quality of products and services, facilitating international trade and improving the environment in which we live in. Conformity to International Standards helps reassure our customers that Accutech Mold and Machine’s products, systems and organizations are safe, reliable and good for the environment.”
Founded in 1996, AMM specializes in plastic injection mold manufacturing. In 2004 the company expanded with an injection molding press to sample molds that were built. Today, AMM continues to build high quality plastic injection molds and also produces plastic injection molded components with 25 presses running 24 hours a day.
Vice President, Darrin Geiger, had this to say, “It was easy to work with simpleQuE and they provided an action plan which our team utilized, working hard to reach our certification goal in just six months. The advantage to being ISO/TS 16949 certified is that it has opened new doors for us in the automotive industry, and our non TS clients are happy because they also benefit from these additional business processes.”
Do you ever wonder how much of a difference quality really makes in an organization? The answer is: a lot! In fact, for every $1 spent on a quality management program, businesses have seen an average of $6 in revenue. Take a look at more interesting stats on today’s infographic.
As a consulting company, simpleQuE specializes in quality and environmental management systems and we are frequently asked what services we provide and how we are different from a certification body. This article explains the objectives, roles and responsibilities of the organization, consulting company and certification body to provide a better understanding of the connection between all three.
Organization (Manufacturing or Service Company)
Seeks to achieve one or more of the following objectives:
Implement and develop a new quality (QMS) and/or environmental management system (EMS)
Upgrade certification or expand to a new standard
Improve and/or simplify an existing QMS or EMS registration
Consulting Company (simpleQuE)
Assists organizations with implementation, improvement or transition by:
Providing customized consulting, training and internal auditing services and solutions
Assessing existing processes through a gap analysis and developing an action plan
Offering internal and supplier audits
Training for internal auditors and management including implementation and full standard reviews
Helps organization partner with Certification Body:
Assuring a common language for auditing and interpretation of the standard so it corresponds with the expectations of the Certification Body and requirements of the standard
Certification Body (Registrar)
Issues certifications: Provides organizations a resource for management system certification by evaluating policies and procedures to verify implementation and effectiveness against the specific requirements of the standard. Assessment consists of a series of audits:
Document review (sometimes combined with Stage 1)
Initial certification audit – Stage 1
Confirm that organization is ready (or not) for a full Certification Audit. Typically 30-60 days prior to the Stage 2 Certification Audit.
Verifies required documentation exists, certain requirements have been met such as a full internal audit completed, a management review completed, and risks considered.
Verifies processes have been established and is appropriate for the scope of certification, and that appropriate monitoring and measuring of processes are in place with appropriate objectives.
Plans the Certification Audit based on information and data gathered
Certification audit – Stage 2
A full QMS or EMS audit. Confirms that the management system fully conforms to the requirements of the standard.
Certification is issued upon successful completion of Stage 2 assessment and closure of any findings.
Certification is maintained through a series of annual surveillance audits (sometimes semi-annual). Every third year a full recertification audit is performed and a new certificate issued.
In summary, good communication between all partners is important to ensure all requirements and objectives are met in a simple straightforward way to comply with the standard. At simpleQuE we partner with the client and Certification Body to make quality excellence “simple”.
Obtaining an ISO certification is so important to businesses that many will specify the distinction next to their business name, and some customers and industries mandate it through the supply chain. A client or potential business partner may ask why having an ISO certification is important. Simply stated, an ISO certification means the client can trust a business and have confidence that It has the processes in place that are independently audited, to improve the likelihood that products and services will meet or exceed customer expectations.
What is an ISO Standard?
ISO standards define and structure a company’s management systems. These standards apply to all industries and require businesses seeking certification to define how their systems meet the standards’ rigorous requirements. Meeting the standards assures customers that all vendor company activities – design, manufacturing, production, purchasing, quality control, packaging, handling, storage, shipping, and customer service – are appropriately managed and controlled.
Certification Builds Confidence
When a business certifies to an international standard, they are representing a trusted symbol of quality, safety, and compatibility. These standards are developed through a process that is balanced, open, and transparent and help elicit trust among the groups and businesses that have placed value in the certification process.
There are several paths to obtaining ISO certification. A company can create its own documents and systems, then prepare for and manage their audit internally, or they can work with a specialist to provide consulting, auditing and training services to expedite the certification process. It is important to note that actual ISO certification is the result of an audit conducted by an external registrar or certification body and not the International Standards Organization who develops the standards.
SimpleQuE’s consultants are experts in their respective fields and are ready to provide unique solutions that fit your specific needs. For more information on choosing an ISO consultant, visit simpleQuE’s YouTube channel.