Would you like to know what 3rd party auditors are looking for when auditing how your company complies with quality system standards like ISO 9001:2015?
What are 3rdparty auditors looking for? This is the second of a three part series by Jim Lee, President of simpleQuE
Clause 5 of ISO 9001:2015 – Leadership
Leadership is the focus of this clause, which means top management now has greater accountability, responsibility and involvement in the organization’s management system. The standard wants to see that leadership demonstrates leadership and support for the quality management system (QMS). They need to integrate the QMS into the organization’s business strategic direction, to ensure the management system achieves its intended outcomes and allocate the necessary resources. Top management is also responsible for communicating the importance of the QMS and enhancing employee awareness and involvement.
With this clause there is a requirement that top management will be present and leading the implementation and monitoring of the QMS. Processes within the QMS must have process owners. In addition, leadership shall demonstrate leadership and commitment with respect to customer focus and the continual improvement aspect of the business. 3rd party auditors will be scheduling time with the management and leadership team asking questions and looking for the items below as objective evidence.
Established and communicated quality policy, objectives, strategic direction, and performance
Organizational chart, job descriptions and other evidence that responsibilities and authorities are defined and communicated
Metrics evaluated in the Management Review and the overall effectiveness of the key business processes
Actions being taken when goals are not met, and when trends for performance are going the wrong way. They want to see management is looking at the data and taking actions when necessary.
Promotion of risk based thinking and evidence of risk management processes with action items when risks are too high. This might include contingency plans, safety stocks, inventory levels, supplier selection and qualification process, etc. as a very few of the many possible ways to demonstrate this.
Involvement in audit activity and reviewing the outcomes and assessing the risks and actions that might be necessary for the QMS
Customer satisfaction and perception
Identification of contract terms and conditions and customer requirements, including any laws that must be met. How are these evaluated, understood, communicated and implemented in the departments that need to know and comply?
Evidence of continued improvement , which denotes that performance is monitored and tracked with trends
The company’s context changes over time, and the needs of stakeholders too. Management needs to be aware of the changing context and issues affecting the business to adjust the strategic direction.
Not that all of the elements listed above will be needed, but organizations may risk failure if they do not:
Identify process owners
Use metrics to monitor performance of the QMS
Include performance metrics in the Management Review
Develop action plans when performance goals are not met
Develop customer communication processes
Respond to customer complaints
Consider results of customer feedback/surveys and take appropriate actions
Identify internal customer requirements
Make improvement part of the quality policy
Align roles and responsibilities with processes
Contingency and emergency roles and responsibilities not defined
Have appropriate training and awareness of the ISO 9001:2015 requirements
The automotive quality standard has come a long way since its first inception in 1994. With the new standard and more than 200 changes, simpleQuE recognized the need for an IATF Gap Audit Checklist to assist companies with the transition. The checklist includes the new automotive requirements (IATF 16949:2016 and ISO 9001:2015) and is intended to be used as a tool to identify both compliance with the new requirements and the differences between IATF 16949:2009 and the new requirements.
The utilization of this checklist, when populated with objective evidence of compliance and non-compliance, will satisfactorily demonstrate you have audited the differences between IATF 16949 standard and the new requirements. It should be used with your certification body as evidence of internal audits to the new IATF 16949 and ISO 9001:2015 requirements. It’s one of the methods simpleQuE auditors and consultants use with our own clients.
A free half hour of phone or email consulting with a simpleQuE expert is included with the checklist for the purchase price of $300.
The simpleQuE team wishes you a smooth and simple transition!
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.
Executive Vice President and Chief Operations Officer Deanne Sparr welcomed Barb with these words, “We’re thrilled to have Barb as part of the simpleQuE team! Her attention to detail and knowledge of certification requirements is exactly the support we are excited to add to our staff and to provide to our clients.”
What is your name? Barbara Dodson.
What is your position and what do you do for simpleQuE? Operations Manager – I’m responsible for client relations and oversight of the performance of audit activities. I am also a lead auditor for ISO 9001.
How long have you worked for simpleQuE? I joined simpleQuE on Oct 31, 2016.
What do you like most about working for simpleQuE? SimpleQuE doesn’t take a one-size-fits-all approach – we understand that each client is unique and has different needs.
What is your greatest accomplishment – work or personal? My greatest personal accomplishment is raising two wonderful children.
When you are not working, where can people find you? Either spending time with my family or relaxing with a good book.
What is your hometown? Canton, OH.
Client satisfaction is pinnacle to your background. What are your client-focused approaches to simpleQuE? I am quick to follow up on any questions and or concerns, I like to pick up the phone and talk to our clients. In this day and age it’s so easy to send off an email, but I have always found that most clients really like to speak to someone personally.
Explain how simpleQuE is different from their competition. Most of our staff and subcontractors have certification body experience which I believe makes a very big difference.
Where is your favorite getaway? I love the beach and one of my favorite vacation spots is Cancun.
How would other people describe you in three words? Ethical, passionate about things that I believe in and caring.
Whether it’s from New York’s George Washington Bridge to multitudes of CVS retail locations or Burger King restaurants around the country, LSI Industries’ high-performance, energy-efficient lighting and image-enhancing graphics are optimizing customers’ brands, products and services. For 40 years, LSI has been proudly serving the commercial, industrial, institutional and specification markets with a broad offering of architectural and professional-grade lighting fixtures utilizing a range of integrated controls and lighting technologies from LED to traditional HID and fluorescent.
LSI is committed to advancing solid-state LED technology to make affordable, high performance, energy-efficient lighting and custom graphic products that bring value to their customers. With a vast offering of innovative solutions for virtually any lighting or graphics application, LSI provides sophisticated lighting and energy management control solutions to help customers manage their energy performance. And in addition, offers a full range of design support, engineering, installation and project management services to customers.
LSI’s major markets include commercial / industrial lighting, entertainment venues, petroleum / convenience stores and multi-site retail facilities (including automobile dealerships, restaurants and national retail accounts). Headquartered in Cincinnati, Ohio, LSI has facilities both there and in seven other states.
Guided by Larry Vance, Jim Bannan and a team of simpleQuE consultants, LSI achieved ISO 9001:2015 certification through Eagle Registrations. Congratulations LSI Lighting!
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”.
SimpleQuE was one of the first consulting companies in the world to become ISO 9001:2015 certified.The transition is simple when utilizing our expert consultants or gap checklist to guide you through the process.
FastTrack your way to success – with our expedited approach to implement the 2015 changes based on lessons we have learned with numerous clients and through historical changes to various standards. Through the FastTrack program your team will develop and complete a clear roadmap in four months (1 day/month for 4 months) and be ready to upgrade your certification in 5 months.(The FastTrack model can be customized and accelerated with your implementation team to meet your timelines.)Click here for more information.
Customized on-site consulting and training – We offer unique quality consulting insights that result in customized solutions. We are known as the consultant that simplifies ISO implementation, transition, training and maintenance, by integrating simple solutions that fit in your company’s culture.We perform a thorough gap analysis to identify what needs to be implemented or changed. With our expertise, we help identify where you’re already in compliance and target only those areas that need work. Part of our job with the gap assessment is to educate you on how you already comply with your current systems. The result of the gap analysis is a thorough action plan of each task that needs to be accomplished. The action plan is laid out against your timing and resources to successfully achieve your upgrade to ISO 9001:2015.
Utilize our ISO 9001:2015 Gap Audit Checklist – Companies that have mature Quality Management Systems and experienced Quality Managers will find this a useful tool to identify the differences between the 2015 standard versus 2008.The checklist can be shared with your certification body as evidence of internal audits to the new ISO 9001:2015 requirements. The purchase of this gap checklist comes with a free half hour of phone or email consulting. Purchase checklist.
For more information or to obtain a quote for implementation consulting services or training, please call 740-305-0868 or contact us by email.