Congratulations to Vinmar on their recommendation for ISO 9001:2015 certification as applicable to the provision of services for logistics, transportation, packaging, distribution, and storage of products via air, sea and land. Visit http://www.vinmar.com/ to learn more about their services.
Most people visit our Texas State Capital, the beautiful city of Austin for parting. We took training on the road. Two days exploring the latest editions of IATF 16949:2016 was almost as entertaining as the sights on Austin's famous 6th Street!
Feedback from the class included:
“Learned about the key points important to IATF that are not as key to ISO 9001. I had fun with the details of the cars – what is needed to fulfill the specified function of the car. The workshop was long but very informative. Moved at a good pace. Day 1 worksheets were good to reinforce the lessons learned.”
“Everything ties to our core processes defined in our context. Had fun when the Quality System team had mapped the same (almost) core processes on Day 1. The workshop was thought provoking on improvement activities; the experience was an introduction to IATF (no prior formal training on IATF 16949) and how to gauge effort needed to implement IATF 16949.”
“Learned a variety of IATF requirements. Clarified the ‘layout’ of the standard in such a way that it made more sense and became more understandable. Epiphany re: product roadmap applicability to product improvement requirement. Workshop – extensive information while remaining interesting and engaging; a level of clarity for both ISO 9001 and IATF that I had not had before.”
“Good re-training of ISO 9001:2015. Good explanation of IATF 16494 requirements. Instructor is very well versed on the standards. For improvement: IATF Standard access was interrupted, perhaps due to Wi-Fi connection. Suggest for instructor to have a downloaded copy.”
“I learned which procedures I need to update to meet requirements. Had fun listening to new requirements; listening to software guys – typical response upon learning ISO requirements. Good hands-on experience from consultant. Ability to apply common sense to standard requirements. Better understanding of IATF requirements. Understanding of which procedures / requirements need to be updated.”
“I learned the details of IATF 16949 and reasoning behind changes to the standards. I had fun discussing detailed applications of the standards and engaging in dialogue with team and Mark. Workshop experience was well-paced, informative, well prepared and productive.”
Participants at our Internal Auditor class did a great job applying their knowledge and understanding of the ISO 9001:2015 Standard to auditing a live ISO 9001:2015 certified Business Management System.
Comments from the class included:
“I learned that some clauses can be identified / cross path with another during the audit process. I had fun when we identified the internal audit steps as a group.”
“I learned the ISO 9001:2015 standard. I had fun setting the dancing feet with the steps in planning an audit. Actually doing a mock audit helped to understand the standard much better. I learned a great deal in the workshop. Thank you.”
“I learned to audit from processes, rather than the standard. No more audit checklists. The training was fun and enjoyable.”
“I learned that time management is essential to auditing and you should have an audit plan prior to the audit. I had fun having group discussions; gives me an opportunity to learn from others.”
Congratulations to Energy Freight Systems for being recommended for ISO 9001:2015 certification, as related to the provision of international transportation services, including ocean freight, air freight, inland freight, warehousing and packing and crating.
This ISO 9001:2015 certification effort included both Energy Freight Systems’ warehouse location in Houston TX, as well as their corporate headquarters in Miami FL. The resulting certification was achieved in just under 5 months.
Founded in 2001, Energy Freight Systems (EFS) is a leading provider of high quality international transportation solutions and services. Learn more about their products and services at http://www.energyfreight.com/.
Congratulations to Zachry Engineering Corp. for being recommended for ISO 9001:2015 certification. Learn more about their products and services at https://www.zachrygroup.com.
ISO 9001 - Planning of Changes (6.3)
ISO 9001:2015, clause 6.3 requires that “when the organization determines the need for changes to the quality management system, the changes shall be carried out in a planned manner (see 4.4)”.
What Does This Mean?
To fully understand this requirement of ISO 9001:2015, let’s first begin with the literal definitions of the key word(s) used. Almost all of the wording used in the ISO 9001:2015 standard is purposeful, with very specific intention.
How Does This Apply?
Next, let’s clarify the application of this requirement, by looking to ISO 9001:2015, clause 4.4, Quality management system and its processes. This particular clause of ISO 9001:2015 requires the organization to determine the processes needed for the quality management system, as well as their sequence and interaction, the inputs required, outputs expected, monitoring and measurement, responsibilities, resources, etc.
Stated in Different Terms
Finally, with both definitions and application established, let’s completely reword this requirement of ISO 9001:2015 as follows:
When the organization ascertains or establishes the need to alter the form, nature, content or future course of the quality management system, its processes, required inputs or desired outputs, resources, or responsibilities, etc., the organization shall establish and organize those activities required.
This requirement of ISO 9001:2015 is intended to address those changes which may have a direct impact on Quality Management System, or the subsequent achievement of its specified outcomes. In the practical application of this requirement, we can use to the Plan-Do-Check-Act model, which is referred to throughout this standard:
Typically, when we’re talking about the planning of changes at a management systems level, we don’t consider those day-to-day changes related to contractual amendments, engineering changes, purchasing modifications, product deviations, alterations or changes to other work-specific deliverables and outputs, which would be considered a normal part of operations and more appropriately, covered under other requirements.
Is documented information required for the planning of changes? Typically, when the words “determined” and “planned” are used in ISO 9001:2015, I’d consider this to be implied. Without objective evidence being retained, there’s no proof that any of the above has actually occurred.
Note also, that not all alterations, modifications or adjustments to a management system require the planning of change. Examples of this could include changing line employees, replacing worn equipment, replenishing inventory, editorial revisions to documents, etc. In most cases, these types of changes can be considered substitutions.
The intent of the change process should not be to prevent anyone from taking immediate steps to protect the health and safety of employees, the environment, company or customer property, etc. during an emergency or unplanned event. However, any changes made under such circumstances should be immediately followed up with an appropriate evaluation once the emergency situation has been resolved.
Scope statement examples for ISO 9001:2015
ISO 9001:2015 requires an organization to determine the boundaries and applicability of its quality management system (QMS). This determination lays the framework for establishing the organization’s scope, which is then required by ISO 9001 to be maintained as documented information.
When determine an organization’s scope, ISO 9001:2015 (4.3) requires that consideration must be given to:
1. the internal and external factors referred to in 4.1;
2. the requirements of relevant interested parties referred to in 4.2;
3. the Products and Services of the organization.
What does this mean? The following are a few examples of scope statements, in this case detailing a fictitious company (XYZ) that provides machine shop services. While the XYZ company is fictional, these are actual examples of scope statements we’ve encountered, just slightly edited for illustrative purposes and to make this example:
Machine Shop Example #1 (Worst Example): “We are a machine shop.”
Commentary: required items #1 and #2 in ISO 9001 (4.3) are not addressed, and item #3 could be much, much better described with regards to the products and services the organization provides.
Machine Shop Example #2 (Slightly Less-Worse Example): “We are an industry-leading provider of machine shop services.”
Commentary: required items #1, #2 in ISO 9001 (4.3) are still not addressed, and item #3 could still be much better defined. Stating the you are an “industry leading provider” is not scope-related, and these types of adjectives and adverbs should be saved for marketing materials. At this point, you’re trying to explain the boundaries and applicability of the management system, not position yourself to make a sale.
Machine Shop Example #3 (Slightly Better Example): “Company XYZ specializes in the precision machining of components for use in the automotive industry.”
Commentary: This statement is somewhat better than previous examples. This version of the scope statement covers the products and services of the organization and refers to, albeit in a very limited manner, the relevant interested parties and their requirements.
Machine Shop Example #4 (Even Better Example): “Located in Houston TX, Company XYZ is a high-volume machine shop that specializes in the precision machining of aftermarket aluminum brake, steering and suspension components, in accordance with OEM specifications and government regulations, for use in the automotive industry.”
Commentary: Now we’re starting to make some real progress. There is still more polishing to be done, but now this statement is coming closer to addressing all requirements. It likely won’t be possible to address every internal and external factor, every interested party and every product in your scope statement, but at least an attempt should be made to summarize these different considerations.
When creating your scope statement, bear in mind that this requirement of ISO 9001:2015 requires you to define the scope of your quality management system, not the scope of your ISO 9001 certification. ISO 9001 certificates also have their own scope statement, which is determined along with your certifying body, if one is used.
Note again, the scope of the quality management system is required by ISO 9001:2015 to be maintained as documented information. It is one of three requirements prescribed by the standard (scope, quality objectives, and quality policy), whereas most other requirements to maintain documented information are “as necessary”. Also, keep in mind that per ISO 9001, this information must also be made available to interested parties.
We delved deep into Context in our ISO 9001 Basics class today. With the organization's context and key processes determined, the rest of the clauses of the ISO 9001:2015 have meaning and a practical application.
Feedback from participants included the following:
“Learned about items needed for 2015. Had fun during activities. I really enjoyed the class today. It was a lot of information in a short period of time.”
“Learned about risk-based thinking, how it should be monitored and measured. Had fun in the ‘Listen and build with the clay’. The workshop experience was excellent and very educational.”
“Learned the changes to the new standard. The whole course was enjoyable.”
“Learned all the new requirements, main changes and what to watch out for. Had fun in the review. On packets, the blank page could be lined for notes.”
“I learned it’s all about ‘context’ and the new standard focuses on top management. I had fun playing games and group exercises.”
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