The 21st century is the century of technology, and all businesses are leaning toward intelligent solutions. From Tesla’s driverless cars to Meta’s augmented reality, businesses are using all colors of technology to give a better user experience.

The cannabis industry is following the same pattern. Because it is a highly regulated industry, using automation to manage all the regulations becomes necessary. Also, from a business perspective, it would make sense to automate all the operational processes as well. Because of these two reasons, both QMS and ERP software in the cannabis industry are gaining popularity.

simpleque shows us how businesses save $16 for every $1 they invest in QMS. Similarly, Genius ERP reports that ERP can also reduce business operational costs by 19%, administrative costs by 15%, and inventory costs by 19%. Therefore, having a QMS and an ERP becomes mandatory for all cannabis businesses.

But if these two systems cannot talk to each other, it becomes difficult to manage. When automating tasks is the primary objective of these solutions, a dual-entry process does not make sense. A strong integration between your QMS and ERP is the solution.

Dutchie POS and Isolocity are the leading platforms in the cannabis industry, and our teams have worked tirelessly over the past few months to build a seamless integration. Marimed was able to prove the product’s success by using it to achieve GMP certification in December 2022.

Brandon Basham

It gives us immense pleasure to say that this integration is live and ready for you to start using it today.

What is Isolocity?

Isolocity is a QMS that helps automate quality processes, procedures, and responsibilities throughout your operation while ensuring you remain compliant.

Isolocity offers a streamlined approach to quality processes, including:

  • CAPA and Deviation Reporting
  • Complaint Handling
  • Supplier Quality 
  • Document Management & Change Management
  • Training and Risk Management
  • Equipment and Inspection Management
  • Free SOP Templates

What is the Dutchie POS?

Dutchie POS is a cannabis ERP solution used to manage your operations and ensure compliance. ERP solutions are typically designed to automate processes related to the supply chain and manufacturing functions.

Dutchie POS provides users with point of sale, cultivation, processing, wholesale and distribution, and e-commerce modules.

Although QMS and ERP systems offer different functionalities, both are crucial for optimizing your operations. A QMS automates quality processes throughout your organization. An ERP manages data within the supply chain and manufacturing process.

How does this integration help businesses?

By activating the Isolocity and Dutchie Point of Sale integration, all overlapping data points will sync between the two systems, including products, vendors, inventory levels, and more. You will be able to rely on a single source of truth across your software stack. The integrity of your quality system will see big improvements. 

DUTCHIE POS AND ISOLOCITY QMS

How to set up this integration?

If you are already an Isolocity user, this integration takes minutes to activate, just contact support@isolocity.com to get started. To get started with Isolocity, contact sales@isolocity.com. Our intuitive software simplifies the onboarding process by taking you from novice to expert in 4 30-minute live training sessions. 

With Isolocity you will get:

  • A complete GMP-Validated Software
  • No activation or implementation fees
  • Unlimited training and support
  • Affordable & transparent pricing – starting at $199/month
  • Free & unlimited employee-level users
  • 21 CFR Part 11 and SOC 2 Compliance
  • Open API

Schedule your free demo now to see how we can help you.

Original Image Credit: Elevated Signals

Quality management is the system that ensures that products, services, and processes meet customer requirements. It ensures that the quality of a product or service meets customer expectations and requirements. The aim of any quality management system is to deliver products and services that consistently satisfy customers’ expectations by focusing on delivering superior value for money.

But then the question comes: how do we achieve that? What are the building blocks of quality management? In this article, we will be discussing the 4 pillars of quality management, which are essential for any business.

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The 4 pillars of quality management

You will find numerous articles on this subject. Some articles would refer to leadership, customer focus, etc. as pillars; some articles would argue that activities like “act” or “plan,” etc. are pillars of quality management. Even though we do not disagree with these points, because they are universal truths for any concept and any business (e.g., customer focus is always important for any vertical of a business), we thought we would answer this topic from a quality management point of view.

If we talk about the fundamentals of quality management, there are essentially 4 pillars,

  1. Quality Planning
  2. Quality Control
  3. Quality Assurance
  4. Quality Improvement

Let’s discuss this in detail.

Quality planning

Quality planning is the process of setting quality goals and objectives. It’s a critical part of your overall quality management plan, and it helps you create strategies to meet your goals.

The first step in quality planning is determining your company’s vision, mission, and core values. This should be done as early in the process as possible so that you can use them to guide future decisions (like choosing between two competing products).

The next step would be defining quality objectives. That should start with a business plan, the goal of the company, requirements, and development.

Once you’ve identified these, it’s time to move on to setting quality goals for your organization. It’s important that you quantify the same. Here are a few examples:

  1. Increasing customer satisfaction by 10% within two years
  2. Cutting down defects by 50% within three years

Once these goals are set, it’s important for managers across all levels of an organization—from executives down through support staff—to fully understand them so they can be put into practice throughout every department and division within their respective areas of responsibility.

4 pillars of quality management - Pillar 1 - Quality Planning

Quality control

Out of the 4 pillars of quality management, quality control is one of the most important. Quality control is the measurement of quality to ensure that the product or service meets the requirements of the customer. It involves all activities that determine whether or not a product or service conforms to established standards.

Until and unless we have proper control measures, a product cannot meet its quality targets. It is divided into three sections:

  1. Pre-event: The quality process would involve certain checks so that any errors can be minimized during or post-event. This involves checking everything periodically.

  2. During the event: This process involves maintaining output specifications, and defining and resolving errors so that the developed product is of the desired quality.

  3. Post-event: After the event, the process checks for wastage so that it can be minimized in the future, and determines the quality as per the standards by short and long observation.

Once all these processes are complete, it moves on to quality assurance.

4 pillars of quality management - Pillar 2 - Quality Control

 

Quality assurance

Quality assurance is a process to ensure that the product or service meets the customer’s needs and expectations. It involves planning, implementing, and monitoring activities aimed at improving quality. For example:

  • The company has contracts with its customers that specify the parameters for acceptable print jobs.
  • The company has performance standards for individual employees who work on print jobs.
  • The company measures performance based on these parameters and standards to ensure customer satisfaction with its services.

Some of the activities of quality assurance are testing, audits, and understanding if the product is developed as required by the customer. For internal audits, you can hire an iso 9001 consultant.

4 pillars of quality management - Pillar 3 - Quality assurance

 

Quality improvement

Quality management is never a one-time activity. It is a continuous process of improvement in the processes and systems that affect quality. The goal of quality improvement is to eliminate the root causes of problems, reduce rework, increase customer satisfaction, and improve employee motivation. Quality improvements can be made in all areas of your business: products, services, and processes.

The quality improvement department tries to find answers to questions like why there is a gap between performance and expectations and how to minimize it, whether we are headed in the right direction, and if not, what can we do differently? Instead of focusing on one single issue, they look at this holistically and try to improve the quality based on available data, opportunities, and records.

4 pillars of quality management - Pillar 4 - Quality improvement

 

Conclusion

Before we jump into implementing a quality management system, it is imperative that we understand the 4 pillars of quality management. It is important that we evaluate a quality management system or quality management software based on these 4 pillars, i.e. if the system or software will allow strengthening these 4 pillars of quality management.

 

Graph credit: Coggle

 

 

It’s important to understand that becoming an ISO 9001 consultant can be both challenging and rewarding. It takes hard work and dedication to get this designation, but once you’ve done it and become certified in the field, you may find yourself with a lot more options for your career path. 

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Think about why you want to become an ISO 9001 consultant.

When you’re starting a career as an ISO 9001 consultant, it’s important to have a clear sense of your motivations and goals. The first step is to think about what you enjoy doing most in life: Do you feel like you’re good at teamwork? Do you get more satisfaction from individual projects? What are the things that excite or motivate you?

If possible, dig even deeper by asking yourself questions like these:

  • What are my strengths and weaknesses? How do I know this is true about myself?
  • What do my colleagues say about me when they give feedback on my performance at work (or outside of work)?
  • What are my goals for the next five years—my career path—and how does becoming an ISO 9001 consultant align with those goals? Or vice versa: How could getting certified help to achieve one of those goals sooner rather than later?

Find out what is involved in becoming an ISO 9001 consultant.

The ISO 9001 consultant is a professional who advises organizations on how to implement and maintain their ISO 9001 certification.

When working as an internal auditor, you’ll be analyzing the company’s performance against requirements set forth by their standard(s). You might look at areas like employee training levels, quality events, or document control systems to ensure they meet the requirements laid out in the standard.

Complete a degree or diploma in quality management.

If you want to enter the field of quality management, it is essential to complete a degree or diploma in quality management. Here’s what you need to know about your options:

  • The most common undergraduate program is a Bachelor of Science in Quality Management (BSQM). This degree will take four years on average but if you have enough credits from previous education or work experience, you can do it in three years too.
  • If you have already completed an undergraduate program and want to continue your studies, there are Master’s programs available as well. These degrees will require two years of full-time study and often require at least one year of relevant work experience before admission.
  • There are also online degrees available for those who would rather not travel to attend class, though these programs may not be accredited by all employers (something we’ll talk about later).

Once you’ve decided which path best suits your learning style and career goals, it’s time for some coursework! But don’t worry—the courses themselves won’t be too difficult or time-consuming; most programs only require students to complete a total of 15-20 courses over the course of their studies.

Complete your certification as a qualified internal auditor (QIA).

The next step is to complete your QIA certification. This will help you land a job as an ISO 9001 consultant, and it will also give you valuable experience in quality management. As a consultant, your primary responsibility is to audit clients’ quality management systems (QMS). You’ll need to be able to identify problems and make recommendations for improvement, and that means understanding how all the pieces fit together.

Gain experience with at least two successful ISO 9001 implementations.

  • The best way to learn how to be an ISO consultant is by gaining some on-the-job experience and building up your skills in the field. While you can still find clients and take on projects without any experience, it’s always better to have a few successful ISO 9001 implementations under your belt before you start working as a consultant.
  • There are many different variables that come into play when implementing a quality management system, but these vary from company to company depending on their industry and requirements. You need to know both how these systems work in general as well as what makes each one unique so that you can suggest the right solution for each client based on their needs.
  • Know how to communicate effectively with clients in order to ensure their success during implementation.
  • Understand and manage time constraints during implementation projects.

Apply to be an ISO 9001 Lead Implementer through an accredited examination provider.

Once you have your CV and cover letter in order, it’s time to apply for the ISO 9001 Lead Implementer examination. It is important that you attend a course that has accreditation from one of the following organizations:

You may also want to check if the training provider has been approved by the Institution of Engineering and Technology (IET) or the Chartered Quality Institute (CQI). This will ensure that they are providing quality training with an emphasis on best practice implementation. Once you’ve found an accredited training provider, set up a meeting with them so they can help guide you through what is required in order to become certified as a lead implementer.

Consider getting your training and working for an established ISO consulting firm that specializes in ISO 9001 certification and consulting services.

If you are just starting out in the field, consider getting your training from an ISO 9001 training provider.

Also, try to find opportunities to work for companies that have already implemented ISO 9001 or are interested in becoming ISO certified. This will allow you to gain experience working with organizations that are implementing an internal quality management system and helping them meet their goals.

Becoming an ISO 9001 consultant can be a good career, but it will take some work.

Becoming an ISO 9001 consultant can be a good career, but it will take some work. You will have to be patient and committed to your goal. You also need to have the right personality and be flexible while remaining organized.

Conclusion

It’s important to think about why you want to become an ISO 9001 consultant before starting down this path so that you know what types of organizations will be good employers and whether or not they need your services. When looking into schools offering training programs related to ISO certification services, look at their accreditation status as well as how many graduates they’ve produced over time so that they’re credible sources when recommending individuals like yourself who want more information on becoming an ISO 9001 consultant.

 

 

 

 

The scope of a quality management system is one of the most important aspects to consider while implementing it. It helps in deciding what needs to be included and excluded from the quality management system. The scope is defined by identifying the products, services, and processes that are covered by the QMS for achieving the desired results. This article, along with the process of deriving the scope of quality management system also provides a scope of quality management system PDF template (and word doc too). Download the same from here.

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scope-of-quality-management-system      (Scope of quality management system Word template)

scope-of-quality-management-system    (Scope of quality management system PDF template)

How to derive the scope of Quality Management System

What is the scope?

The scope of the quality management system is the boundaries of your business. It is a set of activities, products and services that make up your organization.

 

You need to know what the scope is before you start designing a quality management system for your business because you will use this knowledge when creating policies and procedures for your system.

 

It’s important that everyone in the company understands their role in maintaining their work area so that nothing gets missed or overlooked during regular inspections, which ultimately results in better customer satisfaction rates due to fewer errors being made during production cycles with costly consequences if they aren’t caught early enough!

 

How can we define the scope?

Once you’ve defined your quality management system, it’s time to define your scope. The scope is the boundary for what is considered part of the quality management system and what isn’t. To define it, you need to look at three things:

  • What are our organizational boundaries? For example, does the organization operate in more than one country or state? Are there multiple facilities that make up the company?
  • What do we produce or deliver as a product or service? Do we offer multiple products or services with different characteristics from each other (like a restaurant with different types of menu items)?
  • How much variation can be expected in terms of products/services produced within a reasonable timeframe or period of time (for example, manufacturing automobiles)?

How to derive the scope of Quality Management System

 

Main factors of the scope of quality management system

 

The scope of quality management system is a document that defines the boundaries and limitations of your quality management system. It helps to ensure that you are following best practices and prevents you from wasting time, money and resources trying to meet requirements that have not been identified yet. A good scope will also tell you what is not included in your quality management system so that everyone knows what they can expect from it.

 

A well-defined scope should provide answers to all these questions:

  • What does your company do? Who are its main customers? What are their needs? What kind of operations does it perform? How does this relate back to the overall purpose of the company (e.g., providing excellent customer service)?
  • Why does your organization need a QMS? Are there any regulatory issues that require compliance with specific standards/guidelines for example ISO 9000 series). Do any customers require such control systems as a condition for doing business with them (e.g., some government agencies may require contractors working on projects funded by them).

 

Main factors of the scope

Are all requirements applicable to our organization as per the ISO standard, identifying what is not applicable?

As you begin to gather information about the scope of your quality management system, it’s important to remember that ISO has a lot of requirements. You’ll need to evaluate each requirement carefully and determine its applicability to your organization. It’s also important to identify what is not applicable at this time. For example, if there are specific standards that apply only under certain conditions or in relation to particular types of products or services, those will have no relevance for your organization right now. What’s more is that there may be other requirements that are not relevant because they are not practical or achievable with the resources available within your company (e.g., conducting audits).

Once you’ve identified which requirements are relevant and which ones aren’t, you’ll then want to prioritize them based on their importance for operationally effective quality management systems (i.e., QMSs).

 

Should the internal audit be conducted to ensure that all aspects have been considered and covered or not?

The answer is no. A detailed internal audit is not mandatory, but it is a good practice to perform one.

 

The purpose of conducting an internal audit is to ensure that all aspects have been considered and covered in your quality management system (QMS), which will help you maintain compliance with your own QMS regulations and standards such as ISO 9001:2015, ISO 13485:2016 etc.

 

How should you design your Quality Manual?

The Quality Manual is a document that provides in-depth information on how the QMS functions. It should be:

  • Your manual should cover all aspects of your QMS, from top to bottom. This includes procedures and records related to all areas of your operations, as well as internal audits and quality audits.
  • Completely up to date. The manual should reflect any changes you’ve made since its last update—whether it’s new equipment or processes, new staff members or training programs—anything that has significantly changed how you operate should be reflected there with an explanation of what was changed and why it was necessary for the company’s quality improvement process.
  • Easy to read and understand by anyone who needs access to it (employees).

Quality Manual Design

What should be included in the Procedure Manual?

The Procedure Manual should be used by employees to help them do their job. It should include the following:

  • An explanation of the Quality Management System (QMS) and how it works, including any relevant standards and regulations that apply
  • A list of quality management documents, including QMS policies, procedures and work instructions (WIs)
  • A list of any quality-related documents that are referenced in your SOPs for easy access

Procedure Manual Design

 

Conclusion

The scope of quality management system is a very important part of the entire process. It helps in identifying and understanding what is required to be included in the Quality Management System. We hope the scope of quality management system PDF and word template will help you design the document. For any doubt, feel free to reach out to us.

 

Template original source credit: stakeholdermap.com

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Today our article topic is a little different. We have observed that many quality management students from various universities across the world visit our website. We try to provide knowledge and information through our quality management blog section which we believe is beneficial to everyone, be it quality management professionals or students. However, in this article, we have jotted down the top 10 quality management questions and answers that most quality management students come across and get puzzled by.

1. A successful quality strategy features which of the following elements?

  • An organizational culture that fosters quality
  • An understanding of the principles of quality
  • Engaging employees in the necessary activities to implement quality
  • 1st and third option
  • 1st, 2nd and third option

The correct answer is “1st, 2nd and third option”

A successful quality strategy features which of the following elements

2. Which of the following is not an element of TQM?

  • Continuous improvement
  • Competitive benchmarking
  • Employee empowerment
  • Team approach
  • Quality management as a specialized function within the firm

The correct answer is “Quality management as a specialized function within the firm”

Which of the following is not an element of TQM

3. Which of the following is not a manager quality?

  • Maintains stability
  • Organizes
  • Analyzes
  • Rational
  • Personal power

The correct answer is “Personal power”

Which of the following is not a manager quality

4. Who has primary responsibility for assuring product or service quality?

  • Contractor
  • Contracting officer
  • Requesting office
  • Government
  • Quality assurance representative

The correct answer is “Contracting officer”

Who has primary responsibility for assuring product or service quality

5. A distinguishing feature of the total quality management approach is

  • Attention to rewards
  • Development of problem solving skills
  • The improvement of processes
  • Training

The correct answer is “The improvement of processes”

A distinguishing feature of the total quality management approach is

 

6. Which resource management task determines the type, quantity, receiving location, and users of resources?

  • Identify Requirements
  • Track and Report
  • Order and Acquire
  • Mobilize

The correct answer is “Identify Requirements”

Which resource management task determines the type, quantity, receiving location, and users of resources

7. A _____ is a tool used in quality management.

  • Probability Metrics
  • Checklist
  • Critical Path Analysis
  • Request for Proposal

The correct answer is “Checklist”

A _____ is a tool used in quality management.

8. Which of the following best describes total quality management?

  • The process by which a company analyzes a competitor’s products to identify desirable improvements
  • The principle that quality belongs to each person who creates it while performing a job
  • The sum of all activities involved in getting high-quality products into the marketplace
  • The consistency of a product’s quality from unit to unit

The correct answer is “The sum of all activities involved in getting high-quality products into the marketplace”

Which of the following best describes total quality management

9. What quality assurance activity is a purchasing manager responsible for?

  • Inspecting the quality of goods received from a supplier
  • Ensuring that the product design process includes high-quality materials
  • Overseeing the daily operations of suppliers to ensure their compliance with quality standards
  • Responding to service calls from customers whose products have quality issues

The correct answer is “Inspecting the quality of goods received from a supplier”

What quality assurance activity is a purchasing manager responsible for

10. What are the cost types in modern quality management?

  • Costs of good quality – costs of bad quality
  • Planning costs – assurance costs – control costs
  • Planning costs – doing costs – checking costs – acting costs
  • Prevention costs – appraisal costs – failure costs

The correct answer is “Prevention costs – appraisal costs – failure costs”

What are the cost types in modern quality management

 

We hope all these questions and answers will help all quality management students. We also encourage all to subscribe to our newsletter. For any doubt or comment, feel free to reach out to us here.

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ISO 9001 section 8.4 is related to supplier management and it’s one of the most important sections in the ISO 9001 standard.

ISO 9001:2015 has brought in a lot of changes and supplier management is one of them. Gone are those days when it used to be only a list of suppliers. ISO 9001 section 8.4 focuses on controlling processes, products, or Services that are provided by an external party, i.e. supplier.

Having a proper process for your supplier is essential for your business and therefore this section is critical to companies that want to have a sound quality management system in place.

ISO 9001 section 8.4.1 – Qualifying a potential supplier

Who is a supplier

A supplier is anyone from whom your organization receives goods or services. This includes every individual, business, and other entity that provides material, equipment, or labor to your company.

Who is a potential supplier?

Any company that has the potential of providing goods and services for your organization should be considered as a potential supplier regardless of whether they have been contacted by you or not.

How to qualify a potential supplier?

The first step is to set some parameters for filtering potential suppliers. You can use the following parameters for the same,

 

Criteria for shortlisting potential suppliers

  1. Legality – Do they abide by all the legal requirements for this job?
  2. Capability– Do they have the resources you will require, both human and equipment?
  3. Nature – Are they responsive to your requirements? Extra points for being environmentally friendly.
  4. Quality – And most importantly, do they have the proper quality standards?

If you use this filter, you will be able to get the list of your potential suppliers. Now you will have to use the last 3 filters to finalize your supplier.

 

Criteria for finalizing your supplier among all potential suppliers

  1. Price – How competitive their cost is, does it fit in your budget? Is it value for money?
  2. Delivery Time – Delivery time can be crucial for some companies. So you would want to get clarity on this and make sure it is aligned with your objectives.
  3. Reputation – You would want to hire a supplier who has a good reputation in the market.

Qualifying-a-potential-supplier

 

ISO 9001 section 8.4.2 – Controls for Suppliers

This section is really important because it helps you to make sure that the products and services you get from your suppliers are consistently good quality, reliable, and fit for purpose.

This section focused on implementing proper control measures for your suppliers.  The first step is to decide the parameters you would want to measure and then define a measurement as well. It should be well-defined without any vague words. For e.g. for conformance, you can keep a specific certificate or third-party test result as your control measure. You can also have control measures on delivery, specifications, etc.

In Isolocity we have a provision for keeping track of certain control measures.

ISO-9001-Section-8.4.2

 

ISO 9001 section 8.4.3- Communication with Suppliers

Supplier communication is an important part of the ISO 9001 process. Suppliers can be a great resource for your company, so it’s important to maintain good relationships with them. But at the same time, you would want to get the best quality product or service from them. Therefore to be on the same page, you need to have a proper communication process and that process ideally should be documented, else if the supplier screws up and the control measures are not documented anywhere, it’s on you.

Most companies include these in the contract, agreements, work orders, or purchase orders but other communication methods are also okay provided they are documented well. To understand if control measures are met, you can also ask them to share statements of works and test plans. You can also go to their facilities for an audit.

Benefits of ISO 9001 section 8.4

Once you implement all subclauses of ISO 9001 Section 8.4, you will have the following advantages

  1. You will have a number of trusted suppliers and will have less room for surprises
  2. Because of all control measures, the degree of error will be less resulting in superior quality products/services
  3. In case things go south because you have everything documented, you will be able to safeguard yourself and your company from any financial or legal trouble.

Conclusion

We hope you have enjoyed reading this article on ISO 9001 section 8.4. If you have any questions, feel free to reach out to us here.

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Quality management services are a vital part of any business. It helps in ensuring that your products, services, and processes are up to the mark and meet the standards.

If you are a new professional in the quality management vertical, we would suggest some books for you. We understand reading all of them might not be feasible for you, but the more the merrier.

  1. The Quality Toolbox, by Nancy R. Tague
  2. Juran’s Quality Handbook: The Complete Guide to Performance Excellence
  3. Quality Audits for Improved Performance

Quality-Management-Books

Identify the right vendor for quality management services

Finding the right vendor for your quality management services might be tricky. It’s a long-term investment and therefore you need to be careful.

First of all, you need to shortlist 4-5 vendors. For e.g. if you are shortlisting Isolocity, we recommend shortlisting 3-4 more vendors.

we understand you would have your own process to do that and we are not going to comment on that. But once you have shortlisted 4-5 vendors and have done your initial research, you might get overwhelmed with the amount of information you would get from them. All of them will have some USPs and at a time you might think you need all of those features.

No need to get confused, we have already written a detailed blog on this topic where we have discussed some critical points for finalizing a vendor for your quality management services, you might want to check that – Quality management solutions – 3 factors to consider.

Irrespective of whether those vendors mention it or not, most of them will give you a free trial period. During this time,

  • Conduct an audit of their systems and processes
  • Evaluate the results
  • Get an understanding of their customer support, this is going to be very important for you

Establish clear monitoring and measuring criteria

Once you have finalized the vendor for your quality management services, your next priority should be setting all the criteria.

Monitoring and measuring criteria are critical in quality management services. Monitoring means keeping track of the performance of the product or service over time to ensure its improvement or maintenance while measuring is about quantifying progress in terms of specific results.

For example, you may have a criterion for measuring customer satisfaction levels at each stage of your client’s journey with your company by asking them to rate their experience on a scale from 1-5 (1 being highly dissatisfied, 5 being highly satisfied). You should also define any other metrics that help you decide whether the project was successful or not.

The most important thing about defining clear monitoring and measuring criteria is that it should be done based on problem areas within your organization or process flow where changes are needed most urgently.

For example, if there have been few complaints made about an aspect of our business then this could mean that we don’t need much improvement there; however, if our clients complain frequently then there’s definitely room for change as well as an improvement!

Define the problem areas of quality management services clearly

The first step in quality management is to identify the problem areas. This involves looking at your processes and identifying where they can be improved.

Understand the problem areas. Once you’ve identified the problem areas, it’s important to understand why these issues exist and what caused them in the first place.

Select a few aspects of quality management that need immediate attention

When you’re starting out, it can be hard to know which issues are the most important. This is why it’s crucial to start by prioritizing the things that need immediate attention.

While there are many aspects of quality management services that should be considered before hiring a consultant (and these factors will vary depending on your needs), here are some examples of things that might be considered when working with a consultant:

  • How much time do you have? If your project has a deadline and you need help right away, then finding someone who can work quickly may be more important than finding someone who knows everything about quality management services.
  • What kind of budget do you have? If money isn’t an issue for your project, then perhaps it makes sense to hire someone with extensive experience and qualifications from day one. However, if cost is an issue—such as if this is just for internal use—then maybe a cheaper alternative will work just fine for now until funds become available later on down the line when more resources are available for more complex projects later down the line!

Set some achievable goals and objectives which are time bound in nature

Before you start, it is important to set some achievable goals and objectives which are time bound in nature. All the activities in project management are done with the purpose of achieving certain goals. These goals should be realistic and measurable so that they can be achieved within a specific time period.

One should not compare his/her goals with those of others because no two people have the same situation or circumstances so there is no point in copying someone else’s goal-setting strategy.

Conclusion

It is important to work with a quality management service provider who can help you address the issues and make your business processes more effective. The first step is to identify a good quality management service provider, who can help you achieve your set targets.

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Quality event management systems (QEM systems) are essential to ensure that products coming out of your facility are safe and effective, and they also help you identify opportunities for improvement. However, many companies mistake these systems for purely paperwork exercises. In reality, QEM is a data-driven approach that utilizes statistical analysis to understand what works in your manufacturing processes and what doesn’t—all while keeping an eye on critical quality issues such as CAPA (corrective and preventive actions).

Quality event management system (QEM Systems)

Quality event management systems (QEM systems) help companies manage quality events. They’re an important part of the corrective and preventive actions (CAPA) process, contributing to an organization’s ability to identify and reduce risk. A CAPA approach involves identifying the root cause of problems through a systematic analysis, taking action based on that analysis, then evaluating whether those actions were effective.

From this perspective, it can be helpful to think about QEM systems as the “cause” in a CAPA framework: they allow you not just to track and document your quality issues after they happen but also provide tools for analyzing them in order to prevent similar issues from occurring again in future products or services.

capa-v1

Qualification and validation

If you’re in charge of a company that needs to comply with regulations, then you’ll want to make sure that your quality event management system is up to snuff. QEM systems are an essential part of any CAPA plan and help you track your products from beginning to end. If a quality event occurs, you can use the QEM system’s reporting tools to collect information about it and determine how best to correct or prevent it from happening again.

It may seem intimidating at first but once you organize all your documentation, there are many benefits that come along with using a CAPA plan:

How does CAPA connect to QEM systems?

CAPA is a system for managing the process of identifying, evaluating, and correcting problems in a product or process. It’s a key part of quality management systems and is not a one-and-done process. You can’t just fix your issues once and then walk away feeling satisfied with yourself. CAPA is an ongoing effort to continuously improve your organization’s performance, quality, and safety. To keep those improvements happening, you need to keep improving your QMS as well!

Not a one-and-done process

CAPA is a continual process and not a one-and-done process. In other words, it’s not about fixing an issue once and then moving on to the next thing. Instead, it’s about identifying problems in your business so that you can fix them before they become bigger problems.

It’s also important to remember that CAPAs don’t just happen during a crisis. They’re something that should be done at regular intervals (like every quarter) so that you can identify potential issues before they become full-blown problems.

QEM systems can greatly streamline the CAPA processes

Quality event management systems (QEM systems) are used to manage quality events, which are issues that occur at any point in the production process. The CAPA process is a way of identifying, analyzing, and fixing problems. Once a problem has been identified and fixed, it can be determined whether to continue using the same method or change course completely by implementing corrective actions.

This process creates a culture of quality where employees know that the management respects, appreciates, and values their work. This helps prevent future errors from occurring because employees take pride in their work and want to do everything possible not only for their own benefit but also for the good of their organization as well as those around them who may rely on its services or products down the road.

Conclusion

These terms may seem complicated, but they’re just a part of any good QEM system. By creating a quality event management system that incorporates CAPA and qualification and validation, you can streamline your process for managing errors and mistakes at events. You can also reduce the risks that these errors might cause by using CAPA to prevent them from happening in the first place. While these systems are not perfect—they do take time to implement—they offer an extremely valuable service if used correctly.

 

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What is Minimum Automotive Quality Management System Requirements for Sub-Tier Suppliers (MAQMSR)?

If you are wondering why you need Minimum Automotive Quality Management System Requirements for Sub-Tier Suppliers (MAQMSR) and how it helps, this is the article you want to read.

Getting IATF 16949 certification is not easy. Especially when you are new to the business and don’t even have ISO 9001:2015. As per the standard process, suppliers have to meet IATF 16949:2016 requirements in order to register. For small companies (low-tier suppliers) that don’t have that much time or resources, it becomes a bottleneck. Also remember IATF 16949:2016 is not a standalone quality management standard, therefore the supplier will have to meet ISO 9001:2015 too.

That is where Minimum Automotive Quality Management System Requirements for Sub-Tier Suppliers (MAQMSR) comes into the picture. MAQMSR is an interim step towards IATF 16949:2016 certification but with MAQMSR the supplier can register. So The supplier will eventually need to meet IATF 16949:2016 requirements anyway but while meeting that, the supplier will be able to register too. The entire requirement can be seen here as published by IATF.

What are the steps of IATF 16949:2016 with the interim step of Minimum Automotive Quality Management System Requirements for Sub-Tier Suppliers (MAQMSR)?

There are mainly four steps, which are

  1. ISO 9001:2015 certification through 3rd party audits – If you already have ISO 9001:2015 certification, you can skip this step, or else you will have to meet this. We recommend using quality management software for this which will make your process a lot smoother and more efficient. For e.g. you might need to show your audit trail, with a QMS in place, it’s just a click away. If you think you can’t bear the cost, a QMS doesn’t cost much considering the value it brings. For e.g. Isolocity QMS costs only $199/month/admin user and if you want to add a production user, you just have to pay another $29/production user/month. That’s it, no activation fee, no SOP fee, no training fee, and no hidden fee. Talk to us to know more.
  2. ISO 9001:2015 certification + compliance to Minimum Automotive Quality Management System Requirements for Sub-Tier Suppliers through 2nd party audits – If you manage to clear this step, you will be able to register. It works on the principles of ISO 9001:2015 itself and 46 clauses and sub-clauses. All details can be found here.
  3. ISO 9001:2015 certification + compliance to IATF 16949® through 2nd party audits – This is the initiation of  IATF certification. Isolocity can help you here too as our software is IATF 16949 compliant.
  4. IATF 16949® certification through third-party audits with a Certification Body – This is the final step towards IATF certification. For the third-party audit, you need to make sure you have a document management system in place, make sure your system is effective, and follow all the processes with the proper control measures.

ISO 9001 vs MAQMSR vs IATF 6949 Clauses

Though MAQMSR and IATF are developed on the fundamentals of ISO 9001:2015, they all have their individual clauses which are to be fulfilled. ISO 9001:2015 has around 66 clauses and sub-clauses where as MAQMSR has another 46 clauses and subclasses. For IATF the number of clauses are 107 including clauses for MAQMSR.

Minimum-Automotive-Quality-Management-System-Requirements-for-Sub-Tier-Suppliers(MAQMSR)-vs-IATF-vs-ISO-9001

Conclusion

Before you start planning for your MAQMSR, you should always ask your customer and only proceed if they nod. If you need any help, feel free to get in touch with us. For more clarity on pricing, check our dynamic calculator.

Snapshot of MJBizCon 2022

If you are a cannabis industry enthusiast, you would know about MJBizCon, one of the largest (and oldest too) cannabis business tradeshows in the world. The economic turmoil in the USA and the world could not stop 1400+ exhibitors from attending the MJBizCon 2022 in Las Vegas. When they entered the tradeshow, they were up for a shock as they had never seen such a big expo in the 11-year history of MJBizcon, spanning 280,000 square feet on two floors in Las Vegas Convention Center’s South Hall.

MJBizCon 2022 Highlights

This year we have seen many ups and downs in the cannabis industry. For e.g. New countries like Germany entering the legalization process of medical and recreational cannabis is a major event. Similarly, New York giving adult-use conditional cannabis licenses to cultivators, processors, and retailers is also a positive move. In contrast, the drop in wholesale cannabis prices has impacted the cannabis industry. As a result, like other industries, we have also observed many cannabis companies implementing cost-cutting measures.

In a time like this, MJBizCon is definitely a breath of fresh air. Moreover from a business perspective, setting up international trade partnerships is the foundation of scaling up a business, which is why businesses from across the world attended MJBizCon 2022.

This year Isolocity was fortunate enough to participate in MJBizCon 2022 tradeshow. In brief, MJBizCon 2022  was an action-packed event for Isolocity.

The floor space was mainly divided into four parts,

  1. Cultivators
  2. Processors, Labs, and distributors
  3. Retailers
  4. Other business services

Many speakers delivered interesting talks about various aspects of the cannabis industry. But Dr. Bernhard Babel’s talk on German Legalization was enlightening and stood out. He provided some insights on what the German producers are preparing for with the pending recreational market.

MJBiz CEO Chris Walsh talk on “State of the Industry and Predictions for 2023” was also intriguing. Chris warned about the possible growth of the New York illicit cannabis market after the Adult-use cannabis launch. He also touched on the topic of Canadian cannabis and said that the Canadian cannabis inventory will see a spike in 2023 but might fall in 2024.

MJBizCon 2022 – Isolocity Highlights

We were excited to meet some of our existing clients, partners, and friends. First, we met our client Xtra Labs, who recently achieved ISO 9001 certification using Isolocity.

The first annual partner meeting by Elevated Signals was fun where industry experts exchanged ideas on the evolution of the cannabis industry.

Elevated-Signals-AGM

Isolocity sponsored a great event at Top Golf with our partners over at ATG Pharma. During this event, we were reminded that like quality standards, safety standards exist for very specific reasons.

TopGolf

It was a pleasure to meet some of our Australian clients in person for the first time. Big congratulations to Green Farmers on their acquisition of Apollogreen.

Green-Farmers

Look out for our MJBizCon interview with Dutchie where we discussed our integration with their track and trace system – those slippers are like gold at the end of a busy week!

The week was topped off with a great dinner with ASTM, a group full of compliance enthusiasts.

ASTM-Dinner

We loved every bit of MJBizCon 2022, especially meeting clients and partners face to face is always nice. We look forward to another productive MJBizCon next year.