ISO 9001:2015 Training in just 1 day!!

ISO 9001:2008 

TO 

ISO 9001:2015 

in 

just 1 day!! 

                             

                                 Course Title

TRANSITIONING from ISO 9001:2008 to ISO 9001:2015

INCLUDING FREE TRANSFORMER SOFTWARE TO

HELP AUTOMATE THE TRANSITION

Synopsis: 

All requirements of ISO 9001:2008 are intact. Significant net additions. Big difference in structure and presentation. Learn how to make a smooth, 

painless and profitable transition.

Module 1: What is in the New Standard: It’s all good!!

• Background and logic behind the Upgrade
• Highlights of the changes- explains the theme of the new one
• QIA’s LAB method of interpreting the standard
• Explanation of the New Standard from a transition point of view
• Strategy for Planning the transition

Module 2: Relating ISO 9001:2015 to 2008

• The two standards side by side
• Where is 2015 in 2008
• Net additions to 2008, and how to handle them
• Documentation needed

Module 3: Assured Transition

• Clause by Clause planning of new documented system:
  • Determining what is right for your QMS
  • Policies/ Procedures/ Work Instructions/ Quality Manual
  • What to keep from your old QMS
  • Renumbering to the new structure
• Building a transition project plan
• What to expect in an audit
• Re-numbering to the new ISO 9001:2015 standard
• Training employees on ISO 9001:2015

Module 4: Workshop and Quizzes

• Find the 2008 Requirements in ISO 9001:2015
• Check your level of understanding of the ISO 9001:2015 Requirements
• In-class exercise on building your new system
• Review some tools for implementing ISO 9001:2015

PARTICIPANTS WILL RECEIVE

• Certificate and Presentation Material

• **FREE TRANSITION SOFTWARE

  • Upon completion of the training course check out our TRANSFORMER brand Transition Software:

    1. Risk Assessment with Risk database Knowledge Management Module
    2. Root Cause Analysis Module
    3. Local Prevention Module
    4. Automated Document Converter
    5. Knowledge Management Module



• **Each participant can choose one module from #s 1,2,3,4,5. 
  They will have one year worth of free Software as a Service (SaaS). 
  Four attendees from same company can walk off with 80% of the entire TRANSFORMER Software.

  
  
  
  GRADUATES WILL RECEIVE
  FULLY EQUIPPED IMPLEMENTATION TOOLKIT
  
  
  Reference / Presentation Material / Transition Check Lists / Transition Plan
  3 month period for free advice about course topics
• 
  
  
  WHO SHOULD ATTEND
  QA/QC Managers
  ISO Coordinators
  QMS Consultants
  Manufacturing/Process/Reliability Engineers
  Operations & Management Reps

Tuesday, April 12th, 2016

8:30 a.m. - 4:30 p.m.


COST: $490.00 / STUDENT ($50 OFF EACH SEAT ABOVE 3 STUDENTS)
QIA CLIENTS : $440 / STUDENTS ($50 OFF EACH SEAT ABOVE 3 STUDENTS)

Location 

Double-Tree by Hilton Hotel Houston Hobby Airport 8181 Airport Blvd, Houston, TX 77061 

REGISTER NOW!!

CLICK HERE

Student Testimonials

"I would definitely recommend the course to anyone who needs to quickly learn how to understand, transition, and implement to the new standard."

Jennifer Ishee, Sulzer Pumps

"Quality Institute of America (QIA) has given my company the tools and strategies I will need to move forward with transitioning to the new ISO 2015 standard - with confidence!"

Patricia Shepherd, Pemex

"It's the instructors that make the difference--- with their decades of experience in running manufacturing, quality and then consulting, and auditing."

J. R. Kuzniar, Eagle Burgmann

---

INSTRUCTORS

Wali Alam (Lead)

Wali is a degreed engineer with 22 years of leadership experience in manufacturing that included leadership roles in manufacturing engineering, manufacturing, supply-chain, and quality systems. He has spent an additional 23 years working continuously as a certification auditor, consultant, and trainer in North America, UK and Asia. He was one of the first Registered Lead auditors in the USA. Wali is well regarded in the Quality profession and enjoyed major leadership roles in the American Society for Quality. He has spoken several times at Quality conferences, and is a featured speaker at the International Conference on Standards, Indianapolis, Nov 9-10.

Michael Prior

Michael is a Certified Quality Auditor and has a Bachelor of Science from Texas State University. Michael has over 25 years of corporate experience in Fortune 100 companies. He has published several articles related to ISO 9001-2008 and 9001-2015. He is a practicing auditor and professional speaker, and has instructed QMS courses both in industrial and college settings.

Quality Management System Audit

Quality Management Systems Audit

An audit is a systematic evaluation of objective data to determine the level of fulfillment of some predetermined criteria. We conduct assessments (audits) of existing quality systems to determine compliance or degree of compliance with the appropriate ISO 9000 based standard. Examples would be ISO 9001, AS9100, TS16949, TL9000, API-Q1, ISO 13485, ISO 14001, OHSAS 18001, or other standard of the client’s choice. This assessment will be led or performed by fully trained Assessors. The following services are offered:

• Gap Analysis: This is performed on a varying level of comprehensiveness, starting with the lowest level, which would be a survey, to a high level of detail to find minute nonconformities. A gap analysis is typically conducted as first step to designing a system.
• Pre-assessment Audit: this is an audit that typically is performed prior to a registration audit, which is the audit based upon which a certificate is awarded by a registrar. 
• Supplier Evaluation: These are audits that a client would ask us to do on their behalf for the purpose of evaluating potential suppliers. 
• Subcontract Third Party Quality Systems Assessment: These are audits typically requested by registrars to evaluate a company that is seeking certification. 
• Perform your Internal Audits: This is perhaps the most popular. This is where a client would engage us to do audits on their behalf on themselves. Most large companies train a team of auditors that spend a good portion of their time for auditing. Smaller companies, however, are better served by hiring professional auditors on a part time basis. The job gets done better. 

Our Quality Management software QISS has a dedicated module for auditing where specific data regarding audits performed within or by your company is stored.  Audit dates, agendas and schedules are prepared in the module and results are kept in the system for review by management or customers. Dates to remember such as new audit dates, performance or corrective action due dates are available that keep a user up to date and never late with work that is on a schedule or timetable. Employees are automatically notified with tasks and a due date and the company is prompted (by email) if a task or due date is late.  This allows the user to always be on top of the performance of a company’s QMS.

Besides the Audit module, our QISS software has a full suite of integrated modules that help you run a system scalable in complexity and size from a rudimentary single location with a handful of personnel to multi-national organizations with many locations organized in regions, etc, and with thousands of people. QMS Software QISS is designed to take a company to full compliance and keep it there. Since it is a web-based data-base software, the multitudes of records kept automatically by the software and the associated charts and reports makes the job of the auditor easier. She does not have to verify mundane aspects of compliance such as “was this calibration done on time?” “Are these employees fully trained in their relevant requirements?” Charts and reports will give you such answers. The auditor therefore can verify such compliance within minutes, with a few mouse-clicks. The auditor then has the time to concentrate on the process-approach to auditing, and evaluate not just the presence of a system, but also to get a reading on the “quality” of the quality management system.

Please Schedule your audit by clicking on the link below

http://www.qi-a.com/ISO-Auditing.aspx

Implementing A New ISO 9001:2015 Quality Management System

                 Implementing A New         

                       ISO 9001:2015

    Quality Management System

Course Title

Everything you need for building and

Implementing your QMS to comply with

ISO 9001:2015

Synopsis: 

The ISO 9001:2015 Quality Management System Requirements were issued in September 2015. This is the Fifth edition of the standard that has been the most popular of all ISO standards, starting with the First edition in 1987. The wonderful part of this standard is that it is perhaps the most business friendly version, and will be attractive to organizations who are looking to build a management system to help compete and succeed in the new world of business risks. 

Although it is for just one day, we will cover everything you need, and will give you tools that will help you start as soon as you leave the class.

Module 1: What is in the ISO 9001:2015 Standard

• Background and logic behind the Quality System standards
• Highlights and descriptions of the major groups of requirements
• QIA's LAB method of interpreting the standard
• Explanation of the New Standard from a transition point of view
• Strategy for planning a new formal management system

Module 2: Detailed explanation of the Standard

• What is in each of the clauses
• What can it mean to you
• Are you already meeting the requirements?
• If not, how can you do so?
• Documentation needed

Module 3: Assured Implementation

• How to document a formal management system so it is in compliance
• Building an implementation project plan
• What to expect in an audit
• Training employees on ISO 9001:2015

Module 4: Workshop and Quizzes

• Check your level of understanding of the ISO 9001:2015 Requirements
• In-class exercise on building your new system
• Review some tools for implementing ISO 9001:2015

Friday, March 18th, 2016

8:30 a.m. - 4:30 p.m.


COST: $490.00 / STUDENT ($50 OFF EACH SEAT ABOVE 3 STUDENTS)
QIA CLIENTS : $440 / STUDENTS ($50 OFF EACH SEAT ABOVE 3 STUDENTS)

Location 

Double-Tree by Hilton Hotel Houston Hobby Airport 8181 Airport Blvd, Houston, TX 77061 

REGISTER NOW!! 
CLICK HERE

---

Student Testimonials

"I would definitely recommend the course to anyone who needs to quickly learn how to understand, transition, and implement to the new standard."

Jennifer Ishee, Sulzer Pumps

"Quality Institute of America (QIA) has given my company the tools and strategies I will need to move forward with transitioning to the new ISO 2015 standard - with confidence!"

Patricia Shepherd, Pemex

"It's the instructors that make the difference--- with their decades of experience in running manufacturing, quality and then consulting, and auditing."

J. R. Kuzniar, Eagle Burgmann

---

INSTRUCTORS

Wali Alam (Lead)

Wali is a degreed engineer with 22 years of leadership experience in manufacturing that included leadership roles in manufacturing engineering, manufacturing, supply-chain, and quality systems. He has spent an additional 23 years working continuously as a certification auditor, consultant, and trainer in North America, UK and Asia. He was one of the first Registered Lead auditors in the USA. Wali is well regarded in the Quality profession and enjoyed major leadership roles in the American Society for Quality. He has spoken several times at Quality conferences, and is a featured speaker at the International Conference on Standards, Indianapolis, Nov 9-10.

Michael Prior

Michael is a Certified Quality Auditor and has a Bachelor of Science from Texas State University. Michael has over 25 years of corporate experience in Fortune 100 companies. He has published several articles related to ISO 9001-2008 and 9001-2015. He is a practicing auditor and professional speaker, and has instructed QMS courses both in industrial and college settings.

Yes, the New Standard has the same (V. ISO 9001:2008) Requirement, Plus Net Additions to ISO 9001:2008

ISO 9001:2015 Articles Group 3

Yes, the New Standard has the same (V. ISO 9001:2008) Requirement,

Plus Net Additions to ISO 9001:2008

The release of the Final Draft International Standard of ISO 9001:2015 has created a great deal of hand wringing and argument that many requirements of the ISO 9001:2008 standard have been deleted, abandoned and/or lessened.  Some people believe that an organization no longer needs to have a Quality Manual, Quality Objectives, or the six required procedures for their respective Quality Management Systems.  Reality: Nothing could be further from the truth. The fact is that the ISO 9001:2015 standard does not reduce any requirements. It does require them in a different language, and does require/ empower the organization to decide the details.

Quality Institute of America (QIA) has been providing a series of articles to help people who wish to understand the new standard. These are divided into five groups: Group 1 provided an Introduction to the ISO 9001-2015 standard. Group 2, provided a thorough understanding of the new standard by referencing the old version, and pointing out how the new standard essentially has the same requirement with a different twist and location in the new standard.

The ISO 9001:2015 version actually has net additions to the old (ISO 9001:2008) version. This article is the first in the Group 3, and introduces you to a summary of the additions. It will be followed by full length articles on the various additions.

Group 4 will have some articles on how to implement the new ISO 9001:2015, and Group 5 will have some articles to help you audit to the new standard, or face audits to it.

We are presenting these articles through various channels, but principally through our web-sites: http://www.qi-a.com/Articles.aspx as well as our blog page:https://plus.google.com/u/0/b/114348208229269811700/+QualityInstituteofAmericaHouston/posts/p/pub

Net Addition #1

4.1 Understanding the Organization and its context

The Organization shall determine external and internal issues that are relevant to its purpose and strategic direction ant that affect its ability to achieve the intended result(s) of itsQuality Management System (QMS).

The Organization shall monitor and review information about these external and internal issues.

Context of an Organization refers to the scope of a thing, either an Organization as a whole, or its sub-parts such as divisions, locations, departments or an individual employee’s job title.

The new ISO 9001:2015 standard sets forth what an Organization shall monitor and review, but is not specific on the details of how to monitor/review, what is to be done with this data and where an Organization should keep or store the data.  Data analysis (Section 9.1.3) and Organizational knowledge management (Section 7.1.6) are the sections for addressing the requirements of Section 4.1.

Section 9.1.3 mandates that an Organization shall analyze and evaluate appropriate data/information arising from monitoring and measurement in order to evaluate the data/information for various effects upon the Organization’s QMS.

Section 7.1.6 requires an Organization to determine (by monitoring and/or measuring) the knowledge necessary for the operation of its processes and to achieve conformity of its products and services.

Unlike the old standard, the new one expects you to understand your organization's context before you establish its QMS. When ISO 9001:2015 asks you to understand your organization's context it wants you to consider the external and internal issues that are relevant to its purpose and strategic direction and to think about the influence these issues could have on its QMS and the results it intends to achieve.

Net Addition #2

Organizational Knowledge – 7.1.6

• The organization shall determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services.
• This knowledge shall be maintained and be made available to the extent necessary.
• When addressing changing needs and trends, the organization shall consider its current knowledge and determine how to acquire or access any necessary additional knowledge and required updates.

Organizational knowledge has been defined as an asset of a company to which no value can be named (Businessdirectory.com). In other words, it is (or can be) priceless to an organization. 

Organizational Knowledge is knowledge specific to the organization and generally gained from experience. This knowledge is (or can be) based upon Internal Sources (Intellectual property, experience knowledge, etc.) and External Sources (academia, standards, conferences, etc.)

A logical way to think of Organizational Knowledge is for an organization to define what it produces or the service(s) it provides.  From this premise, determine from where knowledge is gained (engineering, advanced degrees held by employees, specific skill sets such as welding, sales, management expertise, instrumentation and production machinery, etc.). Think along the lines of: “This is who we are, what we do and how we do it…”

Never underestimate or overlook sources of knowledge.  Results of Nonconformance NCs, Corrective Actions, etc. can lead to lessons learned from failure, lessons learned from Risk Analysis and from Training can be a gold mine of information/data that an organization should utilize as a competitive advantage in that it arose from within and may be looked upon as unique to competitors in the marketplace.

After a thorough examination of an organization’s structure, the results can then be categorized as either Internal or External, pursuant to the standard.

Net Addition #3

Management of Change – 6.3

Section 6.3 of the ISO 9001:2015 version sets forth the requirements for change planning of an organization’s QMS.  The requirements of the old ISO 9001:2008 version 5.4.2 are contained in the new version with a more detailed explanation of the required components.

Planning of Changes (Section 6.3)

• All changes must be carried out in a planned manner
• Considerations of planning:
  • Purpose of the change(s)
  • QMS health/viability
  • Resources
  • Allocation of resources

Change management is a systematic process for dealing with change, accounting for the considerations of both an organization and an individual. Management of change compels an organization to consider change in three contexts; adapting to change, controlling change, and change affects an organization’s QMS. A proactive approach to dealing with change is at the core of all three aspects. An organization must be able to define a specific change or change need, and implement procedures /processes to handle changes it is presented with on a daily basis.

Net Addition #4

Actions addressing risk and opportunities – 6.1

Why do we assess for Risk? To provide confidence in an organization’s ability to consistently provide customers with conforming goods and services and to enhance customer satisfaction.

• Required for establishment, implementation, maintenance and continual improvement of the Quality Management System (QMS).
• What is Risk-Based thinking?
  • Always been present (but not at the forefront) in ISO 9001
  • Always part of the “process approach” to QMS
  • Does more than “replace” preventative actions-it makes prevention a part of the routine associated with processes
  • DON’T FORGET opportunities – risk can and should help an organization identify these
• What is the Risk-Based Approach requirement?
  • Organizations need to be aware and understand the context of their organization
  • Clause 6.1 – Risks and opportunities are defined and determined
  • Prevention/preventative action is controlled and a direct result of risk-based thinking and management of risks and opportunities (6.1)

• Planning (Section 6.1.1 & 6.1.2)
  • Organization must plan actions to address/recognize risks and opportunities
  • Plan must allow for integration/implementation actions addressing risk
    • These actions MUST be evaluated for effectiveness
  • CAVEAT:  As with most of the ISO 9001:2015 standard, no FORMAL risk management program is required – but an organization must be able to provide evidence that risk has been planned for and actions taken to mitigate same – a formalized (documented) program/process would only make sense for best business practices.

Net Addition #5

Section 8.5.1 Control of production and service provision

• The organization shall implement production and service provision under controlled conditions.
• Controlled conditions shall include, as applicable:
  • (g) the implementation of action to prevent human error;

How could such an all encompassing statement (yet vague, nonetheless) be accomplished –the prevention of human error in a production setting?  Think Poka-Yoke, or the mistake proofing of a production line, team or individual. Think of the adage “safety first”.  Remember the new mandate of Section 6.1 – an organization must address risk and opportunities in everything they do.

Think about: Reducing the number of steps of a process, “idiot proofing” instruments or tools for safer and more efficient use.  Think about a hotel key card – only ONE way to correctly use it – all other avenues of use will fail.  Rethink your organization’s training platform or matrix to include new management skill sets and training for efficiency of results – not simply results themselves.