Tag Archives: iso 9001:2015
ISO 9001:2015 Implementation Guidance & Document Templates Kit
The ‘2015 version’ of our ISO 9001 Implementation and Guidance Kit is available as a Microsoft Word (.docx files) template set that addresses all clauses in ISO 9001:2015.
The documents (plans and procedures) were first developed to assist ISO 9001:2008 management system users to transition to the ISO 9001:2015 framework.
QMSCAPA Software is included and offers a complete set of controls and performance monitoring tools required by the ISO 9001:2015 Standard.
The ISO 9001:2015 Implementation Guidance Kit contains:
- QMSCAPA Software License for (3) Users;
QMSCAPA provides controls and methods for Corrective Actions, Customer Satisfaction (surveys), Documented Information Management, Evaluating Suppliers, Internal Auditing, Measuring Devices, Measuring Key Performance (KPI), Measuring Objectives, Product Life-Cycles, Risk Assessments, Training Validation, plus much more.
- An ISO 9001:2015 Learning Guide;
- A Quality Management System (QMS) Template for a Plan [file name: ISO 9001-2015 QMS Plan v01 (Draft 1)];
- And the following examples of Quality Procedures (QP) Templates:
- QP-0410 Context of the Organization
- QP-0440 Quality Processes
- QP-0520 Quality Policy
- QP-0530 Roles & Responsibilities
- QP-0610 Risk and Opportunity Management
- QP-0620 Quality Objectives
- QP-0630 Change Management
- QP-0714 Business Environment
- QP-0715 Monitoring & Measurement Device Control
- QP-0720 Training
- QP‐0750 Control of Documents and Records
- QP-0810 Production Planning
- QP-0823 Contract Review
- QP-0830 Product Design and Development
- QP-0830 Packaging Design and Development
- QP-0840 Purchasing Services and Materials
- QP-0851 Production Process
- QP-0853 Customer Property
- QP-0854 Preservation of Product
- QP‐0870 Control of Nonconformances
- QP-0912 Measuring Customer Satisfaction
- QP‐0920 Internal Audits
- QP-0930 Management Review
- QP‐1020 Corrective Action
- ISO 9001:2015 Auditor Checklist
Includes Free support for the Microsoft Word templates and QMSCAPA software through email, and optional real-time support is also available on a hourly fee basis.
Getting Ready for ISO 9001:2015
Self-study Course for Transitioning from ISO 9001:2008 to ISO 9001:2015
This self-study or classroom course is designed to provide the most recent information and interpretation of the ISO/DIS 9001:2015 requirements. The course provides participants an opportunity to acquire the necessary knowledge to support an organization in their process of transitioning to ISO 9001:2015. Participants will learn the different components on how to plan and implement the transition to the new version of the standard. Moreover, the training course will also explore on the time frame of implementation and the influence on current processes.
Who should take this course?
• Senior management;
• Persons responsible for the QMS transition and meeting new requirements in their organization;
• Persons considering implementing a new quality management system;
• ISO 9001 auditors and quality practitioners;
• Trainers and consultants;
• Operations personnel; and
• Management Representatives.
Learning objectives
• Identify the anticipated changes in the forthcoming revision of ISO 9001.
• Understand the implementation of a Quality Management System in accordance with ISO 9001:2015
• Gain a comprehensive understanding on how to interpret, plan, and implement the changes of ISO 9001:2015.
• Identify how these changes could affect the organization’s quality management system.
• Identify the timeframe for the implementation and implications of the ISO 9001 management system.
 Self-Study Courses |
 Webinar Courses |
 Classroom Courses |
PECB Certified Course, Accredited by ANSI
Course agenda
Section 1
This section elaborates on the course objectives, structure of the standard and provides an introduction to ISO and its network.
Section 2
This section introduces ISO/DIS 9001, and discusses the differences between the updated version and previous versions. In addition, it explains why and how previous versions have been revised to follow the common structure for management system standards, especially for those organizations practicing integrated management systems.
Section 3
This section defines the Annex SL (former known as ISO Guide 83) and explains its importance and purpose for a management system.
Section 4
This section explains in detail the new version of the standard with primary focus on the major changes that the standard has undergone, such as risk-based and process approach, documentation flexibility, better focus on stakeholders and the context of an organization.
There are also other relevant information included in this section, elaborating other changes of ISO/DIS 9001 in detail. In addition, guidelines are provided on how to measure an organization’s performance and continual improvement.
Section 5
Finally, section 5 lists all corresponding standards which are affected by the transition of ISO 9001.
Furthermore, several procedures and suggestions are provided for the adjustment of the current management system to ensure effective implementation to the recent revision of ISO 9001.
Prerequisites
ISO 9001 Foundation Certification or a basic knowledge of ISO 9001:2008 standard is recommended to ensure effective results.
Exam (Optional)
The ISO 9001:2015 Transition exam fully meets the requirements of the PECB INTERNATIONAL Examination and Certification Program (ECP).
The exam covers the following competence domains:
Domain 1: Fundamental principles of quality management.
Domain 2: Understanding the high-level structure application on the QMS.
Domain 3: Planning the ISO/DIS 9001 changes.
Domain 4: Planning the QMS transition based on ISO/DIS 9001.
Domain 5: Understanding the difference between ISO 9001:2008 and ISO 9001:2015.
Domain 6: Continual improvement of a QMS based on ISO/DIS 9001.
• The exam will be paper-based, lasting 2 hours and it contains 45 exam questions (Multiple choice, Matching, Fill in the blanks, and TRUE/FALSE).
• The exam is available in English only.
For additional information relating the exam, please refer to the PECB International website, on the ISO 9001 Transition section.
Certification
• After successfully completing the exam, the candidate will receive a certificate documenting the positive completion of the course and examination.
• The certificate will be issued by PECB International.
• The certificate will be sent to participants via e-mail.
Self-study Course for Transitioning from ISO 9001:2008 to ISO 9001:2015Offered @ $150.00 USD |
Also, this course may be scheduled as an instructor lead online class or on your premises. Please call or email ABCI Consultants to arrange for private training classes.
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How do you Assess Quality Risk?
Managing Quality Risk
By Jack T. Bogle, Managing Partner | Click here to request the full article and FMEA examples as a Microsoft Excel and Word files.
In ISO 9001:2015, Preventive Actions appear to be giving way to Risk Assessment and Management, similar to what we have learned in AS9100, ISO 13485, ISO 14001, and 19001 among others.
I am exploring ways to us Failure Mode Effects Analysis methods to assess quality risks. Ultimately, I intend to add a working module for assessing risk into QMSCAPA, our quality management software (single-users may have a free license). The functional level of usability that I hope to achieve is to provide support for the evaluation of ISO 14001 Significant Environmental Aspects, and risk assessments associated with medical devices and aerospace components.
In FMEA, failures are prioritized according to how serious their consequences are, how frequently they occur and how easily they can be detected. An FMEA also documents current knowledge and actions about the risks of failures for use in continual improvement. FMEA is used during design, planning and production stages with an aim to avoid future failures and sometimes called preventive actions. Very often it is used for process control, before and during ongoing operation of the process. Ideally, FMEA begins during the earliest conceptual stages of design and continues throughout product or service realization.
The outcomes of an FMEA development are actions to prevent or reduce the severity or likelihood of failures, starting with the highest-priority ones. Also, it may be used to evaluate risk, develop priorities for risk management and mitigating known threat vulnerabilities. Lastly, FMEA helps determine the appropriate selection for remedial actions that reduce cumulative impacts of life-cycle consequences (risks) from a systems failure (fault).
Let me know your thoughts and ideas for assessing risk in quality management systems.
Advantages for Using FMEAs
- Improve the quality, reliability and safety of a product/process
- Improve company image and competitiveness
- Increase user satisfaction
- Reduce system development time and cost
- Collect information to reduce future failures, capture knowledge for lower risk
- Reduce the potential for rework, warranty and product return concerns
- Early identification and elimination of potential failure modes
- Emphasize problem or failure prevention
- Minimize late changes and associated cost
- Promotes collaboration for teamwork and idea exchange between functions
- Accentuates preventive action, which reduces the possibility of same kind of failure in future
- Reduce impact on company profit margin
- Improve production yield
The example Failure Mode Effects Analysis (FMEA) table shown below or on the following page is designed to multiply the ratings for DS * POF * CD, which equals the Priority Risk Number (RPN).
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Failure Mode Effects Analysis (FMEA) for Risk Assessments |
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Note: The Risk Priority Number (RPN) Column contains a formula to multiply P * S * D = RPN |
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Row # |
Activity or Factor |
(P)robability |
(S)everity |
(D)etection |
= RPN |
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1) |
What can happen if … |
0 |
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2) |
The wrong ingredients or components are used, or |
0 |
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3) |
The wrong package is used, or |
0 |
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4) |
The wrong size is made or shipped, or |
0 |
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5) |
The wrong color is shipped, or |
0 |
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6) |
The wrong label is on the product, or |
0 |
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7) |
The delivery is not on-time, or |
0 |
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8) |
The product is damaged in delivery, or |
0 |
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9) |
The product is lost during shipping, or |
0 |
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10) |
You know Murphy, what can go wrong will eventually go wrong in preventive measures are not designed into to your QMS |
0 |
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- Probability (P) of occurrence description and impact rating (1 lowest & 10 highest);
- Degree of Severity (S) description and impact rating (1 lowest & 10 highest);
- Certainty of Detection (D) description; ability to detect from inspection or use and impact rating (1 lowest & 10 highest);
- RPN = Risk Priority Number.
QMSCAPA™ stands for Quality Management System, Corrective Actions and Preventive Actions. QMSCAPA™ is a Microsoft Windows compatible computer application, which is designed to generate a CAPA log for a Quality Management System based upon the ISO Standards. 
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