- ISOXpress ISO 9001/14001 Light. 1,105 downloads Updated: October 22, 2012 Trial n/a. Description Free Download 100% CLEAN report malware. A helper for the companies that want to create ISO 9001.
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- IMSXpress ISO 9001:2015 quality management and document control software is easy to install and very intuitive for users. 10 modules including a powerful training module. There are two ways of purchasing, Software as a Service –SaaS- or purchase to own There are three editions of the software, Light Edition, Standard Edition and Professional Edition making it ideal for small to medium size companies.
Complete ISO Systems and Software Solutions for Small Companies: 9001, 14001, 13485 and 14971. Template Manuals and Procedures, Training Materials, Audit Checklists, Document Control, ISO Mamagement Modules.
ISO 9001 is defined as the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can certify.
ISO 9001 was first published in 1987 by the International Organization for Standardization (ISO), an international agency composed of the national standards bodies of more than 160 countries. The current version of ISO 9001 was released in September 2015.
Who Should Use the ISO 9001:2015 Revision?
ISO 9001:2015 applies to any organization, regardless of size or industry. More than one million organizations from more than 160 countries have applied the ISO 9001 standard requirements to their quality management systems.
Organizations of all types and sizes find that using the ISO 9001 standard helps them:
- Organize processes
- Improve the efficiency of processes
All organizations that use ISO 9001 are encouraged to transition to ISO 9001:2015 as soon as possible. This includes not only organizations that are certified to ISO 9001:2008, but also any organizations involved in training or certifying others.
As of September 14, 2018organizations that are currently registered to ISO 9001:2008 should have transitioned to the 2015 standard.
Guidance on transitioning from ISO 9001:2008 to ISO 9001:2015 can be downloaded from the International Accreditation Forum (IAF).
Purchase ISO 9001:2015
Published hard copy
PDF e-standard
What topics does ISO 9001:2015 cover?
ISO 9001 is based on the plan-do-check-act methodology and provides a process-oriented approach to documenting and reviewing the structure, responsibilities, and procedures required to achieve effective quality management in an organization. Specific sections of the standard contain information on many topics, such as:
- Requirements for a QMS, including documented information, planning and determining process interactions
- Responsibilities of management
- Management of resources, including human resources and an organization's work environment
- Product realization, including the steps from design to delivery
- Measurement, analysis, and improvement of the QMS through activities like internal audits and corrective and preventive action
Changes introduced in the 2015 ISO 9001 revision are intended to ensure that ISO 9001 continues to adapt to the changing environments in which organizations operate. Some of the key updates in ISO 9001:2015 include:
- The introduction of new terminology
- Restructuring some of the information
- An emphasis on risk-based thinking to enhance the application of the process approach
- Improved applicability for services
- Increased leadership requirements
The Seven Principles of ISO 9001:2015
How do I get started with ISO 9001:2015?
Whether you are beginning your ISO 9001 journey or transitioning to the 2015 revision, your first step is to purchase a copy of ISO 9001:2015.
As of September 14, 2018organizations that are currently registered to ISO 9001:2008 should have transitioned to the 2015 standard.
Previous versions of ISO 9001
Originally published in 1987, ISO 9001 underwent revisions in 1994, 2000, and again in 2008. The latest revision was published in September 2015.
- ISO 9001:1994 included changes to improve the control of design and development clause, as well as provide other clarifications. The 1994 series also slightly modified the role of ISO 9002 and 9003.
- The ISO 9001:2008 revision sought to clarify issues raised during the application of ISO 9001:2000.
ISO 9001 Timeline
ISO 9001 helps organizations ensure their customers consistently receive high quality products and services, which in turn brings many benefits, including satisfied customers, management, and employees.
Because ISO 9001 specifies the requirements for an effective quality management system, organizations find that using the standard helps them:
- Organize a QMS
- Create satisfied customers, management, and employees
- Continually improve their processes
- Save costs
In Nevada, the Clark County School District used ISO 9001 to save $174 million over 10 years in actual expenditures and cost avoidance. More than 3,000 employees were trained to the standard, enabling three critical components of the system's success: training, communication and respect, and efficiency.
ISO 9001 Certification
ISO 9001 is the only standard in the ISO 9000 series to which organizations can certify. Achieving ISO 9001:2015 certification means that an organization has demonstrated the following:
- Follows the guidelines of the ISO 9001 standard
- Fulfills its own requirements
- Meets customer requirements and statutory and regulatory requirements
- Maintains documentation
Certification to the ISO 9001 standard can enhance an organization's credibility by showing customers that its products and services meet expectations. In some instances or in some industries, certification is required or legally mandated. The certification process includes implementing the requirements of ISO 9001:2015 and then completing a successful registrar's audit confirming the organization meets those requirements.
Organizations should consider the following as they begin preparing for an ISO 9001 quality management system certification:
- Registrar's costs for ISO 9001 registration, surveillance, and recertification audits
- Current level of conformance with ISO 9001 requirements
- Amount of resources that the company will dedicate to this project for development and implementation
- Amount of support that will be required from a consultant and the associated costs
Read 'What's the cost?' for a checklist you can use to assess the costs of certifying to ISO 9001.
Note: ASQ does not issue ISO 9001 certification.
Training in the ISO 9001 Standard
Training can provide an opportunity to review the ISO 9001:2015 standard and apply quality management principles in a practice environment.
Professionals responsible for developing, implementing, auditing, and managing an ISO quality management system or quality professionals interested in updating their documented ISO 9001-based QMS can take ISO 9000 training courses, which include courses focused on ISO 9001 and quality management systems. Additionally, organizations looking to improve employee performance and employees looking to continually improve will also find ISO 9000 training relevant.
ISO 9001 Resources
You can also search articles, case studies, and publications for ISO 9001 resources.
ISO 9001:2015 Standard
The 2015 revision to ISO 9001, the international standard specifying requirements for quality management systems, is available for purchase in these formats:
- PDF e-standard for immediate download (please note that e-standards cannot be printed)
- Site license for posting an electronic version to your Local Area Network or Intranet
Example Quality Manual
Need to write a quality manual that conforms to ISO 9001:2015? Download an example quality manual and read about how to create one.
Books
Articles
- Auditing Strategy for ISO 9001:2015 (Journal for Quality and Participation) When standards and other frameworks are used as models for an organization's processes, having a suitable audit strategy can ensure appropriate compliance and corrective action.
- The Influence Of Human Factors On ISO 9001:2015 Compliance (Journal for Quality and Participation) Understanding the importance of people is crucial to the success of any management system. The ISO 9001 model is no different.
- ISO 9001:2015 Transition Starts With Top Management (PDF) Why leadership needs to be directly involved in the transition to ISO 9001:2015.
- A New Look (Quality Progress) 15 things you need to know now about the 2015 revision of ISO 9001.
Case Studies
- (E)Quality for All: You, Your Job, and ISO 9001 (PDF) ISO 9001 certification affects everything from how your customers perceive you, to how effective your processes are, to your organization's ability/qualification to bid on major projects.
- Imaging Core Lab Takes Quality Beyond Regulatory Requirements with ISO 9001 (PDF) Though MMI's ISO 9001 certification is recent, it is already seeing improvements to the timeliness of deliverables to clinical trial sponsors, an increase in quality awareness from the implementation, and positive feedback from sponsors.
Videos
- ISO 9001:2015 Overview As you get ready to implement or transition to ISO 9001:2015, it's helpful to get a high-level overview of the standard before jumping in.
- ISO 9001:2015 - 15 Things You Must Know Now In this video interview, Paul Palmes discusses the ISO 9001 revision and key points organizations must consider as the draft international standard progresses through the development process.
- Team Builds ISO 9001 QMS on Wiki Learn how Geometrica, a dome manufacturer based in Texas and Mexico, involved its entire organization in documenting its quality management system for ISO 9001 certification using a Wiki.
Webcasts
- Improving Your QMS While Certifying to ISO 9001 Author Milt Dentch shares how organizations can go beyond ISO 9001:2015 compliance to substantially improve their quality management systems and the bottom line.
- Guidance on Conforming to ISO 9001:2015 Author Milton Dentch provides guidance on conforming to ISO 9001:2015.
- Lean ISO 9001 ISO 9001 expert Mike Micklewright walks through how and why documentation systems get out of control, what's wrong with an overly lengthy documentation system, and how to get it back in control and make it more user friendly with the 5S lean tool.
ISO 9001 Auditing Practices Group
Welcome to the website of the ISO 9001 Auditing Practices Group.
This website has been established as an on-line source of papers and presentations on auditing QMSs. The ideas, examples and explanations given reflect the process-based approach that is essential for auditing the requirements of ISO 9001 Quality management systems - Requirements. The website is primarily aimed at QMS auditors, consultants and quality practitioners.
The papers and presentations that make up the content of this website are not definitive. They reflect a number of different views in QMS auditing. As such, their content may not always be consistent. It is not intended that the website's content will be used as specified requirements, an industry benchmark, or as criteria that all QMS auditors, consultants or practitioners have to follow.
Feedback from users will be used by the ISO 9001 Auditing Practices Group to determine whether additional guidance documents should be developed, or if these current ones should be revised. Comments on the papers or presentations can be sent to the following email address: charles.corrie@bsigroup.com.
The items listed under 'QMS auditing topics' below have papers and presentations associated with them. Simply click on one of the links to view and download the relevant document.
The ISO 9001 Auditing Practices Group is constituted as an informal group of quality management system (QMS) experts, auditors and practitioners, drawn from the ISO Technical Committee 176 Quality Management and Quality Assurance (ISO/TC 176) and the International Accreditation Forum (IAF).
What Is Iso 9001 Standard
The Co-Conveners of the ISO 9001 Auditing Practices Group are Mr Fei Yang (Deputy Director, CNAS, China) and Mrs Joana dos Guimarães Sá (from IQNet - the International Certification Network).
A sister web page for the Accreditation Auditing Practices Group has been established to provide guidance to accreditation auditors.
For further information please see: An introduction to the ISO 9001 Auditing Practices Group
QMS auditing topics for ISO 9001:2015
1. General
2. Auditing General
3. Auditing to ISO 9001:2015
Document Revision Status Information for all the above documents
Further reading:
The ISO Policy Committee for Conformity Assessment (ISO/CASCO) and the International Accreditation Forum (IAF) have developed documents relating to certification, accreditation and the auditing of quality management systems. These are available from ISO or the IAF, or from your national ISO member body or IAF member body.
© Copyright ISO & IAF 2020 – All rights reserved
What's New
21 September 2020
The paper on 'Effective use of ISO 19011' has been revised and expanded to give an overview of ISO 19011:2018. A new paper on 'Auditing Digital Processes' has been published. Both can be found in 'Auditing General'. The paper 'Electronic Documented Information Systems' has been removed as its former content is now covered by the papers on 'Auditing Digital Processes' and 'Remote Audits'.
19 July 2020
The paper on 'Processes' has been revised to follow the audit process and auditors' point of view as well as to make it more concise and clear. The papers on 'Internal Audit' and 'Internal Communication' have been edited to update their references. All 3 papers can be found in the section on 'Auditing to ISO 9001:2015'.
16 April 2020
The paper 'Remote Audits' has been added under 'Auditing General'. This is a new paper, which will assist those trying to conduct remote audits during the COVID 19 pandemic.
Translations
Translations of some of the APG's papers can be found at:
Spanish/Español
( ver: Documentos Información Pública)
Useful web sites:
http://www.iaf.nu/ for the International Accreditation Forum (IAF)
http://www.iso.org/ for the International Organization for Standardization (ISO)
https://committee.iso.org/home/tc176sc2/ for ISO/TC 176, Sub-committee no.2, Quality Systems (ISO/TC 176/SC 2)
Abbreviations and Definitions
On this website the following abbreviations are commonly used:
Auditee = the organization being audited
CAB = Conformity Assessment Body
NCR = Non-conformity report
QMS = Quality management system
Disclaimer
As9100 Vs Iso 9001 Matrix
The contributions on this website have not been subject to an endorsement process by the International Organization for Standardization (ISO), ISO Technical Committee 176 or the International Accreditation Forum (IAF).
The information contained on this website is available to the public for educational and communication purposes and the ISO 9001 Auditing Practice Group does not take responsibility for any errors, omissions or other liabilities that may arise from the provision or subsequent use of such information.
Copyright
The material on this website is subject to ISO and IAF copyright – All rights reserved
Therefore and unless otherwise specified, no part of these ISO / IAF publications may be reproduced or utilized (including reproduction in whole or in part to another Internet site), in any form or by any means, electronic or mechanical, including photocopying, microfilm, scanning, etc., without permission in writing from the publishers.
Requests should be addressed to:
ISO Copyright Office
1, Ch.de la Voie-Creuse
Case postale 56
CH-1211 Geneva 20
Switzerland
Fax +41 22 749 09 47
E-mail copyright@iso.org
IAF Secretary
Box 1811
Chelsea, Quebec
CANADA
J9B 1A0
Email: Secretary@iaf.nu
Phone: +1 (613) 454 8159
Web site: www.iaf.nu
Isoxpress Quality Management
What topics does ISO 9001:2015 cover?
ISO 9001 is based on the plan-do-check-act methodology and provides a process-oriented approach to documenting and reviewing the structure, responsibilities, and procedures required to achieve effective quality management in an organization. Specific sections of the standard contain information on many topics, such as:
- Requirements for a QMS, including documented information, planning and determining process interactions
- Responsibilities of management
- Management of resources, including human resources and an organization's work environment
- Product realization, including the steps from design to delivery
- Measurement, analysis, and improvement of the QMS through activities like internal audits and corrective and preventive action
Changes introduced in the 2015 ISO 9001 revision are intended to ensure that ISO 9001 continues to adapt to the changing environments in which organizations operate. Some of the key updates in ISO 9001:2015 include:
- The introduction of new terminology
- Restructuring some of the information
- An emphasis on risk-based thinking to enhance the application of the process approach
- Improved applicability for services
- Increased leadership requirements
The Seven Principles of ISO 9001:2015
How do I get started with ISO 9001:2015?
Whether you are beginning your ISO 9001 journey or transitioning to the 2015 revision, your first step is to purchase a copy of ISO 9001:2015.
As of September 14, 2018organizations that are currently registered to ISO 9001:2008 should have transitioned to the 2015 standard.
Previous versions of ISO 9001
Originally published in 1987, ISO 9001 underwent revisions in 1994, 2000, and again in 2008. The latest revision was published in September 2015.
- ISO 9001:1994 included changes to improve the control of design and development clause, as well as provide other clarifications. The 1994 series also slightly modified the role of ISO 9002 and 9003.
- The ISO 9001:2008 revision sought to clarify issues raised during the application of ISO 9001:2000.
ISO 9001 Timeline
ISO 9001 helps organizations ensure their customers consistently receive high quality products and services, which in turn brings many benefits, including satisfied customers, management, and employees.
Because ISO 9001 specifies the requirements for an effective quality management system, organizations find that using the standard helps them:
- Organize a QMS
- Create satisfied customers, management, and employees
- Continually improve their processes
- Save costs
In Nevada, the Clark County School District used ISO 9001 to save $174 million over 10 years in actual expenditures and cost avoidance. More than 3,000 employees were trained to the standard, enabling three critical components of the system's success: training, communication and respect, and efficiency.
ISO 9001 Certification
ISO 9001 is the only standard in the ISO 9000 series to which organizations can certify. Achieving ISO 9001:2015 certification means that an organization has demonstrated the following:
- Follows the guidelines of the ISO 9001 standard
- Fulfills its own requirements
- Meets customer requirements and statutory and regulatory requirements
- Maintains documentation
Certification to the ISO 9001 standard can enhance an organization's credibility by showing customers that its products and services meet expectations. In some instances or in some industries, certification is required or legally mandated. The certification process includes implementing the requirements of ISO 9001:2015 and then completing a successful registrar's audit confirming the organization meets those requirements.
Organizations should consider the following as they begin preparing for an ISO 9001 quality management system certification:
- Registrar's costs for ISO 9001 registration, surveillance, and recertification audits
- Current level of conformance with ISO 9001 requirements
- Amount of resources that the company will dedicate to this project for development and implementation
- Amount of support that will be required from a consultant and the associated costs
Read 'What's the cost?' for a checklist you can use to assess the costs of certifying to ISO 9001.
Note: ASQ does not issue ISO 9001 certification.
Training in the ISO 9001 Standard
Training can provide an opportunity to review the ISO 9001:2015 standard and apply quality management principles in a practice environment.
Professionals responsible for developing, implementing, auditing, and managing an ISO quality management system or quality professionals interested in updating their documented ISO 9001-based QMS can take ISO 9000 training courses, which include courses focused on ISO 9001 and quality management systems. Additionally, organizations looking to improve employee performance and employees looking to continually improve will also find ISO 9000 training relevant.
ISO 9001 Resources
You can also search articles, case studies, and publications for ISO 9001 resources.
ISO 9001:2015 Standard
The 2015 revision to ISO 9001, the international standard specifying requirements for quality management systems, is available for purchase in these formats:
- PDF e-standard for immediate download (please note that e-standards cannot be printed)
- Site license for posting an electronic version to your Local Area Network or Intranet
Example Quality Manual
Need to write a quality manual that conforms to ISO 9001:2015? Download an example quality manual and read about how to create one.
Books
Articles
- Auditing Strategy for ISO 9001:2015 (Journal for Quality and Participation) When standards and other frameworks are used as models for an organization's processes, having a suitable audit strategy can ensure appropriate compliance and corrective action.
- The Influence Of Human Factors On ISO 9001:2015 Compliance (Journal for Quality and Participation) Understanding the importance of people is crucial to the success of any management system. The ISO 9001 model is no different.
- ISO 9001:2015 Transition Starts With Top Management (PDF) Why leadership needs to be directly involved in the transition to ISO 9001:2015.
- A New Look (Quality Progress) 15 things you need to know now about the 2015 revision of ISO 9001.
Case Studies
- (E)Quality for All: You, Your Job, and ISO 9001 (PDF) ISO 9001 certification affects everything from how your customers perceive you, to how effective your processes are, to your organization's ability/qualification to bid on major projects.
- Imaging Core Lab Takes Quality Beyond Regulatory Requirements with ISO 9001 (PDF) Though MMI's ISO 9001 certification is recent, it is already seeing improvements to the timeliness of deliverables to clinical trial sponsors, an increase in quality awareness from the implementation, and positive feedback from sponsors.
Videos
- ISO 9001:2015 Overview As you get ready to implement or transition to ISO 9001:2015, it's helpful to get a high-level overview of the standard before jumping in.
- ISO 9001:2015 - 15 Things You Must Know Now In this video interview, Paul Palmes discusses the ISO 9001 revision and key points organizations must consider as the draft international standard progresses through the development process.
- Team Builds ISO 9001 QMS on Wiki Learn how Geometrica, a dome manufacturer based in Texas and Mexico, involved its entire organization in documenting its quality management system for ISO 9001 certification using a Wiki.
Webcasts
- Improving Your QMS While Certifying to ISO 9001 Author Milt Dentch shares how organizations can go beyond ISO 9001:2015 compliance to substantially improve their quality management systems and the bottom line.
- Guidance on Conforming to ISO 9001:2015 Author Milton Dentch provides guidance on conforming to ISO 9001:2015.
- Lean ISO 9001 ISO 9001 expert Mike Micklewright walks through how and why documentation systems get out of control, what's wrong with an overly lengthy documentation system, and how to get it back in control and make it more user friendly with the 5S lean tool.
ISO 9001 Auditing Practices Group
Welcome to the website of the ISO 9001 Auditing Practices Group.
This website has been established as an on-line source of papers and presentations on auditing QMSs. The ideas, examples and explanations given reflect the process-based approach that is essential for auditing the requirements of ISO 9001 Quality management systems - Requirements. The website is primarily aimed at QMS auditors, consultants and quality practitioners.
The papers and presentations that make up the content of this website are not definitive. They reflect a number of different views in QMS auditing. As such, their content may not always be consistent. It is not intended that the website's content will be used as specified requirements, an industry benchmark, or as criteria that all QMS auditors, consultants or practitioners have to follow.
Feedback from users will be used by the ISO 9001 Auditing Practices Group to determine whether additional guidance documents should be developed, or if these current ones should be revised. Comments on the papers or presentations can be sent to the following email address: charles.corrie@bsigroup.com.
The items listed under 'QMS auditing topics' below have papers and presentations associated with them. Simply click on one of the links to view and download the relevant document.
The ISO 9001 Auditing Practices Group is constituted as an informal group of quality management system (QMS) experts, auditors and practitioners, drawn from the ISO Technical Committee 176 Quality Management and Quality Assurance (ISO/TC 176) and the International Accreditation Forum (IAF).
What Is Iso 9001 Standard
The Co-Conveners of the ISO 9001 Auditing Practices Group are Mr Fei Yang (Deputy Director, CNAS, China) and Mrs Joana dos Guimarães Sá (from IQNet - the International Certification Network).
A sister web page for the Accreditation Auditing Practices Group has been established to provide guidance to accreditation auditors.
For further information please see: An introduction to the ISO 9001 Auditing Practices Group
QMS auditing topics for ISO 9001:2015
1. General
2. Auditing General
3. Auditing to ISO 9001:2015
Document Revision Status Information for all the above documents
Further reading:
The ISO Policy Committee for Conformity Assessment (ISO/CASCO) and the International Accreditation Forum (IAF) have developed documents relating to certification, accreditation and the auditing of quality management systems. These are available from ISO or the IAF, or from your national ISO member body or IAF member body.
© Copyright ISO & IAF 2020 – All rights reserved
What's New
21 September 2020
The paper on 'Effective use of ISO 19011' has been revised and expanded to give an overview of ISO 19011:2018. A new paper on 'Auditing Digital Processes' has been published. Both can be found in 'Auditing General'. The paper 'Electronic Documented Information Systems' has been removed as its former content is now covered by the papers on 'Auditing Digital Processes' and 'Remote Audits'.
19 July 2020
The paper on 'Processes' has been revised to follow the audit process and auditors' point of view as well as to make it more concise and clear. The papers on 'Internal Audit' and 'Internal Communication' have been edited to update their references. All 3 papers can be found in the section on 'Auditing to ISO 9001:2015'.
16 April 2020
The paper 'Remote Audits' has been added under 'Auditing General'. This is a new paper, which will assist those trying to conduct remote audits during the COVID 19 pandemic.
Translations
Translations of some of the APG's papers can be found at:
Spanish/Español
( ver: Documentos Información Pública)
Useful web sites:
http://www.iaf.nu/ for the International Accreditation Forum (IAF)
http://www.iso.org/ for the International Organization for Standardization (ISO)
https://committee.iso.org/home/tc176sc2/ for ISO/TC 176, Sub-committee no.2, Quality Systems (ISO/TC 176/SC 2)
Abbreviations and Definitions
On this website the following abbreviations are commonly used:
Auditee = the organization being audited
CAB = Conformity Assessment Body
NCR = Non-conformity report
QMS = Quality management system
Disclaimer
As9100 Vs Iso 9001 Matrix
The contributions on this website have not been subject to an endorsement process by the International Organization for Standardization (ISO), ISO Technical Committee 176 or the International Accreditation Forum (IAF).
The information contained on this website is available to the public for educational and communication purposes and the ISO 9001 Auditing Practice Group does not take responsibility for any errors, omissions or other liabilities that may arise from the provision or subsequent use of such information.
Copyright
The material on this website is subject to ISO and IAF copyright – All rights reserved
Therefore and unless otherwise specified, no part of these ISO / IAF publications may be reproduced or utilized (including reproduction in whole or in part to another Internet site), in any form or by any means, electronic or mechanical, including photocopying, microfilm, scanning, etc., without permission in writing from the publishers.
Requests should be addressed to:
ISO Copyright Office
1, Ch.de la Voie-Creuse
Case postale 56
CH-1211 Geneva 20
Switzerland
Fax +41 22 749 09 47
E-mail copyright@iso.org
IAF Secretary
Box 1811
Chelsea, Quebec
CANADA
J9B 1A0
Email: Secretary@iaf.nu
Phone: +1 (613) 454 8159
Web site: www.iaf.nu
Isoxpress Quality Management
Iso 9001 What Is It
