ISO 9001:2015 REQUIREMENTS (PART 5) PRODUCT REALIZATION
|
ISO 9001:2015 - Sections 8.4 – 8.5.4 & 7.1.5.2
Introduction
This is a continuation of a series of articles. If you have read the earlier ones, you can skip this introduction and start reading after the underlined break, marked Start Requirements, Part 5.
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. Furthermore, it has been replaced by an over worded document that doesn’t address the needed direction for an organization to follow in order to create and maintain a functioning and vibrant Quality Management System. Many tongues have uttered the soliloquy 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.
The Introduction part of this series of articles provided a “30,000 ft.” view of the ISO 9001: 2015 standard. This paper is the fifth in the Requirements series, subdivided into sub parts to handle the standard piece by piece. The series is aimed at readers who currently use the ISO 9001:2008 version, and would like to know how to handle the ISO 9001:2015 version. Each of the sub parts in the Requirements series will take a portion of the ISO 9001:2008 version and help the reader understand the following:
Where it is in the New Standard:
Owing to the changed structure and organization of ISO 9001:2015 version, some may find a bit of a challenge in trying to relate to the new standard from the perspective of ISO 9001: 2008version. This subsection will help in navigating the new standard.
What is Missing?
This subsection will point out parts of the old standard ISO 9001:2008 that may have been omitted in the new standard ISO 9001:2015 .
What is Added/ Changed:
This subsection will point to those requirements that did not exist in the ISO 9001:2008, and have been added to the ISO 9001:2015.
Click to link below for more information
|
Wednesday, January 27, 2016
ISO 9001:2015 REQUIREMENTS (PART 5) PRODUCT REALIZATION ISO 9001:2015 - Sections 8.4 – 8.5.4 & 7.1.5.2
Wednesday, January 13, 2016
ISO 9001:2015 Training Just in 1 Day!!
The New
ISO 9001:2015 Training Course
ISO 9001:2008
TO
ISO 9001:2015
in
TO
ISO 9001:2015
in
Just 1 day!!
Presented by
Everything about the new
ISO 9001:2015
Understand, Implement, Audit
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: Where are the requirements of the
old standard presented in the new one?
- Highlights of the changes-
explains the theme of the new one
- Structure and logic of the new
standard
- Explained mapping of the old to
the new
Module 2: Detailed explanation of the new
standard:
- QIA's LAB© method of
interpreting the standard
- Context of the Organization
- Leadership
- Planning
- Support
- Operation
- Performance Evaluation
- Improvement
Module 3: Fearless Transition/Implementation
strategies:
- When to Start
- Clause by clause strategy for
implementation
- Determining what is
"right" or necessary for your company's QMS
- Documents/Procedures/Work
Instructions/Quality Manual?
- What do I keep from my old QMS?
- Re-numbering to the new ISO
2015 standard
- How to build a transition plan
- Training employees on ISO 2015
Module 4: Auditing to the New Standard:
- Clause by clause explanation of
what is needed to demonstrate compliance
- ISO 9001-2015 Certification
Module 5: Workshop and Quizzes:
- Find the 2008 Requirements in
2015
- Check your level of
understanding of the 2015 Requirements
- Review some tools for implementing 2015
PARTICIPANTS WILL RECEIVE
- Certificate and Presentation Material
**FREE TRANSITION SOFTWARE
Upon completion of the training course check out our TRANSFORMER brand Transition Software:
- Risk Assessment with Risk Database Knowledge Management Module
- Root Cause Analysis Module
- Local Prevention Module
- Automated Document Converter
- 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 RECEIVEFULLY EQUIPPED IMPLEMENTATION TOOLKITReference / Presentation Material / Transition Check Lists / Transition Plan3 month period for free advice about course topics- WHO SHOULD ATTENDQA/QC ManagersISO CoordinatorsQMS ConsultantsManufacturing/Process/Reliability EngineersOperations & Management Reps
February 11th, 2016
- 8:30 a.m. - 4:30 p.m.THURSDAYCOST: $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
8181 Airport Blvd, Houston, TX 77061
REGISTER NOW!!
CLICK HERE
INSTRUCTORS
Wali Alam
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.
Tuesday, January 5, 2016
ISO 9001:2015 REQUIREMENTS (PART 4) PRODUCT REALIZATION
ISO 9001:2015 REQUIREMENTS (PART 4) PRODUCT
REALIZATION
What
is missing in ISO 9001:2015?
Nothing is missing or
has been replaced. However, there has been re arrangement of several of
the subsections of the previous version of ISO
9001 2008.
What is added/ changed?
A new numbering system has been introduced that adds to
the intended “flow” of the new standard. This has allowed for some older
sections/sub sections to be moved around to become a more logical fit with the
requirements of the new standard. To Read more about ISO
9001:2015 REQUIREMENTS click the link below.
Read More
Monday, December 21, 2015
Quality Management Software for Training
TRAINING
This module can be used to ensure that the most important resource of an organization...its human resources is the best it can be. In other words, it provides the tool to ensure optimum competence of the personnel in an organization. This is achieved by ensuring that all requirements for competency are met:
QISS supports a library of training programs that can be offered through the software, as well as mechanisms to schedule and deliver live instructor led programs. The schedules could be unique, or could be driven by the individual training itself, such as fork-lift training that could be driven by periodic requirement.
- Those that are required by the organization
- Those that are required by the department the person works in
- Those required by the job function/ title/
- Those additional requirements from the person’s supervisor or the competence/ HR manager
- Performance evaluations (supported by QISS)
- Any others
QISS supports a library of training programs that can be offered through the software, as well as mechanisms to schedule and deliver live instructor led programs. The schedules could be unique, or could be driven by the individual training itself, such as fork-lift training that could be driven by periodic requirement.
ISO 9001:2015 REQUIREMENTS (PART 3) RESOURCE MANAGEMENT (PROVISION)
Introduction
This is a continuation of a series of articles. If you have read the earlier ones, you can skip this introduction and start reading after the underlined break, marked Start Requirements, Part 3.
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. Furthermore, it has been replaced by an over worded document that doesn’t address the needed direction for an organization to follow in order to create and maintain a functioning and vibrant Quality Management System. Many tongues have uttered the soliloquy 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.
The “Introduction” part of this series of articles provided a “30,000 ft.” view of the ISO 9001 2015 standard. This paper starts the second in the “Requirements” series, subdivided into sub parts to handle the standard piece by piece. The series is aimed at readers who currently use the ISO 9001:2008 version, and would like to know how to handle the ISO 9001 2015 version. Each of the sub parts in the Requirements series will take a portion of the ISO 9001 2008 version and help the reader understand the following:
Where it is in the New Standard:
Owing to the changed structure and organization of ISO 9001 2015 version, some may find a bit of a challenge in trying to relate to the new standard from the perspective of ISO 9001 2008version. This subsection will help in navigating the new standard.
What is Missing?
This subsection will point out parts of the old standard ISO 9001 2008 that may have been omitted in the new standard ISO 9001 2015.
What is Added/ Changed:
This subsection will point to those requirements that did not exist in the ISO 9001 2008, and have been added to the ISO 9001 2015.
Part 3 of this series will discuss the net additions to the ISO 9001 2008 version, Part 4 will discuss implementation issues for each of the sections discussed in the Part 2 subseries, and Part 4 will discuss how to audit to the new standard ISO 9001 2015.
Start Requirements, Part 3
We intend to present these articles through various channels, but principally through our web site: www.qi a.com as well as our blog page:https://plus.google.com/u/0/b/100418610237055178555/+QisssoftwareQMSsoftware/posts/p/pub
Below is a refresher on the requirements related to Resource Management in ISO 9001:2008
ISO 9001 2008 version Section 6 – Resource Management
Section 6.1 of ISO 9001 2008 discusses provision of resources. It is found, in total, in Section 7.1.1 of the ISO 9001 2015 version with the noted exception of subsection (b) enhancement of customer satisfaction by meeting customer requirements – this subsection is omitted in the new version. This omission is appears to be intentional because more detailed customer satisfaction explanation is found in Section 5.1.2 of the ISO 9001 2015 version – Customer Focus.
Section 6.2 of the old version – Human Resources is now found in Section 7.2 of the ISO 9001 2015 version – Competence. Section 6.2.1 of the ISO 9001 2008 version has been omitted but all of Section 6.2.2 has been included in the aforementioned Section 7.2 (a d).
Section 6.3 – Infrastructure is now found, in whole, in Section 7.1.3 of the ISO 9001 2015 version.
Section 6.4 – Work Environment is now found in Section 7.1.4 of the ISO 9001 2015 version. The ISO 9001 2008 version’s single paragraph has been replaced by more detailed requirements of compliance (a c) which speak to social, psychological and physical factors that impact an organization’s work environment.
What is missing in ISO 9001:2015?
Subsection (b) of the ISO 9001 2008 version has been omitted but appears in more detailed form in Section 5.1.2 of the ISO 9001 2015 version – Customer Focus.
Subsection 6.2.1 of the ISO 9001 2008 version has been omitted relating to Human Resources.
What is added/ changed?
Very little has changed. Sections 6.2, 6.3 and 6.4 have been retained in verbatim (with the aforementioned exceptions) and renumbered in the ISO 9001 2015 version of the standard.
Summary:
With very little changes (mostly cosmetic), the new sections of the ISO 9001 2015 version reflect those corresponding sections in the ISO 9001 2008 version.
ISO 9001:2015 REQUIREMENTS (PART 2) MANAGEMENT RESPONSIBILITY (LEADERSHIP)
Introduction
This is a continuation of a series of articles. If you have read the last one (Part 2 A), you can skip this introduction and start reading after the underlined break, marked Start Part 2 B
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. Furthermore, it has been replaced by an over worded document that doesn’t address the needed direction for an organization to follow in order to create and maintain a functioning and vibrant Quality Management System. Many tongues have uttered the soliloquy 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.
The “Introduction” part of this series of articles provided a “30,000 ft.” view of the ISO 9001 2015 standard. This paper starts the second in the “Requirements” series, subdivided into sub parts to handle the standard piece by piece. The series is aimed at readers who currently use the ISO 9001:2008 version, and would like to know how to handle the ISO 9001 2015 version. Each of the sub parts in the Requirements series will take a portion of the ISO 900 2008 version and help the reader understand the following:
Where it is in the New Standard:
Owing to the changed structure and organization of ISO 9001 2015 version, some may find a bit of a challenge in trying to relate to the new standard from the perspective of ISO 9001 2008 version. This subsection will help in navigating the new standard.
What is Missing?
This subsection will point out parts of the old standard ISO 9001 2008 that may have been omitted in the new standard ISO 9001 2015.
What is Added/ Changed:
This subsection will point to those requirements that did not exist in the ISO 9001 2008, and have been added to the ISO 9001 2015.
Part 3 of this series will discuss the net additions to the ISO 9001 2008 version, Part 4 will discuss implementation issues for each of the sections discussed in the Part 2 subseries, and Part 4 will discuss how to audit to the new standard ISO 9001 2015.
Start Part 2 B:
We intend to present these articles through various channels, but principally through our web site: www.qi a.com as well as our blog page:https://plus.google.com/u/0/b/100418610237055178555/+QisssoftwareQMSsoftware/posts/p/pub
Below is a refresher on the requirements related to Management Responsibility in ISO 9001:2008
What is in ISO 9001 2008 – Section 5 Quality Management System (QMS):
ISO Section 5 – Management Responsibility (5.1 – 5.6.3)
Section 5.1 Management Commitment
This subsection contains the requirement of top management that it shall provide evidence of its commitment to the development and implementation of the Quality Management System (QMS) and to continually improve it…
5.2 Customer Focus
Customer requirements are to be determined and met with the aim of enhancing customer satisfaction.
5.3 Quality Policy
Quality Policy is appropriate to the purpose of the company, has a commitment to comply with requirements and continual improvement of the Quality Management System (QMS).
5.4 1 Quality Objectives
Objectives, including those needed to meet requirement for product, are established at relevant functions and levels within the organization.
5.4.2 QMS Planning
This subsection states that management is required to ensure that the planning of the QMS is carried out to meet the requirements of section 4.1 and the integrity of the Quality Management System (QMS) is maintained when changes are introduced.
5.5.1 Responsibility and authority
Responsibilities and authorities are to be defined and communicated within the organization.
5.5.2 Management Representative
This subsection articulates the requirement of an appointed member of top management who shall have responsibility and authority that includes ensuring processes needed for Quality Management System (QMS) are established, implemented and maintained.
5.3 Internal Communication
Appropriate communication processes are to be established within the organization.
5.6.1 Management Review
Top management shall review the Quality Management System (QMS), at planned intervals, to ensure its continual suitability, adequacy and effectiveness.
5.6.2 Review Input
A list of items relating to the Quality Management System (QMS) are required as an input for the review.
5.6.3 Review Output
A list of items is specified as a minimum as an output of the management review process.
Where is it in the ISO 9001 2015 – Standard:
Section 5.1.1 of the new standard contains subsections (b), (c) and (e) from the ISO 9001 2008 version. – see also 4.4.1 (d) where resources availability is listed. Subsection (a) of the 9001 2008 version has emerged in two separate subsections of the ISO 9001 2015 new version – 5.1.1 (f) and 5.1.2 (a). Subsection (f) relates to communicating the importance of effective quality management and conforming to Quality Management System (QMS) requirements – one of which is communicating customer requirements within the organization. 5.1.2 (a) requires management to ensure customer and applicable regulatory requirements are determined, understood and consistently met.
Please click the link below to read more about "ISO 9001:2015 REQUIREMENTS (PART 2) MANAGEMENT RESPONSIBILITY (LEADERSHIP)"
ISO 9001:2015 REQUIREMENTS (PART 1) DOCUMENTATION
Preface
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. Furthermore, it has been replaced by an over worded document that doesn’t address the needed direction for an organization to follow in order to create and maintain a functioning and vibrant Quality Management System. Many tongues have uttered the soliloquy 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) is providing a series of articles to help people who wish to understand the new standard. These are divided into four groups: Group 1 provided an Introduction to the ISO 9001 2015 standard. This paper starts Group 2, subdivided into sub parts to handle the standard piece by piece. The series is aimed at readers who currently use theISO 9001:2008 version, and would like to know how to handle the ISO 9001 2015 version. Each of the sub parts in the Part 2 series will take a portion of the ISO 9001 2008 version and help the reader understand the following:
Where it is in the New Standard:
Owing to the changed structure and organization of ISO 9001 2015 version, some may find a bit of a challenge in trying to relate to the new standard from the perspective of ISO 9001 2008version. This subsection will help in navigating the new standard.
What is Missing?
This subsection will point out parts of the old standard ISO 9001 2008 that may have been omitted in the new standard ISO 9001 2015.
What is Added/ Changed:
This subsection will point to those requirements that did not exist in the ISO 9001 2008, and have been added to the ISO 9001 2015.
Part 3 of this series will discuss the net additions to the ISO 9001 2008 version, Part 4 will discuss implementation issues for each of the sections discussed in the Part 2 subseries, and Part 4 will discuss how to audit to the new standard ISO 9001 2015.
We are presenting these articles through various channels, but principally through our web site: www.qi a.com as well as our blog page:https://plus.google.com/u/0/b/100418610237055178555/+QisssoftwareQMSsoftware/posts/p/pub
START of REQUIREMENTS (Part 1)
Below is a refresher on the requirements related to Documentation in ISO 9001:2008
What is in ISO 9001 2008 – Section 4 Quality Management System (QMS)
Section 4.1 of the ISO 9001 2008 standard requires and organization to establish, document, implement, and maintain a Quality Management System (QMS), and continually improve its effectiveness. This needs to be achieved by determining the processes needed for the Quality Management System (QMS), their sequence and interaction, criteria and methods for operation and control of these processes, provide resources for these processes, and lastly: monitor, measure, analyze these processes and take actions to improve these processes.
Section 4.2.1 of the ISO 9001 2008 standard introduced the general requirements of the documentation needed for a Quality Management System (QMS). It speaks of the need to have a writtenQuality Policy, Quality Objectives, a Quality Manual (QM), specific documented procedures and the need for documents that would be necessary to ensure proper planning, operation and control of the organization’s processes. When compared to the version of ISO 9001 2015, the contrast is, at first, quite striking. (as discussed and contrasted below).
In section 4.2.2 of the ISO 9001 2008 standard, the three requirements related to the Quality Manual are discussed: scope of the Quality Management System (QMS), documented procedures and description of the interactions between processes.
Section 4.2.3 of the ISO 9001 2008, standard, Control of Documents, sets forth the requirement for a documented procedure to govern the control of documents. Seven subsections articulated the needs to: approve, review, ensure changes, have relevant versions available, be legible, ensure external documents are identified and prevent the unintended use of obsolete documents.
Section 4.2.4 discusses the Control of Records. Records that are established or produced to provide evidence of requirement conformity and of the effectiveness of operation of the Quality Management System QMS shall be controlled. Furthermore, the organization is required to produce and maintain a documented procedure to define the aforementioned controls. All records are to remain legible, identifiable and retrievable.
Where is it in ISO 9001:2015?
ISO 9001 2015 – Sections 4.4.1, 4.4.2, 7.5.1, 7.5.2 and 7.5.3 (7.5.3.1 & 7.5.3.2)
The new version ISO 9001 2015 expands the documentation process into two sections (4.4 Quality Management System QMS and its Processes and 7.5 Documented Information).
Click the below link to ready more about "ISO 9001:2015 REQUIREMENTS (PART 1) DOCUMENTATION"
Subscribe to:
Posts (Atom)