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#1 2020-09-13 07:50:41

GaryEdmund
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From: Australia, Indented Head
Registered: 2020-09-13
Posts: 2

b)      Rationale – Creation of unity of purpose

Training Micro Focus Vibe: Admins
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Nothing Found
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IBM BigFix and IBM Security QRadar SIEM
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Castle of Illusion HD – Retro Reflection
Posted on Tuesday September 08, 2020

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when I visited Skyrim of an evening
Posted on Tuesday September 08, 2020

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ISO 9001:2015.

Category Archives: ISO 9001:2015

, , , , ,                                                                                                           Important  enhancement s have been made to the ™ software module for Risk Assessments and Management.

The single-user version of QMSCAPA software may be downloaded free of charge

simply.
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ISO 9001:2008 vs.
ISO 9001:2015 (2013 CD).
May 12, 2014                ,                                                                                                    A Focus on Clause 4.
A direct clause by clause comparison of ISO 9001:2008 vs.
ISO 9001:2015 is difficult at best.
Eight clauses in the 2008 version are replaced by ten in the 2013 committee draft.
Clauses 1 th rough  3 have the least changes, sans the word ‘continual’.
Clause 4 is a major rewrite and suggest a new approach to documentation and planning  requirements .
The process model and role is expanded to included expected output, risks of conformity for goods and services.
Plus,  customer satisfaction  if unintended outputs are delivered or process interaction is ineffective.
ISO 9001:2008.
ISO 9001:2015.
Quality Management  System.
4.1 QMS: General  Requirements .
The organization will establish, document, implement, .

Maintain and continually improve a Quality Management System (QMS)

This is where we find the  Requirement  to identify processes that need to be controlled, and determine how they interrelate.
The  organization  must also determine how to control any outsourced processes.
Steps that need to be taken are:  Identify the processes needed for the QMS.
Determine the sequence and interaction of these processes.
Determine criteria and methods required to ensure the effective operation and control of these processes.
Ensure the availability of information necessary to support the operation and monitoring of these processes.
Measure, monitor and analyze these processes and implement action necessary to achieve planned results and continual improvement.
This section does not address the documentation of the processes.
It focuses on the development and implementation of the process and goes on to require that they are managed and continually improved.
4.2 Documentation Requirements.
4.2.1 General.
Quality management system documentation must include:  Documented procedures required by the standard.
Documents required by the organization for effective operation and process control.
Quality policy and objectives.
The standard only identifies six places where a documented procedure is required.
The organization determines if additional documentation is needed.
The only documented procedures specifically required by ISO 9001:2008 are procedures for:  Document Control (now appears in 7.5.3).
Control of Quality Records.
Internal Quality Audits.
Control of Nonconformity.
Corrective Action.
Preventive Action.
However, this does not mean that they are the only procedures required.
You must identify what else is required in your organization.
In 4.1, the standard asks organizations to Identify key processes and their interrelation.
You will need to document your key processes.
Key processes must be identified early in your transition to the new revision.
This will help you identify procedures and work instructions needed for effective operation and control of key processes.
From the list of key processes, additional needed documentation must be developed to meet each organization’s needs.
4.2.2 Quality Manual (does not appear in the 2013 CD).
The standard also requires a documented quality policy and objectives.
A quality manual must be created and maintained that includes : A description of the sequence and interaction of the processes included in the quality management system (QMS) Identification of permissible exclusions 4.2.3 Control of documents.
You must have a system in place to control your documents- your quality manual, procedures and work instructions Establish a process to approve documents, control the revision and distribution of the documents, and control changes to the documents You must make sure that people are working from the current, correct document.
Quality records must be controlled and protected, quality records are your evidence of complying with your quality system Have a process in place that identifies what quality records you have, where they are kept, how long they are kept, how they are protected from damage Most companies will use a “Master List” to list the current revision and location of each document.
Online systems work very well for document control if electronic files are protected from change.
Recording the distribution of documents is important; if a document is revised all previous revisions of the document must be replaced.
This is only possible if you know where all those copies are.
Documents must be reviewed on a regular basis to make sure they are up to date.
Some organizations may choose to review all documents on a regular basis.
For example, annually.
However, there is not a requirement to do it on a regular basis, but “as necessary”.
This could be with regular use, and during internal audits.
If employees are using the documents they should be watching for documents that need updating, and submitting document change requests.
The internal audit program measures compliance with documentation requirements (along with other requirements) and should identify required revisions.
In other words, if staff are using the system as it is designed, documents are continually updated, reviewed and revised and an annual review step is not necessary to build into the system.
4.2.4 Control of records.
Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled.
A table works well for listing all your quality records, where they are generated and stored, how long they are stored and who is responsible for them.
Include a requirement in your procedure that says quality records must be legible.
The procedure must address storage, retention times and disposition.
If you archive records either on-site or off-site include your process in your procedure.
ISO does not specify how long you have to keep your records, but remember that the auditor will want to see six months to a year worth of records.
4 Context of the organization.
4.1 Understanding the organization and its context.
The terms ‘document’ and `record’ have both been replaced throughout the requirements text by ‘documented information’.
The word ‘shall’ appears 133 times; the word ‘documented’ appears 47 times.
The organization shall determine external and internal issues, that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended outcome(s) of its quality Management system.
The organization shall update such determinations when needed.
When determining relevant external and internal issues, the organization shall consider those arising from: a) changes and trends which can have an impact on the objectives of the organization; b) relationships with, and perceptions and values of relevant interested parties; c) governance issues, strategic priorities, internal policies and commitments; and d) resource availability and priorities and technological change.
Note 1 Understanding the external context can be facilitated by considering issues arising from legal, Technological, competitive, cultural, social, economic and natural environment, whether international, national, regional or local.
Note 2   When understanding the internal context the organization could consider those related to perceptions, values and culture of the organization.
4.2 Understanding the needs and expectations of interested parties.
The organization shall determine a) the interested parties that are relevant to the quality management system, and b) the requirements of these interested parties The organization shall update such determinations in order to understand and anticipate needs or expectations affecting customer requirements and customer satisfaction.
The organization shall consider the following relevant interested parties: a) direct customers; b) end users; c) suppliers, distributors, retailers or others involved in the supply chain; d) regulators; and e) any other relevant interested parties.
Note: Addressing current and anticipated future needs can lead to the identification of improvement and innovation opportunities.
4.3 Determining the scope of the quality management system.
The organization shall determine the boundaries and applicability of the quality management system to establish its scope. When determining this scope, the organization shall consider a) the external and internal issues referred to in 4.1, and b) the requirements referred to in 4.2.
The scope shall be stated in terms of goods and services, the main processes to deliver them and the sites of the organization included.
When stating the scope, the organization shall document and justify any decision not to apply a requirement of this International Standard and to exclude it from the scope of the quality management system.
Any such exclusion shall be limited to clause 7.1.4 (Monitoring and measuring devices) and 8 (Operations) and shall not affect the organization’s ability or responsibility to assure conformity of goods and services and customer satisfaction, nor can an exclusion be justified on the basis of a decision to arrange for an external provider to perform a function or process of the organization.
Note: An external provider can be a supplier or a sister organization (such as a headquarters or alternate site location) that is outside of the organization’s quality management system.
The scope shall be available as documented information.
4.4 Quality management system.
4.4.1 General.
The organization shall establish, implement, maintain and (continual deleted) improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard.
4.4.2 Process approach.
The organization shall apply a process approach to its quality management system.
The organization shall: a) determine the processes needed for the quality management system and their application throughout the organization; b) determine the inputs required and the outputs expected from each process; c) determine the sequence and interaction of these processes; d) determine the risks to conformity of goods and services and customer satisfaction if unintended outputs are delivered or process interaction is ineffective; e) determine criteria, methods, measurements, and related performance indicators needed to ensure that both the operation and control of these processes are effective; f) determine the resources and ensure their availability; g) assign responsibilities and authorities for processes; h) implement actions necessary to achieve planned results; i) monitor, analyse and change, if needed, these processes ensuring that they continue to deliver the intended outputs; and j) ensure continual improvement of these processes.
Read More                                                        ISO 9001:2008 Compared to ISO 9001:2015 (2013 Committee Draft).
April 27, 2014                ,                                                                                                    .

ISO 9001:2015 Part 1: Quality Management Principles

Introduction.
This document introduces the seven quality management principles (QMP) on which the quality management system standards of the ISO 9000 series are based and the essential importance for establishing communications for nonconformity and corrective actions.

The principles were developed and updated by international experts of ISO/TC 176

which is responsible for developing and maintaining the ISO 9000 series on quality management standards.
This guidance document provides a “statement’ describing each principle and a “rationale’ explaining why an organization should address the principle.
QMP 1 — Customer Focus.
a)      Statement – The primary focus of quality management is to meet customer requirements and to strive to exceed customer expectations.
b)      Rationale – Sustained success is achieved when an organization attracts and retains the confidence of customers and other interested parties on whom it depends.
Every aspect of customer interaction provides an opportunity to create more value for the customer.
Understanding current and future needs of customers and other interested parties contributes to sustained success of an organization.
QMP 2 — Leadership.
a)      Statement – Leaders at all levels establish unity of purpose and direction and create conditions in which people are engaged in achieving the quality objectives of the organization.
b)      Rationale – Creation of unity of purpose, direction and engagement enable an organization to align its strategies, policies, processes and resources to achieve its objectives.
QMP 3 — Engagement of People (involvement in 2008).

A)      Statement – It is essential for the organization that all people are competent

empowered and engaged in delivering value.
Competent, empowered and engaged people throughout the organization enhance its capability to create value.

B)      Rationale – To manage an organization effectively and efficiently

it is important to involve all people at all levels and to respect them as individuals.
Recognition, empowerment and enhancement of skills and knowledge facilitate the engagement of people in achieving the objectives of the organization.
QMP 4 — Process Approach.
a)      Statement – Consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as a coherent system.

B)      Rationale – The quality management system is composed of interrelated processes

Understanding how results are produced by this system, including all its processes, resources, controls and interactions, allows the organization to optimize its performance.
QMP 5 — Improvement (continual improvement in 2008).

A)      Statement – Successful organizations have an ongoing focus on improvement

b)      Rationale – Improvement is essential for an organization to maintain current levels of performance, to react to changes in its internal and external conditions and to create new opportunities.
QMP 6 — Evidence-based Decision Making (factual approach to decision making).
a)      Statement – Decisions based on the analysis and evaluation of data and information are more likely to produce desired results.

B)      Rationale – Decision-making can be a complex process

and it always involves some uncertainty.
It often involves multiple types and sources of inputs, as well as their interpretation, which can be subjective.
It is important to understand cause and effect relationships and potential unintended consequences.
Facts, evidence and data analysis lead to greater objectivity and confidence in decisions made.
QMP 7 — Relationship Management (mutually beneficial supplier relationships in 2008).

A)      Statement – For sustained success

organizations manage their relationships with interested parties, such as suppliers.

B)      Rationale – Interested parties influence the performance of an organization

Sustained success is more likely to be achieved when an organization manages relationships with its interested parties to optimize their impact on its performance.
Relationship management with its supplier and partner network is often of particular importance.
Essential to the seven QMPs is the organization should establish an effective communications method for notifying the organization of nonconformities.
System approach to management, which appears in the 2008 version has been somewhat commingled into the 2015 seven principles.
Read More.
ISO 9001:2015.
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