ISO 9001 Standards Certification

ISO 9001 Standards Certification

When an organization chooses not to pursue ISO 9001 certification or not to retain the ISO 9001 certificate, it should make no difference to the way the organization is managed. It’s similar to the man who chooses not to take the course examination. He still has the knowledge he has acquired whether or not he takes the exam and gets a certificate. What he cannot do is demonstrate to others that he has reached a certain level of education without having to prove it every time. People who know him don’t care that he didn’t take the exam. It is only those who don’t know him that he will have difficulty convincing.

Audit Of Electronic Documents In ISO 9001 Standards

Audit Of Electronic Documents In ISO 9001 Standards

Electronic documents that establish management system policies and procedures can be in a variety of file formats depending on the software applications that are utilized by the organization to generate the documents. Electronic file formats include, Text, HTML, PDF, etc. Spreadsheets and databases formats are also considered to be electronic “documents” subject to the control elements of the management system to being audited.

Given the relative ease with which users can now create electronic spreadsheets and other electronic documents, auditors (either internal or external) should ensure that policies governing the controls that apply to management system documentation in-general are also employed for electronic documents through appropriate procedures.

Organizations need to employ suitable and effective methods within the electronic environment for ensuring the adequate review, approval, publication and distribution of its management system documentation. These should be consistent with the methods for the development and modification of electronic documents.

In many cases document control measures may also be standard features of software applications used for their creation. Therefore auditors should understand these application-specific controls to the degree that these are utilized as a basis for conformance to the applicable management system standard.

Given the increased capacity to modify, update, reformat and otherwise improve documents within an electronic-based management system, auditors should pay particular attention to control elements such as document identification and document revision level.

As electronic media facilitates an increased rate of document modifications, auditors should verify that the controls being employed for the management of obsolete documents are considered within the organizations’ document control policies and procedures.

Auditors should verify that electronic-based documentation exists to provide orientation to users with regard to the functional and control aspects associated with electronic documents. Additionally, “Point-of-use” requirements associated with the applicable management system standards will typically be addressed in part by the organization’s document access policies. Auditors should understand the organization’s policies and procedures regarding user privileges as these become important factors for properly realizing the organization’s processes.

External electronic communication with suppliers, customers and other interested parties may involve the exchange of documents. Given that these external documents may contain key parameters that specify the functioning of the organization’s processes, auditors should verify the degree to which these documents are formally introduced and controlled within the electronic-based management system.

Different Between Quality Assurance & Quality Control

QA: Quality Assurance is the process which are having their eyes on the process to provide the assurity of the quality. like doing the testing at the time of development, giving the review comments and forced the developers to fixed the defects of the requirement, designed, coding and testing phase is the Quality Assurance.

Quality Control: Before delivering the product to make sure that all the documentation are provided, product has meet with the requirement criteria, all the SDLC phase are met with the exit criteria is the Quality control.

Difference between Quality Control and Quality Assurance? Quality Control Quality Assurance Definition QC is about checking at the end of some development process (e.g. – a design activity) that we have built quality in i.e. that we have achieved the required quality with our methods. QA is about having an overall development and management process that provides right environment for ensuring quality of final product. Description QC is like testing a module against requirement specification or design document, measuring response time, throughput etc. QA gives us added assurance that the whole producing or checking process is properly planned and executed and thus maintaining high quality. What it does To check that the modern methods of software development are largely designed to ensure right quality is achieved. QC checks that these methods are in place and to discover where they are not then corrections are to be made. It gives us added assurance that the while producing / checking process is being properly planned and executed and hence is keeping high our chances of producing software of required quality. Stages Define features and levels Define feature check procedure Carrying out the check procedure Record the result take and record any corrective action taken. 1. Determination of quality policy through Quality Management System 2. Checking that predetermined Quality control activities are being properly taken care off. Best carried out on QC is best carried out on products QA is best carried out on process. Phase of implementation QC should take place at every stage of SDLC. QA should be done at end of every SDLC i.e. when product building is complete. Technique Structured walkthrough, Fagan Techniques are some of QC techniques. Quality policy defined and generally implemented in the form of Quality Management System is used to carry out QA.

As per ISO 9000 Standards:

Quality Control means – The Operational Techique and activities that are used to fullfill requirements of Quality,

Quality Assurance means – All Those planned and systematic activites implemented already , to provide adequate confidence that an entity will fulfillrequirements of Quality.

The following table can explain in detail:

QC QA

Product Process

Reactive Pro-active

Line Function Staff Function

Find the defects Prevent the defects

e.g.

QC QA

Walkthrough Quality Audit

Testing Defining Process

Inspection Selection of tools

Checkpoint Review Trainings

Step by Step: Leading your company to Successful ISO 9001:2008 Registration

Step by Step: Leading your company to Successful ISO 9001:2008 Registration

1. ISO 9000 Introduction, a Process approach.

2. Gap Analysis: Schedule the Gap Analysis, Conduction and ISO 9001 Gap Analysis.

3. Prepare a Project Plan: The Team approach, Steering Team, Task Teams.

4. Train employees on ISO 9001: Mamagement Overview, Employee awareness, Keeping them informed.

5. Document your system: How much Documentation do you need, Importance of Documentation control

6. Implement the QMS in your Organization:Training on new procedures, Training of internal auditors.

7. Audit your QMS: Train internal Auditors, Conduct Internal Audits.

8. ISO 9001:2008 Registration Audit: Selecting a Registrar and then go ahead with registration.

Document Review In ISO 9000 Standards

Document Review In ISO 9000 Standards

The ISO 9000 Standard requires that documents be reviewed.
Previously the implication was that the review was a check by potential users that the document was fit for purpose before it was offered for approval. It
could be construed that for a document to receive approval it must be checked and therefore review and approval in this context are one and the same
and the requirement is in this instance enhanced rather than relaxed.
A review is another look at something. Therefore document review is a task that is carried out at any time following the issue of a document.
This requirement responds to the Continual Improvement principle.
Reviews may be necessary when:
- Taking remedial action (i.e. Correcting an error)
- Taking corrective action (i.e. Preventing an error recurring)
- Taking preventive action (i.e. Preventing the occurrence of an error)
- Taking maintenance action (i.e. Keeping information current)
- Validating a document for use (i.e. When selecting documents for use in connection with a project, product, contract or other application)
- Taking improvement action (i.e. Making beneficial change to the information)
Reviews may be random or periodic. Random reviews are reactive and arise from an error or a change that is either planned or unplanned. Periodic reviews
are proactive and could be scheduled once each year to review the policies, processes, products, procedures, specification etc. for continued suitability. In
this way obsolete documents are culled from the system. However, if the system is being properly maintained there should be no outdated information
available in the user domain. Whenever a new process or a modified process in installed the redundant elements including documentation and equipment
should be disposed of.

ISO 9000 Standards Document control procedures

ISO 9000 Standards Document control procedures

BACKGROUND TO THE ISO 9001:2008 REVISION PROCESS

BACKGROUND TO THE ISO 9001:2008 REVISION PROCESS

In order to assist organizations to have a full understanding of the new ISO 9001:2008, it may be useful to have an insight on the revision process, how this revision reflects the inputs received from users of the standard, and the consideration given to benefits and impacts during its development.

Prior to the commencement of a revision (or amendment) to a management system standard, ISO/Guide 72:2001 Guidelines for the justification and development of management system standards recommends that a “Justification Study” is prepared to present a case for the proposed project and that it outlines details of the data and inputs used to support its arguments. In relation to the development of ISO 9001:2008 user needs were identified from the following:

-the results of a formal “Systematic Review” on ISO 9001:2000 that was performed by the members of ISO/TC 176/SC2 during 2003-2004

-feedback from the ISO/TC 176/Working Group on “Interpretations”

-the results of an extensive worldwide “User Feedback Survey on ISO 9001 and

The Justification Study identified the need for an amendment, provided that the impact on users would be limited and that changes would only be introduced when there were clear benefits to users.

The key focuses of the ISO 9001:2008 amendment were to enhance the clarity of ISO 9001:2000 and to enhance its compatibility with ISO 14001:2004.

A tool for assessing the impacts versus benefits for proposed changes was created to assist the drafters of the amendment in deciding which changes should be included, and to assist in the verification of drafts against the identified user needs. The following decision making principles were applied:

1) No changes with high impact would be incorporated into the standard;

2) Changes with medium impact would only be incorporated when they provided a correspondingly medium or high benefit to users of the standard;

3) Even where a change was low impact, it had to be justified by the benefits it delivered to users, before being incorporated.

The changes incorporated in this ISO 9001:2008 edition were classified in terms of impact into the following categories:

-No changes or minimum changes on user documents, including records

-No changes or minimum changes to existing processes of the organization

-No additional training required or minimal training required

-No effects on current certifications

The benefits identified for the ISO 9001:2008 edition fall into the following categories:

-Provides clarity

-Increases compatibility with ISO 14001.

-Maintains consistency with ISO 9000 family of standards.

-Improves translatability.