Best Ways Of Implementing ISO 9001 Standards

Best Ways Of Implementing ISO 9001 Standards

While each implementation is dependent on the company, the industry, customers, etc., here’s a good starting point:

1.) Identify what your customer expects of your company. Consider both sales and after-sales aspects, from the customer’s point of view.

2.) Develop a philosophy (Quality Policy) that addresses (1). This means clause 5.3.

3.) Identify your processes, keeping in mind the importance of each as compared to (1) above. This means clause 4.1.

4.) Identify your management structure, being sure it supports and does not conflict with (1), (2) or (3). This means the rest of Clause 5 in the standard.

5.) Figure out resource issues. This means all of Clause 6.

7.) From there, work on clauses 7 & 8. This part is particularly hard to define as a generic plan, because how it is done is unique to each company, and the results of (1) through (6) above.

Tips:

(a) Keep documentation to the absolute minimum.

(b) Put “required procedures” and process maps in your Quality Manual, instead of subordinate documents. This makes the QM useful, instead of just a throwaway restatement of the standard. Limits documentation overall.

(c) Spend a lot of time on process identification and definition, so that you understand them and can manage them

(d) Develop an internal audit program (process!) that reflects your company needs, not a checklist method used by registrars

10 steps on the implementation of ISO 9001 Standards are as below:

1. Analyze your businesses’ core process(es) for converting customer needs into cash at a high level to show the sequence and interaction of the key processes within the core process (one page).

2. Identify (and assign a code) each of the key processes within your system (as-is) and the new ones necessary for the system to be used to add value faster and prevent loss sooner (the chosen system standard is very helpful for listing the missing processes). Expect 20 to 50 key processes.

3. Analyze each of the key processes by working with the process owner to determine each processes’ objective, team, inputs, value-adding steps (tasks, meetings, decisions), outputs; then link the procedure to the other controls and process with which it interacts (one page each).

4. Leaders explain their policy, the obligations of the system (already 85% or so implemented) and its benefits.

5. Train process teams in any new processes so they are working effectively from day one.

6. Describe the system and how it works, the policy and objectives in a less than 10 page manual.

7. Launch the system and invite lots of suggested improvements.

8. Gather and analyze data to become information for use by decision makers to improve products, processes and the system.

9. Audit the performance of the system independently of any other process control to provide impartial information on how well the system is helping employees to do their jobs.

10. Use and improve the system, its processes and your products so your organization adds value faster and prevent loss sooner.

How To Prepare ISO 9001 Standards Audit Check List

How To Prepare ISO 9001 Standards Audit Check List

There are a few steps to prepare ISO 9001 Standards Check List, namely:

1. Apply the concept of Plan Do Check Act (PDCA). This PDCA concept is applied at the Quality Management System and the process levels.

2. Convert the question to requirement raised by QMR or the QMS Committee which derived from theISO 9001 standards. In this case, several questions can lead to one single requirement.

3. To edit those questions to suit the process that is to be audited. For example, you are going to audit the Purchasing/Procurement Department and you’re sitting down with the Audit Team trying to come up with relevant questions.

The main objective in auditing any process is to extract adequate information and evidence in order to verify that the process is conformant to the ISO 9001 requirements and that, it is effective in achieving its objectives. As an auditor, you need to be able to investigate, assess and verify the conformity and effectiveness of a given process, in terms of its planning, implementation, monitoring & measurement and improvement. As a Lead Auditor, preparing your Audit Team for the actual audit is crucial in ensuring success of the audit excercise. There is no better way to do that than by developing the audit questions with them.

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.

ISO 9001 Standards & ISO 14001 Standards

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 ofISO 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.