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.

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.

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 the ISO 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.