Question

Please explain the following stages of iso 9001 2015 in as nuch detail as possible

Please explain the Stages of lso 9001 2015 Stages 1. Preparation 2. Documentation 3. Implementation 4. Internal audits 5. Certification

Answer 1

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ISO 9001 add tremendous benefits to your business. The best way to get ISO 9001 certification with minimal investment and maximum rewards is through following steps:

Step 1: Preparation

The first step addresses how to best prepare for the implementation of ISO 9001.

Set the Objectives that Benefit Your Business

ISO 9001 can greatly benefit business, including its internal operations, efficiency and profitability, as well as provide marketing advantages and the ability to tap markets that are only open to ISO 9001 certified companies. Organizations can realize these powerful benefits if they actively pursue them and if they identify and set the right objectives at the start of their ISO 9001 certification process. Prerequisite for benefiting most from ISO 9001 as well as making the required, initial decisions is the understanding of the ISO 9001:2015 standard and the certification process.

There are three common certification approaches, each with its own pros and cons.

Popular Approaches to ISO 9001 Certification

In-house implementation - company insiders are best suited to set up a widely-accepted and sustainable ISO 9001 system that fits the company's operations and culture at low cost but internal efforts are high and time frames slow.

Consultant (hands-on) - time to certification may be fastest and internal efforts minimal but costs are high, the resulting ISO 9001 system tends to be ill-fitting, and the typical lack of internal ownership often leads to eventual failure.

Consultant (hands-off) - internal ownership and sustainability of the ISO 9001 system are very high and time to certification is moderate but costs are by far the highest and internal efforts significant. The best hands-off consultants are able to improve internal operations.

Certification kit - company insiders supported by a good certification kit can rather quickly set up a suitable, widely-accepted and sustainable ISO 9001 system while costs and required internal efforts are comparably low. The best certification kits are easy to use, often require no prior experience, and effectively streamline internal operations.

Step 2: Documentation

Writing the quality policy, procedures and other ISO 9001 documents is usually considered the most difficult step when implementing ISO 9001. This is because these documents have to meet all of the numerous technical requirements of the ISO 9001:2015 standard, which many find difficult to understand, interpret and apply to their company's circumstances

Which Documents Are Required by ISO 9001?

Though ISO 9001 has become less prescriptive regarding the number of required documents, the following are part of any quality management system:

Quality policy

Procedures

Scope of the quality management system

Process map (flowchart)

Quality objectives

Work instructions

Forms

Good documentation is prepared by company insiders to ensure it is both specific and suitable to the company. There is no required format but a well-designed format and layout makes the documentation more user-friendly.

The best templates meet the following conditions:

Efficient processes: Good templates form the basis of efficient processes that are free of bureaucracy and unnecessary paperwork. They create simple and effective processes that minimize required efforts and the possibility for errors.

Clarity: Good templates are easy to understand and easy to use. They should be free of jargon and time-consuming references to other documents.

Layout: Good templates are laid out in a practical and user-friendly way. Lists of numbered sentences should be avoided.

Customization instructions: Without good and detailed customization instructions, the templates couldn't be properly customized to fit the company's circumstances, including its work processes, management style and culture, and the results likely wouldn't even comply with ISO 9001 requirements. Good customization instructions are very detailed and in form of a separate document (as opposed to simple tips within the templates). They are also easy to understand and apply to the company's situation.

Step 3: Implementation

During this phase company will help employees to adjust their way of working accordingly. To make this step a success, it is most important that employees understand how the new processes and requirements will benefit them. Obviously, this requires that the new processes are in fact efficient, non-bureaucratic and user-friendly and that their benefits are clear.

There must be proper work instructions. Employees should be instructed to think of the best way of doing their work, then document the main steps. Documentation could be in any format, ranging from text to flowcharts, from pictures or screenshots to videos. The criteria for choosing the format are simple: make the instructions most useful to the user.

Step 4: Internal Audit

Internal ISO 9001 audits are inspections in which the company evaluates itself to see if all ISO 9001 requirements are being followed. These internal audits are not only conducted when implementing ISO 9001 processes but also periodically after achieving ISO 9001 certification. All internal audits are performed by one or more employees of the company who has been trained in ISO 9001 auditing; alternatively, a subcontractor could be used. The job of the internal auditor is to verify that the company meets the requirements of ISO 9001:2015 as they are described in the new ISO 9001 procedures and work instructions.

Step 5: Certification

In order to achieve ISO 9001 certification, it will be necessary to have an independent, third-party ISO 9001 auditor visit the company and perform a site audit. The certification audit can be performed soon after the completion of internal audit and after collection of about two months worth of records using the ISO 9001 processes.

Selecting the ISO 9001 Registrar

The ISO 9001 registrar is the independent entity that sends the auditor and issues the ISO 9001 certificate.

The ISO 9001 Certification Audit

The ISO 9001 certification audit is similar to the internal audits. A third-party auditor or audit team will perform a site audit in which they visit some or all departments of the company and randomly verify that the requirements in the procedures and work instructions are being implemented and followed by management and employees.

Unless the auditor uncovers significant problems with ISO 9001 quality management system, the company will receive the ISO 9001 certificate shortly after the site audit. If, however, the auditor finds some significant problems, then company will have an opportunity to correct those problems before the ISO 9001 certification is issued.

How to Prepare for the Certification Audit

It's important to prepare the staff for the certification audit. There are several items that should be addressed prior to the day the auditor arrives:

Make staff relaxed - explain what to expect from the audit and the auditor.

Documents - document control is always verified so be sure that there are no outdated or uncontrolled documents floating around.

Questions - practice typical audit questions to ensure staff will understand the auditor. Some of the frequently asked questions include "How do you know that you perform your work correctly" (the auditor wants to know about performance criteria and measurements) and "How do you contribute to the objectives of your company's quality policy?" (checking understanding of the quality policy and its application in daily work).

Answers - employees should answer auditor questions truthfully but without volunteering additional information.

An easy way of preparing staff for this important day is presenting a short multimedia video. Also, good certification kits should include audit preparation tools, ideally including a list of typical auditor questions and issues that most auditors will focus on during the site audit.

Maintaining Certification

ISO 9001 certification is not a one-time event. The ISO 9001 registrar will perform a surveillance site audit once or twice a year in order to verify continued ISO 9001 compliance and even improvement of the ISO 9001 quality management system. If the implementation of ISO 9001 quality management system is done correctly and is already designed to continually improve itself. Make sure your ISO 9001 processes remain implemented, continue the internal audits.