ISO 9001
-QUALITY MANAGEMENT SYSTEM-
why ISO 9001?
1- What is a management system?
A management system is the way in which an organization manages the interrelated parts of its business in order to achieve its objectives. These objectives can relate to a number of different topics, including product or service quality, operational efficiency, environmental performance, health and safety in the workplace and many more.
The level of complexity of the system will depend on each organization’s specific context. For some organizations, especially smaller ones, it may simply mean having strong leadership from the business owner, providing a clear definition of what is expected from each individual employee and how they contribute to the organization’s overall objectives, without the need for extensive documentation. More complex businesses operating, for example, in highly regulated sectors, may need extensive documentation and controls in order to fulfil their legal obligations and meet their organizational objectives.
2-Abstract
ISO 9001:2015 specifies requirements for a quality management system when an organization:
a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
All the requirements of ISO 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.
3-The Registration Audit
If you haven’t already, you will need to registrar with IBSC-UK Click Here, When you finish your registrar, you are starting a relationship that will last at least 3 years, most likely longer. You will want to make a careful decision to lay the groundwork for a smooth and lasting relationship.
When the day of your registration audit has arrived, it is time to showcase your Quality Management System. The auditor or auditors are coming in to see how you have addressed the requirements of ISO 9001, and how you have designed your QMS.
4-Preparing for the Audit
A-Prepare the employees
- Before the IBSC-UK Audit, you will want to make sure that all employees know that the audit will be taking place, and the purpose of the audit. This will help them understand how to respond to the auditor’s questions. You want employees to respond openly and honestly to the IBSC-UK auditor. The auditor is looking for evidence that you are complying with the requirements of ISO 9001, your employees are the ones that will be providing that evidence. Preparing them to answer the auditors questions will make the audit go more smoothly.
- This is not a test. If the IBSC-UK auditor asks a question, they are looking for information on how something works, not if the employee has all the answers but how the employee goes about finding answers and information. Do procedures provide information? If the information is not in a procedure, where does the employee go next, do they ask a supervisor? Use our Employee Flyers to update employees on this issue and other implementation steps throughout your project.
B-Prepare the facility
- Make sure all areas of the facility are clean and neat; there are potential nonconformances hiding in any given mess.
- Make sure documents are available where every they need to be used.
- Check bulletin boards, counters, cupboards, drawers for uncontrolled documents, uncalibrated measuring and monitoring instruments and unidentified parts or supplies.
C-Prepare for the Auditor
- Have a copy of the Quality Manual and Procedures available for the auditor.
- Designate a place for them to work when they are not out in the facility. They will need to work on their documentation and reporting.
- Assign someone to go with the Auditor to show them where different areas and departments are. Coach this person to let employees answer the auditor’s questions, not answer the questions themselves unless the question was directed to them
Remote auditing and certification
Remote audits offer a flexible alternative to traditional audit methods. Our remote audits offer the same level of quality you’ve come to expect from IBSC-UK.
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