Ask about ISO 9001

GOOD MANUFACTURING PRACTICE (cGMP) QUALITY MANAGEMENT SYSTEMS - ISO 9001:2000
1

Hello everyone!
I am an old member, but I was absent on the board for a long time, I have just returned with new account ( I don’t remember my password and email I registered) I do not know if this might be room to ask questions about ISO 9001
http://iso-90012008.net/
. If I misplaced, I thanks to the administrator put in place. I’m learning about ISO 9001 but my english is not very good to read these specialized materials in English. Can you tell me a simple and easy way to understand about it ? The concept, purpose and use in organizations. I’m sorry because my english is not good. I hope that you can understand what I wrote.
Many thanks for your helping!
Jenny

I’m afraid of learning about ISO 9001 and stuff relating…

2

No worries about your English!

The question is a bit broad. ISO 9001, in general, is a means to establish a quality-centric system in an organization. It can be applied to any industry and is the foundation for other, industry-specific systems such as ISO 13485 for medical devices. The scope covers the entire product lifecycle: product conception, R&D, manufacturing (product realization), and post market.

The best way to understand it is to first get a copy of the standard (available at the ISO store - it is copyrighted so you can’t get a free copy legally), read through it, and see how it applies to your organization. If you have specific questions, you can come back to forums like this to get help / understand the finer points.

3

Hello Jenny,

Here’s the overview of ISO 9001.

ISO 9001 - Quality Management Standard

ISO 9001 is the internationally recognised standard for the quality management of businesses. ISO 9001 applies to the processes that create and control the products and services an organisation supplies prescribes systematic control of activities to ensure that the needs and expectations of customers are met is designed and intended to apply to virtually any product or service, made by any process anywhere in the world
ISO 9001 is one of the standards in the ISO 9000 family.

The benefits of implementing ISO 9001

Implementing a Quality Management System will motivate staff by defining their key roles and responsibilities. Cost savings can be made through improved efficiency and productivity, as product or service deficiencies will be highlighted. From this, improvements can be developed, resulting in less waste, inappropriate or rejected work and fewer complaints. Customers will notice that orders are met consistently, on time and to the correct specification. This can open up the market place to increased opportunities.

Why seek ISO 9001 certification?

ISO 9001 certification by an accredited certification body shows commitment to quality, customers, and a willingness to work towards improving efficiency.
It demonstrates the existence of an effective quality management system that satisfies the rigours of an independent, external audit.

ISO 9001 certification enhances company image in the eyes of customers, employees and shareholders alike.

It also gives a competitive edge to an organisation’s marketing.

How do you start to implement ISO 9001? What is involved?

Identify the requirements of ISO 9001 and how they apply to the business involved.
Establish quality objectives and how they fit in to the operation of the business.
Produce a documented quality policy indicating how these requirements are satisfied.
Communicate them throughout the organisation.
Evaluate the quality policy, its stated objectives and then prioritise requirements to ensure they are met.
Identify the boundaries of the management system and produce documented procedures as required.
Ensure these procedures are suitable and adhered to.
Once developed, internal audits are needed to ensure the system carries on working.

Hope this helped you. :slight_smile:
If you want to seek training, you may check out CavendishScott.com for
ISO 9001 Training
http://www.cavendishscott.com/iso-training/irca-certified-iso-9001-2008-lead-auditor-training-course.html
.

4

Thanks so much for your postings!
Do you know the meaning of the numbers after the ISO, for example: ISO 9001, ISO 9000, ISO 14000, ISO17025 … What do they mean?

5

The ISO 9000 standards are a collection of formal International Standards, Technical Specifications, Technical Reports, Handbooks and web based documents on Quality Management. There are approximately 25 documents in the collection altogether, with new or revised documents being developed on an ongoing basis.