ISO 9001:2000 Requirements in API Units

Any one please provide/Explain , how to implement In API unit ISO, how to get ISO certificate, how to maintain ISO document/ Records

Please explain how to implement ISO in Pharma /Bulk units , what document required

regards
Murali

Below 4 major steps to get ISO certified:

1.Write documentation.

You’ll need a written quality manual, certain written procedures, and probably some forms. Some records will have to be kept. Your documentation will have to meet the requirements of the ISO quality standard. It will also have to fit your company’s quality goals. Your quality documentation says what you do, how you do it, and provides proof that you do it. You must be able to demonstrate that you are continuously improving your quality system as well as your product or service, and your customers’ satisfaction.

2.Training.

All of your people will require some training. The amount of training is dependent on each individual’s responsibilities.

3.Practice and live with your quality system for a few months.

Undoubtedly you will find that some changes need to be made. Keep records in accordance with your quality system. After a few months your quality system and your people should be ready for the registration audit.

4.Get audited.

The number of auditors needed, and the time involved to conduct a registration audit will vary according to the size and complexity of your company. During an ISO audit, the auditor(s) will examine your records and will talk with your people. It is very important that your staff is properly trained and that your records are in order. Auditors write up problems as “nonconformances”. Nonconformances can be “major” or “minor”. Auditors can also write up “observations”.
A major nonconformance will cause you not to get certified to the ISO standard. Minor nonconformances may or may not prevent your certification, it all depends on the number and severity of your nonconformances. Auditors have a fair amount of discretion in what they write up, and whether or not you will get certified on your first try.

You can visit ISO 9001
http://iso-90012008.net/
for having more informations.

Best rgs

Hi

This topic help me a lot in developing my project. I will contribute more when I finished it.

If you want to get more materials that related to this topic, you can visit: ISO 9001 2008 requirements
http://iso-90012008.net/iso-9001-2008-requirements/

Best regards.

Getting and ISO certificate would be hard and would take a long time, about 6 months to 2 years. Anyway you can follow these steps on how to get ISO certificate,

  1. You should educate yourself. Educate yourself on what ISO 9001 means and how this certification can help you business.

  2. Preliminary Audit. You can perform your own preliminary audit using audit checklists available online as a guideline, or by preparing your own audit checklist based on the manual and training you received in step 1. Use this as a chance to evaluate how things are done now, versus what you would have to change in order to get certified.

  3. Hire a Consultant. It might be wise to hire a consultant, even for a one-day evaluation of your company, to make sure you’re on the right track. The consultant will perform his/her own audit and interview various members of the company to get an idea of what your company does and how things are done. You can then make an educated choice whether to let them continue with the certification process and prepare your documents for you, or whether you might be able to go it alone. For ISO 9001 Consulting
    http://www.cavendishscott.com/iso-consulting/iso-9001-consulting.html
    , cavendish scott is one of the best.

  4. Establish Staff Roles. You need to establish the roles of various managers and staff in terms of who will be performing audits, who will maintain certain documents and who will conduct management reviews and implement improvements. All auditors should receive auditor training. In a large company, it might be cost-effective to have an accredited instructor come to you. Smaller companies can take advantage of the frequently offered public courses.

  5. Prepare Process Diagrams. Most consultants will recommend you take this organizational approach to planning your application. The act of preparing process diagrams helps you visualize all the inputs and outputs of each product your company produces. This will aid in setting up controls and documentation for each step of each process.

  6. Prepare Documentation. Take advantage of existing documentation in your company, as mentioned in step 2. You will likely find that some documents require updating or minor revisions. Implement these changes and then proceed to preparing your ISO 9001:2000 QMS Manual. In the manual, you outline how each of the QMS requirements are being met, by referring to the existing (or newly prepared) documents for daily tasks such as ordering, customer relations, production, R&D, quality control and more. This is the most time consuming step of becoming ISO certified.

  7. Staff Training. Once the QMS manual is prepared and you have all documentation in place, it’s time to train the remainder of staff on the ISO process and what it entails. Passing the audit requires compliance at all levels. Ensure management recognizes their role in setting examples and motivating staff.

  8. Pre-Certification Audit. Performing another internal audit ensures there will be no surprises when the external (third party) auditor comes. You could consider bringing back the consultant that you hired in step 3, to make sure you have understood and addressed all of his/her concerns. By now, you should find only minor non-compliance issues, if any. Address these now, and, if necessary, perform a second internal audit.

  9. Certification Audit. Once you are satisfied you are complying with all the QMS requirements, you are ready for your third party audit by an accredited certification body. If you have followed the guidelines and everything is in place, you should hopefully pass your audit with flying colors!

Tips:

Don’t make things more complicated than they need to be. Use existing documentation/manuals and keep the QMS Manual as simple as possible.
Talk to as many consultants as you can at the beginning, and take an auditor training course to make sure you don’t overlook anything and are very familiar with what the auditors are looking for.

source:
http://biotech.about.com/od/isocertification/ht/HowtoQMS.htm

The major requirements of the ISO 9001:2000 standard are described in sections 4.1 through 8.5.3 of the actual Standard. Although the Standard is copyrighted, and we cannot provide a copy here, we have summarized the major requirements of the standard.