Tags Posts tagged with "ISO 9001"

ISO 9001

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If your organization is ready to become ISO 9001 certified, there are a number of steps you can expect to go through on your path to certification. Once an organization has decided to obtain certification and has made a choice of the certification body (CB), the organization must:

 Make a formal certification application to the CB.

  • Fill out the application forms, which require a large amount of information about the organization and its operations. This will enable the CB to determine the scope of the certification activities and to appoint the team leader for the audit process.

 The initial certification audit consists of a two-stage audit as described below:

 The Stage 1 Audit determines if an organization is ready or not for a compliance audit.

  • Organizations need to supply all relevant management and quality documentation to the CB.
  • The CB determines if the organization is ready or not to undergo Stage 2 or compliance audit.
  • If the organization is not ready, the CB will inform accordingly and stop the process.
  • If the organization is ready, but a few nonconformities have to be rectified before the compliance audit can take place, the CB will provide the organization with a report.
  • After nonconformities have been corrected, the organization must inform the CB, and if they concur with the actions taken, a compliance audit is arranged.

 The Stage 2 Audit evaluates the implementation and effectiveness of the organization’s QMS.

  • The team leader assembles a team of auditors and experts concomitant with the organization’s scope of activities, complexities and size of operations.
  • A time for the audit is agreed and scheduled.
  • Auditors will assess whether the contents of the documentation provided is consistent with the activities of the organization as well as the requirements of the standard.
  • Overall findings and the list of non-conformities (if any) are presented.
  • If the QMS complies with the requirements, the team will recommend to the certification committee of the CB that the organization should be certified.
  • If there are non-conformities found, the team will agree with the organization a time schedule (typically 3 months) and the modalities for rectifying the non-conformities.
  • The team may wish to witness the new procedures, or if the non-conformities are of a minor nature, the organization can send them evidence that these non-conformities have been fixed.
  • The team will recommend to the certification committee of the CB that the organization should be certified.

Learn more about Stage 1 and 2 audits.

Certification

  • Authorized persons or a committee which was not involved in the audit will review the audit report and the clearance report of the nonconformities and make a decision regarding certification.
  • The decision will be followed by the issue of certification documents.

 Surveillance Audits

  • The CB will conduct a surveillance audit usually once a year.
  • There are a few areas that will always be included in the surveillance audit, such as internal audits and management reviews as well as the non-conformity system.
  • If any non-conformity is raised during the surveillance audits, the organization must correct them efficiently within an agreed time frame, otherwise certification may be lost.

 Recertification Audit

  • In the third year of certification, a re-certification audit will be conducted, similar to the original compliance audit.
  • If this is negotiated successfully, the organization will be recertified for another three-year period, and the whole cycle repeats itself.

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Ten ISO 9000 Facts You Need To Know - ISOUpdate.com

The ISO 9000 series of quality standards is the most used management system worldwide; thousands of organizations rely on these standards to establish an effective quality management system.

Here are some facts every organization pursuing to implement ISO 9001 should know.

1. ISO 900 Family of Standards

The ISO 9000 family of standards are a set of standards and guidelines that have global reputation as being the basis for the establishment of quality management systems (QMS).

2. It’s Voluntary

The adoption of all standards published by ISO, including standards in the ISO 9000 family, is voluntary in nature.

3. You Don’t Need a Certificate to Use ISO 9000

In the ISO 9000 series, all standards can be implemented without certification. Any business can use the models from the standards to improve quality management systems.

4. Names Vary in Different Country

Many countries have adopted the ISO 9000 family of standards and have also appropriated its numbering system for their national standards. For instance in the United Kingdom, ISO 9001 is referred to as BS EN ISO 9001:2008, with BS standing for British Standard and EN for European Norm. In Sri Lanka, the standard is numbered SLS ISO 9001:2008, with SLS denoting Sri Lankan Standard.

5. Everyone Can Use the ISO 9000 Series

Any organization, regardless of the type of products or services they offer, can use ISO 9001 as their guideline to implement, maintain and improve a successful QMS.

6. The Focus is on Your Company Performance

ISO 9001 provides a process approach for its execution, which enables the QMS to connect with other organizational processes; and its focus on continuous improvement and customer satisfaction will lead to an improved business performance.

7. ISO 9001 Promotes Flexibility Within the Standards

ISO 9001 specifies what an organization “should” do, but not “how” they should do it, giving great flexibility for any company, large or small, to use this standard. Additionally, ISO 9001 does not establish specific quality requirements; this is a decision taken by each organization; the standard is only a guide to achieve the goals and objectives set by each organization.

8. ISO Industry Specific Requirements Don’t Dilute the ISO 9000 Family

Specific industry requirements were added to ISO 9001 to create standards for organizations in the automotive, telecommunications, aerospace, medical devices, oil and gas, and information technology sectors. These QMS standards have not diluted or modified the requirements of the ISO 9001 generic standard, but have added some sector-specific requirements, guidelines and clarifications. Some of these are:

  • Automotive industry:  ISO/TS 16949
  • Medical devices: ISO 13485
  • Primary packaging materials for medicinal products: ISO 15378
  • Petroleum, petrochemical and natural gas industries: ISO/TS 29001
  • Telecommunications industry: TL 9000
  • Aerospace Industry: AS 9100; AS9110 and AS9120

9. Understand the Benefits of an Accredited Certification

Certification of your QMS by an accredited certification body generates confidence among your existing and potential customers and other interested parties that you are capable of supplying consistently conforming products or services.

10. You Can Promote Your Certification

Adherence to the ISO standards can be publicized to gain market access abroad, because many foreign buyers place a premium on these standards.

Learn Tips and Tricks for ISO 9001 Certification