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ISO 9001

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Today, more and more organizations are deciding to adopt the ISO 9001 standard as a guideline for their quality management system (QMS). With the implementation of ISO 9001, an organization demonstrates its ability to consistently provide products or services that comply with applicable law and meet the demands of its customers. If an organization implements and maintains a successful QMS it will gain a number of benefits.

Benefits of ISO 9001 within the market:

  • Improved image of products or services offered.
  • Level playing field with large companies when bidding for new contracts.
  • Preferential treatment from potential customers who themselves have implemented ISO 9001.
  • Adherence to the ISO standards can be publicized to gain market access abroad, because many foreign buyers place a premium on these standards.
  • For organizations that obtain certification, most certification bodies keep an updated list of certified companies and organizations and provide this list upon request to potential customers or other interested parties.

Benefits of ISO 9001 with customers:

  • Improved customer satisfaction.
  • Obtaining certification will reduce the frequency of audits of the QMS by different customers.
  • Secure customers’ loyalty as their needs and expectations will be continually met, leading to more business opportunities.

Benefits of ISO 9001 for the organization’s QMS:

  • Quality will be seen as everyone’s responsibility instead of being the sole responsibility one person (the quality control inspector or manager).
  • Serve as a means to maintain and improve the effectiveness and adequacy of the QMS, by highlighting areas with potential for improvement.
  • Increase motivation and participation of staff and improve resources management.
  • QMS will provide you with a means of documenting the organization’s experience in a structured manner (quality manual, procedures, instructions, etc).
  • You will generate savings, as the costs of reprocessing, rework, repeat inspections, replacing products, penalties due to delayed deliveries, customer returns, customer complaints and warranty claims will gradually fall.

The biggest benefit to be gained from maintaining a QMS from ISO 9001 is the huge savings an organization can make by considerably reducing the cost of failures. By aiming to consistently produce quality products or services, organizations will reduce waste and thus lower costs. They will have more satisfied customers who will have fewer problems with their product or service.

All these will have a major effect on sales revenue, improve market share and engender in an organization’s customers a higher level of satisfaction.

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In order for organizations to successfully implement an ISO 9001 Quality Management System (QMS) that provides confidence to customers and serves as an instrument for continuous improvement, the implementation process should be taken up as a project, following these steps and recommendations:

Step 1: Nominate a Team.

  • A small team consisting of a senior person from each department should be appointed by management for system development.
  • A coordinator must be designated.
  • The team should undergo awareness and documentation training on the ISO 9000 family of standards with a professional training organization.

Step 2: Carry out a gap analysis

  • Start with a flow chart showing how information currently circulates, from order placement by the customer to delivery of the product or service.
  • Follow with a flow chart of activities in each department.
  • Formulate a list of existing procedures and work instructions for the most relevant activities in each department.
  • Other activities and processes that are considered relevant at this point can be added.
  • Identify gaps throughout this process.
  • A time-bound action plan to close the gaps identified during this exercise should be prepared and action taken as planned.

Step 3: Prepare documentation

  • Procedures should be limited the documentation that is required.
  • Additional procedures and records should be devised only if they add value to the system.
  • Involve all personnel concerned in the development of the procedures and work instructions applicable to their areas.
  • Documentation should reflect current practice and not ideas of what should be implemented.
  • New forms and checklists should be created if necessary; otherwise adopt existing ones to the extent possible.

Step 4: Train and implement

  • Train all employees. Everyone should know their responsibilities in order to successfully implement and maintain the QMS.

Step 5: Conduct Internal audit and improvement

  • Some managers and staff members should be trained by a professional trainer to carry out internal auditing.
  • Conduct the first internal audit approximately three months from implementation.
  • Correct any gap found during the audit.
  • Once the system stabilizes, internal audits should be conducted at planned intervals.
  • To improve the system internal audits, customer feedback data, process and product monitoring data, evidence of the attainment or not of quality objectives, corrective actions taken, etc. should be used.
  • Management should provide financial and other resources for improvement projects and monitor the progress of improvement.

Step 6: Management review

  • Top management should review the QMS.
  • As a result of this review, management may decide to set new targets for quality objectives and to make the improvements needed in the QMS.

Step 7: Certification

  • Certification is voluntary; therefore the need for it should be decided by management.
  • Once the system has been in operation for a few months, organizations may consider making an application for certification.

An action plan for developing QMS covering the above activities should be prepared. The plan should define the responsibilities of team members and management and set target dates. Full implementation may require six to nine months.

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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

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