Authors Posts by admin

admin

74 POSTS 0 COMMENTS

0 1962

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.

0 1436

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.

0 2140

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. 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. The adoption of all standards published by ISO, including standards in the ISO 9000 family, is voluntary in nature.
  3. 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. 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. 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. 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 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. 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. 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. Adherence to the ISO standards can be publicized to gain market access abroad, because many foreign buyers place a premium on these standards.

0 2469

Ready to implement ISO 9001 in your organization? Here are some ISO 9001 tips that will help make the process easier.

Implement ISO 9001 for the right reason.

When implementing a quality management system (QMS) for ISO 9001, management should be clear about the purpose of the QMS. If the only driver is to get on customers’ tender lists or because a competitor has already got one, it’s highly likely that the QMS will remain a set of documents for certification purposes only. Rather, management should aim for a QMS that will help the organization produce quality products or services, continuously improve its process, and provide confidence to customers that the organization is capable of meeting their requirements all the time.

Motivate your workforce.

In order for organizations to achieve a desired level of quality, people need to get involved. People are the essence of organizations and their full involvement is essential to implement and maintain ISO 9001. Employees can be motivated by:

  • Ensuring that everyone knows and understands the organization’s quality policy;
  • Defining and communicating responsibilities and authorities within the organization;
  • Building the competence of employees;
  • Providing adequate infrastructure and work environment;
  • Initiating improvements, e.g. by implementing employees’ suggestions.

Hire a consultant if…

If an organization’s staff does not have the time or skills to develop the QMS by themselves, a good consultant will make possible a speedy transfer of knowledge and skills. If the staff does have the time, there are enough published materials available from the web that will help staff obtain the necessary skills to develop the QMS.

Take the necessary time to implement your QMS.

All too often organizations are in a hurry to obtain certification and do not spend the time needed to implement the system effectively. Before applying for certification, your QMS needs to be in place for at least three months and its effectiveness checked through an internal audit, followed by corrective actions on audit findings.

Define SMART objectives.

Many organizations set quality objectives that are impossible to meet. Objectives need to be specific and relevant to the process or task to which they are being applied. They also need to be measurable and achievable within the resources that can be made available in a realistic and timely manner. It’s helpful to have a start and completion date.

Go easy with the paperwork.

Many believe that everything in the system needs to be elaborately documented. ISO 9001 only requires one quality manual, six procedures, and approximately 20 records. Many organizations are better off sticking to what is required and keeping those documents simple; additional procedures and records should be considered only if they add value to the system.

Set the example.

Some employees, especially mid-level managers, may find it difficult to change their ways of doing things and some can have a tendency to deviate from defined procedures. To change this, top management should ‘walk the talk’, i.e. they should not allow deviations from set procedures or permit the release of materials with deviations. Under such an approach, the mid-level managers will start respecting system requirements and everyone will take account of their responsibilities for the success of the QMS.