Objectives of Quality Management System Certification

Objectives of Quality Management System Certification

ISO 9001(1)1QMS standard may be a set of quality management tips that are adopted by thousands of organizations round the world. It provides processes and procedures to assist corporations improve the standard of the merchandise or service they supply. So as to attain ISO accreditation, businesses have to be compelled to demonstrate to meet variety of objectives for effective QMS implementation.

Senior Management Commitment

Effective Quality Management System requires that the complete commitment and backing of senior management may be a very important component of achieving ISO accreditation. While not the complete support of the senior management team, the creation and implementation of quality management systems and processes can lack the impetus needed to form them winning. This will increase the chance that any enforced procedures will quickly fail, so compromising quality.


Design Process

ISO 9001 states that everyone comes should be planned completely and with quality as a priority in any respect stages within the life cycle of the merchandise, from style to manufacture to maintenance. Any changes or alterations within the style of the merchandise have to be compelled to be QMS 9001 documentation and recorded, and therefore the data of the amendment communicated to any or all relevant parties.


Supplier Vetting

It may be requirements of QMS 9001 that every one new supplier is completely vetted before any contracts are awarded. This is to determine the standard of service and products that the provider can give; similarly as guaranteeing that they need the resources necessary to satisfy your demand. This can lead to long and productive operating relationships with suppliers.


Inspection and Testing

All materials and product utilized in the creation and producing of an item should be completely inspected before use. This is often to confirm that they’re fit purpose, and every one testing records should be maintained and filed. Before a product is free to the general public, it should endure final testing and attain the sign-off of senior management.

Internal Audits

All businesses seeking QMS certification should do regular and thorough internal audits to check that the processes and procedures that are enforced among the corporate are operating and being well maintained. Any shortcomings, discrepancies or areas of improvement should be communicated to senior management and a point in time given for any issues to be corrected.

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Steps involved in ISO9001:2008 Certification

Steps involved in ISO9001:2008 Certification 

ISO 9001
The steps involved in any ISO9000 certification project are the following:

  • Gap Analysis: Assessment of existing quality management practices vis-a-vis ISO9001 requirements.
  • Orientation Training: Top/Senior Management orientation on ISO9001 requirements and action plans.
  • System Documentation: Preparation of quality manuals and design of quality record formats.
  • System Implementation: Implementation of quality system as per the quality manuals.
  • Company-wide Training: Training on ISO9000 clauses, Statistical Quality Control Techniques, and Quality Audit.
  • Internal Quality Audits: Periodic assessment of quality system implementation and corrective actions.
  • Pre assessment: Initial audit by Certifying agency, and, implementation of corrective actions.
  • Final Assessment: Certification audit by the Certifying agency and recommendation for certification

Internal Auditing – How Often ?

Any organisation/business is required to conduct internal audits to maintain its ISO9001 standard. The audit involves testing out company processes and procedures to determine the standard at which they operate when compared to how they should work. Audits are designed to help employees but the mere mention of the word can see your staff sent into a panic, scrambling around to make everything look perfect. However, communicating yourself well to your staff on the benefit of the audits, and letting them know that this is not a finger pointing exercise, can serve well to make these audits more positive.

Internal audits should be viewed in a positive light, a chance to take a step back and have your process reviewed by a fresh set of objective eyes. They are an ideal way to prepare for external assessment too. In some ways internal assessments can be more thorough as processes are examined more closely, more frequently and in greater detail than external auditors.

ISO 9001 does not specify how often internal audits should be conducted. Instead, the requirements are that organisations audit based on how important a process is, the risks involved and whether there is an existing record of previous concerns. Consideration should also be given to quality objectives as these can dictate audit frequency. At the least, internal audits should be carried out annually. There are two ways around this – auditors may decide to review processes in one go, or they may portion off aspects and have a plan which details the schedule over a number of months. Complex processes may require more frequent assessment and this should be built into an internal audit plan.

The audit plan removes the need for panic and helps eliminate an atmosphere of mistrust. It lets everyone know what will be happening and when, as well as allowing process owners time to complete any improvements that may be taking place. Although the audit plan is made general knowledge, the detail relating to timings should be confirmed with respective process owners as soon as is possible.

The internal audit should not be seen as second string to an external audit and for that reason it needs to be as thorough as possible. Appointed auditors may benefit from some training and development to support them in getting the best out of the process. Auditors should apply a variety of methods to test the process including talking to employees, reviewing data and relevant documentation as well as and perhaps most importantly observing the process in practice. Part of being thorough is keeping accurate documentation that is a true reflection of the findings, for both management and future audits.

The aim of the audit should not be to purely report non-conformance, but auditors should also use the opportunity to highlight areas of a process which may benefit from change. Therefore as important as the audit is the follow up. Follow ups are critical to ensuring that the audit cycle is closed off, and they are also a great motivating factor for further improvements.

source: http://synergosconsultancy.co.uk

Conducting Audits: Science or Art:

contact:  kris@themanagementsystems.com

Conducting Audits can be a Science but Meaningful Audits is an Art:

  • Identifying missing elements and obvious     audit image6noncompliance/nonconformances is easy,
  • Identifying what is good and/or done right is necessary but difficult,
  • Identifying nonconformances to the intent of the standards or ineffective processes and activities is  difficult in a working environment,
  • Separating the trivial (observations and findings) from the Important takes judgement and experience,
  • Lecturing about audit conduct and policy is easy,
  • Asking the right questions is harder,
  • Getting people to talk and listening to what they have to say can be difficult,
  • Establishing credibility (audit has value) is an art, it must be earned,
  • Maintaining control of the audit without turning off communications takes leadership,
  • Separating fact from fancy takes experience; reliance on objective evidence, 
  • Making recommendations to resolve findings & observations is not good audit practice:          – Lack of familiarity with the process and practice                                                                                – Lose objectivity and become part of the problem,
  • Making suggestions that would stimulate resolution is recommended, where necessary.