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Archive for the ‘Quality Management’ Category

In order to stay ahead of your competitors, you constantly need to be on the lookout for new ideas.  Cutting edge technology is one such factor.  Because more and more people are getting technologically advanced, the IT gurus are not alone anymore when it comes to understanding the newest quality management software.  Managing quality and processes manually is extremely difficult without the correct tools and may lead to many problems.  These usually include delays in project timelines, poor customer satisfaction, a lack of team motivation, and poor resource allocation.  In order to address these and other issues, the use of quality management software is highly recommended to save both time and costs.

The top five myths relating to Quality Management Software are listed below:

  • Myth no. 1: Only Technical Personnel can use Quality Management Software

 

A common misconception concerning quality management software is that anything relating to software must be dealt with by the company’s technical team.  This subsequently gives rise to this myth that only IT departments/technical personnel of companies can handle and use quality management software.  However, there are numerous quality management software programs which are designed for everyday users who are familiar with internet usage; programs designed to be user-friendly.

  • Myth no. 2: Risk of losing data with Quality Management Software

 

A well-known myth associated with quality management software systems involves the perception that the electronic storage of data is somehow riskier than retaining paper versions of the data.  In contrast, quality management software is far safer than any other methods of documentation.  For example, with quality management software you can create a backup of all your data every day, therefore ensuring that your data is always safe and secure.  The same does not apply to a paper based system.

  • Myth no. 3: Implementing Quality Management Software can have a negative impact financially

 

Due to the demand for quality management software, the competition has increased amongst vendors.  This benefited companies, seeing as they can now select quality management software at affordable prices.  The myth surrounding quality management software having a negative impact financially on companies thus holds no truth.  Many vendors now even offer less-expensive, cost effective quality management software through services such as on demand/SaaS, where the software is hosted on the vendor’s server for a small monthly fee.  In addition, this reduces the cost of ownership by over 60% and makes the implementation thereof possible in a much shorter time period.

  • Myth no. 4: Quality Management Software is  only for big companies

 

The fourth myth surrounding quality management software involves that it is designed and meant only for large organizations with multiple sites.  However, in such a competitive environment, where the smallest of things can help companies gain a competitive edge over their competition, it is mandatory for every organization to track and control documents, manage non-conformances, and adhere to regulatory requirements with the help of quality management software.  No matter the company size, amount of locations or number of employees, all companies must demonstrate the highest standards and quality to auditors if they are to be certified to a standard that meets industry regulations, as well as customer demands.  Achieving these goals can be easy with quality management software, as it ensures continuous improvement, critical information security, issue visibility, quick problem resolution, and fast regulatory approvals in order to effectively and efficiently market new products.

  • Myth no. 5: Poor to no return on investment on Quality Management Software

 

When considering using quality management software, senior management will usually question its potential return on investment.  In contrast to the myth that suggests that quality management software are a poor return on investment, various studies actually indicate that using quality management software can save administrative time, reduce printing costs, improve production cycles, speed up change control processes, and improve speed of response – all of which adds up to a considerable return on investment.  Depending on the scope of implementation, quality management software can offer return on investment in as little as 12 months.

One of the best known and most used management systems throughout the world is offered by the International Organization for Standardization (ISO).  It is estimated that ISO 9001 quality management system are implemented by more than one million organizations in 75 countries worldwide.  Companies that are ISO 9001 certified follow guidelines as set by ISO.  ISO 9001 quality management system is probably the most comprehensive standard used nowadays.  ISO 9001 quality management system is a tried and tested framework helping companies to ensure that they always meet the needs of their respective clients.

Find below the general requirements of the ISO 9001 Quality Management System:

  • Documentation

To fully comply with ISO 9001 quality management system, certified companies that offer services or products must possess documented statements of a quality policy that contains the quality objectives.

  • Quality Manual

Companies seeking ISO 9001 quality management system certification must be in possession of a quality manual.  A quality manual contains the scope of the ISO 9001 quality management system and related documented procedures to address all quality related issues.

 

  • Control of Documentation

Control of documentation is important to ensure that all related ISO 9001 quality management system documents are approved before being issued.  When control of documentation is applied, it is easy for all documentation to be kept up-to-date.  When changes are made, revisions must be resubmitted for approval.

  • Management Responsibility

ISO is only responsible for putting the ISO 9001 quality management system together, not for auditing companies as well.  Companies implementing the ISO 9001 quality management system may perform a self-audit, but in most cases companies want to be certified as compliant.  To achieve this, the business management practices of companies need to be reviewed by an independent quality system certification company.  An independent assessment is perceived to be much more credible.

  • Avoiding Multiple Audits

Companies can eliminate costly and numerous audits through the institution of ISO 9001 quality management system certification.  Meeting the ISO 9001 quality management system certification requirements allows for a known set of rules to be followed within a business.

  • Measurement and Analysis

The monitoring, measurement, analysis and improvement processes regarding the ISO 9001 quality management system need to be planned and implemented to demonstrate conformity to product requirements, ensure conformity of the ISO 9001 quality management system, as well as continually improve the effectiveness of the ISO 9001 quality management system.  This includes determination of applicable methods, including statistical techniques, and the extent of their use.

  • Continual Improvement

Continual development and improvement of guidelines are essential if a company wants to remain compliant with the ISO 9001 quality management system standard.  This also ensures that corrective and preventative measures are in place to deal with any nonconformity that may arise.

A Gap Analysis Audit basically defines the relationship between your organisation’s current Quality Management System (QMS) and the ISO 9001:2008 standard. The current extent of ISO 9001 compliance is determined by trained, qualified ISO auditors. It is an initial audit that identifies the “gap” (if any) that exists between your current quality management system and the requirements of ISO 9001.

The importance of the document known as the Quality Manual cannot be underestimated. It contains the top management’s intentions for operating the quality system of the organisation. The Quality Manual encompasses policies concerning the quality system, including all areas affected by, or affecting, the mentioned quality system. Department managers within the organisation make use of the Quality Manual once procedures need to be implemented. Quality Manuals also provide a measure for procedures, processes, and results.

Requirements of a Quality Manual

The Quality Manual of an organisation should include the following:

  • The scope of the quality management system, including details of, and justification for, any exclusions;
  • The documented procedures established for the quality management system, or reference to them; and
  • A description of the interaction between the processes of the quality management system.

Quality Manual Format and Content

It should be noted that the format of the quality manual has no specific guidelines. It is left to your organisation to decide on the structure of the document to best support your organisation’s objectives.

Below is the content that makes up the Quality Manual:

  • The quality policy of the organisation;
  • An explanation concerning the documentation structure of the organisation;
  • Policy statements to demonstrate the intention of management to comply with ISO 9001 requirements. All areas of the ISO 9001 standard should be covered by these policy statements. It should thus include:

* How management is expecting company operations to function?

* Who is responsible for implementing these expectations?

* Where and when the policies are applicable within the organisation?

* What interdependencies exist between functions and processes?

  • Reference should be made to the company’s “second tier” operating procedures;
  • Management representatives should be assigned who are responsible for quality in the organisation; and
  • A description of the set-up of the organisation.

The quality manual does not contain any confidential/proprietary information and is therefore made available to third party auditors and customers.

You should ensure that a clear distinction is made between the contents of the quality manual and the operating procedures. The quality manual defines the intention of management for operation of the quality system, while the operating procedures define how these intentions are implemented within the organisation.

Primary Uses of the Quality Manual

The primary uses of the quality manual include:

  • Communicating management’s expectations for quality to the organisation;
  • Demonstrating the organisation’s compliance with ISO 9001 requirements; and
  • Serving as a measure for compliance to management’s expectations for:

* Customer Audits;

* Internal Audits;

* ISO Registrar Audits.

Development of the Quality Manual

Several steps are involved during the development stage of the Quality Manual:

  • Listing policies that are to be written;
  • Listing second-tier operating procedures that are cross-referenced to policies;
  • Drafting policies based on ISO 9001 requirements;
  • Input from all departments is necessary;
  • Identifying quality system inadequacies;
  • Determining the structure and the format of the of the manual;
  • Publishing the first draft of the manual; and
  • Formal review, approval, and release.

The importance of the document known as the Quality Manual cannot be underestimated. It contains the top management’s intentions for operating the quality system of the organisation. The Quality Manual encompasses policies concerning the quality system, including all areas affected by, or affecting, the mentioned quality system. Department managers within the organisation make use of the Quality Manual once procedures need to be implemented. Quality Manuals also provide a measure for procedures, processes, and results.

Requirements of a Quality Manual

The Quality Manual of an organisation should include the following:

  • The scope of the quality management system, including details of, and justification for, any exclusions;
  • The documented procedures established for the quality management system, or reference to them; and
  • A description of the interaction between the processes of the quality management system.

Quality Manual Format and Content

It should be noted that the format of the quality manual has no specific guidelines. It is left to your organisation to decide on the structure of the document to best support your organisation’s objectives.

Below is the content that makes up the Quality Manual:

  • The quality policy of the organisation;
  • An explanation concerning the documentation structure of the organisation;
  • Policy statements to demonstrate the intention of management to comply with ISO 9001 requirements. All areas of the ISO 9001 standard should be covered by these policy statements. It should thus include:

* How management is expecting company operations to function?

* Who is responsible for implementing these expectations?

* Where and when the policies are applicable within the organisation?

* What interdependencies exist between functions and processes?

  • Reference should be made to the company’s “second tier” operating procedures;
  • Management representatives should be assigned who are responsible for quality in the organisation; and
  • A description of the set-up of the organisation.

The quality manual does not contain any confidential/proprietary information and is therefore made available to third party auditors and customers.

You should ensure that a clear distinction is made between the contents of the quality manual and the operating procedures. The quality manual defines the intention of management for operation of the quality system, while the operating procedures define how these intentions are implemented within the organisation.

Primary Uses of the Quality Manual

The primary uses of the quality manual include:

  • Communicating management’s expectations for quality to the organisation;
  • Demonstrating the organisation’s compliance with ISO 9001 requirements; and
  • Serving as a measure for compliance to management’s expectations for:

* Customer Audits;

* Internal Audits;

* ISO Registrar Audits.

Development of the Quality Manual

Several steps are involved during the development stage of the Quality Manual:

  • Listing policies that are to be written;
  • Listing second-tier operating procedures that are cross-referenced to policies;
  • Drafting policies based on ISO 9001 requirements;
  • Input from all departments is necessary;
  • Identifying quality system inadequacies;
  • Determining the structure and the format of the of the manual;
  • Publishing the first draft of the manual; and
  • Formal review, approval, and release.

We can help with the following:

 

  • Implement your Quality Management System;
  • Preparing for the Certification Audit;
  • Update/ adjust your current Quality Management System;
  • Managing and Maintaining Quality Management Systems;
  • Quality Management System Development;
  • Compiling a Quality Manual Draft;
  • Conducting a Review of current Policies and Procedures;
  • Development of Quality Control Policies and Procedures;
  • Development of Document Control Policies and Procedures;
  • Conducting Internal Quality Management System Audits;
  • Conducting Gap Analysis Audits;
  • Conducting Supplier/Third Party Audits;
  • Documentation Management and Control;
  • Service regarding Advise and Consultancy;
  • Conducting a study concerning Quality Due Diligence.

 

We at RynMag will ensure that we deliver our best services that your business is ready for your ISO 9001 Certification.

RynMag Management Systems is a South African based company specializing in the creating and implementing of Computer based Management Systems for small and large enterprises in all regions of the world, which has a need for a system based on any of the following Standards or requirements:

We have a computer based fully automated management system that will give people in your company, access to relevant SHEQ information. The legal register of your Enterprise (inclusive of all Legislation) would form part of the system along with all Amendments and Regulations.

The RynMag System is not only for companies needing ISO / OHSAS based Management systems, but also companies who has their system fully implemented but in need of a Computer based management System for the distribution of information and maintenance of the ISO based management system.

Read more about the different options within the RynMag Management System:

The RynMag Management System will address management and documentation distribution or maintenance issues within the following industries along the requirements set by you along with the requirements of the particular ISO / OHSAS Standard:

  • Industrial Companies
  • Manufacturing Companies
  • Construction Companies
  • Transport
  • Mining Industry
  • Petro Chemical Industry
  • Retail

Your documentation will be woven to an integrated unit. The ISO and OHSAS Standards are loaded to the system together, as an integrated unit that covers all the necessary aspects.

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