Foundations Of Quality Management System (QMS)- part-01

Foundations Of Quality Management System

We will start foundation of quality management system course as per ISO-9001-2015. 

This course will contain around 10 modules. the first module we will speak  about the 

history of ISO 9001 Revisions , the global status of ISO 9001 & changes in revision , 

explain what companies should do with change , clarify and describe common 

misconceptions about revision and the benefit to follow ISO 9001-2015 . let us start.

History of ISO 9001 Revisions 

The idea behind ISO 9001 can be traced back to the British Standard 5750 in

 1979,however the ISO 9000 history is as follow :-

-The first version of ISO 9000 was published in 1987 and was based on BS 575 

 standard. It was also  influenced by Defense Military standard .

-The second version of ISO 9000:1994 was published in 1994. This version stressed 

quality assurance through preventative action. 

-The third version was published in 2000 as ISO 9001:2000. This version radically 

changed thinking as it held the belief that process management should be the core of 

the standard .

-ISO 9001:2000 made the goals of standard crystal clear i.e. that standard should be ‘a 

documented system’ not just a ‘system of documents’. The idea was to create system 

efficiency that can be measured and validated by process performance.

-The fourth version is ISO 9001:2008 standard. This edition on made slight changes 

to the previous version. The goal of this revision was to better explain 2000 edition 

requirements and to increase compatibility with other management systems, such as 

ISO 14001. 

-The fifth major revision was published in 2015. This version is called ISO 

9001:2015. Because the revision in 2008 was just a minor update of the 2000 version, 

this revision sought to fill in gaps that have been formed over the fifteen years 

since 2000.

Global Status of ISO 9001 and Revision

By 2014, the ISO: 9001 standard was used by more than 1.1 million people and

organizations in 180 countries worldwide, which makes it easy to believe that this number 

will have surely grown as of 2017.

BSI Group claims to have achieved the first global accreditation for ISO 9001:2015.

This revision will influence all certification and authorization bodies, training bodies, 

advisors, implementing agencies and business clients.

The standard has helped to build systems for various sectors such as the manufacturing 

sector, automotive sector, the medical sector, governments and more.

ISO 9001 version 2015 is meant for companies who want to:

Prove that they are capable of delivering high quality products and services, which will then 

fulfill client requirements and regulatory needs.

Enhance customer satisfaction.

 Key changes in ISO 9001 version 2015 include the

 following key changes:

• Building a quality management system that is well matched to each organization’s particular needs.
• Top management must be involved in the management system in order to make comprehensive enterprise strategy.
• The prevalence of risk-based thinking across the standard enables the entire management system to be used as a preventive instrument, which will continually boost improvement.
• Less enforcing requirements for records and documentation. The enterprise can now decide independently what documented information it requires and what is the appropriate format.
• Integration with other important and widespread management system standards.

          Fundamental Concepts in ISO 9001:2015

Nigel Croft, Chairperson of the ISO subcommittee for revising the standard, emphasizes that the revision 

is based on three basic concepts:

  -    Process approach

   -   PDCA Model i.e. Plan Do Check & Act

  -    Risk Based Thinking

Misconceptions about Revision

There are two prevalent misconceptions about revision due to incorporation of risk-based 

thinking:

1-  Substitution of Process Approach by Risk Based Thinking

2-  Preventive Action Has Been Removed

When risk-based thinking in included, preventive action will become a habit and thus 

prevention is involved in every phase of the process.

Action Plan for Organizations

Currently accredited management systems can be adapted with some minor modifications. 

In many situations, organizations should have sufficient documentation and protocols 

already in place with their presently certified management system.

As risk is incorporated in many sections of the revision of ISO 9001, companies should 

focus on establishing their risk management protocols if they do not currently have a 

system in place for controlling risks. The companies must start thinking about how to 

incorporate risk in their businesses at both a strategic level as well as an operational level.

The transitional period does not end until 2018, so organizations will have had three years 

to update their systems and make sure it comply with the revision.

Certification Process - Phases

Starting Point: Outline the scope of the certification program.

Pre-Audit (not mandatory): This is a gap analysis phase against standard. This helps 

companies to identify what they need to do to prepare for a certification audit.

Certification Audits are actually conducted in 2 stages:

-Stage 1 Audit is a readiness review audit to prove that the organization is prepared for 

certification.

- Stage 2 Audit is an assessment of implementation, along with the effectiveness, and 

performance evaluation of the management system of the organization. This is the stage 

where certification is awarded.  A certificate is valid for 3 years and is awarded based on 

the results of stage 2 audit.

Surveillance Audits are conducted to prove that the management system maintains 

fulfillment against requirements of standard and are also conducted to observe the 

continual improvement of the management system.

Re-Certification Audits are done after 3 years to endorse the effectiveness of the 

management system as a whole. Certificate is then reissued for next 3 years.

 Certification Process – Implementation Benefits

          Improved customer retention, satisfaction, and acquisition.

         Exhibition of management commitment towards quality of services and products.

        Improving cost control through conserving input materials.

        Reducing defects that result in complaints, therefore reducing compensation costs.

         Increase in efficiency, productivity, and profit.

           Creation of knowledge database for effective management of company knowledge.

            Consistent outcomes which are measured and monitored.

            High Level Structure (HLS) to easily integrate with more than one standard.

     Benefits of ISO 9001 Certification Program to 

     Customers.

      

 Some clients will only purchase or buy services or products from certified companies since it provides

 them the assurance that management systems are continuously assessed, improved, and monitored.

Some of the benefits to customers are: 

         Reduces repeated mistakes.

         Develops a complaint reporting system and improves performance.

         Improved quality products and services by internal auditing.

         Consistent and robust scheduling of production and delivery.

         Performance will be maintained with the help of external certification body annual assessments program.

What Can't Companies Do?

Companies cannot do following with ISO 9001 certification:  

        Companies cannot employ or change ISO’s logo. It is ISO’s brand and intellectual property.

         Companies cannot equate ISO 9001 certification to being ISO certified. Companies which are ISO  9001:2015 certified are not certified by ISO or by ISO 9001 technical committee, but rather by an     Accreditation Body like UKAS.

         ISO 9001:2015 cannot be branded on company products or utilized in literature to denote that product is   certified by ISO 9001. It is not a product certification but a company quality management system   certification.

         Companies must be careful with their scope so to correctly describe their certified activities and     geographic locations. A certification is only awarded on the defined scope. Activities of companies   outside the certification scope cannot be implied to gain benefits of ISO 9001 certification.