- Evolution of ISO 9000 Standards – ISO began operations in 1947. ISO mission is to promote development of standardization and related activities in the world. It helps international exchange of goods and services. It helps in promoting scientific, technical, intellectual and economical activities.
- History & Revisions ISO 9000 – History of ISO 9000 series dates back to world war 2 when ministry of defense in Briton decided to implement set of standards to reduce mistakes and resulting accidents. Standards focus on management of procedures rather than actual manufacturing. ISO 9000 series focuses on Quality Management and has undergone many revisions over the years. World’s leading quality management system has been revised. All ISO standards are revised every five years to keep standards updated and current according to market trends.
- Back Ground – ISO management standards are series of frameworks that help you run your business effectively. ISO 9001 is internationally recognized standard for Quality Management System. It is most widely used standard worldwide. 1.1 million certificates issued to various organization’s in the world. ISO certification is proof of certification body that organization comply with ISO management standards. ISO certification gives your organization credibility. ISO creates documents that provide requirements, specification, guidelines and characteristics that can be used consistently to ensure that materials, processes, products and services are fit for their purpose. There are 22,598 ISO standards that are used by organizations worldwide. These standards are industry specific. Regulators and governments count on ISO standards to help develop regulations. ISO 9000 was first published in 1987 by International Standards Organization. It was based on BS 5750 series of standards from BSI that were proposed by ISO in 1970. However, its history can be traced backed to 20 years before that publication of government procurement standards. Large organizations which supplied government procurement agencies often has to comply with variety of quality assurance requirements for each contract awarded. Eventually ISO was adopted suitable option.
- Reason for Use – Global adoption of ISO 9001 may be attributable to number of factors. In the early days ISO 9001 requirements were intended by procuring organizations. This helps in reducing “Supplier Development” by establishing basic requirements for suppliers to assure product quality. ISO 9001 requirements could be tailored to meet specific contractual situations depending upon complexity of products, business types and risk to the producer. If the supplier is weak on control of measurement equipment and qc/ inspection results, that specific requirement would be invoked in the contract. Adoption of single quality assurance requirement also lead to cost saving through out supply chain by reducing administrative burden of separate quality assurance manuals and journals.
- Global Adoption – increase in iso 9001 certifications is increased is shown in the table below:
TOP 10 Countries ISO 9001 certificates (Year 2014)
| Rank | Country | No of Certificates |
| 1 | China | 3,42,800 |
| 2 | Italy | 1,68.960 |
| 3 | Germany | 55,363 |
| 4 | India | 41,016 |
| 5 | United Kingdom | 40,200 |
| 6 | Spain | 36,005 |
| 7 | United States | 33,008 |
| 8 | France | 29,122 |
| 9 | Australia | 19,731 |
| 10 | Japan | 45,785 |
- What is ISO 9001? – ISO 9001 is international quality standard for quality management system. In order to be certified ISO 9001, companies must follow quality standards laid down in QMS. Standard is designed to help companies at many levels, including focus on customer requirements, improving leadership with in companies, finding ways to continuously improve and many more. ISO 9001 is only standard series that requires certification. Typically, entire organization will need certification. Organization my go for certification for particular business unit or department initially and then later on other Business units or department in phase manner.
- What is Quality Management System? – Quality Management System is set policies, procedures and processes required for planning and execution in business organizations. Most of QMS emphasizes use of the some of systems that is repeatable, measurable and constantly evolving. This structured way of delivering best quality product and services is supported by documents viz. policies, work instruction, forms and procedures. Documented QMS defines responsibilities, actions to achieve quality goals. Most of the system include some types of internal as well as auditing process which ensures that system is following compliance standards.
- What is Quality Management System Manual? – Quality Manual is most important manual of QMS. It is similar to constitution of country or manifesto of party. Typical quality management system manual will include company quality policy goals as well as detailed description of quality control management system that might include staff and their relationship, procedures, system and other resources that relate to producing quality products and services.
- ISO 9000 Series Quality Management Principles – ISO 9000 Series are based on 7 Quality Management Principle. 1. Customer focus, 2. Leadership, 3. Engagement of people, 4. Process Approach, 5. Improvement, 6. Evidence based decision making, 7. Relationship Management.
- ISO 9000 Standards Series – ISO 9001 Quality Management, ISO 22000 Food safety Management, ISO 14000 Environmental Management, ISO 13485 Medical Devices. ISO / IEC 17025 testing and calibration laboratories, ISO / IEC 27001 Information Security Management, ISO 20021 Sustainable Events, ISO 639 Language Codes ISO 9001:2008, ISO 27001 series standards are ISO 27001, ISO 27002, ISO 27003, ISO 27004, ISO 27005, ISO 27006. This series primarily used for IT Security products.
- Structure of ISO 9001 – iso 9001 requirements are broadly categorized into 8 sections. Out of 8 sections 5 sections are most useful sections. These 5 sections A) Quality management system requirement clause 4, B) Management responsibility clause 5, C) resource management clause 6, D) product realization clause 7, E) measurement, analysis and improvement clause 8
- What benefits will it bring to my business or organization? – Better business, better products and services, better regulations, cost reduction, consumer safety, open access to new markets, improved environment performance, roadmap to better regulations, mitigate climate change impact.
- Implementing iso 9001 requirements – Planning – Implementation plan, communication plan, System design – designing documentation of quality management system, System implementation, Audit, Review & Implement, Certification
- Purpose of ISO 9001 documentation – documentation helps in communicating project related information to multiple stakeholders. Communication mediums are email, group chats, web forums, telephone calls, company mailing system etc. Frequency of communication is weekly, daily, monthly. All the important information should be communicated to stakeholders in the time bound manner. Providing evidence of completed activity, knowledge sharing & preserving or dispersing organization experiences.
- Change management process of ISO 9001 – Steps of change management processes of iso 9001 are Implement change control requirements to encourage more consistent results, update internal audit and system performance processes, take a corrective action for preventing re-occurring of problems, Plan and take actions to stop preventing problems in the beginning itself.
- Clauses of ISO 9001 (Planning Phase) – Understanding your organization and its context clause 4.1, Understanding needs & expectations of interested parties clause 4.2, Understanding the scope of QMS clause 4.3, Leadership and commitment clause 5.1, Leadership and commitment clause 5.1, Quality Policy clause 5.2, Organizational roles, responsibilities and authorities clause 5.3, Addressing risks and opportunities clause 6.1, Quality objectives clause 6.2, Resources clause 7.1, Competence clause 7.2, Awareness clause 7.3, Communication clause 7.4, Documented information clause 7.5, Operational planning and control clause 8.1, Requirements for products and services 8.2 Design and development of planning and input clause 8.3, Design and development control, output and changes clause 8.3, Control of externally provides products, services clause 8.4, Control of production and service provisions clause 8.5, Post production activities clause 8.5 and 8.6
- Clauses of ISO 9001 (Operations Phase) – Operational planning and control clause 8.1, Requirements for products and services 8.2, Design and development of planning and input clause 8.3, Design and development control, output and changes clause 8.3, Control of externally provides products, services clause 8.4, Control of production and service provisions clause 8.5, Post production activities clause 8.5 and 8.6, Control of non-performing output clause 8.7, Operating QMS clause 8
- Clauses of ISO 9001 (Check & Act Phase) – Monitoring, measurement, analysis and evaluation clause 9.1, Internal audit clause 9.2, Management review clause 9.3, Non conformities and corrective actions clause 10.1, Continual Improvement clause 10.2
- ISO 27000 Standards – ISO 27001 series standards are ISO 27001, ISO 27002, ISO 27003, ISO 27004, ISO 27005, ISO 27006. This series primarily used for IT Security products.
- ISO 9001 benefits –
- Benefits to the organizations
- Provides senior management with an efficient management process
- Sets out area of responsibility across the organization
- Mandatory if you want to tender public sector work
- Communicates a positive message for staff and customers
- Identifies and encourages more efficient and time saving process
- Highlight deficiencies
- Reduced your cost
- Provides continuous assessments and improvement
- Marketing opportunities
- Benefits to the customers
- Improved quality and service
- Delivery on time
- Right first-time attitude
- Fewer return products and complaints
- Independent audit demonstrate commitment to products and quality
- ISO 9001 VS ISO 9002 – ISO 9002 standard is most updated version of international standards compare to ISO 9001. Major difference between iso 9001 and iso 9002 is ISO 9001 is the model for quality assurance in design, development, production and installation while ISO 9002 is a model of quality assurance in production, servicing, installation. Iso 9001 sets out requirement for the organization whereas business processes range from design to development, production, servicing, installation. Iso 9002 is appropriate for those organization that do not concern on designing and developing products as it does not include design control requirements of iso 9001
- Why was ISO 9001 was revised? – ISO 9001 standards need continuous reviews in order to stay up to date and it must be initiated within 3 years of publication. standards. User inputs came from various sources to determine the revisions that includes world wide survey and questioner’s, market justification study, general suggestions that arrive from interpretations process, identified opportunities for enhanced compatibility with iso standards. To increate user ability, increase clarity and improve translation. current trend is to keep updated knowledge resources.
- What are Key Improvements? – Please refer following link – https://www.nqa.com/en-us/resources/blog/march-2015/step-7
- What benefits does new version bring? – Benefits of new version iso 9001:2015 are put greater emphasis on leadership engagement, helps in addressing organizational risks and opportunities in the structured manner, uses common terminologies and simplified language are particularly helpful to those organizations that uses multiple systems, addresses supply chain management effectively and efficiently, more user friendly for services based and knowledge-based organizations.
- Should I become ISO 9001 Certified Professional? – ISO 9001: 2000 combines three set of standards 9001, 9002, 9003 into one. Design and development are required only if company engages in creation of new products.
- How do I get started with ISO 9001: 2015? – ISO 9001:2015 will bring 6 benefits to your business or organization. 6 benefits when implementing quality management system: Assess overall context of your organization to define who is affected by your work and what they expect from you. It helps organizations to more efficient and improve customer satisfaction. You may purchase new standard guidelines from parent body international standard organization (ISO), analyze gaps, new procedures shall need to be established drafted, employees responsible for implanting new systems must be trained.
- Content OF ISO 9001:2015 – Requirements is approximately of 30 pages which is available from National Standards Organization of each country. Only ISO 9001 is directly audited against for third party assessment purpose only. Contents of ISO 9001:2015 is as mentioned below – Section 1: Scope, Section 2: Normative References, Section 3: Terms and Definitions, Section 4: Context of the organization, Section 5: Leadership, Section 6: Planning, Section 7: Support, Section 8: Operations, Section 9: Performance Evaluation, Section 10: Continual Improvement
- ISO 9000:2015 Principles OF Quality Management – ISO 9001:2015 describes fundamental principle of quality management which are universally applicable to the organizations seeking sustainable success through the implementation of quality management systems. Sustained success achieved when organization retains confidence of customers and interested parties. Every aspect of customer interaction provides more opportunity to create more value for the customer.
- Certification – ISO 9001 certification is suitable for all sizes and types of organizations and is well established around the globe.It is suitable for organizations across all the industry sectors.It helps organizations in competing locally as well as globally. Certification benefits are customer satisfaction, reduced operating costs, improved stakeholder relationships, legal compliance, improved risk management, proven business credentials and ability to win more business.
- Auditing – ISO audit is basic term means checking you are actually doing what you are saying doing.During iso audit auditor verify thatmanagement systems are following compliance standards laid down by accreditation body. Check to ensure that actions taken to meet quality goals of organization are suitable.
- What is Audit Process – Audit process is thespecific steps performed in finance, operational and compliance audits.Steps may vary depending upon the company and type of audit servicing company owner requested from accounting and auditing firms.
- Industry-Specific Interpretations – Please refer following link. https://www.youtube.com/watch?v=aYILbY9K7DE
- Effectiveness OF ISO 9000 –
- Advantages OF ISO 9000 Series – There are many advantages associated with adaption of iso 9000 certification systems. Both business analyst and investor can benefit by implementation of iso 9000 systems. Benefits range from minor staff issues, operations issues, shop floor issues, operational strategies, impact production, quality of production, delivery cycle, product and services life cycle, increasing productivity, reduction of unnecessary costs and quality of processes and
- Advantages v/s Disadvantages of ISO 9001 – Please refer following link http://www.rfwireless-world.com/Terminology/Advantages-and-Disadvantages-of-ISO-9001-QMS.html
- Other standards in ISO 9000 families ISO 9001 Quality Management, ISO 22000 Food safety Management, ISO 14000 Environmental Management, ISO 13485 Medical Devices. ISO / IEC 17025 testing and calibration laboratories, ISO / IEC 27001 Information Security Management, ISO 20021 Sustainable Events, ISO 639 Language Codes ISO 9001:2008 ISO 9004 etc.
- Success Stories of ISO 9000 & Other ISO Standards – https://www.iso.org/news/2013/02/Ref1712.html
