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What are ISO Standards?
Webster dictionary defines standard as “something set up and established by authority as a rule for the measure of quantity, weight, extent, value, or quality”
ISO standards are the rules set by International Organization for Standardization (ISO). Earlier this Organization was called as International Standards Organization and after a prolonged deliberation the organization shifted its focus from Organization to Standardization and hence now the name stands at International Organization for Standardization and referred to as ISO standards.
ISO has a membership of 164 national standards organizations and representation from companies, quality practitioners, academicians, government and private bodies who formed an independent conglomeration to write universally acceptable rules which are now called ISO standards. ISO has published standard for every conceivable product or services. Enforcement of these ISO standards uniformly across the globe has been possible through a ISO certification process which ensures that certain benchmarks setup in the standard are met by all facilities that intend to get certified.
ISO certification is conferred by ISO based on the recommendation by accredited ISO Certification Bodies. These ISO Certification Bodies must earn their credentials by registering in a forum called International Accreditation Forum (IAF) through Multi-Lateral Agreements (MLA)
ISO certification process is complicated to those who do not understand the intent of the standard. ISO standards auditors are trained to seek evidence for every claim made by any facility before they approve compliance to the standard. Thus, it is imperative that an evidence based system is built to ensure compliance and obtain ISO certification.
- ISO certification for any facility is necessary to assure their customers that the facility can produce products or services with consistent quality
- ISO certification is helpful in streamlining all the processes in to a single management system
- ISO certification brings in continual improvement in any organization
- ISO certification elevates any facility to be a global level company
- ISO certification is required as a good marketing tool
- ISO certification is required to reap many benefits like process control, monitoring and measurement of process outputs, control of products and services from providers etc.
- ISO standards pave the way for building quality for any product or service by utilizing relevant standard
- ISO standards defined management system is an effective monitoring tool for all operations within the facility and hence could be one of the best management tools
- ISO certification is required for global acceptance of all goods or services from a facility
- ISO certification encompasses all activities under each facility and takes in to account all issues and concerns of all interested parties
- All facilities who require acceptance by the customers for consistency and continuity in quality
- All facilities who want to avoid audit by regulatory authorities
- All facilities who require a comprehensive management system whose efficacy can be tested should get ISO certified.
- Facilities requiring global acceptance for their products and services
- Facilities requiring to provide confidence to customers regarding consistency in quality of their goods and services should get certified to ISO standards
- Any facility small, big or huge corporation are all treated equal for ISO certifications hence any facility can get certified
- Any facility who wants to be system dependent instead of being dependent on few experienced individuals must get certified
- Any facility getting certified to the ISO standard relevant to them increases their market share by improving their acceptability. Hence should get certified
- Any facility requiring disciplined approach for their processes, have methods for monitoring and measurement of processes, control on goods and services incoming and control on goods and services being provided should get certified
- Any facility seeking continual improvement should get certified, since ISO standards provide for a system of continual improvement
- Any facility requiring control on nonconformities, consequent corrective and preventive actions should get certified
- In short any facility requiring to get rid of quality problems , procurement problems and control problems should get certified
Different ISO Standards
There are many published ISO standards applicable to various types of industries products and services some of them are discussed below:
Standard for Quality Management Systems. This is considered as a parent or main standard. Since quality is important in all spheres of industrial or business activity this standard is a must for all types products and services. QSE provides ISO 9001 Consulting services to assist organizations in developing ISO 9001:2015 procedures using IS0 9001 templates, ISO 9001:2015 checklists, conducting ISO 9001 internal audits using ISO 9001 Internal Audit checklists. A competent ISO 9001 consultant uses a disciplined ISO 9001 certification process to meet all the requirements of ISO 9001:2015 through providing ISO 9001 training to all interested parties to ensure dissemination of Quality Policy, Quality Objectives and targets, Benefits of ISO 9001:2015 certification, implications of not adhering to ISO 9001:2015 compliance requirements, benefits of process approach application and continual improvements through risk considerations. Total ISO 9001 certification cost cannot be fully determined since ISO 9001 certification is a never-ending process and a race with no finish line.
This is standard for biological evaluation of medical devices. The purpose of this standard is to determine the potential for an unacceptable adverse biological response resulting from contact of the component materials of the device with the body of human or animal. For effective implementation for ISO 10993 standard, the organizations develop ISO 10993 audit checklists to conduct ISO 10993 Gap analysis, develop ISO 10993 training materials to disseminate to all interested parties related to ISO 10993 requirements, develop ISO 10993 Quality Management System (use Annex FDA guidance of ISO 10993-1 standard), conduct ISO 10993 internal audits, using ISO 10993 audit checklists and conduct management review of the ISO 10993 Quality Management System for ISO 10993 standard compliance prior to ISO 10993 certification audit. Any organization seeking ISO 10993 certification may use ISO 10993 Consulting, ISO 10993 Auditing and ISO 10993 Training entities. A competent ISO 10993 consultant may be present during ISO 10993 certification audit to defend the established ISO 10993 Quality Management System without interfering with ISO 10993 certification auditors
ISO 13485:2016 is a standard for Medical Devices. This International Standard specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services. For effective implementation for ISO 13485 standard, the organizations develop ISO 13485 audit checklists to conduct ISO 13485 Gap analysis, develop ISO 13485 training materials to disseminate to all interested parties related to ISO 13485 requirements, develop ISO 13485 Quality Management System, conduct ISO 13485 internal audits, using ISO 13485 audit checklists and conduct management review of the ISO 13485 Quality Management System for ISO 13485 standard compliance prior to ISO 13485 certification audit. Any organization seeking ISO 13485 certification may use ISO 13485 Consulting, ISO 13485 Auditing and ISO 13485 Training entities. A competent ISO 13485 consultant may be present during ISO 13485 certification audit to defend the established ISO 13485 Quality Management System without interfering with ISO 13485 certification auditors
ISO 17025:2017 This standard is for all types of laboratories. This standard refers to the requirements of all types of laboratories to demonstrate their ability to provide accurate and consistent results on the tests and measurements performed by them. A reputed ISO 17025 consultant or ISO 17025 consulting company provides effective ISO 17025 training, to meet all requirements of ISO 17025 standard initially through a gap analysis using ISO 17025 audit checklist and fully prepare organizations to ISO 17025 certification. ISO 17025 internal auditors to develop a comprehensive ISO 17025 internal audit reports and submit them to top management for appropriate and timely corrective actions. ISO 17025 emphasizes total customer satisfaction related to laboratory testing & measuring equipment calibration, with results accuracy using competent laboratory technicians. ISO 17025 standard requires laboratory technicians use appropriate audit checklists to record test results with accuracy and correctness. It is essential to conduct internal audits using ISO 17025 audit checklists to judge the effectiveness of the entire ISO 17025 quality management system in maintaining and retaining customer satisfaction related to laboratory testing/ measuring equipment calibration.
ISO 15189:2013 Standard uses ISO 17025 and ISO 9001 as straw documents for developing all the requirements essential for medical laboratories. ISO 15189 requirements emphasize the importance of connection to both human and animal lives during medical laboratory testing activities. A reputed ISO 15189 consultant provides effective ISO 15189 training, to meet all requirements of ISO 15189 standard initially through a gap analysis using ISO 15189 checklist and fully prepare organizations to ISO 15189 certification. ISO 15189 emphasizes total patient satisfaction related to laboratory testing, results accuracy using competent laboratory technicians. ISO 15189 standard requires medical laboratory technicians use appropriate checklists to record medical test results with accuracy and correctness. It is essential to conduct internal audits using ISO 15189 Audit checklists to judge the effectiveness of the entire ISO 15189 quality management system in maintaining and retaining patient satisfaction related to medical laboratory testing
ISO 15378:2017 This standard is for primary packaging material for medical supplies and the care required for hygiene and sterilization. This International Standard identifies Good Manufacturing Practice (GMP) principles and specifies requirements for a quality management system applicable to primary packaging materials for medicinal products. A competent ISO 15378 consultant provides effective ISO 15378 training, to meet all requirements of ISO 15378 standard initially through a gap analysis using ISO 15378 audit checklist and fully prepare organizations to ISO 15378 certification. ISO 15378 emphasizes continual improvement throughout the manufacturing and nonmanufacturing processes for continued customer satisfaction. ISO 15378 standard requires meeting FDA guidelines adherence in manufacturing processes, through cGMP compliance and employee hygiene conditions. A third-party ISO 15378 consulting/auditing firm can be used to perform internal audits for ISO 15378 standard using appropriate ISO 15378 Audit checklists to measure effectiveness in the implementation of ISO 15378 Quality Management System. Organization’s top management to ensure all interested parties receive ISO 15378 training to demonstrate competence in performing assigned tasks for effective implementation. A discipline path for ISO 15378 certification is essential for achieving ISO 15378 certificate.
ISO 27001:2013 Standard is for Information Security Management Systems(ISMS). ISO 27001 has been prepared to provide a model for establishing, implementing, operating, monitoring, reviewing, maintaining and improving an Information Security Management System (ISMS). The adoption of an ISMS should be a strategic decision for an organization. The design and implementation of an organization’s ISMS is influenced by their needs and objectives, security requirements, the processes employed, the size and structure of the organization, using ISO 27001 tool kit and ISO 27001 control list. QSE provides ISO 27001 Consulting services to assist organizations in developing ISO 27001:2013 procedures using IS0 27001 templates, ISO 27001:2013 audit checklists, conducting ISO 27001 internal audits using ISO 27001 Internal Audit checklists. A competent ISO 27001 consultant or ISO 27001 consulting companies use(s) a disciplined ISO 27001 certification process to meet all the requirements of ISO 27001:2013 through providing ISO 27001 training to all interested parties to ensure dissemination of Information Security Policy, Information Security Objectives and targets, benefits of ISO 27001:2013 certification, implications of not adhering to ISO 27001:2013 compliance requirements, benefits of process approach application and continual improvements through risk considerations. Total ISO 27001 certification cost cannot be fully determined since ISO 27001 certification is a never-ending process and a race with no finish line.
ISO 14001:2015 is a Standard for Environment Management Systems. The purpose of this International Standard is to provide organizations with a systematic framework to protect the environment and respond to changing environmental conditions in balance with socio-economic needs. It does so by specifying requirements for an environmental management system that enables an organization to enhance environmental performance. QSE provides ISO 14001 Consulting services to assist organizations in developing ISO 14001:2015 policies and procedures using IS0 14001 templates, ISO 14001:2015 checklists, conducting ISO 14001 internal audits and ISO 14001 environmental compliance audits using ISO 14001 Internal Audit checklists and ISO 14001 compliance audit checklists. A competent ISO 14001 consultant or ISO 14001 consulting companies use a disciplined approach for ISO 14001 certification process to meet all the requirements of ISO 14001:2015 through providing ISO 14001 training to all interested parties to ensure dissemination of Environmental Policy, Environmental Objectives and targets, Environmental compliance obligations, Emergency preparedness activities, Determination of significant Environmental aspects and impacts, and Environmental operational controls. Any organization planning for ISO 14001:2015 certification, requires ISO 14001 training of all employees related to internal and external issues of interested parties and mitigation of environmental risks in preventing pollution of land, air, water and protection of natural resources. All interested parties to understand implications of not adhering to ISO 14001:2015 compliance requirements, and continual improvements through risk considerations. Total ISO 14001 certification cost cannot be fully determined since ISO 14001 certification is a never-ending process and a race with no finish line.
ISO 22000:2018 Food Safety Management Systems. Requirements for any organization in the food chain. Food safety is related to the presence of food safety hazards at the time of consumption (intake by the consumer). Food safety hazards can occur at any stage of the food chain. Therefore, adequate control throughout the food chain is essential. The adoption of a food safety management system (FSMS) is a strategic decision for an organization that wants to be an effective contributor to food safety. QSE provides ISO 22000 Consulting services to assist organizations in developing ISO 22000:2018 procedures using IS0 9001 templates, ISO 22000:2018 checklists, conducting ISO 22000 internal audits using ISO 22000 Internal Audit checklists. A competent ISO 22000 consultant uses a disciplined ISO 22000 certification process to meet all the requirements of ISO 22000:2018 through providing ISO 22000 training to all interested parties to ensure dissemination of Food Safety Policy, Food Safety Objectives & Targets, Benefits of ISO 22000:2018 certification, understanding prerequisite programs, operational prerequisite programs, 7 principles of HACCP, 12 steps of HACCP implementation , 7 requirements/steps of HARPC implementation, implications of not adhering to ISO 22000:2018 compliance requirements, and continual improvements through risk considerations. Total ISO 22000 certification cost cannot be fully determined since ISO 22000 certification is a never-ending process and a race with no finish line.
ISO 55001:2014 Asset Management System This International Standard specifies the requirements for the establishment, implementation, maintenance and improvement of a management system for asset management, referred to as an “asset management system”. This International Standard can be used by any organization for assessing asset management system to proactively manage asset life cycles from acquisition to decommissioning. QSE provides ISO 55001 Consulting services to assist organizations in developing ISO 55001:2014 procedures using IS0 55001 templates, ISO 55001:2014 checklists, performing ISO 55001 audit process using ISO 55001 Internal Audit checklists. A competent ISO 55001 consultant uses a disciplined ISO 55001 certification process to meet all the requirements of ISO 55001:2015 through providing ISO 55001 training to all interested parties to ensure dissemination of Asset management Policy, Asset Management Objectives and Targets, Benefits of ISO 55001:2014 certification, implications of not adhering to ISO 55001:2014 compliance requirements, benefits of process approach application and continual improvements through risk considerations. Total ISO 55001 certification cost cannot be fully determined since ISO 55001 certification is a never-ending process and a race with no finish line.
ISO 45001: 2018 Occupational Health & Safety Management Systems of the International Organization for Standardization (ISO), ISO 45001 replaces other occupational health and safety standards such as OHSAS 18001 as the world’s most recognized occupational health and safety management systems standard as well as AS/NZS 4801 as an Australian/New Zealand standard. ISO 45001:2018 enables an organization, through its OH&S management system, to integrate other aspects of health and safety, such as worker wellness/wellbeing. This standard does not address issues such as product safety, property damage or Occupational Health and Safety impacts, beyond the risks to workers and other relevant interested parties. QSE provides ISO 45001 Consulting services to assist organizations in developing ISO 45001:2018 policies and procedures using IS0 45001 templates, ISO 45001:2018 checklists, conducting ISO 45001 internal audits and ISO 45001 Occupational Health and Safety compliance audits using ISO 45001 Internal Audit checklists and ISO 45001 compliance audit checklists. A competent ISO 45001 consultant or ISO 45001 consulting companies use(s) a disciplined approach for ISO 45001 certification process to meet all the requirements of ISO 45001:2018 through providing ISO 45001 training to all interested parties to ensure dissemination of Occupational Health &Safety Policy, Occupational Health & Safety Objectives$ targets, Occupational Health and Safety compliance obligations, Emergency preparedness activities, reduction of Occupational Health & Safety injuries& diseases, and Occupational Health & Safety operational controls. Any organization planning for ISO 45001:2018 certification, requires ISO 45001 training of all employees related to internal and external issues of interested parties and mitigation of Occupational Health and Safety risks in preventing human hazard. All interested parties to understand implications of not adhering to ISO 45001:2018 compliance requirements, and continual improvements through risk considerations. Total ISO 45001 certification cost cannot be fully determined since ISO 45001 certification is a never-ending process and a race with no finish line.
ISO 50001:2018 is an Energy Management Standard. This standard specifies requirements for an energy management system, which enables an organization to take a systematic approach to the continual improvement of energy efficiency and energy performance. It does not itself state specific performance criteria with respect to energy, but emphasizes, reduction of energy use, saving of energy costs and reduction in greenhouse gas emissions. This standard applies to all organizations. QSE provides ISO 50001 Consulting services to assist organizations in developing ISO 50001:2018 policies and procedures using IS0 50001 templates, ISO 50001:2018 checklists, conducting ISO 50001 internal audits and ISO 50001 energy compliance audits using ISO 50001 Internal Audit checklists and ISO 50001 energy audit checklists. A competent ISO 50001 consultant or ISO 50001 consulting companies use(s) a disciplined approach for ISO 50001 certification process to meet all the requirements of ISO 50001:2015 through providing ISO 50001 training to all interested parties to ensure dissemination of Energy Policy, Energy Objectives & Targets, energy compliance obligations, determination of significant energy costs and consumption. Any organization planning for ISO 50001:2018 certification, requires ISO 50001 training for all employees related to internal and external issues of interested parties and mitigation of energy usage/consumption risks in energy conservation and protection of natural resources. All interested parties to understand implications of not adhering to ISO 50001:2018 requirements, and continual improvements through risk considerations. Total ISO 50001 certification cost cannot be fully determined since ISO 50001 certification is a never-ending process and a race with no finish line.
How to Get ISO Certification?
- ISO certification process starts from procuring the relevant standard and studying it for application at the facility
- Next step would be to gather issues and concerns of all interested parties
- Develop a documented management system suitable for your organizations
- Implement the system and gather data
- Audit the system for your benefit to check if all elements of the standard have been covered or not
- Invite an accredited registrar to conduct an initial audit on your documentation for the management system developed
- Make corrections to the documentation if required based on initial audit findings
- Implement and gather data for about 3 months of operation
- Invite the same accredited ISO certification body for final audit
- Make corrections to any nonconformities indicated by certifying body and submit the same to certifying body
- Get clearance and get recommendation for obtaining ISO certification
- Get your ISO Certification after a short wait.
Our Services Regarding ISO Standards and Our Differentiators
Quality Systems Enhancement Inc. is a premier Consulting, Auditing and training firm for ISO standards and in business for over 27 Years now.
ISO Standards Consulting
Consulting firms develop the documented management system as applicable to the organization based on their specific needs and in keeping with the requirements of the standard
- QSE offers total consulting for all ISO standards and other standards referred above and more
- President of QSE has been a member of ISO/US TAG/TC 176, the technical committee which wrote family of ISO 9001 Quality Management Standards since its inception in 1985
- President QSE is also a member of ISO/USTAG/TC 207 the technical committee which wrote family of ISO 14001 Environment Management Standards since its inception
- President, QSE is also a member of the ISO/USTAG/TC301(TC242) the technical committee which wrote family of ISO 50001 Energy Management System Standards
- QSE ISO consultants thoroughly understand the intent of ISO standards
- QSE has a 10-step disciplined path for ISO certification which is insensitive to failure
- QSE guarantees ISO certification of all 10 steps are followed
- QSE has assisted over 700 facilities obtain ISO certification to various ISO Standards and Sector-Specific Standards and Food Safety Standards
- QSE has a success rate of 100%
- 98% of QSE customers have passed audit without a single nonconformity first time around
- QSE develops all documentation on site at customer’ works involving all relevant employees and practicality of implementation
- QSE engages competent and qualified consultants to prepare the management system without any letups and ensuring compliance to all elements of the standard clause by clause.
- QSE has a Data Driven, Evidence Based, Single Level, Comprehensive, Simplified Documentation System which is easy to understand follow, and sustain the certificate earned by any facility
- For example, QSE’s format for gathering internal and external issues of all interested parties is so complete that no facility following this system can have a nonconformity for context of the organization which is difficult to interpret and implement by many others
- Another example is the format designed for Management Review is so comprehensive that seldom any management can miss appoint for review as mandated by the standard. Any facility that follows this format will never have a nonconformity against management review
- QSE‘s documentation system includes acceptable and simple solutions to the ambiguous elements in some ISO standards and will defend the documentation if required
- QSE’s documentation will pass scrutiny of any audit
- In addition to developing documentation QSE helps in implementing the documentation, helps in understanding the application of documents, its relevance and importance in complying with the standard
- QSE assist in deficiency corrections for all nonconformities identified through internal audits or Audit by ISO Certification Body
- QSE also assists in preparing for final audit
- QSE guarantees ISO certification when all 10 steps are followed
ISO Standards Auditing
Auditing firms conduct audits on facilities seeking ISO certification. Normally these audits are conducted by accredited ISO Certification Bodies accredited by IAF. It is mandatory as per the ISO standards to conduct internal audits by the firm or firm’s appointed agency to conduct an Internal audit prior to audit by ISO Certification Body. No facility can go to ISO Certification Audit before an internal audit is conducted. ISO promotes process approach in formulating and auditing the documented system
The QSE Difference in ISO Standards Compliance
- QSE’s consulting includes Internal Auditing
- QSE engages competent and qualified auditors for all its audits
- QSE follows all guidelines prescribed by ISO 19011:2018 guidance standard for audits
- President QSE is a member of the committee which wrote the ISO 19011 standards from its inception and has a thorough knowledge about all the requirements stated in the guidance standard
- QSE conducts brutal and more stringent audit than the audits by Certifying Bodies. This is to eliminates the possibility of any nonconformity showing up at final audit
- QSE engages process approach in its audits in the right way to cover all elements of the standard, all processes of the facility and all shifts of operation
- QSE ensure to audit all 4 aspects of quality control Viz. Incoming inspection, Setup Inspection, In Process inspection and Final Release inspection
- QSE provides a comprehensive report at the end of the audit which details the nonconformity with respect to the requirements of the standard and for which corrective actions may be generated by the facility
- QSE’s audit seldom leaves any scope for Certifying Bodies to find fault with internal audits, or give scope to point out any major nonconformity on the facility
- QSE’s audit takes into account the humanistic elements involved in auditing
- QSE’s audits never criticize any individual it only points out nonconformities in the system according to clauses of the standard.
- QSE’s audit in a nutshell is a system audit using process approach
ISO Standards Training
ISO Standards Training Firms train individuals or groups for understanding the content of the standard or for becoming eligible to conduct audits or management policies in regards to the ISO standards.
- QSE ‘s Training covers all aspects of requirements for the ISO standards
- QSE’s training involves in explaining in detail; about the intent of the standard
- QSE’s training is an accelerated process of learning by making clear on Terms, Concepts and Principles involved in every standard
- QSE’s class 1 Audio visual presentations are supplemented by Quizzes and Hands -on-Exercises to ensure the concepts are clear, adaptable and applicable straightaway in normal work
- QSE conducts on Implementation Assistance, Internal Auditing, Supplier Audits, Process Audits, Product Audits and Layered Process Audits as per requirement
- QSE trains for all Six Automotive Quality Core Tools and their application
- QSE’s Trainer has over 40 Years’ experience in Quality assurance, An exemplar global certified auditor, a certified quality engineer and winner of several awards as a best speaker at international conventions
- Every Training session is interactive and includes a question answer session at the end of each day for any clarifications required
- In addition to ISO Standards comprehension and implementation QSE also trains internal auditors for selected standard
- QSE also offers training in excellence tools such as Lean, Six Sigma, Total productive Maintenance, Statistical problem solving, Bottom line Improvement etc
- QSE also offers training in Solutions such as Root cause analysis Corrective and Preventive Actions
- QSE Trains in problem solving techniques such as 8D, 5 WHY, 7 S etc
- Some of the fortune 500 companies trained by QSE are Nissan, Panasonic Industrial Products, Mercedes Benz, Kia Motors, Gulf Stream among others
- QSE has trained other 700 Small and big companies for obtaining ISO certifications, internal auditors etc
Frequently Asked Questions
QSE has helped several small organizations with employee strength varying from 2 to 15. QSE has also helped organizations employee strength running in to few thousands. QSE can assist any organization depending on their needs.
QSE can assist in all stages right from concept to commissioning of the ISO Standards Certification. QSE is very flexible and can offer tailor made ISO Standards solutions to any facility.
QSE will utilize all resources to meet deadlines given by your customer within the frame work of practical feasibility. However, ISO Certification Bodies usually require a minimum of 3 months of data for certification. Subject to availability of ISO Certification Bodies QSE will leave no stone unturned to meet the Target dates.