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ISO 9001:2015 Standard
ISO 9001 is an internationally binding quality assurance standard that has been used to gauge Quality Management Systems (QMS) at all organizational levels. The internationally acclaimed standard measure is indiscriminate and has been widely used to monitor the management practices of all organizations, whether small or big, national or multi-national. The ISO 9001:2015 revision makes it easier to integrate all Management System Standards (MSS), such as ISO 9001, ISO 14001, ISO 22000, ISO 27001, ISO 45001, ISO 50001, ISO 55001, IATF 16949, AS 9100, AS 9110, AS 9129, ISO 13485, ISO 15378, TL 9000, MDSAP, and GFSI recognized Food Safety standards including BRC, IFS, FSSC 22000, and SQF, into one Integrated Management System (IMS) for ease of use and ease of implementation.
Attaining ISO 9001:2015 certification provides many benefits, not to mention the fact that it may also be used as a very powerful marketing tool for your organization.
Industry players and establishments have recommended that industries work with suppliers that have ISO 9001:2015 certification. The ISO 9001 standard provides a standardized global charter through which management practices can be measured against internationally recognized benchmarks. The aim of the ISO 9001:2015 standard is to enhance customer satisfaction through problem solving and continual improvement. Aside from monitoring management practices, the certification allows organizations to produce effective management ideas that have translated into increased productivity and profits for companies. The ISO 9001:2015 requires the promotion and usage of three critical concepts: Process Approach, Risk-Based Thinking, and Continual Improvement.
The ISO 9001:2015 standard has introduced Context of the Organization, Understanding the needs and Expectations of Interested Parties, Organizational Knowledge, Processes and Services, Planning of Changes, Documented Information (previously known as documents and records), External Providers (previously known as suppliers), and Control of Externally Provided Products as some of the additional requirements.
The ISO 9001 certification has been the milestone of modern management at all levels of organizations. The certification is a clear manifestation of the commitment of any organization to promote well-researched and effective management systems that are recognized from global perspectives.
To meet ISO 9001 audit and certification requirements, QSE has developed a simplified documentation system which covers all Quality Management System requirements through an effective document simplification approach. This approach, when coupled with QSE’s Ten Step Disciplined Path for certification, is impervious to failure in achieving ISO 9001:2015 certification.
- Any company that wants to assure customers about their quality system should achieve ISO 9001:2015 certification.
- Any organization that needs to have the interests of all stakeholders covered in their system by having adequate provisions for mitigating risks in their processes must get ISO 9001:2015 certification.
- Any organization that wants a strong marketing tool to showcase their quality capabilities must be able to boast ISO 9001:2015 certification.
- Any facility that offers products or services and wants a globally acceptable quality assurance system needs to get certified to ISO 9001:2015.
- Any facility that wants a complete system which covers all aspects of operations in one single system for Management Review must have ISO 9001:2015 certification.
- Any management team that desires having one single system through which they can build teamwork, review progress, measure, monitor, make corrections, and give impetus for continual improvement must achieve ISO 9001:2015 certification.
- The process of ISO 9001:2015 certification starts with the preparation of a Quality Management System (QMS).
- ISO consultants assist in developing a comprehensive, simplified QMS to meet all ISO 9001:2015 requirements and all requirements for third-party certification body Stage 1 Audits. Stage 1 Audits vary depending on the selected certification body which verifies whether or not the documented system meets all the requirements of ISO 9001:2015.
- An ISO 9001:2015 consulting firm provides the techniques for implementation and trains the organization’s internal ISO auditors to become competent to perform internal audits, or the consulting firm provides ISO Internal Auditing Services to audit all processes, all ISO 9001:2015 standard requirements, and effective implementation of the ISO 9001:2015 standard.
- Facilities need to initiate corrective actions, and continual improvement is realized through the control of nonconforming products and/or services.
- Facilities need to implement the prepared QMS for a minimum of three months and gather and record adequate data to show as evidence.
- Facility management needs to conduct one full scale review of the entire QMS and ensure its adequacy for their organization. The management team needs to identify action items to make corrections to any ISO requirement not being fulfilled.
- Once a QMS is ready, an internal audit is performed and one full set of Management Review takes place, the facility needs to contact a certification body for a certification audit.
- ISO Certification Bodies conduct audits in two stages. During Stage 1, an ISO auditor will evaluate the documentation system and status of meeting the basic requirements of the ISO 9001:2015 standard.
- The certification body will return for final audit where all ISO 9001:2015 requirements will be thoroughly audited to ensure that requirements are met and documentary evidence exists to demonstrate compliance.
- Once the certification body is satisfied, a recommendation is sent to accrediting agencies to issue ISO certification.
- ISO 9001:2015 consulting is the practice of assisting small, medium, and large organizations in developing, training, implementing, and maintaining a documented Quality Management System (QMS) for achieving ISO 9001:2015 certification.
- QSE’s Consulting Services prepare your facilities to have a Quality Management System (QMS) and associated documents and records to show as evidence of having implemented the system. When preparing facilities for ISO 9001:2015 certification, QSE always follows its tried and tested “Ten Step Disciplined Path,” which is impervious to failure in achieving ISO 9001:2015 certification.
- QSE’s ISO consultants assist your facilities in preparing a comprehensive, simplified documentation system to show as evidence of having a streamlined process which ensures quality products and services every time, without fail.
- With your simplified documentation system in place, your organization can effectively control document information (Documents and Records) related to changes and conduct ISO Management Review meetings which cover all Management Review inputs (as per ISO 9001:2015 requirements).
- Your documentation system will meet Annex SL, a section of the ISO/IEC Directives Part 1, which prescribes how ISO Management System Standards (MSS) should be written and in turn meets ISO 9001:2015 requirements.
- Our ISO consultants help to identify all manufacturing and nonmanufacturing (or operations/non-operations) processes and establish metrics for process performance, or “Process Performance Indicators” (PPIs), to effectively monitor and measure the status of your organization’s intended goals and objectives.
- In preparing a comprehensive QMS for your ISO 9001:2015 certification, we also help your organization identify the issues and concerns of all stakeholders and take them into account, to identify risks within every process, and to have steps to mitigate those risks.
- QSE helps you match your personnel’s competence levels to assigned tasks and develop methods to select external providers (suppliers) who supply quality products and services. We build a robust system which compels task performers to have defined roles, responsibilities and controls to ensure quality.
- Internal Quality Audits conducted by QSE’s ISO consultants help facilities to find all deficiencies in their implementation which are not normally found during organizations’ first-party audits.
- QSE’s ISO consultants provide training to top management to promote Risk-Based Thinking, Process Approach, and Continual Improvement within your organization.
- Including the 7 trends to be monitored, internal ISO audit results are fully addressed, root causes are identified with analysis fully applied, and risk-related activities are identified, assessed, and mitigated.
- QSE’s ISO consultants will ensure that certification is achieved with zero or minimal nonconformities the first time around.
- QSE has over 27 Years in the field of consulting, auditing, and training for any ISO standard, Sector-Specific standard, AISC standard, or Food Safety standard.
- QSE has helped over 700 facilities to earn their ISO certification and other certifications.
- All QSE customers passed certification ISO audits, and over 98% of them passed with zero or minimal nonconformities the first time around. QSE has a 100% success rate in obtaining certifications for its customers!
- Unlike our competitors, QSE has a unique, comprehensive, evidence-based, and simplified, single-level documentation system which is easy to implement and provides evidence of QMS implementation to earn ISO 9001:2015 certification.
- With proven lists, forms, and tables, QSE’s designed templates are tried and tested for accuracy and correctness and provide objective evidence during internal ISO audits and certification ISO audits.
- QSE’s simplified system is easy to implement, easy to use, and easy to audit.
- President and CEO of QSE, Baskar Kotte, is an original and active member of ISO/US TAG/TC 176, the Technical Committee that originally developed the ISO 9000 family of standards, ISO/US TAG/TC 207 which developed the ISO 14000 family of standards, ISO/US TAG/TC 301 (TC 242) which developed ISO 50001 and ISO 19011 (the Guidelines for Auditing Management Systems). Mr. Kotte also participated and provided input to the development of the current ISO 9001:2015, ISO 14001:2015, ISO 50001:2018 family of standards, and ISO 19011:2018 revised standards.
The major benefits of ISO 9001:2015 certification include:
- Noticeable improvement in productivity and quality
- ISO 9001:2015 certification is a powerful marketing tool that brings your organization long-term global recognition and improvement in business opportunities.
- Customer satisfaction is enhanced through problem solving and continual improvement.
- It’s an effective Risk Management tool which identifies the internal and external issues of all interested parties and provides a vehicle to mitigate risk.
- An organization’s Strategic Direction is aligned with customer-focused Objectives and Goals, Quality Policy, and all Key Performance Indicators (KPIs).
- It helps in Knowledge Preservation (a process for maintaining knowledge which is important to an organization’s mission and goals).
- It promotes Process Approach, Risk-Based Thinking, and Continual Improvement.
- Internal ISO Auditing provides an effective management tool to run any business while considering “Quote to Cash” processes to strengthen customer satisfaction and bottom-line improvement.
QSE has assisted over 700 organizations in obtaining ISO and other certifications. Contact details can be furnished on demand for any certification.
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Free Manufacturing Division Checklist for Meeting ISO 9001:2015 Audit Requirements
- Understand and adapt Quality Policy and Objectives knowledge and understand your Contributions towards achieving Objectives.
- Ensure the availability of Work Procedures.
- Ensure that all Incoming Quality Verifications are performed and recorded as Documented Evidence.
- Ensure that, during Job Setup, Quality Verifications are done and Documented as Evidence.
- Ensure that In-Process Quality Verifications are done and Documented as Evidence.
- Ensure that Final Quality Verifications are performed and countersigned by Quality personnel periodically as a second check and Documented as Evidence.
- Ensure that the Criteria to choose Good from Bad (Acceptance Criteria) is clear and available as documentary Evidence.
- Ensure that the Control of Nonconforming Products Procedure is clear, documented, and followed for compliance.
- Ensure that all measuring instruments are accurate and have valid calibration certificates at the time of measurement. Ensure that the Accuracy of Gauges/Measuring Instruments is verified periodically for Repeatability and Reproducibility (R&R). Retain Documentary Evidence for all the measurements and R&R studies on Measuring Instruments/Equipment.
- Understand the methods of Identification and Traceability followed by the organization, ensure that the system is adapted fully, and Documentary Evidence is available for verification.
Frequently Asked Questions
ISO Audits are unbiased, structured, and documented evaluations of any given international standards such as ISO 9001, ISO 10993-1, ISO 14001, ISO 45001, ISO 50001, ISO 55001, ISO 22000, ISO 27001, IATF 16949, AS 9100, AS 9110, AS 9120, BRC, FSSC 22000, SQF, TL 9000, with the evaluation results recorded.
- First-Party Audit: Audits performed by a team within the facility are called First-Party Audits.
- Second-Party Audit: Audits performed by organizations on their suppliers are called Second-Party Audits.
- Third-Party Audit: Audits performed by ISO Certification Bodies are known as Third-Party audits.
Third-Party Audit ISO Certification Bodies (Accredited by the International Accreditation Forum, or IAF) perform the audits on organizations to grant ISO 9001:2015 certifications with demonstrated evidence of conformity to all the requirements of ISO 9001:2015.
Typically, it takes anywhere between seven to eight months for certification when you start from scratch. QSE has well developed systems and ISO 9001 templates which are easily understood for implementation. Therefore, it is possible to get certification within about 5 months through QSE.