ISO 9001:2015 Quality Management System (QMS)

ISO 9001 is defined as the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can certify. ISO 9001 was first published in 1987 by the International Organization for Standardization (ISO), The current version of ISO 9001 was released in September 2015. It presents fundamental management and quality assurance practices that can be applied by any organization. The requirements represent an excellent foundation of planning, control, and improvement for just about any enterprise. Without a QMS, organizations have little chance of sustaining any improvements or innovations they might realize.

The present version of ISO 9001—ISO 9001:2015—is the fifth iteration of the standard. Here is a brief history of ISO 9001 through the years: • ISO 9001:1987. The first publication of ISO 9001. Truly a manufacturing standard and very heavily focused on documentation. The requirements were based on U.S. military standards used by government contractors since World War II. • ISO 9001:1994. A minor revision to the standard. Still very proscriptive and focused on manufacturing. Difficult for services providers to interpret and apply. • ISO 9001:2000. A significant revision of the standard with a focus on continuous improvement, customer satisfaction, leadership, and process management. An attempt to make the standard more applicable to service providers, and to make it more flexible in general. • ISO 9001:2008. A very minor revision with only slight changes in wording. No actual requirements were added, removed, or changed. • ISO 9001:2015. A significant revision to the standard and another step away from its manufacturing origins. Much more of a model for managing and improving an organization, with risk lying at the heart of the standard. An excellent framework for long-term success and customer satisfaction.

Quality Objectives, Quality Manual, Organizational Structure & Responsibilities, Data Management, Processes – Including Purchasing, Product Quality Leading to Customer Satisfaction, Continuous Improvement including Corrective Action, Quality Control - General Tools & Instruments, Document Control.

Quality objectives are measurable goals relevant to enhancing customer satisfaction and are consistent with the quality policy. These objectives are initially established when planning your QMS and redefined in management reviews as needed. Examples can include goals to improve on time delivery, defects, or scrap. The objectives should be designed to be S.M.A.R.T (specific, measurable, achievable, realistic and time-based) and should have relevance at all levels of the company.

Examples can include goals to improve on time delivery, defects, or scrap. The objectives should be designed to be S.M.A.R.T (specific, measurable, achievable, realistic and time-based) and should have relevance at all levels of the company.

Process for ISO Certification The Certification process shall consist of the following key stages:

• Application Review & Contract Review
• Initial Certification Audit: Stage-1 & Stage 2 Audit
• Certification Decision
• Continual Assessment (Surveillance Audit)
• Renewal Audit
• Suspending, Withdrawing, Extending or Reducing Scope of Certification

With the right Consulting, Implementation, preparation and a good understanding of what is required for ISO 9001 certification, Required some documentation needed ready for Certification Process.

The documentation will define:

Quality Manual, Organisation Structure, Who Should Record Information & What Information is Recorded, Responsibilities of Employees, Lines of Communication throughout the Company, Internal Audit & Management Review Meeting Quality Policy & Quality Objectives, Risk Assessment, Gap Analysis, Documented SOP, Documented Procedures

• Puts greater emphasis on leadership engagement
• Helps address organizational risks and opportunities in a structured manner
• Uses simplified language and a common structure and terms, which are particularly helpful to organizations using multiple management systems, such as those for the environment, health and safety, or business continuity
• Addresses supply chain management more effectively
• Is more user-friendly for service and knowledge-based organizations
• Improvement of customer satisfaction
• Help Business, Government & Society
• help organization for avoidance of Risk
• Better process integration
• Create a continual improvement culture

Road Map and Plan for ISO 9001 Covering Key Points:

Training on Standard Requirement Organizations needs to have the knowledge, skills and capability to support a standard beyond the certification audit.

GAP analysis We do gap analysis to identify what you do and what ISO 9001 recommends, it may be process addition or modification to adopt International Best Practices.

System Document Development Based on the training the client reviews their own management system and evaluates their existing policies and procedures and modifies them to comply with the international best practice.

Internal Auditor Training Regular internal audits against the system are the requirements of the standard.

Standard Implementation Client must ensure that their employees are adopting the new protocols and procedures inline of the standards.

Internal Audit Client conducts an internal audit of their management system implementation. They must examine their own processes and procedures in terms of effectiveness.

Management Review Client to discuss the future of their management system with their senior management about the strengths and weakness of the system to identify areas for continual improvement

Pre-assessment A pre-assessment audit done prior to and outside the formal scope of certification to identify area that need more work whilst also preparing key employees for the eventual audits. A useful audit to rehearse, align and de-bug your system:

Stage 1 - Assessment: Document Review

Stage 2 - Assessment: Run through of the implemented systems.

Certification Issue A certificate is provided to your organization.

Continuing assessment Visit: A routine surveillance visit which every year (12 Months) or 9 or 6 months cycle over a three year period to monitor and evaluate continuing systems performance.

Re-Assessment: Re certification of your management system is required every three years after the initial certification and covers a comprehensive review of the whole system. It may include an additional stage 1 review where significant problems have been encountered during the course of the certification cycle.

Contact Us: If you plan to go for ISO Certification, you may ask for Quotation by providing your organization's information in application form, you can download the inquiry form available at the website or submit your inquiry through feedback. Alternatively, you may send your inquiry through mail to sujal.amin@gmail.com or call us at: 09898078093