ISO 9001-2015

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 of departmental wise quality objectives: 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 of departmental wise quality objectives:

Marketing Examples

• Earn 30% of overall company revenue from marketing efforts • Increase annual product subscribers by 25% • Increase marketing ROI by 7.5% • Triple social media following • Double newsletter subscriptions • Double unique web traffic • Increase regular weekly website visitors by 45% • Increase landing page conversion rates by 25% • Increase surveyed brand awareness by 20% • Get 10 media placements • Hire 5 new account executives

Sales Examples

• Achieve the new bookings target of 20 per month • Hit the win rate of 20% • Achieve average deal size of $ Or Rs. • Decrease sales cycle to 3 months

Human Resources Examples

• Maintain employee satisfaction index of 85% • Keep quarterly retention rate at 97% • Increase employee engagement to 85% • Maintain compensation at 10% above industry average • Meet with sales department to define sales hiring requirements • Hold a minimum of three interviews for new hires • Increase rate of meeting new hire deadline to 80% • Get 15% of hires from employee references • Hire a training agency for the sales department • Implement a leadership training program • Give at least 1/3 of all managerial positions to internal applicants

Software Engineering Examples

• Migrate completed story points less than a week after completion • Launch 3 new product features • Develop 20 new front-end software tests • Launch alpha testing phase • Meet with customer service and product departments for development coordination. • Increase system architecture speed by 25% • Maintain system architecture up-time of 99.9% • Maintain rate of no more than 3 P-0 and P-1 bugs at once • Participate in one hackathon • Prioritize blocker bugs • Optimize UI for 15% faster on boarding process • Conduct review of programming team optimization

Product Management Examples

• Maintain Net Promoter Score of 80 • Ideate for three new product features • Meet with programming and marketing departments to collaborate on new features • Maintain production consistency ratio of 99.8% • Complete assessment of customer product usage behavior through software monitoring • Contribute 50k in revenue by collaborating with the software engineering team to complete a product demo • Create annual product plan to integrate competitors’ strongest product features • Identify 5 leading competitors’ product strategies • Complete market projections of product lifecycles

Customer Success Examples

• Decrease on boarding time to three days • Decrease customer service tickets during on boarding by half • Achieve 20% higher customer satisfaction with on boarding process • Increase customer references of qualified leads by 20% • Decrease customer success related quarterly churn rate by 15% • Collaborate with sales department to increase up selling by 10%

Customer Support Examples

• Decrease average first-response time to less than 10 minutes • Increase customer service call capacity by 40% (open new call center) • Decrease tickets per resolution by 20% • Reduce call abandonment to 3.5% • Hire and train 8 new outsourced workers • Reduce incidence rate by 10% • Reduce manager call intervention by 15% • Maintain customer service feedback database • Complete 5 new customer service script scenarios • Collaborate with product department to help fix product issues

Finance Examples

• Develop annual procedures for cash handling and budgeting • Complete independent financial audit • Increase rate of debt collection by 25% • Increase financial automation by 5% • Finish reviewing and approving compensation agreements • Research and approve the use of some crypto-currencies • Resolve 50% of outstanding contract conflicts • Maintain regulatory financial compliance • Conduct patent research, application and resolution • Increase asset to debt ratio by 2.5% • Help increase quarterly shareholder value by 2.5%

Operations Examples

• Create annual operational plan • Project seasonal consumer demand prediction • Hold bi-weekly meetings to adapt planning throughout software engineering process • Reduce product failure rate to under 2.5% (5/1 ROI) • Reduce product sourcing and logistics expenses by 5% • Reduce logistics shipping travel time & distance by 5% (local sourcing) • Deliver 98.5% of products on time • Fulfill 100% of warranty obligations • Help facilitate the fixing of new P-0 and P-1 bugs within 72 hours • Contribute to 1.5% quarterly growth in company shares • Seek one independent operational consulting report

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

Client Side Preparedness Requirement:

With the right 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:-

UNDERSTANDING

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

PREPARE

GAP analysis We do gap analysis to identify what you do and what ISO9001 recommends to do, it may be process addition or modification to adopt International Best Practices.

IMPLEMENT

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.

REVIEW

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

ASSESS

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.

PROMOTE

Certification Issue A certificate is provided to your organization.

CONTINUING ASSESSMENT

Continuing assessment Visit: A routine surveillance visit which every year or 12 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 info@eurocertindia.com or call us at Mob: +91-9769903178

Charges for ISO 9001:2015 Certification may depend on the size, location, Complexity of operation, Processes and it’s inter relevance. Eurocert produces a guidance price list based on company nature & size. For a Quotation please get in touch with us either by sending your inquiry through mail to info@eurocertindia.com or call us at Mob: +91-9769903178

An integrated management system (IMS) combines all related components of a business into one system for easier management and operations. Quality, Environmental, and Safety management systems are often combined and managed as an IMS.

Integrated Management System (IMS) integrates all of an organization’s systems and processes in to one complete framework, enabling an organization to work as a single unit with unified objectives.

• INTEGRATED MANAGEMENT SYSTEM (IMS) with ISO 9001 :2015 + ISO 14001:2015
• INTEGRATED MANAGEMENT SYSTEM (IMS) with ISO 9001 :2015 + ISO 45001:2018
• INTEGRATED MANAGEMENT SYSTEM (IMS) with ISO 9001 :2015 + ISO 22000:2018
• INTEGRATED MANAGEMENT SYSTEM (IMS) with ISO 9001 :2015 + ISO 27001:2013
• INTEGRATED MANAGEMENT SYSTEM (IMS) with ISO 9001 :2015 + ISO 13485:2016
• INTEGRATED MANAGEMENT SYSTEM (IMS) with ISO 9001 :2015 + ISO 50001:2018

• All integrated Standards have a document control requirement
• Meeting all standards’ requirements with one set of policies and procedures
• Increased efficiency and effectiveness.
• Reductions in costs associated with audits.
• Displays commitment to continuous improvement for the organisation as a whole.
• Presents a clear uniform image of the whole organisation.
• Reduces duplication, bureaucracy and maximises Resources.
• Increases time available to management to implement proactive measures.
• Improves internal and external communications.
• The control of records is specified in all three
• Training, competence and awareness is seen in all three
• All three have a requirement for internal auditing
• Management review is seen as critical for all three
• Standards Monitoring and measuring devices are referred to in each
• Continual improvement is key to all three
• Corrective and Preventative Action are major requirements

ISO 9000 -Quality management systems

Fundamentals and Vocabulary

ISO 9001 -Quality management systems

Requirements, contains the requirements an organization must comply with to become ISO 9001 certified.

ISO 9002 – Guidelines

For the application of ISO 9001:2015

ISO 9004 – Managing for the sustained success of an organization

Provides guidelines for sustaining QMS success through evaluation and performance improvement

ISO 9001:2000 - Quality management systems – Requirements

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 - Quality management systems – Requirements

A very minor revision with only slight changes in wording. No actual requirements were added, removed, or changed.

ISO 9001:2015- Quality management systems – Requirements

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.