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ISO 9001 2015

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An Overview of ISO 9001 2015

ISO 9001 2015 is an international standard for maintaining, creating and implementing a Quality Management System (QMS). ISO 9001 2015 was first introduced in September 2015 and is already the most widely adopted standard in the history of standards. It outlines a framework for improving quality & a vocabulary of understanding for any company or organisation looking to provide goods & services that steadily meet the customers’ expectations & requirements and other pertinent interested parties in the most effective manner. The Quality Management System is the collective of all the resources, cultural values, processes & assets that support the goal of customer satisfaction & organizational efficiency.

ISO 9001 2015 doesn’t order what a company or an organisation’s objectives should be or how to achieve them. In simple terms, it doesn’t tell any company or organisation how to run its business. This standard defines the controlling principles that can be used to create efficiencies by streamlining & aligning processes throughout the organisation, meet regulatory requirements and help organisations to expand into new markets where clients demand ISO Certification.

What is the Fundamental Mission of ISO?

  • The fundamental mission of ISO is to provide common specifications, standards, terms, & units of measurement to organisations around the globe.
  • ISO doesn’t provide certification or conformity assessment. Rather, it facilitates international trade & innovation to allow every organisation in every sector from around the globe to have a common language & common expectations for everything from manufacturing & technology to food safety, agriculture & healthcare.

Overall ISO's mission is built on the following core initiatives for its members:

  1. Ensuring the efficient operation of their organisation while managing finances;
  2. Increasing adherence to GSP (Good Standardisation Practices) among standards experts in every organisation and evaluating all processes to find out their alignment with the WTO (World Trade Organisation) Technical Barriers to Trade Agreement (TBT);
  3. Strengthening the links between public policy & standardisation by providing thought leadership & promoting awareness of best practices;
  4. Risk & sustainability;
  5. Ensuring collaboration with or participation of key stakeholders in all standardisation projects.

Why is ISO 9001 Certification Essential?

This certification provides your customers reassurance that you have set up a QMS based on the 7 management principles of ISO 9001. In fact, ISO 9001 is such a vital and significant standard that it is used as the foundation when industry groups desire to create their own industry standards; this includes ISO 13485 for the medical devices industry, and AS 9100 for the Aerospace Industry and so on.

A survey of this certification in 2017 tells that in spite of the global recession, the number of companies or entities that have implemented the ISO 9001 QMS still remains stable globally. ISO 9001 Certification for individuals is not a requirement of the standard, but this certification is the best method to get knowledge and competence regarding this standard.

What is QMS?

QMS or Quality Management System is defined as a set of interrelated or interacting elements to create policies, objectives & processes to achieve those objectives regarding quality. Quality Management System is part of the overall management system based on a business risk approach to operate, monitor, establish, review, implement, maintain & improve quality.

ISO 9001 2015 specifies requirements to implement, monitor, maintain, establish, plan, operate and continually improve a documented management system used to manage quality. The requirements under ISO 9001 2015 are flexible, standard, and useful to all types of organisations. Hence, this standard aligned & united with other Management Systems such as Business Continuity Management, Energy Management and other management systems due to their identical structure.

The standardisation of Quality Management evolves with ISO 9001 2015 by adding:

  • Greater importance on process approach, monitoring performance & metrics, and risk management;
  • Focus on interested parties;
  • Analysis of the context of the organisation required for ensuring quality improvement.

Key Clauses of ISO 9001 2015

Following are some important clauses of ISO 9001 2015:

  • Clause 1: Scope – The clause defines the scope of the ISO 9001 2015 standard and the scope of this standard comprises specifying requirements for a Quality Management System of any organisation.
  • Clause 2: Normative References – The supporting standard referenced in this standard is indispensable for its application is ISO 9001:2015, which covers fundamentals & terminology.
  • Clause 3: Terms & Definitions – Terminology used throughout this standard comes directly from ISO 9000:2015, QMS – Vocabulary & Fundamentals.
  • Clause 4: Context of the Organisation – When you are implementing a Quality Manual System, the 1st step is to align your business objectives & intent with the QMS. Know the external & internal issues, needs & expectations of interested parties, QMS scope & its processes.
  • Clause 5: Leadership - This clause covers leadership responsibility. Top management must demonstrate leadership & commitment, establish & communicate a quality policy and ensure responsibilities & authorities are communicated, assigned & understood.
  • Clause 5: Planning for the QMS – This clause covers organisational OMS planning to address organisational risks, changes, opportunities & quality objectives.
  • Clause 7: Support – This clause of ISO 9001 2105 covers the resources required for the Quality Management System, such as ensuring employees are capable & aware, providing resources, and including documented details to support your QMS.
  • Clause 8: Operation – This clause covers the control & plan processes required to meet the requirements for goods & services (such as production & service provision, design & development, the release of goods & services, external providers, etc,).
  • Clause 9: Performance Evaluation Clause – The ISO 9001 requires your organisation’s Quality Management System to measure, analyse, monitor, and evaluate your QMS.
  • Clause 10: Improvement: This clause of ISO 9001 2105 covers continual improvement. Select opportunities for improvement, take action against non-conformities, implement corrective actions as necessary & continually improve your quality management system.

List of Vital Documents and Records Required by ISO 9001 2005

Following are some vital documents you need to produce if you want to be compliant with ISO 9001 2005:

  • Scope of the QMS;
  • Quality objectives;
  • Quality Policy;
  • Criteria for evaluation & selection of suppliers.

Following are some Mandatory Records:

  1. Records of skills, experience, qualifications, and training;
  2. Record of non-conforming outputs;
  3. Product or service requirements review records;
  4. Characteristics of product to be produced & services to be provided;
  5. Records about customer property;
  6. Internal audit program;
  7. Results of the management review;
  8. Results of corrective actions;
  9. Monitoring & measurement review;
  10. Results of the management review;
  11. Record of conformity of product/service with acceptance criteria;
  12. Production or service provision change control records;

Following are other records that are only mandatory when the relevant clause is not excluded:

  1. Monitoring & measuring equipment calibration records;
  2. Records of design & development outputs;
  3. Records of design & development inputs;
  4. Records of design & development controls;
  5. Records of design & development outputs review;
  6. Design & development changes records.

Non-Mandatory Documents for the Implementation of ISO 9001

There are many non-mandatory documents that can be used for the implementation of ISO 9001. However, the following are some non-mandatory documents to be most commonly used:

  • Procedure for addressing risks & opportunities;
  • Sales Procedure;
  • Procedure for Internal Audit;
  • Procedure for design & development;
  • Procedure for measuring equipment and equipment maintenance;
  • Warehousing procedure;
  • Procedure for document & record control;
  • Procedure for competence, training & awareness;
  • Procedure for determining the context of the organisation & interested parties;
  • Procedure for production & service provision;
  • Procedure for management review;
  • Procedure for management of non-conformities & corrective actions;
  • Procedure monitoring customer satisfaction.

Procedure for a Company to get ISO 9001 2015 Certified

For the company QMS to be certified, you need to finish the implementation first. After finishing all your documentation & implementing your processes, your company also needs to perform the following steps to ensure a successful certification:

  1. Internal Audit: This is in place for you to check your QMS processes. The goal is to confirm that records are in place to confirm compliance with the processes & to find problems and weaknesses that would otherwise stay hidden.
  2. Management Review: A review by your management to evaluate the facts regarding the management system processes in order to make appropriate decisions & assign resources.
  3. Corrective Actions: After the internal audit & management review, you need to correct the root cause of any identified problems & document how they were resolved.

The company certification process is further diving into 2 different stages:

  • Stage 1 (Documentation Review): The auditors from your chosen certification body will check to confirm your documents meets the ISO 9001 2015 requirements.
  • Stage 2 (Main Audit): In this stage, the certification body auditors will check whether your activities comply with both ISO 9001 & your documentation by checking documents, company practices & records.

Corpbiz Support for ISO 9001 2015

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Frequently Asked Questions

It’s the world’s most used standard for QMS and it gives organisations a set of management guidelines that help ensure consistently high—quality products & results.

This certification has the capability to benefit businesses in a wide variety of industries such as construction, medical device manufacturing, automotive, aerospace, and many more.

The cost varies based on various factors, including business size, risk, audit duration & how close you are meeting ISO 9001 requirements when you begin implementing the system.

Retain documented evidence such as records and you maintain elements of the system for example, infrastructure.

The standards were created & introduced by the International Organisation for Standardisation (ISO).

Prior to Dec 2000, there were ISO 9001, ISO 9001 & ISO 9003 standards; all were generally referred to as ISO 9000. Eventually, all these standards were merged into ISO 9001. As for ISO 9001 2015, 2015 indicated the year of revision of ISO 9001.

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