IRCA ISO 9001 QMS Lead Auditor Course

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What is ISO 9001:2015?
ISO 9001 is the title of an ISO standard (who is ISO?) that outlines the requirements an organization must maintain in its quality system for certification to ISO 9001. There are several different documents in the ISO 9000 family of standards, but ISO 9001 is the only standard in the 9000 series that requires certification. The current version is ISO 9001:2015 (thus the :2015). The standard can help companies meet their customers’ requirements for their product/service while fulfilling any regulatory requirements. Typically an entire organization will seek certification, but the scope of the QMS can be tailored to improve performance at a particular facility or department.

Some things to understand about ISO 9001:

1.It does NOT matter what size your organization is: 1 person or 1M people
2.It does NOT matter what industry you are in (Service or manufacturing) – it can be a restaurant, consultancy, manufacturing company, government entity, etc. There are other standards based upon ISO 9001 for a few specific industries.
3.It is NOT a product standard. It does not define product quality. This is a process-based standard: you use it to control your processes, then your end product should meet the desired results.
4.It is NOT a personal Standard – a person cannot get certified to ISO 9001. They can become an ISO 9001 Certified Lead Auditor after a 5 day training course. This allows them to audit 3rd party companies.
5.It is NOT a membership group – An organization doesn’t “join” ISO 9001. Your organization must follow the steps to implement an ISO 9001 quality management system in your organization. Then a Certification Body (CB or Registrar) audits the performance of your organization against the latest version of the ISO 9001 Requirements. If you pass this audit, the Registrar issues an ISO 9001 Certificate demonstrating that your organization is Registered to ISO 9001 for a three year period.
These are important items related to ISO 9001:

What is a Quality Management System?
-Learn about the ISO 9001:2015 Requirements
-Learn about the entire ISO 9000 Family
-Learn the Steps to ISO 9001:2015 Certification
-ISO 9001:2015 Training reviews all the clauses of ISO

Benefits of ISO 9001:2015

“ISO 9001 Certified” means an organization has met the requirements in ISO 9001. It defines an ISO 9000 Quality Management System (QMS). ISO 9001 evaluates whether your Quality Management System is appropriate and effective, while forcing you to identify and implement improvements.

Continuous improvement assures your customers benefit by receiving products/services that meet their requirement, and that you deliver consistent performance. Internally, the organization will profit from increased job satisfaction, improved morale, and improved operational results (reduced scrap and increased efficiency).
ISO 9001:2015
ISO 9001:2015 is the current version of the ISO 9001 standard which outlines the requirements an organization must maintain in their quality system for ISO 9001:2015 certification. ISO 9001 is explained in detail on this page.
It is the most recent version of the standard which included several changes from ISO 9001:2008 including:

Adaption of the new ISO structure (Annex SL) to align with other standards including ISO 14001, ISO 45001, etc.
Enlarging the relationship between organizations and quality management systems
ISO 9001:2015 promotes a process approach in order to produce the sought after quality outcomes
Presents requirements for quality performance in the organization’s strategic planning
Greater emphasis on top level management for ownership of the QMS
Less prescriptive requirements compared to previous versions
The main focus is on customer satisfaction
Straightforward terminology throughout the standard
How long does it take to get ISO 9001 certification?
With the right preparation and a good understanding of what is required for ISO 9001 certification, most organisations can expect to achieve certification within 3 to 6 months depending on their size and complexity.

ISO 9001 Requirements and Structure
The ISO 9001 requirements provide a set of standard elements that will guide you in the implementation of a Quality Management System (QMS). The requirements are designed to be applicable to any company in any industry – both production and service based, and as such the requirements tell you what elements are mandatory in a QMS, but not how to implement these necessary elements.

The ISO 9001 requirements are broadly separated into eight sections (called ISO 9001 clauses), five of which contain mandatory requirements for a QMS: general Quality Management System requirements (clause 4), Management Responsibility (clause 5), Resource Management (clause 6), Product Realization (clause 7), and Measurement, Analysis and Improvement (clause 8). All elements of these five clauses are mandatory with the exception of the Product Realization section, which allows for a company to exclude portions that are not applicable. Clauses 1 through 3 include no requirements, but instead deal with the scope of the standard, references to understand the standard better, and terms and definitions.

Quality Management System
This section deals with general requirements for a QMS, as well as all documentation requirements. It also includes the requirements for the necessary Quality Manual, Control of Documents, and Control of Records.

Management Responsibility
The section on Management Responsibility outlines the requirements for customer commitment and focus, and the important Quality Policy and Quality Objectives. The elements of planning in the QMS are covered, along with the need to define responsibility, authority and communication in the company. Finally, the requirements of the management review, including the mandatory inputs and outputs for the review, are included.

Resource Management
The short section on resources covers the requirements for management to provide resources, including infrastructure, work environment and human resources. The importance of competence, awareness and training for human resources is emphasized.

Product Realization
This section is the only part of the structure where a company can choose to exclude sections of the requirements (such as excluding the design requirements if your company does not do design work). The requirements deal with planning for product (or service), starting with determining and reviewing the product requirements, design and development and purchasing, which leads to the provision to create and supply the product or service. The final requirements deal with the control of any equipment used to monitor or measure the product or service.

Measurement, Analysis and Improvement
The last section deals with how you know your QMS is working and improving. The Monitoring and Measurement section outlines requirements for assessing customer satisfaction, Internal Audit, and monitoring the product and processes. The section deals with how to control non-conforming product, since this will happen in any business, and how you will analyze and improve, including corrective and preventive actions.

Some Difficulties in Implementation
The greatest difficulty of implementing the standard requirements is to ensure that the resulting collection of policies, procedures, processes and records meets the needs of the company and their customers, while still allowing for improvement of the system. Improvement of the system is one of the main reasons for implementing a QMS, as it benefits the company in the long run.