ISO 9001 Standard - ISO 9001:2008 Standards

History Of ISO 9001 Standards

History Of ISO 9001 Standards

Pre ISO 9000
During World War II, there were quality problems in many British industries such as munitions, where bombs were exploding in factories during assembly. The solution adopted to address these quality problems required factories to document their manufacturing procedures and to prove by record-keeping that the procedures were being followed. The standard was BS 5750, and it was known as a management standard because it specified not what to manufacture, but how the manufacturing process was to be managed. In 1987, the British Government persuaded the International Organization for Standardization (ISO) to adopt BS 5750 as an international standard. The international standard was named ISO 9000.

ISO 9000: 1987 Version
ISO 9000:1987 had the same structure as the British Standard BS 5750, with three ‘models’ for quality management systems, the selection of which was based on the scope of activities of the organisation:
• ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing was for companies and organisations whose activities included the creation of new products
•ISO 9002:1987 Model for quality assurance in production, installation, and servicing had basically the same material as ISO 9001 but without covering the creation of new products.
•ISO 9003:1987 Model for quality assurance in final inspection and test covered only the final inspection of finished product, with no concern for how the product was produced.
ISO 9000:1987 was also influenced by existing U.S. and other Defense Standards (MIL SPECS), and so was well-suited to manufacturing. The emphasis tended to be placed on conformance with procedures rather than the overall process of management—which was likely the actual intent.

ISO 9000 Process Based Auditing

ISO 9000 Process Based Auditing

Any effective quality management system (including the subsystems) works as a control process, which has the ability to detect deviations and nonconforming products and assures that the corrective and preventive action measures are effective. The regulatory auditor should check that all subsystems and processes of the quality management system are structured as self-regulating control processes. For example Deming’s PDCA cycle demonstrates such a process with the following components:

i) Plan – Has the manufacturer established the objectives and processes to enable the quality system to deliver the results in accordance with the regulatory requirements?

ii) Do – Has the manufacturer implemented the quality system and the processes?

iii) Check – Has the manufacturer checked process monitoring and measurement results against the objectives and the regulatory requirements? Does the manufacturer evaluate the effectiveness of the quality system periodically through internal audits and management reviews?

iv) Act – Has the manufacturer implemented effective corrective and preventive actions? Confirm that the company is committed to providing high quality safe and effective medical devices, and that the company is conforming with applicable laws and regulations.

ISO 9001 Standards – Document Repository

All QMS and product realization documents can be stored electronically within the computerize Document Management System like ISO 9001 Document Control Sytem. This provides a set of category and sub-category headings that enable users to drill down into
the different levels of the documentation category tree.
QMS documents are created and maintained within a top level category entitled “ISO 9001 Quality Management System (QMS)“. Documents in this category follow a 4-tier approach:
• Quality Manual – company scope and process interactions within the QMS
• Quality Procedures – responsibilities, controls and activities within the QMS that effect customer service
• Records – objective evidence to demonstrate our goal in achieving customer satisfaction
• Forms & Reports to support the QMS processes
Product realization documents are stored in categories corresponding to Products, Projects and Departments. Each document is unique, but can be accessed from multiple categories.
Documents created within the FablessSemi Inc CogniDox system are assigned a unique identifier using the format “PO-NNNNNN-XX”; where the “PO” prefix identifies them as FablessSemi Inc documents, the “NNNNNN” is an automatically generated and uniquely assigned numerical ID, and the “XX” suffix indicates the document type.
All Fabless Semi Inc personnel are responsible for creating document part numbers and uploading documents to an appropriate category. Selected users with additional system privileges are responsible for creating and maintaining document categories.

Useful Aids to Implement ISO 9001 Standards

Useful Aids To Implement ISO 9001 Standards

Many companies implement ISO 9001 without using all the available tools. As a result, some companies may not fully optimize their implementation. This issue could be manifested as confusion over terms, misunderstanding about requirements, and perplexity concerning intention.
ISO, the International Organization for Standardization, based in Geneva Switzerland issues thousands of standards, but we limit our scope to ISO 9001:2008 and its immediate “family”.
This includes ISO 9000:2005 and ISO 9004:20002. ISO 9001 is a general industry standard for quality management, but ISO also issues industry specific standards. Many of these standards, such as ISO 13485 for medical devices, are based on ISO 9001 and can also utilize these available tools.

In addition to the information discussed below, ISO also issues standards related to specific activities that may arises in a quality management system. The following lists these supporting documents.

Automotive ISO/TS 16949:2002
Education IWA 2:2007
Energy PC 242, ISO 50001
Food safety ISO 22000:2005
Information security ISO/IEC 27001:2005
Health care IWA 1:2005
Local government IWA 4:2005
Medical devices ISO 13485:2003
Petroleum and gas ISO 29001:2003
Ship recycling ISO/PAS 30000:2008
Supply chain security ISO 28000:2007

Process Approach In ISO 9001 Standards

The process approach was introduced into ISO 9001 with the year 2000 version of the standards.
Prior versions used an element approach. The document Guidance on the concept and use of the process approach for management systems describes to process approach and offers an implementation paradigm.
1. Identification of processes of the organization
1.1. Define the purpose of the organization
1.2. Define the policies and objectives of the organization
1.3. Determine the processes in the organization
1.4. Determine the sequence of the processes
1.5. Define process ownership
1.6. Define process documentation
2. Planning of a process
2.1. Define the activities within the process
2.2. Define the monitoring and measurement requirements
2.3. Define the resources needed

2.4. Verify the process and its activities against its planned objectives
3. Implementation and measurement of the process
4. Analysis of the process
5. Corrective action and improvement of the process Implementation
This document explains the process used to evaluate changes to the 2008 version. In particular, it explains the revision process and illustrates the impact vs. benefit analysis used to evaluate potential changes.
In addition to the guidance documents, ISO maintains a web site with “official interpretations” of ISO 9001. Currently, these interpretations only include ISO 9001:2000, but, because the changes to the 2008 version were limited, they are valuable.
Consider a common question. An organization needs a documented procedure for preventive action (8.5.3), and must keep records of the results of preventive action (8.5.3.d). One of the interpretation requests asks, “Does sub-clause 8.5.3 a) require organizations to demonstrate, with objective evidence in the form of records, that they have undertaken actions to determine the existence of ‘potential nonconformities and their causes’?” The answer is “No”.
Auditing Practices
The ISO 9001 Auditing Practices Group maintains a website9 with guidance and information on auditing ISO 9001 quality management systems. It is an informal group of quality management system (QMS) experts, auditors, and practitioners drawn from the ISO Technical Committee 176 Quality Management and Quality Assurance (ISO/TC 176) and the International Accreditation Forum (IAF).
The website, primarily aimed at QMS auditors, consultants, and quality practitioners, is an online source of papers and presentations on auditing a QMS and reflect the process based approach.
The website contains almost forty guidance documents with practical advice ranging from “How to audit top management processes” to “The role and value of the audit checklist”.

Why Deploy Six Sigma?

Why Deploy Six Sigma in your organization?

Here are some reasons why we should be using Six Sigma to make process improvements:

a) It is a structured approach – if we follow the process, people will not forget any important steps along the way before they implement the solution.

b) It helps quantify the benefits and thus make it easier to sell the improvements to senior managers in the company.

c) It uses facts & data and the rigor of statistical testing to arrive at the right root cause instead of fixing symptoms or putting band-aids.

d) There is a greater likelihood of the solution being sustainable if we follow the Six Sigma process.

e) Six Sigma focuses of solving the right problems using the project selection matrix.

f) It has proven itself in a large number of deployments. Frankly, there is no better tool out there to make process improvements – especially when the root cause or the solution is not known.