Showing posts with label Quality management system. Show all posts
Showing posts with label Quality management system. Show all posts

Tuesday, 16 February 2016

Annex SL AN ISO Management Guide?

Annex SL is part of ISO Directive earlier known as ISO Guide 83 is not a standard rather an ISO management system guide.  It specifies how to write Management system standard (MSS). Annex SL consists of eight clauses and four appendices that include universal high level structure, common terms or definition and actual shared clause title and text for all management system standards. Annex SL describes the framework for a generic management system; ISO over the years published various management system standards such as quality, environment, service management, information security, business continuity, record management. Despites sharing common elements, ISO management system standards are described and organized substantially different. This led to confusion and causes difficulties at the implementation stage for the organization.

Origin of Annex SL

Most of the organization uses more than one quality management system in their organization such as ISO 9001 along with ISO 14001 and ISO 18001, ISO 9001 along with ISO 27001 and ISO 20000 or ISO 9001 along with 16949. This has prompted the need to effortlessly consolidate or integrate them in a compelling and efficient manner. To date subtle and not so subtle unobtrusive in requirements and terminology across MSS (Management Standard System) have made such integration troublesome. For this purpose we uses Annex SL this will helps to manage all the different ISO management standard and led business organization towards the success. Annex SL is freely obtainable; it is contained within the ISO supplements, procedures specific to ISO. ISO Technical Management Board ISO/TMB has created this Annex. All the technical work associated with implementing new standard is carried out under the charge of TMB.



Annex SL Structure

Annex SL is a “high level structure” created under ISO reveals the conformance of international organization for standardization this is the best way to implement the structure so that so many standard are come under the one management standard system.

Annex SL Clauses

 Scoop

Scope defines the intended outcomes of the management system; and cannot be specified as expected outcomes. The outcomes are industry specified and should be aligned with the context of organization which is determined in the Clause 4.

Normative references

Provides the normative generals of the reference standard or publication relevant to the particular standard.

Terms and definitions

Complete Terms and definitions (divided into 3 parts); high level structure, identical core text and common terms and core definition; applicable to the specific standard in addition to any formal related terms and definitions standards.

Context of the organization

Context of the organization: Clause 4 consists of four sub clauses:

4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the managements system
4.4 The management system

Leadership

 Clause 5 comprises three sub clauses:

5.1 Leadership and commitment
5.2 Policy
5.3 Organizational roles, responsibilities and authorities

Planning: Clause 6 includes two sub clauses:

6.1 Actions to address risks and opportunities
6.2 Management system objectives and planning to achieve them

Support: Clause 7 consists of five sub clauses:

7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information

Operation: Clause 8 has one sub clause:

8.1 Operational planning and control

Performance evaluation: Clause 9 is formed of three sub clauses:

9.1 Monitoring, measurement, analysis and evaluation
9.2 Internal audit
9.3 Management review

Improvement: Clause 10 looks at how non conformities and corrective actions should be managed. It includes two sub clauses:

10.1 Nonconformity and corrective action
10.2 Continual improvement

Annex SL has 45 ‘shall’ statements (generating 84 requirements) in Annex SL appendix 2. Clearly each discipline has their own requirements, so the total for any new standard will have more – this is the minimum.

New Standard Revisions Using Annex SL

Every ISO standards that comes for revision, they will all be acquired line with Annex SL too. Existing and upcoming standards based on the Annex SL structure include:
ISO 9001:2015, Quality management systems
ISO 14001: 2015, Environmental management systems
ISO/TS 16959:2016, Automotive quality management systems (will be based on ISO 9001:2015)
AS9100C:2016, Aerospace quality management systems (will be based on ISO 9001:2015)
ISO/IEC 27001, Information technology: Security techniques, Information security management systems
ISO 30301:2011, Information and documentation: Management systems for records
ISO 22301:2012, societal security: Business continuity management systems
ISO 20121:2012, Event sustainability management systems
ISO 39001, Road-traffic safety (RTS) management systems &                                                         ISO 55001, Asset management.

The new version ISO 9001:2015 is based on Annex SL, which is common framework for all management system ISO 9001, ISO 14001, ISO 27001 or ISO 22301. Want to learn basic changes check here ISO 9001:2015 vs ISO 9001:2008.
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Monday, 30 November 2015

ISO 9001: 2008 Quality Management System

About ISO 9000 Family

The ISO 9000 family of standards compacts mainly with the use of quality management systems to ensure that the customers and clients of an organization encompass their needs met. More than one million organizations are ISO 9000 certified world-wide, making it one of the most used standards created by the International Organization of Standardization. When organizations are ISO 9000 certified, they are telling their customers that they want to bring quality products and services to them, in addition to communicating that they have plans in place to make sure that quality is always managed and is one of the organization's greatest concerns.

ISO 9001: Quality Management Systems and its Requirements

The biggest part of the ISO 9001 standard is the creation and implementation of a quality management system. These systems are used to deliver quality products to customers and guarantee that quality remains reliable.

Quality Management System Process



In order to rally the requirements for the ISO 9001, an organization ought to create a booklet or document that illustrates every aspect of their quality management system. A quality management system is in fact anything that the company or organization does to develop the quality of its products or services. Quality management systems generally necessitate enhancement as time goes on.
The document must include the scope of the system and what it relates to, as well as defining numerous terms so that every level of the organization can identify with it. The document must also have a section that includes the layout of the system and a portion that is designated to management liability. A portion must also be included that outlines resource management in reference to the quality management system, and it must also comprise the approaches that the system is measured and enhanced over time. The ISO 9001 also requires a quality manual or quality policy, both of which can be integrated in the document.

Internal Audits

Often time’s businesses need to audit themselves in order to ensure they are following their quality management system so their certification does not get stripped. Internal audits can be approved by any level of the organization and obligation follow the quality manual and document that were created. In some organizations, teams of internal auditors are trained to mark and correct certain violations of the ISO 9001 so that they are fixed ahead of external audits are done.

Certification

There are several authorization bodies located in several countries around the world that are able to provide certification for the ISO 9001, as well as numerous other ISO standards. These Certification Boards (CBs) are not technically authorized entities, but they are frequently supported by local governments.

Benefits of Implementing QMS

There are several benefits concerned with creating a QMS. Not only has ISO 9001 compliance revealed to increase customer constancy and trust, but it has also been shown to increase competence and operational excellent in organizations. The ISO actually forces organizations to become more operationally well-organized because they want to get certification. Organizations that are looking to raise their efficiency and are having hitch with retaining clients or customers should reflect on implementing a QMS and acquiring ISO 9001 certification.

Proper and regular audit checks will only heighten the business. Lead auditor courses will give an auditor who is efficient, proficient and knows the work properly. While selection of lead auditor training courses, try to enroll with organizations which are accredited with IRCA. As irca approved lead auditor courses are recognized at global level and enhance your chances to become lead auditor in ISO Certification Company.



Wednesday, 4 November 2015

What Is ISO 9001: 2008 Standard?


The recent edition of the ISO 9001 standard ISO 9001: 2008, Quality Management Systems Requirements, was officially published by (ISO) the International Organization for Standardization on November 14, 2008. It is the fourth edition of the ISO 9001 standard as it was first published in 1987.

ISO 9001:2008 is a standard that offers a generic set of requirements for organizations wishing to develop a quality management system (QMS). The ISO 9001:2008 standard focuses on developing organizations business processes. It does not indicate any requirements for product or service quality.  Customers typically set product and service quality requirements. However, the anticipation is that an organization with an effective ISO 9001 based QMS will indeed get better its ability to meet customer, legal and regulatory requirements.

This is the merely QMS standard to which an organization may perhaps obtain formal third party certification. Because requirements are generic and not specific, organizations have flexibility in tailoring their QMS to fit their business, ethnicity and hazards.

ISO 9001 requirements set off contractual and applicable statutory and regulatory requirements. Those implementing a QMS conforming to ISO 9001 must ensure that the explicit requirements of their customers and relevant statutory and regulatory agencies are met.

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Concepts of Quality Management System

ü  A Quality Management System in its fundamental concept is fairly simple. It seeks to: Recognize the external quality related requirements specified in Licenses to Trade, principles, particular customer requirements, and the preferred management system standard(s)
ü  Ensure that all rations have been documented within the management system in the appropriate location in requisites of defined explicit system requirements
ü  Confirm that employees receive appropriate training in the quality system requirements
ü  Outline performance processes, wherever applicable, to the quality system requirements
ü  Produce records or substantiation that system requirements have been met
ü  Measure, observe and report the level of observance with these performance procedures
ü  Continually monitor and analyze changes to the requirements and confirm that all changes are reflected in changes to the specific requirements when necessary
ü  Implement the audit and evaluate the system processes and correct them when required
ü  Comprise processes that will assist persistently improve the quality system.