• ISO 9001 Certification. ISO 9001 is the only standard in the ISO 9000 series to which organizations can certify. Achieving ISO 9001:2015 certification means that an organization has demonstrated the following: Follows the guidelines of the ISO 9001 standard. Fulfills its own requirements.
• First ISO-9001:2015 certified institute in town, registered with the scope: International certification facility with collaboration with Phoenix Health & Safety, UK so as to offer NEBOSH International recognized courses through distance learning program.
• List of magazines in Pakistan 1. List of magazines in Pakistan List of English magazines in Pakistan (Engineering Magazine-ISO 9001:2008 certified) Monthly ENGINEERING & INDUSTRIAL REVIEW (EIR) Karachi ‘www.eironline.com) (Engineering Magazine Website) EIRONLINE.COM – Pakistan’s First Commercial International Engineering Website, Karachi ‘www.eironline.com) Monthly CENTRELINE Islamabad.
• The ISO 9001: 1994—the most comprehensive model for quality assurance in design/development, production and installation and servicing is used as the working standard. This standard is sub.

1. Iso 9001 Notes In Urdu Download
2. Iso 9001 Notes In Urdu Language
3. Iso 9001 Notes In Urdu Free

• • Approve documents for adequacy prior to issue
  • Review, update as necessary, and re-approve documents
  • Identify the changes and current document revision status
  • Make relevant documents available at points of use
  • Ensure the documents remain legible and readily identifiable
  • Identify external documents and control their distribution
  • Prevent obsolete documents from unintended use
  • Apply suitable identification if obsolete documents are retained

It is a certification which has been issued by a Certification Body which has been accredited by an Accreditation Body who is a member of the IAF. IAF CertSearch only includes valid certifications which have been issued by a certification body who has been accredited by an IAF MLA signatory Accreditation Body under main scope ISO/IEC 17021-1.

Control of Records

Establish and control records as evidence of conformity to requirements and to demonstrate the effective operation of the quality management system.

Establish a documented procedure to define the controls needed for records:

• Identification
• Storage
• Protection
• Retrieval
• Retention
• Disposition
• Keep records legible, readily identifiable, and retrievable.

What Documentation does ISO 9001:2015 Really Require?

While the ISO 9001:2008 version was explicit about documentation, ISO 9001:2015 allows more freedom in how, what, and when to document a quality management process (such as specific procedures).

It appears this evolution is not only to accommodate more modern forms of communication such as video, audio, and other electronic records, but to allow an organization the flexibility to reuse appropriate information, maintain current versions easier, provide broader access/distribution and reduce costs associated with documentation. (Note: This change does not require changing mediums and allows an organization to also reuse existing QMS documentation, as long as it conforms. See explanation below.)

The Changed Nature of ISO 9001 Documentation

The ISO 9001:2015 standard has removed the distinction between documents and records. Both are now called “documented information”. As per ISO’s definition, the term “documented information” refers to information that must be controlled and maintained. Therefore, it expects that you also maintain and control the medium as well as the information. Documented information is used as evidence of conformance.

Having It Your Way (Sort Of)

ISO 9001:2015 essentially allows the organization to tailor the completeness or complexity of documentation to its own situation, as long as it still achieves its overall objectives. The shift does not, however, lessen the requirement for proper documentation. As noted in the standard, “documented information” can be required:

• When information needs to be disseminated or shared.
• To prove (and retain that proof) that a quality process has been completed and what the results were.
• To retain organizational knowledge including:
  • Processes
  • Specifications and revisions
  • Goals and expectations
  • Monitoring and measuring
  • Analysis, reviews, evaluations, and validations
  • Terminology
  • Decisions made
  • Negotiations
  • Notifications
  • Authorizations
  • Actions taken
  • Assets, inventories and property management
  • Position descriptions and qualifications

So What Is Required?

ISO 9001:2015 clause 7.5, requires an organization to:

“Maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confident that the processes are being carried out as planned.”

ISO’s Guidance on the requirements for Documented Information of ISO 9001:2015 provides these guidelines on what to document:

1. Documenting critical portions of the quality management system (QMS) such as its scope, key operational processes, policies, and objectives.
2. Documenting important, but perhaps less critical information that supports the QMS such as process flowcharts, specific quality and operational procedures, schedules, information collection approaches (i.e. forms, surveys), business plans, etc.

Will a Quality Manual be required?

The short answer is that under ISO 9001:2015, a quality manual will not be required. The ISO 9001:2015 standard does not specify requiring a formal quality manual. However, a quality manual can still satisfy the requirement for documented information concerning:

• The quality policy
• The scope of the QMS
• Information to support quality related processes

In many cases, the information required by the QMS will still be most convenient and accessible if collected, published and maintained through a traditional quality manual format.

Document Maintenance

As noted in section 7.5, the standard still applies traditional rigor in updating, protecting and retaining documents for information that has been deemed a critical part of the QMS (and other related management systems). There are many specific clauses that essentially call for this documentation (see sample section from ISO documented information guidance below) integrity.

While ISO 9001 2015 documentation requirements are less restrictive than previous revisions, there are still specific instances where documented information must be recorded and retained by the organization’s evidence of achieved results, as noted above.

From ISO’s Guidance on the requirements for Documented Information of ISO 9001:2015

What Is Most Important

Whether an organization has an existing QMS or is just starting, the key is to let the processes that are used to meet its goals determine documentation requirements. If documentation that exists can be shown to support the QMS’ processes effectively, then it can and should be used for that goal. If not, then the appropriate level of effort to transform or re-purpose that documentation into the proper function should be applied.

This flexibility does not, however, relieve the organization from being able to prove that it is meeting its quality management goals. As noted above, the standard has many instances where it calls for specific evidence of conformity. Documentation must accordingly be accurate, objective and current in this regard, and in practice, must stand up to the scrutiny that a properly executed external audit will demand. So, while ISO 9001:2015 is more accommodating regarding documentation directives, the discipline used in compiling previous revision’s quality management system requirements may still be a viable approach.

Please note that certain text from the ISO 9001 standard is only used for instructional purposes. Standard Stores recognizes and respects the International Organization for Standardization (ISO) copyright and intellectual property guidelines.

Gap Analysis Service

A consultant can save you time by performing a gap analysis for you. They are well versed in all of the ISO 9001:2015 requirements, and will help you focus in on the areas of your organization that need improvement to achieve certification. (Remote analysis also available.)

Not less than thirteen times the term ‘statutory and regulatory requirements’ has been stated in the ISO/FDIS 9001:2015 QMS Standard including the Introduction and Annex A. This article is an attempt to understand the meaning of the term, and how organization needs to comply it.

The term ‘statutory and regulatory requirements’ can be expressed legal requirements; as clarified in Note 2 under the clause 1.1 (General) of ISO/FDIS 9001:2015 - QMS Standard.

This term expresses two types of requirements:

(i) Statutory requirements

(ii) Regulatory requirements

Both statutory requirements and regulatory requirements are those requirements that are required by law. These requirements are non-negotiable and must be complied with. Failure to comply a legal requirement may result in a fine or penalty and possibly a custodial sentence for the person or persons responsible or organization for such failure.

Iso 9001 Notes In Urdu Download

“Statutory refers to laws passed by a state and/or central government, while regulatory refers to a rule issued by a regulatory body appointed by a state and/or central government.”

Iso 9001 Notes In Urdu Language

Statutory requirements are those requirements which are applicable by virtue of law enacted by the government. These are enacted by passing the law in the legislative assembly or parliament. A regulatory requirement can be termed as administrative legislation that constitutes or constraints rights and allocates responsibilities. It is somewhat different from the statutory legislation and there can be following types of regulations applicable on an organization:

- Legal restrictions or responsibilities declared by a government authority

- Self regulation by an industry through trade association

A simple example for Educational Institution:

• Educational System developed and passed in parliament of India is a statutory requirement.
• Controls applied by Directorate of Controller of Examinations to institutions are regulatory requirement.

Another example for automotive industries:

Iso 9001 Notes In Urdu Free

• Companies Act 2013 (amendment bill 2014) and Motor Vehicles Act 1988 (amendment bill 2015) are statutory requirement.
• ARAI (Automotive Research Association of India) is a regulatory body responsible for the car mileage figure in India.

ISO/FDIS 9001:2015 QMS Standard requires an organization to determine and control the statutory and regulatory requirements applicable to the organization’s products and services. It is the responsibility of the organization to demonstrate compliance within its quality management system. On perusal this ISO/FDIS 9001: 2015 QMS Standard, we find, in the introduction part of the standard indicates that this standard, can be used by internal and external parties. So it is imperative for the organization to be aware of the general and specific statutory and regulatory requirements applicable to the product and services within the scope of the quality management system.

The term ‘statutory and regulatory requirements’ has been used in 0.1 General of this standard, which states, ‘The potential benefits to an organization of implementing the quality management system based on this international standard are i) the ability to consistently provide products and services that meet the customer and applicable statutory and regulatory requirements.

In Clause 1 - Scope of the standard, it has been used three times to emphasize the importance of meeting and conforming to applicable to statutory and regulatory requirements.

Clause 4.2 uses the statutory and regulatory requirements, while understanding the needs and expectations of the interested parties.

As a demonstration method for Leadership and Commitment by Top Management, statutory and regulatory requirements are to be determined, understood and met. In Clause 8.2.2 and 8.2.3.1, while determining and review of the requirements related to products and services.

During the determination of design and development inputs in Clause 8.3.3, statutory and regulatory requirements are addressed.

In Clause 8.4.2, statutory and regulatory requirements need to be considered while applying type and extent of control on externally provided processes, products and services.

Clause 8.5.5 requires statutory and regulatory requirements to be considered in determining the extent of post-delivery activities required.

Annex A provides the clarification on statutory and regulatory requirements for understanding the needs and expectations of interested parties.

Accordingly, the organization should have a methodology in place

1. for determining, maintaining and updating all applicable statutory and regulatory requirements,
2. for communicating all applicable statutory and regulatory requirements within the organization.
3. The organization should ensure that determined statutory and regulatory requirements are utilized as ‘process inputs’.
4. The organization should monitor ‘process outputs’ for compliance with statutory and regulatory requirements.

In this regard, it is suggested to have a task-force team in place, having legal knowledge. The team should determine the applicable statutory and regulatory requirements related to the product and services of the organization. The responsibility of personnel/functions in meeting these requirements should be determined and implemented. Team members may also study the best practices prevailing in industries to gain ideas about smooth implementation of such requirements.

The team should ensure communication of determined statutory and regulatory requirements to the personnel/functions concerned with a copy to the Top Management.

Top Management should demonstrate the leadership & commitment by ensuring the compliance to the requirements.

It should be the responsibility of the personnel/functions concerned to meet these determined requirements. The top management should also review at defined intervals meeting applicable statutory and regulatory requirements.

The internal audit process can support the compliance and demonstration through assessment of the ‘statutory and regulatory requirements’. It will be a good idea that the auditor during the audit preparation phase obtains relevant information from internal as well as external sources with respect to the applicable statutory and regulatory requirements of products and services.

Through these methods the quality management system can demonstrate the compliance to statutory and regulatory requirements of products and services.

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