ISO 9001 Quality

ISO 9001 is a published International Standard giving the essential features for an effective Quality Management System.
It is also recognized as European Standard EN ISO 9001
and British Standard BS EN ISO 9001.  

Independent third party certification is recognized as the 'Hallmark' of a good quality firm or organization. In many cases it will also be recognized by government purchasing bodies, such as the military, trade and industry departments, health departments and by firms from private industry, both large and small.  Certification is obtained by a formal and detailed assessment of the organization.  

The reasons for obtaining ISO 9001 certification vary, depending on the needs and market of each organization.
The priorities will vary from company to company
.

    •  Certification provides an excellent working model for good business practice.
    •  It can be vital/essential for survival of the company.
    •  It can also provide objective evidence of taking due care and diligence in case of litigation under the Consumer Protection, Product Liability or Health & Safety at Work Acts.
    •  It can cut the costs of poor quality and instil a culture of continuous improvement.
    •  It gives effective management controls.
    •  It reduces internal and external conflicts.
    • It gives a firm foundation for organizational development and growth.
    • Staff absence or resignation can be effectively managed.
    • It satisfies actual or probable contract requirements of major customers.
    • The status of the organization is enhanced and it can be a source of pride to its staff
    • Successful certification can reduce or eliminate multiple second party assessments from customers.  

 The time taken to obtain successful certification can vary enormously. The main factors being:

    • The size and complexity of the organization.
    • The scope of operation being assessed.
    • The commitment of the management and staff.
    •  The skill, training and experience of the team implementing the system.

 Initial certification for ISO 9001 processes are:

    • Enquiry for certification
    •  Enquiry review by INSPEC
    •  Issue of a quotation by INSPEC
    • Application for certification, including provision of quality system documentation by the client
    •  Review of quality system documentation by INSPEC
    •  Stage 1 onsite initial audit (can be combined with Stage 2 onsite initial audit)
    • Stage 2 onsite initial audit
    •  Follow up audit may be required*
    •  Return of corrective actions by the client, as applicable
    • Certification decision made by INSPEC*
    • Issue of the certificate (valid for 3 years)
      * see sections below

Maintenance of ISO 9001 certification processes are:

    • Schedule of annual surveillance audit(s) for first year
    • Undertake onsite surveillance audit
    • Return of corrective actions by the client as applicable
    • Decision to maintain certification by INSPEC*
    • Schedule of annual surveillance audit(s) for second year
    •  Undertake onsite surveillance audit
    • Return of corrective actions by the client as applicable
    •  Decision to maintain certification by INSPEC*
      * see sections below       

Renewal of ISO 9001 certification processes are:

    • Schedule of recertification audit
    • Undertake onsite recertification audit
    • Return of corrective actions by the client as applicable
    • Certification decision by INSPEC*
    •  Issue of the certificate (valid for 3 years)
      * see sections below

BACK-TO-BACK STAGE 1 AND STAGE 2 INITIAL AUDITS
There can be an interval between the stage 1 and stage 2 initial audits to allow for any findings, or issues, identified at the stage 1 audit to be addressed prior to the stage 2 audit. However, if no interval is preferred, the stage 1 and stage 2 audits can be undertaken at a single visit. In such cases, the client should be aware of the possibility that the stage 2 audit may need to be postponed dependant on the findings of the stage 1 audit.
 

EXTENSIONS TO SCOPE
Extensions to scope will follow a quotation process to ascertain the assessment requirements, which may include an onsite audit. If an onsite extension to scope audit is required, this can be undertaken either as a special standalone audit or in conjunction with a scheduled audit. Audit, post-audit and certification decision activities will follow standard procedures.

FOLLOW UP AUDIT
A follow up audit can be recommended by the auditor following any audit, or by the certification decision maker at certification decision analysis. The audit duration of the follow up audit will be decided dependent on the issues requiring resolution. A follow up audit can either be agreed with the client following acceptance of proposed corrective actions, or be unannounced. The auditor recommendation on the audit report and subsequent certification decision will decide the next audit schedule and type.

OTHER AUDITS
Other special audits will be decided as required, including: audits following a move of certification holder/manufacturing location, unannounced audits following complaints, suspension or other reasons. In all cases, the decision to proceed with the audit will be advised to the client. Audit, post-audit and certification decision activities will follow standards procedures. 

CERTIFICATION DECISION
The decision to grant, maintain, renew or refuse certification will be taken following each audit. Any decision to refuse certification will be provided in writing to the organisation and details provided of the INSPEC appeals procedure.

 

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Independent third party certification is recognized as the 'Hallmark' of a good quality firm or organization. In many cases it will also be recognized by government purchasing bodies, such as the military, trade and industry departments, health departments and by firms from private industry, both large and small.  Certification is obtained by a formal and detailed assessment of the organization.  

The reasons for obtaining ISO 9001 certification vary, depending on the needs and market of each organization. The priorities will vary from company to company.

·         Certification provides an excellent working model for good business practice.

·         It can be vital/essential for survival of the company.

·         It can also provide objective evidence of taking due care and diligence in case of litigation under the Consumer Protection, Product Liability or Health & Safety at Work Acts.

·         It can cut the costs of poor quality and instil a culture of continuous improvement.

·         It gives effective management controls.

·         It reduces internal and external conflicts.

·         It gives a firm foundation for organizational development and growth.

·         Staff absence or resignation can be effectively managed.

·         It satisfies actual or probable contract requirements of major customers.

·         The status of the organization is enhanced and it can be a source of pride to its staff.

·         Successful certification can reduce or eliminate multiple second party assessments from customers.  

 

The time taken to obtain successful certification can vary enormously. The main factors being:

·         The size and complexity of the organization.

·         The scope of operation being assessed.

·         The commitment of the management and staff.

·         The skill, training and experience of the team implementing the system.  

 

Initial certification for ISO 9001 processes are:

·         Enquiry for certification

·         Enquiry review by INSPEC

·         Issue of a quotation by INSPEC

·         Application for certification, including provision of quality system documentation by the client

·         Review of quality system documentation by INSPEC

·         Stage 1 onsite initial audit (can be combined with Stage 2 onsite initial audit)

·         Stage 2 onsite initial audit

·         Follow up audit may be required*

·         Return of corrective actions by the client, as applicable

·         Certification decision made by INSPEC*

·         Issue of the certificate (valid for 3 years)

* see sections below

Maintenance of ISO 9001 certification processes are:

·         Schedule of annual surveillance audit(s) for first year

·         Undertake onsite surveillance audit

·         Return of corrective actions by the client as applicable

·         Decision to maintain certification by INSPEC*

·         Schedule of annual surveillance audit(s) for second year

·         Undertake onsite surveillance audit

·         Return of corrective actions by the client as applicable

·         Decision to maintain certification by INSPEC*

* see sections below

           

Renewal of ISO 9001 certification processes are:

·         Schedule of recertification audit

·         Undertake onsite recertification audit

·         Return of corrective actions by the client as applicable

·         Certification decision by INSPEC*

·         Issue of the certificate (valid for 3 years)

* see sections below